Mary Ann Moon

Providing intravenous stress-dose hydrocortisone for 1 week reduced the rate of hospital-acquired pneumonia among intubated patients with multiple trauma, according to a report in the March 23/30 issue of JAMA.

The treatment also decreased the number of days on mechanical ventilation, the incidence of acute respiratory distress syndrome, and the length of stay in the ICU, said Dr. Antoine Roquilly of the departments of anesthesiology and intensive care medicine, University Hospital of Nantes (France), and his associates.

The researchers evaluated stress-dose hydrocortisone therapy in a double-blind clinical trial because it was thought that the treatment might "attenuate the overwhelming inflammatory response without immunosuppression, restoring an adequate immune response to infection." They postulated that this would be particularly helpful in reducing the prevalence of hospital-acquired pneumonia, the major cause of infection among trauma patients.

A total of 150 intubated patients with multiple trauma who were aged older than 15 years and were expected to require mechanical ventilation for more than 48 hours were enrolled at seven ICUs in France over a 3-year period. Half were randomly assigned to receive stress-dose (200 mg/day) IV hydrocortisone and half to receive placebo infusions for 7 days.

The study’s primary end point was the rate of hospital-acquired pneumonia within 28 days. The subjects were evaluated twice daily for the development of pneumonia during the first month in the ICU.

Of the 73 patients treated with hydrocortisone who completed the trial, 26 (36%) developed pneumonia, a significantly lower rate than the 39 (51%) of 76 patients in the placebo group who developed pneumonia. The findings were similar in an intention-to-treat analysis, Dr. Roquilly and his colleagues said (JAMA 2011;305:1201-9).

When the analysis was restricted to the 103 patients who showed corticosteroid insufficiency at baseline, the results were similar: a 36% rate of pneumonia with hydrocortisone therapy and a 54% rate with placebo.

"Subgroup analysis suggests that hydrocortisone was particularly effective for patients with traumatic brain injury," the investigators noted.

Among those with traumatic brain injury who presented with corticosteroid insufficiency, 41% in the hydrocortisone group developed pneumonia, compared with 71% in the placebo group.

The short duration of exposure to IV hydrocortisone did not adversely affect the 47 patients who did not have corticosteroid insufficiency at baseline, they pointed out.

Patients who received hydrocortisone were weaned from mechanical ventilation earlier (12 vs. 16 days) and had a shorter length of ICU stay (18 vs. 24 days) than did those who received placebo. Three patients (4%) in the hydrocortisone group developed acute respiratory distress syndrome, compared with 11 (14%) in the placebo group.

The two groups did not differ with respect to mortality, the rate of other infections, the number of organ failures, or the duration of vasopressor support.

Both these beneficial effects and the safety of hydrocortisone therapy must be confirmed in future studies of ICU patients, particularly in those with traumatic brain injury, Dr. Roquilly and his associates said.

This study was sponsored by the University of Nantes. The French Ministry of Health provided additional support. No financial conflicts of interest were reported.

"In addition, a better understanding of the true incidence of corticosteroid insufficiency and the mechanism of manipulation of the immune inflammatory response after injury would better guide this therapeutic approach," they noted.

Dr. Bulger and Dr. Cuschieri are in the department of surgery at the University of Washington, Seattle. They reported no financial conflicts of interest.

Providing intravenous stress-dose hydrocortisone for 1 week reduced the rate of hospital-acquired pneumonia among intubated patients with multiple trauma, according to a report in the March 23/30 issue of JAMA.

The treatment also decreased the number of days on mechanical ventilation, the incidence of acute respiratory distress syndrome, and the length of stay in the ICU, said Dr. Antoine Roquilly of the departments of anesthesiology and intensive care medicine, University Hospital of Nantes (France), and his associates.

The researchers evaluated stress-dose hydrocortisone therapy in a double-blind clinical trial because it was thought that the treatment might "attenuate the overwhelming inflammatory response without immunosuppression, restoring an adequate immune response to infection." They postulated that this would be particularly helpful in reducing the prevalence of hospital-acquired pneumonia, the major cause of infection among trauma patients.

A total of 150 intubated patients with multiple trauma who were aged older than 15 years and were expected to require mechanical ventilation for more than 48 hours were enrolled at seven ICUs in France over a 3-year period. Half were randomly assigned to receive stress-dose (200 mg/day) IV hydrocortisone and half to receive placebo infusions for 7 days.

The study’s primary end point was the rate of hospital-acquired pneumonia within 28 days. The subjects were evaluated twice daily for the development of pneumonia during the first month in the ICU.

Of the 73 patients treated with hydrocortisone who completed the trial, 26 (36%) developed pneumonia, a significantly lower rate than the 39 (51%) of 76 patients in the placebo group who developed pneumonia. The findings were similar in an intention-to-treat analysis, Dr. Roquilly and his colleagues said (JAMA 2011;305:1201-9).

When the analysis was restricted to the 103 patients who showed corticosteroid insufficiency at baseline, the results were similar: a 36% rate of pneumonia with hydrocortisone therapy and a 54% rate with placebo.

"Subgroup analysis suggests that hydrocortisone was particularly effective for patients with traumatic brain injury," the investigators noted.

Among those with traumatic brain injury who presented with corticosteroid insufficiency, 41% in the hydrocortisone group developed pneumonia, compared with 71% in the placebo group.

The short duration of exposure to IV hydrocortisone did not adversely affect the 47 patients who did not have corticosteroid insufficiency at baseline, they pointed out.

Patients who received hydrocortisone were weaned from mechanical ventilation earlier (12 vs. 16 days) and had a shorter length of ICU stay (18 vs. 24 days) than did those who received placebo. Three patients (4%) in the hydrocortisone group developed acute respiratory distress syndrome, compared with 11 (14%) in the placebo group.

The two groups did not differ with respect to mortality, the rate of other infections, the number of organ failures, or the duration of vasopressor support.

Both these beneficial effects and the safety of hydrocortisone therapy must be confirmed in future studies of ICU patients, particularly in those with traumatic brain injury, Dr. Roquilly and his associates said.

This study was sponsored by the University of Nantes. The French Ministry of Health provided additional support. No financial conflicts of interest were reported.

"In addition, a better understanding of the true incidence of corticosteroid insufficiency and the mechanism of manipulation of the immune inflammatory response after injury would better guide this therapeutic approach," they noted.

Dr. Bulger and Dr. Cuschieri are in the department of surgery at the University of Washington, Seattle. They reported no financial conflicts of interest.

Providing intravenous stress-dose hydrocortisone for 1 week reduced the rate of hospital-acquired pneumonia among intubated patients with multiple trauma, according to a report in the March 23/30 issue of JAMA.

The treatment also decreased the number of days on mechanical ventilation, the incidence of acute respiratory distress syndrome, and the length of stay in the ICU, said Dr. Antoine Roquilly of the departments of anesthesiology and intensive care medicine, University Hospital of Nantes (France), and his associates.

The researchers evaluated stress-dose hydrocortisone therapy in a double-blind clinical trial because it was thought that the treatment might "attenuate the overwhelming inflammatory response without immunosuppression, restoring an adequate immune response to infection." They postulated that this would be particularly helpful in reducing the prevalence of hospital-acquired pneumonia, the major cause of infection among trauma patients.

A total of 150 intubated patients with multiple trauma who were aged older than 15 years and were expected to require mechanical ventilation for more than 48 hours were enrolled at seven ICUs in France over a 3-year period. Half were randomly assigned to receive stress-dose (200 mg/day) IV hydrocortisone and half to receive placebo infusions for 7 days.

The study’s primary end point was the rate of hospital-acquired pneumonia within 28 days. The subjects were evaluated twice daily for the development of pneumonia during the first month in the ICU.

Of the 73 patients treated with hydrocortisone who completed the trial, 26 (36%) developed pneumonia, a significantly lower rate than the 39 (51%) of 76 patients in the placebo group who developed pneumonia. The findings were similar in an intention-to-treat analysis, Dr. Roquilly and his colleagues said (JAMA 2011;305:1201-9).

When the analysis was restricted to the 103 patients who showed corticosteroid insufficiency at baseline, the results were similar: a 36% rate of pneumonia with hydrocortisone therapy and a 54% rate with placebo.

"Subgroup analysis suggests that hydrocortisone was particularly effective for patients with traumatic brain injury," the investigators noted.

Among those with traumatic brain injury who presented with corticosteroid insufficiency, 41% in the hydrocortisone group developed pneumonia, compared with 71% in the placebo group.

The short duration of exposure to IV hydrocortisone did not adversely affect the 47 patients who did not have corticosteroid insufficiency at baseline, they pointed out.

Patients who received hydrocortisone were weaned from mechanical ventilation earlier (12 vs. 16 days) and had a shorter length of ICU stay (18 vs. 24 days) than did those who received placebo. Three patients (4%) in the hydrocortisone group developed acute respiratory distress syndrome, compared with 11 (14%) in the placebo group.

The two groups did not differ with respect to mortality, the rate of other infections, the number of organ failures, or the duration of vasopressor support.

Both these beneficial effects and the safety of hydrocortisone therapy must be confirmed in future studies of ICU patients, particularly in those with traumatic brain injury, Dr. Roquilly and his associates said.

This study was sponsored by the University of Nantes. The French Ministry of Health provided additional support. No financial conflicts of interest were reported.

"In addition, a better understanding of the true incidence of corticosteroid insufficiency and the mechanism of manipulation of the immune inflammatory response after injury would better guide this therapeutic approach," they noted.

Dr. Bulger and Dr. Cuschieri are in the department of surgery at the University of Washington, Seattle. They reported no financial conflicts of interest.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The low-molecular-weight heparin dalteparin was found to be no better than unfractionated heparin in preventing proximal leg deep vein thrombosis among critically ill adults, according to an international study published online March 22 in the New England Journal of Medicine.

Rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar with the two agents. Although dalteparin was associated with significantly fewer pulmonary emboli and significantly less heparin-induced thrombocytopenia, these were not primary outcomes, and "caution is warranted in making inferences about nominally significant findings in secondary outcomes," said Dr. Deborah Cook and her coinvestigators in the Prophylaxis for Thromboembolism in Critical Care Trial (PROTECT). The study was published online simultaneously with its presentation at the International Symposium on Intensive Care and Emergency Medicine in Brussels.

The study was done because two previous randomized trials comparing the two types of heparin were inconclusive. PROTECT was conducted in 67 ICUs within academic or community hospitals in Australia, Brazil, Canada, Saudi Arabia, the United Kingdom, and the United States. A total of 3,746 patients were randomly assigned in equal numbers to receive either dalteparin or unfractionated heparin to prevent thromboembolism.

Approximately three-fourths of the study subjects were medical patients and the remainder were surgical patients. Ninety percent required mechanical ventilation and 45% required vasopressors.

"Throughout the trial, the rates of cointerventions with drugs or devices that influence bleeding or thrombotic risk were similar in the two groups," noted Dr. Cook of the departments of medicine and clinical epidemiology and biostatistics at McMaster University, Hamilton, Ont., and her colleagues.

Twice a week until discharge, the study subjects underwent ultrasonography of the proximal venous system in the leg at 1-cm intervals to detect deep vein thrombosis (DVT). Compressibility was documented at the common femoral, proximal, middle, and distal superficial femoral and popliteal veins, and at the venous trifurcation.

Even though screening compression ultrasonography has limitations in this regard, it was chosen because "classic signs and symptoms of DVT do not develop in comatose, recumbent, critically ill patients." Moreover, it is safe, noninvasive, readily available, and recommended for such research, the investigators said.

The median duration of the use of both drugs was 7 days.

The primary end point – incident proximal leg DVT – developed in 96 (5.1%) of the patients receiving dalteparin, compared with 109 (5.8%) of those receiving unfractionated heparin, a nonsignificant difference.

However, "the confidence interval around the hazard ratio for the primary end point was fairly wide, so it did not exclude either a 32% benefit or a 23% harm associated with dalteparin, as compared with unfractionated heparin. Thus, the result for the primary outcome was not clinically directive," the researchers said (N. Engl. J. Med. 2011 March 22 [doi:10.1056/NEJMoa1014475]).

The rates of venous thrombosis, venous thromboembolism, major bleeding, and death also were similar between the two groups.

Patients in the dalteparin group had significantly fewer pulmonary emboli (1.3% vs. 2.3% of patients) and significantly less heparin-induced thrombocytopenia (0.3% vs. 0.6% of patients), but these outcomes must be interpreted with caution, given the small numbers, Dr. Cook and her associates said.

These study findings were consistent in further adjusted analyses of the data, as well as in sensitivity analyses and a per-protocol analysis.

"Our results might have been different if the study enrollment had been larger or if we had used different drugs or doses," they noted.

The PROTECT study was funded by the Canadian Institutes of Health Research, the Australian and New Zealand College of Anesthetists Research Foundation, and the Heart and Stroke Foundation of Canada. Study drugs were provided by Pfizer and Eisai. The investigators reported ties to numerous industry sources.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

The long-term outcomes of laparoscopic adjustable gastric banding appear to be relatively poor, according to a study published online March 21 in Archives of Surgery .

In a 13-year follow-up study of about half of the obese patients who underwent laparoscopic adjustable gastric banding (LAGB) at one institution between 1994 and 1997, only 43% maintained a loss of excess weight, nearly 60% required reoperation, and obesity-related comorbidities such as diabetes, hypertension, and sleep apnea persisted.

"The high failure rate of LAGB, at least in our hands, could be detrimental to its future continued widespread use as a restrictive weight loss operation," said Dr. Jacques Himpens and his associates at the European School of Laparoscopic Surgery, Saint Pierre University Hospital, Brussels.

In Europe there has been a marked shift in treatment, away from LAGB in favor of gastric bypass. "In contrast, in the United States, an opposite trend has been noted," even though some experts contend that LAGB "can result in a mediocre quality of life and a significant number of complications, and ... there is a tendency for patients to regain weight after some years," the investigators noted.

Dr. Himpens and his colleagues performed what they described as the first study of outcomes beyond the 10-year mark in patients who underwent LAGB using the perigastric technique. (The more recent "pars flaccida" technique and the current use of wider, softer bands than those used in the late 1990s may be improving outcomes, but that has not yet been proven, and many surgeons continue to use the perigastric technique, the researchers said.)

During the study period, 151 patients underwent LAGB using the perigastric technique at the hospital, but only 82 were available for a follow-up evaluation in 2009. "LAGB patients lost to follow-up are likely to experience very little weight loss. Our results must be viewed from this perspective," Dr. Himpens and his colleagues noted.

The 82 study subjects included 74 women and 8 men, with a mean body mass index of 42 kg/m² (range 35-57), and a mean age of 50 years (range 28-73 years) at baseline.

Fifty patients (59%) developed complications, including 33 major complications such as pouch dilation, band erosion, and band infection. Incisional hernia, port-tubing disconnection, and port infection were considered minor complications.

It is noteworthy that most band erosions and pouch dilations developed "quite late," at a mean of 4 years after surgery, the authors wrote (Arch. Surg. 2011 March 21 [doi:10.1001/archsurg.2011.45]).

Approximately 60% of patients required at least one reoperation, because of complications or because they failed to lose weight or regained their weight.

Complete weight loss data were available for 70 patients. The mean percentage of excess weight loss was 43% in this group (range 24%-143%).

Overall, weight loss was modest. In the 70 patients, mean weight fell from 114 kg to 93 kg, and mean BMI decreased from 42 to 34. At follow-up, patient weight ranged from 37 to 165 kg, and BMI ranged from 35 to 57.

Hypertension, type 2 diabetes, and sleep apnea persisted or developed anew in 30%, 7%, and 8% of the participants, respectively.

Fourteen patients who switched to gastric bypass surgery after failure of LAGB showed better success with that procedure.

Despite these relatively poor outcomes with LAGB, 47 patients said they were "pleased" or "very pleased" with the procedure, and their scores on quality-of-life measures were the same as those in a nonsurgical population. This may explain why the public has not yet rejected "lap-band" surgery, even though many surgeons, at least in Europe, have done so, said Dr. Himpens and his associates.

Dr. Himpens is a consultant with Ethicon Endosurgery and Covidien, and his associates reported ties to Storz.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 and 12 months after revascularization than does percutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the March 17 issue of the New England Journal of Medicine.

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Luke’s Mid America Heart Institute, University of Missouri–Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial, which was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007. The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

"Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months," the investigators said.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

"There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life 5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months," Dr. Cohen and his colleagues reported (New Engl. J. Med. 2011:364:1016-26).

Subgroup analysis showed that CABG’s superiority in reducing the frequency of angina persisted across a broad range of patients. Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although "the extent of the benefit was small" (76.3% vs. 71.6%, respectively, P = .05).

However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup.

The researchers noted that these findings "reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently unknown."

Dr. Cohen and his associates reported ties to numerous industry sources, including Boston Scientific.

Adding omalizumab to guideline-based asthma treatment decreased symptoms, exacerbations, hospitalizations, and the need for glucocorticoids in children, adolescents, and young adults living in the inner city, according to a report in the March 17 issue of the New England Journal of Medicine.

The monoclonal anti-IgE antibody was particularly effective in patients who were allergic to cockroach and dust allergens. Moreover, "a striking additional post hoc finding was the marked reduction in seasonal exacerbations seen with omalizumab," said Dr. William W. Busse of the University of Wisconsin, Madison, and his associates.

"Our purpose in designing this study was to examine whether specifically targeting the allergic component in persistent asthma would offer a benefit beyond that provided by conventional treatment for asthma control, regardless of disease severity," they noted.

The investigators compared subcutaneous injections of omalizumab vs. placebo injections in a multicenter clinical trial involving 419 children, adolescents, and young adults (aged 6-20 years) who had persistent allergic asthma. After 1 month on guideline-based treatment, the study subjects were randomly assigned to additionally receive active (208 subjects) or placebo (211 subjects) injections every 2 weeks or 4 weeks, for a total of 60 weeks.

At baseline, the average number of days during the preceding 2 weeks in which participants had asthma symptoms was 4.9, and 25% of patients had been hospitalized at least once during the preceding year for an asthma-related event. The average age of the study subjects was 11 years. In all, 58% were male; 60% were black, and 37% were Hispanic.

The primary outcome (defined as the number of symptomatic days during the preceding 2 weeks) was decreased to 0.48 days with omalizumab, compared with 1.48 days with placebo, a significant 25% reduction. Exacerbations occurred in 49% of the placebo group, compared with 30% of the omalizumab group, which was also a significant difference. And the rate of asthma-related hospitalizations also was significantly lower with omalizumab (1.5%) than with placebo (6.3%).

Patients who took omalizumab were able to significantly reduce their use of inhaled glucocorticoids, with an overall budesonide-equivalent dose of 663 mcg/day, compared with 771 mcg/day with placebo.

These benefits "were similar in patients of all ages and at all levels of asthma severity," and were first observed within 4 weeks of beginning the injections, Dr. Busse and his colleagues said (N. Engl. J. Med. 2011;364:1005-15).

"No differences of concern regarding safety were noted between the two groups," they added.

The greatest treatment effect was seen in participants who were sensitized to cockroach allergen and were known to be exposed to it, based on environmental sampling from their bedrooms. These subjects showed a 71% reduction in asthma exacerbations. Subjects who were allergic to dust mites also showed greater reductions in days with symptoms and the use of glucocorticoids, compared with those who were not sensitized to dust mites.

"Even though we found omalizumab effective at all levels of asthma severity, we do not advocate its use outside of current recommendations given its cost and remaining questions regarding long-term safety in children. We do, however, believe that this study provides a strong proof of concept that the allergic component of asthma is crucial in this population," the investigators said.

"This postulate is further supported by our finding that omalizumab’s benefit was greatest in participants who were both sensitized and exposed to cockroach allergen and in those sensitized to dust mites, two major indoor allergens," they added.

In a post hoc analysis, the researchers found that omalizumab also markedly reduced seasonal exacerbations of asthma. "Viral respiratory infections are a major cause of exacerbations, especially in the fall, with the start of school, but they were identified in less than 60% of the samples available for analysis, suggesting that other factors, such as allergen exposure, pollution, stress, or bacteria, also contribute to the risk of exacerbation.

"Omalizumab was equally effective in reducing exacerbations in the fall and the spring, with or without a viral infection, but it did not appear to prevent viral respiratory infections," Dr. Busse and his associates said.

These findings imply that targeting the drug to patients who are sensitized to cockroach and dust mite allergens, as well as focusing its use on preventing seasonal peaks in asthma exacerbations, would yield the optimal effectiveness and cost benefit, they added.

This study was supported by the National Institute of Allergy and Infectious Diseases, the National Center for Research Resources, and Novartis Pharmaceuticals. Dey Pharma provided EpiPens and S.C. Johnson provided household pest control products. Dr. Busse and his associates reported ties to numerous drug and device manufacturers.

Adding omalizumab to guideline-based asthma treatment decreased symptoms, exacerbations, hospitalizations, and the need for glucocorticoids in children, adolescents, and young adults living in the inner city, according to a report in the March 17 issue of the New England Journal of Medicine.

The monoclonal anti-IgE antibody was particularly effective in patients who were allergic to cockroach and dust allergens. Moreover, "a striking additional post hoc finding was the marked reduction in seasonal exacerbations seen with omalizumab," said Dr. William W. Busse of the University of Wisconsin, Madison, and his associates.

"Our purpose in designing this study was to examine whether specifically targeting the allergic component in persistent asthma would offer a benefit beyond that provided by conventional treatment for asthma control, regardless of disease severity," they noted.

The investigators compared subcutaneous injections of omalizumab vs. placebo injections in a multicenter clinical trial involving 419 children, adolescents, and young adults (aged 6-20 years) who had persistent allergic asthma. After 1 month on guideline-based treatment, the study subjects were randomly assigned to additionally receive active (208 subjects) or placebo (211 subjects) injections every 2 weeks or 4 weeks, for a total of 60 weeks.

At baseline, the average number of days during the preceding 2 weeks in which participants had asthma symptoms was 4.9, and 25% of patients had been hospitalized at least once during the preceding year for an asthma-related event. The average age of the study subjects was 11 years. In all, 58% were male; 60% were black, and 37% were Hispanic.

The primary outcome (defined as the number of symptomatic days during the preceding 2 weeks) was decreased to 0.48 days with omalizumab, compared with 1.48 days with placebo, a significant 25% reduction. Exacerbations occurred in 49% of the placebo group, compared with 30% of the omalizumab group, which was also a significant difference. And the rate of asthma-related hospitalizations also was significantly lower with omalizumab (1.5%) than with placebo (6.3%).

Patients who took omalizumab were able to significantly reduce their use of inhaled glucocorticoids, with an overall budesonide-equivalent dose of 663 mcg/day, compared with 771 mcg/day with placebo.

These benefits "were similar in patients of all ages and at all levels of asthma severity," and were first observed within 4 weeks of beginning the injections, Dr. Busse and his colleagues said (N. Engl. J. Med. 2011;364:1005-15).

"No differences of concern regarding safety were noted between the two groups," they added.

The greatest treatment effect was seen in participants who were sensitized to cockroach allergen and were known to be exposed to it, based on environmental sampling from their bedrooms. These subjects showed a 71% reduction in asthma exacerbations. Subjects who were allergic to dust mites also showed greater reductions in days with symptoms and the use of glucocorticoids, compared with those who were not sensitized to dust mites.

"Even though we found omalizumab effective at all levels of asthma severity, we do not advocate its use outside of current recommendations given its cost and remaining questions regarding long-term safety in children. We do, however, believe that this study provides a strong proof of concept that the allergic component of asthma is crucial in this population," the investigators said.

"This postulate is further supported by our finding that omalizumab’s benefit was greatest in participants who were both sensitized and exposed to cockroach allergen and in those sensitized to dust mites, two major indoor allergens," they added.

In a post hoc analysis, the researchers found that omalizumab also markedly reduced seasonal exacerbations of asthma. "Viral respiratory infections are a major cause of exacerbations, especially in the fall, with the start of school, but they were identified in less than 60% of the samples available for analysis, suggesting that other factors, such as allergen exposure, pollution, stress, or bacteria, also contribute to the risk of exacerbation.

"Omalizumab was equally effective in reducing exacerbations in the fall and the spring, with or without a viral infection, but it did not appear to prevent viral respiratory infections," Dr. Busse and his associates said.

These findings imply that targeting the drug to patients who are sensitized to cockroach and dust mite allergens, as well as focusing its use on preventing seasonal peaks in asthma exacerbations, would yield the optimal effectiveness and cost benefit, they added.

This study was supported by the National Institute of Allergy and Infectious Diseases, the National Center for Research Resources, and Novartis Pharmaceuticals. Dey Pharma provided EpiPens and S.C. Johnson provided household pest control products. Dr. Busse and his associates reported ties to numerous drug and device manufacturers.

Adding omalizumab to guideline-based asthma treatment decreased symptoms, exacerbations, hospitalizations, and the need for glucocorticoids in children, adolescents, and young adults living in the inner city, according to a report in the March 17 issue of the New England Journal of Medicine.

The monoclonal anti-IgE antibody was particularly effective in patients who were allergic to cockroach and dust allergens. Moreover, "a striking additional post hoc finding was the marked reduction in seasonal exacerbations seen with omalizumab," said Dr. William W. Busse of the University of Wisconsin, Madison, and his associates.

"Our purpose in designing this study was to examine whether specifically targeting the allergic component in persistent asthma would offer a benefit beyond that provided by conventional treatment for asthma control, regardless of disease severity," they noted.

The investigators compared subcutaneous injections of omalizumab vs. placebo injections in a multicenter clinical trial involving 419 children, adolescents, and young adults (aged 6-20 years) who had persistent allergic asthma. After 1 month on guideline-based treatment, the study subjects were randomly assigned to additionally receive active (208 subjects) or placebo (211 subjects) injections every 2 weeks or 4 weeks, for a total of 60 weeks.

At baseline, the average number of days during the preceding 2 weeks in which participants had asthma symptoms was 4.9, and 25% of patients had been hospitalized at least once during the preceding year for an asthma-related event. The average age of the study subjects was 11 years. In all, 58% were male; 60% were black, and 37% were Hispanic.

The primary outcome (defined as the number of symptomatic days during the preceding 2 weeks) was decreased to 0.48 days with omalizumab, compared with 1.48 days with placebo, a significant 25% reduction. Exacerbations occurred in 49% of the placebo group, compared with 30% of the omalizumab group, which was also a significant difference. And the rate of asthma-related hospitalizations also was significantly lower with omalizumab (1.5%) than with placebo (6.3%).

Patients who took omalizumab were able to significantly reduce their use of inhaled glucocorticoids, with an overall budesonide-equivalent dose of 663 mcg/day, compared with 771 mcg/day with placebo.

These benefits "were similar in patients of all ages and at all levels of asthma severity," and were first observed within 4 weeks of beginning the injections, Dr. Busse and his colleagues said (N. Engl. J. Med. 2011;364:1005-15).

"No differences of concern regarding safety were noted between the two groups," they added.

The greatest treatment effect was seen in participants who were sensitized to cockroach allergen and were known to be exposed to it, based on environmental sampling from their bedrooms. These subjects showed a 71% reduction in asthma exacerbations. Subjects who were allergic to dust mites also showed greater reductions in days with symptoms and the use of glucocorticoids, compared with those who were not sensitized to dust mites.

"Even though we found omalizumab effective at all levels of asthma severity, we do not advocate its use outside of current recommendations given its cost and remaining questions regarding long-term safety in children. We do, however, believe that this study provides a strong proof of concept that the allergic component of asthma is crucial in this population," the investigators said.

"This postulate is further supported by our finding that omalizumab’s benefit was greatest in participants who were both sensitized and exposed to cockroach allergen and in those sensitized to dust mites, two major indoor allergens," they added.

In a post hoc analysis, the researchers found that omalizumab also markedly reduced seasonal exacerbations of asthma. "Viral respiratory infections are a major cause of exacerbations, especially in the fall, with the start of school, but they were identified in less than 60% of the samples available for analysis, suggesting that other factors, such as allergen exposure, pollution, stress, or bacteria, also contribute to the risk of exacerbation.

"Omalizumab was equally effective in reducing exacerbations in the fall and the spring, with or without a viral infection, but it did not appear to prevent viral respiratory infections," Dr. Busse and his associates said.

These findings imply that targeting the drug to patients who are sensitized to cockroach and dust mite allergens, as well as focusing its use on preventing seasonal peaks in asthma exacerbations, would yield the optimal effectiveness and cost benefit, they added.

This study was supported by the National Institute of Allergy and Infectious Diseases, the National Center for Research Resources, and Novartis Pharmaceuticals. Dey Pharma provided EpiPens and S.C. Johnson provided household pest control products. Dr. Busse and his associates reported ties to numerous drug and device manufacturers.