Sharon Worcester

CHICAGO – Sentinel lymph node dissection without axillary lymph node dissection offers excellent regional control in select patients with early metastatic breast cancer who are treated using breast-conserving therapy and adjuvant systemic therapy, according to 10-year results from the American College of Surgeons Oncology Group (ACOSOG) Z0011 Randomized Trial. ACOSOG is now part of Alliance for Clinical Trials in Oncology.

The findings confirm the previously reported 5-year outcomes, which demonstrated no significant difference in locoregional recurrence for patients with positive sentinel nodes who were randomized to undergo axillary lymph node dissection (ALND) or no further axillary treatment, Dr. Armando E. Giuliano of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Surgical Association.

“In fact, the [5-year] results were highly significant showing noninferiority of sentinel lymph node dissection,” he said.

At a median follow-up of 9.25 years, there still was no statistically significant difference between 446 sentinel lymph node dissection (SLND)–only patients and 445 completion ALND patients with respect to the rate of locoregional recurrence, Dr. Giuliano said.

“The 10-year locoregional recurrence incidence after axillary lymph node dissection is 6.2%, compared to 5.3% after sentinel lymph node dissection alone,” he said, noting that most recurrences were seen in the first 5 years.

Of the ALND patients, 27% had additional positive nodes removed beyond the sentinel nodes.

“Therefore, about 27% of patients who underwent sentinel node dissection alone had residual disease remaining in the axilla undissected. Despite this high possibility of residual disease, very few regional recurrences were seen in either arm,” he noted.

Local recurrences occurred in 19 (5.6%) of patients in the ALND group and 12 (3.8%) in the SLND group, and regional recurrence was seen in 2 (0.5%) patients in the ALND group and 5 (1.5%) in the SLND group. The differences were not statistically significant.

Only hormone receptor status, Bloom-Richardson score, and tumor size were associated with locoregional recurrence. Omission of radiation increased local but not regional recurrence, but numbers were too few to draw further conclusions, he said.

“We can conclude, however, that sentinel lymph node dissection provides excellent locoregional control comparable to completion axillary lymph node dissection in these selected patients,” he said.

ACOSOG Z0011 subjects were patients with hematoxylin-eosin (H&E)–detected sentinel lymph node metastases undergoing breast-conserving therapy. The groups randomized to undergo ALND or to receive no further axillary treatment were similar with respect to age, Bloom-Richardson score, estrogen-receptor status, adjuvant systemic therapy, histology, and tumor size.

Nearly all patients had adjuvant systemic therapy (96% and 97% in the ALND and SLND groups, respectively), and about 60% in each group received chemotherapy.

Dr. Giuliano concluded that, despite the potential for residual axillary disease after SLND, SLND without ALND offers excellent regional control for selected patients with early metastatic breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

“Axillary lymph node dissection is not necessary for patients with early metastatic breast cancer and should be abandoned,” he said.

Dr. Giuliano had no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review

sworcester@frontlinemedcom.com

CHICAGO – Sentinel lymph node dissection without axillary lymph node dissection offers excellent regional control in select patients with early metastatic breast cancer who are treated using breast-conserving therapy and adjuvant systemic therapy, according to 10-year results from the American College of Surgeons Oncology Group (ACOSOG) Z0011 Randomized Trial. ACOSOG is now part of Alliance for Clinical Trials in Oncology.

The findings confirm the previously reported 5-year outcomes, which demonstrated no significant difference in locoregional recurrence for patients with positive sentinel nodes who were randomized to undergo axillary lymph node dissection (ALND) or no further axillary treatment, Dr. Armando E. Giuliano of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Surgical Association.

“In fact, the [5-year] results were highly significant showing noninferiority of sentinel lymph node dissection,” he said.

At a median follow-up of 9.25 years, there still was no statistically significant difference between 446 sentinel lymph node dissection (SLND)–only patients and 445 completion ALND patients with respect to the rate of locoregional recurrence, Dr. Giuliano said.

“The 10-year locoregional recurrence incidence after axillary lymph node dissection is 6.2%, compared to 5.3% after sentinel lymph node dissection alone,” he said, noting that most recurrences were seen in the first 5 years.

Of the ALND patients, 27% had additional positive nodes removed beyond the sentinel nodes.

“Therefore, about 27% of patients who underwent sentinel node dissection alone had residual disease remaining in the axilla undissected. Despite this high possibility of residual disease, very few regional recurrences were seen in either arm,” he noted.

Local recurrences occurred in 19 (5.6%) of patients in the ALND group and 12 (3.8%) in the SLND group, and regional recurrence was seen in 2 (0.5%) patients in the ALND group and 5 (1.5%) in the SLND group. The differences were not statistically significant.

Only hormone receptor status, Bloom-Richardson score, and tumor size were associated with locoregional recurrence. Omission of radiation increased local but not regional recurrence, but numbers were too few to draw further conclusions, he said.

“We can conclude, however, that sentinel lymph node dissection provides excellent locoregional control comparable to completion axillary lymph node dissection in these selected patients,” he said.

ACOSOG Z0011 subjects were patients with hematoxylin-eosin (H&E)–detected sentinel lymph node metastases undergoing breast-conserving therapy. The groups randomized to undergo ALND or to receive no further axillary treatment were similar with respect to age, Bloom-Richardson score, estrogen-receptor status, adjuvant systemic therapy, histology, and tumor size.

Nearly all patients had adjuvant systemic therapy (96% and 97% in the ALND and SLND groups, respectively), and about 60% in each group received chemotherapy.

Dr. Giuliano concluded that, despite the potential for residual axillary disease after SLND, SLND without ALND offers excellent regional control for selected patients with early metastatic breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

“Axillary lymph node dissection is not necessary for patients with early metastatic breast cancer and should be abandoned,” he said.

Dr. Giuliano had no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review

sworcester@frontlinemedcom.com

CHICAGO – Sentinel lymph node dissection without axillary lymph node dissection offers excellent regional control in select patients with early metastatic breast cancer who are treated using breast-conserving therapy and adjuvant systemic therapy, according to 10-year results from the American College of Surgeons Oncology Group (ACOSOG) Z0011 Randomized Trial. ACOSOG is now part of Alliance for Clinical Trials in Oncology.

The findings confirm the previously reported 5-year outcomes, which demonstrated no significant difference in locoregional recurrence for patients with positive sentinel nodes who were randomized to undergo axillary lymph node dissection (ALND) or no further axillary treatment, Dr. Armando E. Giuliano of Cedars-Sinai Medical Center, Los Angeles, reported at the annual meeting of the American Surgical Association.

“In fact, the [5-year] results were highly significant showing noninferiority of sentinel lymph node dissection,” he said.

At a median follow-up of 9.25 years, there still was no statistically significant difference between 446 sentinel lymph node dissection (SLND)–only patients and 445 completion ALND patients with respect to the rate of locoregional recurrence, Dr. Giuliano said.

“The 10-year locoregional recurrence incidence after axillary lymph node dissection is 6.2%, compared to 5.3% after sentinel lymph node dissection alone,” he said, noting that most recurrences were seen in the first 5 years.

Of the ALND patients, 27% had additional positive nodes removed beyond the sentinel nodes.

“Therefore, about 27% of patients who underwent sentinel node dissection alone had residual disease remaining in the axilla undissected. Despite this high possibility of residual disease, very few regional recurrences were seen in either arm,” he noted.

Local recurrences occurred in 19 (5.6%) of patients in the ALND group and 12 (3.8%) in the SLND group, and regional recurrence was seen in 2 (0.5%) patients in the ALND group and 5 (1.5%) in the SLND group. The differences were not statistically significant.

Only hormone receptor status, Bloom-Richardson score, and tumor size were associated with locoregional recurrence. Omission of radiation increased local but not regional recurrence, but numbers were too few to draw further conclusions, he said.

“We can conclude, however, that sentinel lymph node dissection provides excellent locoregional control comparable to completion axillary lymph node dissection in these selected patients,” he said.

ACOSOG Z0011 subjects were patients with hematoxylin-eosin (H&E)–detected sentinel lymph node metastases undergoing breast-conserving therapy. The groups randomized to undergo ALND or to receive no further axillary treatment were similar with respect to age, Bloom-Richardson score, estrogen-receptor status, adjuvant systemic therapy, histology, and tumor size.

Nearly all patients had adjuvant systemic therapy (96% and 97% in the ALND and SLND groups, respectively), and about 60% in each group received chemotherapy.

Dr. Giuliano concluded that, despite the potential for residual axillary disease after SLND, SLND without ALND offers excellent regional control for selected patients with early metastatic breast cancer treated with breast-conserving therapy and adjuvant systemic therapy.

“Axillary lymph node dissection is not necessary for patients with early metastatic breast cancer and should be abandoned,” he said.

Dr. Giuliano had no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review

sworcester@frontlinemedcom.com

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – Lower extremity duplex scans should be performed prior to colorectal surgery, and anticoagulation should be tailored to the result, findings from a randomized clinical trial suggest.

The findings also raise questions about the fairness of financial penalties imposed by the Centers for Medicare & Medicaid Services for perioperative venous thromboembolism, Dr. Karen Zaghiyan of Cedars Sinai Medical Center, Los Angeles said at the annual meeting of the American Surgical Association.

In 376 consecutive adult patients undergoing laparoscopic or open major colorectal surgery who had no occult preoperative deep vein thrombosis (DVT) on lower extremity venous duplex scan and who were randomized to preoperative or postoperative chemical thromboprophylaxis (CTP) with 5,000 U of subcutaneous heparin, no differences were seen with respect to the primary outcome of venous thromboembolism within 48 hours of surgery, Dr. Zaghiyan said.

“There was no significant difference in our primary outcome – early postoperative VTE [venous thromboembolism] – in patients managed with postoperative or preoperative prophylaxis,” she said, noting that three patients in each group developed asymptomatic intraoperative DVT, and two additional patients in the postoperative treatment group developed asymptomatic DVT between postoperative day 0 and 2.

Two additional patients in the postoperative treatment group developed clinically significant DVT between postoperative day 2 and 30.

“Both patients had a complicated prolonged hospital course, and developed DVT while still hospitalized. This difference still did not reach statistical significance, and there were no post-discharge DVT or PEs [pulmonary embolisms] in the entire cohort,” she said.

Bleeding complications, including estimated blood loss and number receiving transfusion, were similar in the two groups, she said, noting that no patients developed heparin-induced thrombocytopenia, and that hospital stay, readmissions, and overall complications were similar between the two groups.

Study subjects had a mean age of 53 years, and 52% were women. The preoperative- and postoperative treatment groups were similar with respect to demographics and preoperative characteristics. They underwent lower extremity venous duplex just prior to surgery, immediately after surgery in the recovery room, on day 2 after surgery, and subsequently as clinically indicated.

Thromboprophylaxis in the preoperative treatment group was given in the “pre-op holding area” then 8 hours after surgery and every 8 hours thereafter until discharge. Thromboprophylaxis in the postoperative treatment group was given within 24 hours after surgery, and then every 8 hours until discharge.

Preoperative and postoperative CTP were equally safe and effective, and since occult preoperative DVT is twice as common as postoperative DVT, occurring in a surprising 4% of patients in this study, the findings support preoperative scans and anticoagulation based on the results – especially in older patients and those with comorbid disease, Dr. Zaghiyan said.

The findings could help improve patients care; although VTE prevention and chemical prophylaxis in colorectal surgery have been extensively studied, current guidelines are vague, with both the American College of Chest Physicians and the Surgical Care Improvement Project recommending that prophylaxis be initiated 24 hours prior to or after major colorectal surgery, she said.

The findings could also help avoid CMS penalties for postoperatively identified VTE,” she added.

Further, those penalties may not be supported by the clinical data; in this study, the majority of early postoperative DVTs were unpreventable, with no additional protection provided with preoperative prophylaxis, she explained.

“CMS should reevaluate the financial penalties, taking preventability into account,” she said.

Dr. Zaghiyan reported having no disclosures.

The complete manuscript of this presentation is anticipated to be published in the Annals of Surgery pending editorial review.

sworcester@frontlinemedcom.com

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

sworcester@frontlinemedcom.com

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

sworcester@frontlinemedcom.com

CHICAGO – The superiority of metabolic surgery over intensive medical therapy for achieving glycemic control in patients with type 2 diabetes was largely maintained at the final 5-year follow-up evaluation in the randomized, controlled STAMPEDE trial.

The 150 subjects, who had “fairly severe diabetes” with an average disease duration of 8 years, were randomized to receive intensive medical therapy alone, or intensive medical therapy with Roux-en-Y gastric bypass surgery or sleeve gastrectomy surgery. The primary endpoint of hemoglobin A_1c less than 6% was achieved in 5%, 29%, and 23% of patients in the groups, respectively. The difference was statistically significant in favor of both types of surgery, Dr. Philip Raymond Schauer reported at the annual meeting of the American College of Cardiology.

Furthermore, patients in the surgery groups fared better than those in the intensive medical therapy group on several other measures, including disease remission (defied as HbA_1c less than 6% without diabetes medication), HbA_1c less than 7% (the American Diabetes Association target for therapy), change in fasting plasma glucose from baseline, and changes in high- and low-density lipoprotein cholesterol levels, said Dr. Schauer, director of the Cleveland Clinic Bariatric and Metabolic Institute.

Patients in the surgery groups also experienced a significantly greater reduction in the use of antihypertensive medications and lipid-lowering agents, he added.

The “very dramatic drop” in HbA_1c seen early on in the surgical patients was, for the most part, sustained out to 5 years, he said.

The results for both surgeries were significantly better than those for intensive medical therapy, but the results with gastric bypass were more effective at 5 years than were those for sleeve gastrectomy, he added, noting that the surgery patients had better quality of life, compared with the intensive medical therapy patients.

As for adverse events in the surgery groups, no perioperative deaths occurred, and while there were some surgical complications, none resulted in long-term disability, Dr. Schauer said.

Anemia was more common in the surgery patients, but was fairly mild. The most common complication was weight gain in 20% of patients, and the overall reoperation rate was 7%.

Of note, patients in the study had body mass index ranging from 27 to 43 kg/m², and those with BMI less than 35 had similar benefits as those with more severe obesity. This is important, as many insurance companies won’t cover metabolic surgery for patients with BMI less than 35, he explained.

These findings represent the longest follow-up to date comparing the efficacy of the two most common metabolic surgery procedures with medical treatment of type 2 diabetes for maintaining glycemic control or reducing end-organ complications. Three-year outcomes of STAMPEDE (Surgical Treatment and Medications Potentially Eradicate Diabetes Efficiently) were reported in 2014 (N Engl J Med. 2014;370:2002-13).

The participants ranged in age from 20 to 60 years. The average HbA_1c was about 9%, the average BMI was 36, and most were on at least three antidiabetic medications at baseline. Half were on insulin.

The findings are important, because of the roughly 25 million Americans with type 2 diabetes, only about half have good glycemic control on their current medical treatment strategies, Dr. Schauer said.

Though limited by the single-center study design, the STAMPEDE findings show that metabolic surgery is more effective long term than intensive medical therapy in patients with uncontrolled type 2 diabetes and should be considered a treatment option in this population, he concluded, adding that multicenter studies would be helpful for determining the generalizability of the findings.

Dr. Schauer reported receiving consulting fees/honoraria from Ethicon Endosurgery and The Medicines Company, and having ownership interest in Surgical Excellence.

sworcester@frontlinemedcom.com

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Sooner may be better than later when it comes to the timing of bariatric surgery in patients with morbid obesity.

Of 828 patients with body mass index of at least 35 kg/m² who underwent laparoscopic adjustable gastric banding performed by a single surgeon and were followed for up to 11 years (mean of 10 years), 423 were aged 45 years or younger, and 405 were over age 45 years at the time of surgery. A comparison of outcomes between the two age groups showed that older age at the time of surgery was an independent predictor of cardiovascular events (hazard ratio, 1.8), Maharaj Singh, Ph.D., a biostatistician at the Aurora Research Institute, Milwaukee, reported in a poster at the annual meeting of the American College of Cardiology.

James P. Gray/Wikimedia Commons/CC-ASA 3.0

Despite a similar reduction in body weight after gastric banding surgery, the older patients experienced more cardiovascular events: myocardial infarction occurred in 0.2% and 1.7% of patients in the younger and older age groups, respectively, pulmonary embolism occurred in 0.7% and 4.3%, congestive heart failure occurred in 2.8% and 7.8%, and stroke occurred in 3.7% and 7.6%, Dr. Singh said.

“Although the older group had more comorbidities, these were accounted for by multivariate analysis and age over 45 years remained an independent predictor of poor cardiovascular outcomes,” senior coauthor Dr. Arshad Jahangir, professor of medicine at the University of Wisconsin–Madison, said in an interview.

Other independent predictors of adverse cardiovascular outcomes in the study were sleep apnea (hazard ratio, 4), history of hypertension (HR, 1.9), and depression, (HR, 1.8), Dr. Jahangir said.

“Gender, race, and diabetes mellitus did not independently predict cardiovascular events,” he said.

Weight loss after bariatric surgery has been shown to reduce the risk of adverse cardiovascular events, but it has remained unclear whether the reduction in risk varies based on age at the time of surgery, he said.

The current findings suggest that the effects of laparoscopic adjustable gastric banding–induced weight loss on cardiovascular outcomes are greater in patients who undergo the surgery at a younger age, he said, adding that the findings also “raise important questions about whether better control of sleep apnea, hypertension, and depression could help further reduce cardiovascular events in morbidly obese individuals undergoing bariatric surgery and should be addressed in a prospective study of these patients.”

The authors reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Early intravenous administration of the beta-blocker metoprolol before primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) was safe but did not reduce infarct size in the randomized, placebo-controlled Early-BAMI trial.

No difference was seen in infarct size, as measured by magnetic resonance imaging at 30 days, between 336 patients with STEMI who presented within 12 hours of symptom onset and were randomized to receive intravenous metoprolol (2 vials with 5 mg) before undergoing angioplasty, and 347 such patients who received placebo (left ventricular volume, 15.3% and 14.9%, respectively), Dr. Vincent Roolvink of Isala Hospital, Zwolle, the Netherlands, reported at the annual meeting of the American College of Cardiology.

No differences were seen between the groups for the secondary endpoints of blood flow from the left ventricle or levels of cardiac enzymes, Dr. Roolvink noted.

Further, while significantly fewer cases of ventricular arrhythmia occurred in the metoprolol patients (3.6% vs. 6.9%), this difference was not clinically significant, he said.

No significant differences were seen with respect to safety endpoints, including abnormally slow heart rate, low blood pressure, or cardiogenic shock.

The Early-BAMI subjects had a mean age of 62 years, and most (75%) were men. They were enrolled at centers throughout the Netherlands and Spain.

“In this nonrestricted STEMI population, early intravenous metoprolol before primary percutaneous intervention did not reduce infarct size,” Dr Roolvink said, noting that the findings follow conflicting results from prior studies, with some suggesting that beta-blockers could reduce heart attack severity or improve blood flow from the left ventricle when given to STEMI patients prior to angioplasty.

However only one randomized trial took place in the primary percutaneous coronary intervention era, and that trial – METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) – involved only patients with STEMIs involving the anterior wall of the left ventricle (J Am Coll Cardiol. 2014;63[22]:2356-62).

Early-BAMI (The Effect of Early Administration of Intravenous Beta Blockers in Patients with ST-elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention) was the first double blind, placebo-controlled international multicenter study to test this approach.

“Our results do not confirm the effect observed in the METOCARD-CNIC trial,” Dr. Roolvink said.

He noted, however, that the current findings are limited by the fact that study subjects had lower than expected overall heart attack severity.

Additional large randomized trials are needed to clarify whether early beta-blocker treatment is of benefit before angioplasty in STEMI patients. The safety profile, low cost of beta-blocker administration, and the reduction of acute malignant arrhythmias among those receiving beta-blocker treatment in the current trial should encourage the performance of additional larger trials, he said.

The findings were simultaneously published online (J Am Coll Cardiol. 2016 Apr 3. doi:10.1016/j.jacc.2016.03.522)

Early-BAMI was funded by the Dutch Heart Foundation and Medtronic. Dr. Roolvink reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Early intravenous administration of the beta-blocker metoprolol before primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) was safe but did not reduce infarct size in the randomized, placebo-controlled Early-BAMI trial.

No difference was seen in infarct size, as measured by magnetic resonance imaging at 30 days, between 336 patients with STEMI who presented within 12 hours of symptom onset and were randomized to receive intravenous metoprolol (2 vials with 5 mg) before undergoing angioplasty, and 347 such patients who received placebo (left ventricular volume, 15.3% and 14.9%, respectively), Dr. Vincent Roolvink of Isala Hospital, Zwolle, the Netherlands, reported at the annual meeting of the American College of Cardiology.

No differences were seen between the groups for the secondary endpoints of blood flow from the left ventricle or levels of cardiac enzymes, Dr. Roolvink noted.

Further, while significantly fewer cases of ventricular arrhythmia occurred in the metoprolol patients (3.6% vs. 6.9%), this difference was not clinically significant, he said.

No significant differences were seen with respect to safety endpoints, including abnormally slow heart rate, low blood pressure, or cardiogenic shock.

The Early-BAMI subjects had a mean age of 62 years, and most (75%) were men. They were enrolled at centers throughout the Netherlands and Spain.

“In this nonrestricted STEMI population, early intravenous metoprolol before primary percutaneous intervention did not reduce infarct size,” Dr Roolvink said, noting that the findings follow conflicting results from prior studies, with some suggesting that beta-blockers could reduce heart attack severity or improve blood flow from the left ventricle when given to STEMI patients prior to angioplasty.

However only one randomized trial took place in the primary percutaneous coronary intervention era, and that trial – METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) – involved only patients with STEMIs involving the anterior wall of the left ventricle (J Am Coll Cardiol. 2014;63[22]:2356-62).

Early-BAMI (The Effect of Early Administration of Intravenous Beta Blockers in Patients with ST-elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention) was the first double blind, placebo-controlled international multicenter study to test this approach.

“Our results do not confirm the effect observed in the METOCARD-CNIC trial,” Dr. Roolvink said.

He noted, however, that the current findings are limited by the fact that study subjects had lower than expected overall heart attack severity.

Additional large randomized trials are needed to clarify whether early beta-blocker treatment is of benefit before angioplasty in STEMI patients. The safety profile, low cost of beta-blocker administration, and the reduction of acute malignant arrhythmias among those receiving beta-blocker treatment in the current trial should encourage the performance of additional larger trials, he said.

The findings were simultaneously published online (J Am Coll Cardiol. 2016 Apr 3. doi:10.1016/j.jacc.2016.03.522)

Early-BAMI was funded by the Dutch Heart Foundation and Medtronic. Dr. Roolvink reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Early intravenous administration of the beta-blocker metoprolol before primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction (STEMI) was safe but did not reduce infarct size in the randomized, placebo-controlled Early-BAMI trial.

No difference was seen in infarct size, as measured by magnetic resonance imaging at 30 days, between 336 patients with STEMI who presented within 12 hours of symptom onset and were randomized to receive intravenous metoprolol (2 vials with 5 mg) before undergoing angioplasty, and 347 such patients who received placebo (left ventricular volume, 15.3% and 14.9%, respectively), Dr. Vincent Roolvink of Isala Hospital, Zwolle, the Netherlands, reported at the annual meeting of the American College of Cardiology.

No differences were seen between the groups for the secondary endpoints of blood flow from the left ventricle or levels of cardiac enzymes, Dr. Roolvink noted.

Further, while significantly fewer cases of ventricular arrhythmia occurred in the metoprolol patients (3.6% vs. 6.9%), this difference was not clinically significant, he said.

No significant differences were seen with respect to safety endpoints, including abnormally slow heart rate, low blood pressure, or cardiogenic shock.

The Early-BAMI subjects had a mean age of 62 years, and most (75%) were men. They were enrolled at centers throughout the Netherlands and Spain.

“In this nonrestricted STEMI population, early intravenous metoprolol before primary percutaneous intervention did not reduce infarct size,” Dr Roolvink said, noting that the findings follow conflicting results from prior studies, with some suggesting that beta-blockers could reduce heart attack severity or improve blood flow from the left ventricle when given to STEMI patients prior to angioplasty.

However only one randomized trial took place in the primary percutaneous coronary intervention era, and that trial – METOCARD-CNIC (Effect of Metoprolol in Cardioprotection During an Acute Myocardial Infarction) – involved only patients with STEMIs involving the anterior wall of the left ventricle (J Am Coll Cardiol. 2014;63[22]:2356-62).

Early-BAMI (The Effect of Early Administration of Intravenous Beta Blockers in Patients with ST-elevation Myocardial Infarction Before Primary Percutaneous Coronary Intervention) was the first double blind, placebo-controlled international multicenter study to test this approach.

“Our results do not confirm the effect observed in the METOCARD-CNIC trial,” Dr. Roolvink said.

He noted, however, that the current findings are limited by the fact that study subjects had lower than expected overall heart attack severity.

Additional large randomized trials are needed to clarify whether early beta-blocker treatment is of benefit before angioplasty in STEMI patients. The safety profile, low cost of beta-blocker administration, and the reduction of acute malignant arrhythmias among those receiving beta-blocker treatment in the current trial should encourage the performance of additional larger trials, he said.

The findings were simultaneously published online (J Am Coll Cardiol. 2016 Apr 3. doi:10.1016/j.jacc.2016.03.522)

Early-BAMI was funded by the Dutch Heart Foundation and Medtronic. Dr. Roolvink reported having no disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Ischemic postconditioning in patients with ST-segment elevation myocardial infarction failed to significantly reduce death from any cause or hospitalization for heart failure in the randomized, controlled DANAMI 3-iPOST trial.

At a mean follow-up of 37.5 months, the primary composite endpoint of death from any cause and hospitalization for heart failure occurred in 69 of 617 patients with STEMI who received standard angioplasty and in 65 of 617 patients who received ischemic postconditioning in DANAMI 3-iPOST (the Third Danish Study of Optimal Acute Treatment of Patients With ST-Segment Elevation Myocardial Infarction: iPOST conditioning during primary PCI). The 7% difference (hazard ratio, 0.93) was not statistically significant, Dr. Thomas Engstrøm reported at the annual meeting of the American College of Cardiology.

Sharon Worcester/Frontline Medical News

For the individual component of all-cause mortality, the reduction in the ischemic postconditioning group was 25%, occurring in 50 patients, compared with 38 in the conventionally treated group (hazard ratio, 0.75), but this difference also did not reach statistical significance, Dr. Engstrøm said.

Thirty patients in each group required hospitalization for heart failure.

However, an improvement in a secondary endpoint of left ventricular ejection fraction above 45% in patients with anterior infarcts was statistically significant, occurring in 72% of patients in the standard angioplasty group and 80% of those in the ischemic postconditioning group, said Dr. Engstrøm of Rigshospitalet University of Copenhagen.

This finding may translate into improved survival with longer follow-up, he noted.

Patients in the DANAMI-3 iPOST trial, who had a mean age of age 61 years, had acute STEMI (ST-segment elevation MI) symptoms of less than 12 hours’ duration at the time of randomization. They were followed for at least 2 years.

Ischemic postconditioning – a variation on angioplasty that involves using 30-second bursts of blood flow interspersed with 30-second pauses to restore blood flow to the heart – was shown in earlier studies to improve ST-segment resolution, reduce damage to heart muscle, and – in some patients – limit the extent of reperfusion injury.

Whether these factors would reduce hospitalizations or improve patient survival remained unclear, Dr. Engstrøm said.

Abrupt reperfusion by angioplasty may itself damage the heart muscle. In fact, up to 35% of patients may experience such injury during angioplasty.

“The thinking was that performing the reperfusion in a gentle, graded fashion would protect the heart against reperfusion injury,” Dr. Engstrøm explained.

The findings of DANAMI 3-iPOST – the first large clinical trial designed to evaluate clinical outcomes in STEMI patients (as opposed to surrogate endpoints such as ST-segment resolution) were disappointing, but larger trials may be required to definitively establish whether ischemic postconditioning improves clinical outcomes, Dr. Engstrøm said.

The DANAMI 3-iPOST trial was funded by the Danish Agency for Science, Technology, and Innovation and the Danish Council for Strategic Research. Dr. Engstrøm reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Ischemic postconditioning in patients with ST-segment elevation myocardial infarction failed to significantly reduce death from any cause or hospitalization for heart failure in the randomized, controlled DANAMI 3-iPOST trial.

At a mean follow-up of 37.5 months, the primary composite endpoint of death from any cause and hospitalization for heart failure occurred in 69 of 617 patients with STEMI who received standard angioplasty and in 65 of 617 patients who received ischemic postconditioning in DANAMI 3-iPOST (the Third Danish Study of Optimal Acute Treatment of Patients With ST-Segment Elevation Myocardial Infarction: iPOST conditioning during primary PCI). The 7% difference (hazard ratio, 0.93) was not statistically significant, Dr. Thomas Engstrøm reported at the annual meeting of the American College of Cardiology.

Sharon Worcester/Frontline Medical News

For the individual component of all-cause mortality, the reduction in the ischemic postconditioning group was 25%, occurring in 50 patients, compared with 38 in the conventionally treated group (hazard ratio, 0.75), but this difference also did not reach statistical significance, Dr. Engstrøm said.

Thirty patients in each group required hospitalization for heart failure.

However, an improvement in a secondary endpoint of left ventricular ejection fraction above 45% in patients with anterior infarcts was statistically significant, occurring in 72% of patients in the standard angioplasty group and 80% of those in the ischemic postconditioning group, said Dr. Engstrøm of Rigshospitalet University of Copenhagen.

This finding may translate into improved survival with longer follow-up, he noted.

Patients in the DANAMI-3 iPOST trial, who had a mean age of age 61 years, had acute STEMI (ST-segment elevation MI) symptoms of less than 12 hours’ duration at the time of randomization. They were followed for at least 2 years.

Ischemic postconditioning – a variation on angioplasty that involves using 30-second bursts of blood flow interspersed with 30-second pauses to restore blood flow to the heart – was shown in earlier studies to improve ST-segment resolution, reduce damage to heart muscle, and – in some patients – limit the extent of reperfusion injury.

Whether these factors would reduce hospitalizations or improve patient survival remained unclear, Dr. Engstrøm said.

Abrupt reperfusion by angioplasty may itself damage the heart muscle. In fact, up to 35% of patients may experience such injury during angioplasty.

“The thinking was that performing the reperfusion in a gentle, graded fashion would protect the heart against reperfusion injury,” Dr. Engstrøm explained.

The findings of DANAMI 3-iPOST – the first large clinical trial designed to evaluate clinical outcomes in STEMI patients (as opposed to surrogate endpoints such as ST-segment resolution) were disappointing, but larger trials may be required to definitively establish whether ischemic postconditioning improves clinical outcomes, Dr. Engstrøm said.

The DANAMI 3-iPOST trial was funded by the Danish Agency for Science, Technology, and Innovation and the Danish Council for Strategic Research. Dr. Engstrøm reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com

CHICAGO – Ischemic postconditioning in patients with ST-segment elevation myocardial infarction failed to significantly reduce death from any cause or hospitalization for heart failure in the randomized, controlled DANAMI 3-iPOST trial.

At a mean follow-up of 37.5 months, the primary composite endpoint of death from any cause and hospitalization for heart failure occurred in 69 of 617 patients with STEMI who received standard angioplasty and in 65 of 617 patients who received ischemic postconditioning in DANAMI 3-iPOST (the Third Danish Study of Optimal Acute Treatment of Patients With ST-Segment Elevation Myocardial Infarction: iPOST conditioning during primary PCI). The 7% difference (hazard ratio, 0.93) was not statistically significant, Dr. Thomas Engstrøm reported at the annual meeting of the American College of Cardiology.

Sharon Worcester/Frontline Medical News

For the individual component of all-cause mortality, the reduction in the ischemic postconditioning group was 25%, occurring in 50 patients, compared with 38 in the conventionally treated group (hazard ratio, 0.75), but this difference also did not reach statistical significance, Dr. Engstrøm said.

Thirty patients in each group required hospitalization for heart failure.

However, an improvement in a secondary endpoint of left ventricular ejection fraction above 45% in patients with anterior infarcts was statistically significant, occurring in 72% of patients in the standard angioplasty group and 80% of those in the ischemic postconditioning group, said Dr. Engstrøm of Rigshospitalet University of Copenhagen.

This finding may translate into improved survival with longer follow-up, he noted.

Patients in the DANAMI-3 iPOST trial, who had a mean age of age 61 years, had acute STEMI (ST-segment elevation MI) symptoms of less than 12 hours’ duration at the time of randomization. They were followed for at least 2 years.

Ischemic postconditioning – a variation on angioplasty that involves using 30-second bursts of blood flow interspersed with 30-second pauses to restore blood flow to the heart – was shown in earlier studies to improve ST-segment resolution, reduce damage to heart muscle, and – in some patients – limit the extent of reperfusion injury.

Whether these factors would reduce hospitalizations or improve patient survival remained unclear, Dr. Engstrøm said.

Abrupt reperfusion by angioplasty may itself damage the heart muscle. In fact, up to 35% of patients may experience such injury during angioplasty.

“The thinking was that performing the reperfusion in a gentle, graded fashion would protect the heart against reperfusion injury,” Dr. Engstrøm explained.

The findings of DANAMI 3-iPOST – the first large clinical trial designed to evaluate clinical outcomes in STEMI patients (as opposed to surrogate endpoints such as ST-segment resolution) were disappointing, but larger trials may be required to definitively establish whether ischemic postconditioning improves clinical outcomes, Dr. Engstrøm said.

The DANAMI 3-iPOST trial was funded by the Danish Agency for Science, Technology, and Innovation and the Danish Council for Strategic Research. Dr. Engstrøm reported having no relevant financial disclosures.

sworcester@frontlinemedcom.com