Anticoagulation Hub

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

LONDON – Statin therapy, given the week before a host of noncardiac surgical procedures, reduced the postoperative risk for death and cardiac complications at 30 days by 17% when compared with no statin use in a large, international observational study.

Results of the prospective VISION (Vascular Events in Noncardiac Surgery Patients Cohort Evaluation) study showed that the primary composite endpoint of all-cause mortality, myocardial injury after noncardiac surgery (MINS), or stroke at 30 days was 11.8% in a propensity-matched cohort of patients, 2,845 of whom were treated with a statin and 4,492 who were not. The relative risk (RR) for this composite endpoint was 0.83 favoring the use of preoperative statins, with a 95% confidence interval (CI) of 0.73-0.95 and a P value of .007.

Sara Freeman/Frontline Medical News

Perioperative statin vs. no statin use also cut all-cause mortality by 42% (RR, 0.58; 95% CI, 0.40-0.83; P = .003), cardiovascular mortality by 58% (RR, 0.42; 95% CI, 0.23-0.76; P = .004), and MINS by 14% (RR, 0.86; 95% CI, 0.73-0.98; P = .002).

“These study results are hypothesis generating at most,” emphasized Dr. Otavio Berwanger, who presented the findings at the annual congress of the European Society of Cardiology while they were simultaneously published online (Eur Heart J. 2015 Sept. 1. doi: 10.1093/eurheartj/ehv456).

“It is true that, in this large representative cohort of contemporary patients, statins were associated with lower event rates,” added Dr. Berwanger of Hospital do Coração in São Paulo, Brazil, and “together with the previous body of evidence, statins appear to be an interesting and attractive intervention to reduce postoperative events.” A large-scale, randomized trial is needed, however, to answer the question of whether statins should be used preoperatively to prevent postoperative events in noncardiac surgery patients.

Over a 4-year period that started in August 2007, more than 15,000 individuals aged 45 years or older who were undergoing a variety of noncardiac surgical procedures that required regional or a general anesthetic and at least an overnight stay in the hospital were recruited at 12 centers in eight countries in North and South America, Africa, Asia, Australia, and Europe.

One of the objectives of the study was to examine the use of perioperative statins on cardiovascular events at 30 days, and to do this, the VISION investigators identified the patients who had received a statin in the 7 days prior to surgery and then used propensity matching to form a control group of patients that had not received a statin in the week before surgery.

Just under half of the propensity-matched population was male, with an average age of nearly 69 years. Around 70% of the population had hypertension, 9%-10% had a prior stroke, and 13% had active cancer. Surgeries were urgent in about 2% and emergent in 8%. Around a quarter had undergone orthopedic procedures, and 4% were vascular surgeries. Overall, 36% of surgeries were classified as low risk and 39% as other.

One of the limitations of the study, however, is that, despite the propensity matching, there were some variables that remained different between the two groups, with higher rates of coronary artery disease (20% vs. 14%), peripheral vascular disease (8% vs. 5%), diabetes (30% vs. 25%), and preoperative use of aspirin (25% vs. 19%) and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (53% vs. 48%) in the statin- versus nonstatin-treated patients.

Other limitations are that these data are observational and the use of statins could be just a surrogate for unmeasured confounders that relate to prognosis. Information on the type and dosing of statins also was not obtained, and there was no information collected on potential liver or muscle function side effects.

Nevertheless, the VISION investigators noted in the published paper that the results are consistent with those from other observational studies and prior small-scale, randomized trials and so do add important information. They noted that these data were collected prospectively in a broader range of patients and types of surgeries than has been reported previously. In addition, patients were recruited from several countries and were actively monitored for outcomes and events were centrally adjudicated. VISION is also the only study to report on the effects of statins on MINS.

“Another message from our results is that the use of long-term statins is sub-optimal in high cardiovascular risk patients, who should be on long-term lipid-lowering therapy independently of surgery,” the VISION investigators wrote in their report.

The study was funded by Hamilton Health Sciences Corp. at McMaster University. Dr. Berwanger disclosed receiving research contracts from AstraZeneca, Bayer Healthcare, Amgen, Boehringer-Ingelheim, Pfizer, and Roche Diagnostics.

LONDON – Bivalirudin did not prove superior to unfractionated heparin in reducing the rate of major adverse cardiovascular events in two nested, open-label, randomized clinical trials involving patients presenting with acute coronary syndrome who were expected to undergo percutaneous coronary intervention, Dr. Marco Valgimigli reported.

In addition, post-PCI infusions of bivalirudin for 4 hours or longer did not reduce the rate of adverse bleeding events, compared with no infusion.

These findings add important data to the understanding of antithrombotic therapy in ACS patients undergoing invasive treatment, but they do not resolve the persistent question of which method is best for preventing thrombotic complications while limiting the risk of bleeding during and after such procedures, said Dr. Valgimigli of Erasmus University in Rotterdam.

Previous studies comparing bivalirudin, a direct thrombin inhibitor, against unfractionated heparin, an indirect thrombin inhibitor, have yielded conflicting results regarding ischemic and bleeding outcomes, so Dr. Valgimigli and his fellow investigators in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial conducted two industry-sponsored superiority trials to try to settle the question.

The findings of one of these trials were reported by Dr. Valgimigli at the annual congress of the European Society of Cardiology on Sept. 1, when the results of both were simultaneously published online (N Engl J Med. 2015 Sept 1. doi: 10.1056/NEJMoa1507854).

The MATRIX studies were conducted at 78 medical centers in Italy, the Netherlands, Spain, and Sweden. They involved 7,213 patients who presented with either ST-elevation MI or non-STEMI ACS and were expected to undergo PCI. The first trial, MATRIX Antithrombin, assessed outcomes in 3,610 of these participants who were randomly assigned to receive bivalirudin and 3,603 assigned to receive unfractionated heparin. In the second trial, MATRIX Treatment Duration, the bivalirudin group was further randomized to receive either a post-PCI bivalirudin infusion (1,799 patients) or no post-PCI infusion (1,811 patients).

MATRIX Antithrombin

At 1-month follow-up, the rate of major adverse cardiovascular events (MACEs) – a composite of death from any cause, myocardial infarction, or stroke – was no lower in the bivalirudin group (10.3%) than in the heparin group (10.9%), for a rate ratio of 0.94. Similarly, the rate of net adverse clinical events was not significantly lower with bivalirudin (11.2%) than with heparin (12.4%), for a rate ratio of 0.89.

MATRIX Treatment Duration

The primary outcome in the MATRIX Treatment Duration study – a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events at 30 days – occurred in 11.0% of patients who received post-PCI bivalirudin infusions and 11.9% of those who did not, a nonsignificant difference (rate ratio, 0.91). However, the rate of subacute definite stent thrombosis was significantly higher in the post-PCI infusion group, at 0.7%, compared with 0.2% in the group that didn’t receive post-PCI infusions (RR, 4.37).

“I believe the option to prolong or stop bivalirudin infusion after PCI remains open for clinicians, who will have to decide based on the ischemic and bleeding risk of individual patients as well as, perhaps, based on type of acute coronary syndrome, timing of loading dose, and type of oral P2Y12 inhibitors,” Dr. Valgimigli said, noting that this is in keeping with the current labeling of the drug in Europe and the United States.

The MATRIX study was sponsored by the nonprofit Italian Society of Invasive Cardiology and financially supported by the Medicines Company and Terumo Medical. Dr. Valgimigli reported ties to AstraZeneca, the Medicines Company, Terumo Medical, St. Jude Vascular, Alvimedica, Abbott Vascular, and Correvio; his associates reported ties to numerous industry sources.

Mary Ann Moon contributed to this report.

LONDON – Bivalirudin did not prove superior to unfractionated heparin in reducing the rate of major adverse cardiovascular events in two nested, open-label, randomized clinical trials involving patients presenting with acute coronary syndrome who were expected to undergo percutaneous coronary intervention, Dr. Marco Valgimigli reported.

In addition, post-PCI infusions of bivalirudin for 4 hours or longer did not reduce the rate of adverse bleeding events, compared with no infusion.

These findings add important data to the understanding of antithrombotic therapy in ACS patients undergoing invasive treatment, but they do not resolve the persistent question of which method is best for preventing thrombotic complications while limiting the risk of bleeding during and after such procedures, said Dr. Valgimigli of Erasmus University in Rotterdam.

Previous studies comparing bivalirudin, a direct thrombin inhibitor, against unfractionated heparin, an indirect thrombin inhibitor, have yielded conflicting results regarding ischemic and bleeding outcomes, so Dr. Valgimigli and his fellow investigators in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial conducted two industry-sponsored superiority trials to try to settle the question.

The findings of one of these trials were reported by Dr. Valgimigli at the annual congress of the European Society of Cardiology on Sept. 1, when the results of both were simultaneously published online (N Engl J Med. 2015 Sept 1. doi: 10.1056/NEJMoa1507854).

The MATRIX studies were conducted at 78 medical centers in Italy, the Netherlands, Spain, and Sweden. They involved 7,213 patients who presented with either ST-elevation MI or non-STEMI ACS and were expected to undergo PCI. The first trial, MATRIX Antithrombin, assessed outcomes in 3,610 of these participants who were randomly assigned to receive bivalirudin and 3,603 assigned to receive unfractionated heparin. In the second trial, MATRIX Treatment Duration, the bivalirudin group was further randomized to receive either a post-PCI bivalirudin infusion (1,799 patients) or no post-PCI infusion (1,811 patients).

MATRIX Antithrombin

At 1-month follow-up, the rate of major adverse cardiovascular events (MACEs) – a composite of death from any cause, myocardial infarction, or stroke – was no lower in the bivalirudin group (10.3%) than in the heparin group (10.9%), for a rate ratio of 0.94. Similarly, the rate of net adverse clinical events was not significantly lower with bivalirudin (11.2%) than with heparin (12.4%), for a rate ratio of 0.89.

MATRIX Treatment Duration

The primary outcome in the MATRIX Treatment Duration study – a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events at 30 days – occurred in 11.0% of patients who received post-PCI bivalirudin infusions and 11.9% of those who did not, a nonsignificant difference (rate ratio, 0.91). However, the rate of subacute definite stent thrombosis was significantly higher in the post-PCI infusion group, at 0.7%, compared with 0.2% in the group that didn’t receive post-PCI infusions (RR, 4.37).

“I believe the option to prolong or stop bivalirudin infusion after PCI remains open for clinicians, who will have to decide based on the ischemic and bleeding risk of individual patients as well as, perhaps, based on type of acute coronary syndrome, timing of loading dose, and type of oral P2Y12 inhibitors,” Dr. Valgimigli said, noting that this is in keeping with the current labeling of the drug in Europe and the United States.

The MATRIX study was sponsored by the nonprofit Italian Society of Invasive Cardiology and financially supported by the Medicines Company and Terumo Medical. Dr. Valgimigli reported ties to AstraZeneca, the Medicines Company, Terumo Medical, St. Jude Vascular, Alvimedica, Abbott Vascular, and Correvio; his associates reported ties to numerous industry sources.

Mary Ann Moon contributed to this report.

LONDON – Bivalirudin did not prove superior to unfractionated heparin in reducing the rate of major adverse cardiovascular events in two nested, open-label, randomized clinical trials involving patients presenting with acute coronary syndrome who were expected to undergo percutaneous coronary intervention, Dr. Marco Valgimigli reported.

In addition, post-PCI infusions of bivalirudin for 4 hours or longer did not reduce the rate of adverse bleeding events, compared with no infusion.

These findings add important data to the understanding of antithrombotic therapy in ACS patients undergoing invasive treatment, but they do not resolve the persistent question of which method is best for preventing thrombotic complications while limiting the risk of bleeding during and after such procedures, said Dr. Valgimigli of Erasmus University in Rotterdam.

Previous studies comparing bivalirudin, a direct thrombin inhibitor, against unfractionated heparin, an indirect thrombin inhibitor, have yielded conflicting results regarding ischemic and bleeding outcomes, so Dr. Valgimigli and his fellow investigators in the MATRIX (Minimizing Adverse Hemorrhagic Events by Transradial Access Site and Systemic Implementation of Angiox) trial conducted two industry-sponsored superiority trials to try to settle the question.

The findings of one of these trials were reported by Dr. Valgimigli at the annual congress of the European Society of Cardiology on Sept. 1, when the results of both were simultaneously published online (N Engl J Med. 2015 Sept 1. doi: 10.1056/NEJMoa1507854).

The MATRIX studies were conducted at 78 medical centers in Italy, the Netherlands, Spain, and Sweden. They involved 7,213 patients who presented with either ST-elevation MI or non-STEMI ACS and were expected to undergo PCI. The first trial, MATRIX Antithrombin, assessed outcomes in 3,610 of these participants who were randomly assigned to receive bivalirudin and 3,603 assigned to receive unfractionated heparin. In the second trial, MATRIX Treatment Duration, the bivalirudin group was further randomized to receive either a post-PCI bivalirudin infusion (1,799 patients) or no post-PCI infusion (1,811 patients).

MATRIX Antithrombin

At 1-month follow-up, the rate of major adverse cardiovascular events (MACEs) – a composite of death from any cause, myocardial infarction, or stroke – was no lower in the bivalirudin group (10.3%) than in the heparin group (10.9%), for a rate ratio of 0.94. Similarly, the rate of net adverse clinical events was not significantly lower with bivalirudin (11.2%) than with heparin (12.4%), for a rate ratio of 0.89.

MATRIX Treatment Duration

The primary outcome in the MATRIX Treatment Duration study – a composite of urgent target-vessel revascularization, definite stent thrombosis, or net adverse clinical events at 30 days – occurred in 11.0% of patients who received post-PCI bivalirudin infusions and 11.9% of those who did not, a nonsignificant difference (rate ratio, 0.91). However, the rate of subacute definite stent thrombosis was significantly higher in the post-PCI infusion group, at 0.7%, compared with 0.2% in the group that didn’t receive post-PCI infusions (RR, 4.37).

“I believe the option to prolong or stop bivalirudin infusion after PCI remains open for clinicians, who will have to decide based on the ischemic and bleeding risk of individual patients as well as, perhaps, based on type of acute coronary syndrome, timing of loading dose, and type of oral P2Y12 inhibitors,” Dr. Valgimigli said, noting that this is in keeping with the current labeling of the drug in Europe and the United States.

The MATRIX study was sponsored by the nonprofit Italian Society of Invasive Cardiology and financially supported by the Medicines Company and Terumo Medical. Dr. Valgimigli reported ties to AstraZeneca, the Medicines Company, Terumo Medical, St. Jude Vascular, Alvimedica, Abbott Vascular, and Correvio; his associates reported ties to numerous industry sources.

Mary Ann Moon contributed to this report.

LONDON – Routine catheter ablation that electrically isolates the left atrial appendage safely boosted the success rate of treatment for long-standing, persistent atrial fibrillation in a randomized trial with 173 patients.

This finding from the first prospective randomized trial to test adding routine left atrial appendage (LAA) electrical isolation to the established catheter-ablation protocol of pulmonary-vein isolation should encourage electrophysiologists to make LAA isolation a more standard part of their approach to treating long-standing, persistent atrial fibrillation (Afib), Dr. Jagmeet P. Singh commented in an interview at the annual congress of the European Society of Cardiology.

“A lot of us have, in the past, been hesitant to ablate the LAA” out of concern that it could render the LAA inert and more likely to become a source of blood clots, noted Dr. Singh, professor of medicine at Harvard Medical School and director of the cardiac resynchronization therapy program at Massachusetts General Hospital in Boston. “This study result provides, for the first time in a randomized fashion, direction on this area of ablation.” Based on the results, Dr. Singh said that in his practice now he would “look for LAA activity” when assessing an Afib patient in the electrophysiology laboratory, “and if the LAA was active I would ablate it,” he said.

The BELIEF (Effect of Empirical Left Atrial Appendage Isolation on Long-Term Procedure Outcome in Patients With Persistent or Long-Standing Persistent Atrial Fibrillation Undergoing Catheter Ablation) trial enrolled 173 patients with long-standing persistent Afib that was refractory to treatment with antiarrhythmic drugs at two U.S. centers and randomized them to receive either conventional pulmonary vein isolation alone, or pulmonary vein isolation and additional point ablations to also produce LAA isolation. The study’s primary endpoint was freedom from Afib episodes at 12 months after treatment.

At 12 months after treatment, freedom from Afib recurrence occurred in 48 of the 85 patients (56%) assigned to LAA isolation and in 25 of the 88 patients (25%) treated with pulmonary vein isolation only, a statistically significant difference, reported Dr. Luigi Di Biasi at the congress. In an analysis that adjusted for patient age, sex, and left atrial diameter the addition of LAA ablation linked with a statistically significant 55% reduction in Afib recurrence, said Dr. Di Biasi, director of the arrhythmia service at Montefiore Medical Center in New York.

Adding LAA isolation to the standard ablation procedure did not result in additional complications, said Dr. Di Biasi, although it did increase procedure time by about 15 minutes. The patients who underwent LAA isolation had no strokes during 2 years of follow-up, and no statistically significant change in the incidence of Afib-related hospitalizations or hospitalizations for heart failure, compared with control patients. One pericardial effusion occurred in each of the study arms during follow-up, and there were no deaths during follow-up in either group. LAA isolation resulted in impaired LAA function in about half of the patients who had the isolation procedure, detected by transesophageal echocardiography after the procedure, but the clinical outcomes indicated that this did not appear to affect patients’ stroke risk.

Dr. Singh has been a consultant to Boston Scientific, St. Jude, Medtronic, Sorin, and Biotronik. Dr. Di Biasi has been a consultant to Biosense Webster, Stereotaxis, and St. Jude, and a speaker for Biotronik, Medtronic, Boston Scientific, and Epi EP.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – Routine catheter ablation that electrically isolates the left atrial appendage safely boosted the success rate of treatment for long-standing, persistent atrial fibrillation in a randomized trial with 173 patients.

This finding from the first prospective randomized trial to test adding routine left atrial appendage (LAA) electrical isolation to the established catheter-ablation protocol of pulmonary-vein isolation should encourage electrophysiologists to make LAA isolation a more standard part of their approach to treating long-standing, persistent atrial fibrillation (Afib), Dr. Jagmeet P. Singh commented in an interview at the annual congress of the European Society of Cardiology.

“A lot of us have, in the past, been hesitant to ablate the LAA” out of concern that it could render the LAA inert and more likely to become a source of blood clots, noted Dr. Singh, professor of medicine at Harvard Medical School and director of the cardiac resynchronization therapy program at Massachusetts General Hospital in Boston. “This study result provides, for the first time in a randomized fashion, direction on this area of ablation.” Based on the results, Dr. Singh said that in his practice now he would “look for LAA activity” when assessing an Afib patient in the electrophysiology laboratory, “and if the LAA was active I would ablate it,” he said.

The BELIEF (Effect of Empirical Left Atrial Appendage Isolation on Long-Term Procedure Outcome in Patients With Persistent or Long-Standing Persistent Atrial Fibrillation Undergoing Catheter Ablation) trial enrolled 173 patients with long-standing persistent Afib that was refractory to treatment with antiarrhythmic drugs at two U.S. centers and randomized them to receive either conventional pulmonary vein isolation alone, or pulmonary vein isolation and additional point ablations to also produce LAA isolation. The study’s primary endpoint was freedom from Afib episodes at 12 months after treatment.

At 12 months after treatment, freedom from Afib recurrence occurred in 48 of the 85 patients (56%) assigned to LAA isolation and in 25 of the 88 patients (25%) treated with pulmonary vein isolation only, a statistically significant difference, reported Dr. Luigi Di Biasi at the congress. In an analysis that adjusted for patient age, sex, and left atrial diameter the addition of LAA ablation linked with a statistically significant 55% reduction in Afib recurrence, said Dr. Di Biasi, director of the arrhythmia service at Montefiore Medical Center in New York.

Adding LAA isolation to the standard ablation procedure did not result in additional complications, said Dr. Di Biasi, although it did increase procedure time by about 15 minutes. The patients who underwent LAA isolation had no strokes during 2 years of follow-up, and no statistically significant change in the incidence of Afib-related hospitalizations or hospitalizations for heart failure, compared with control patients. One pericardial effusion occurred in each of the study arms during follow-up, and there were no deaths during follow-up in either group. LAA isolation resulted in impaired LAA function in about half of the patients who had the isolation procedure, detected by transesophageal echocardiography after the procedure, but the clinical outcomes indicated that this did not appear to affect patients’ stroke risk.

Dr. Singh has been a consultant to Boston Scientific, St. Jude, Medtronic, Sorin, and Biotronik. Dr. Di Biasi has been a consultant to Biosense Webster, Stereotaxis, and St. Jude, and a speaker for Biotronik, Medtronic, Boston Scientific, and Epi EP.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – Routine catheter ablation that electrically isolates the left atrial appendage safely boosted the success rate of treatment for long-standing, persistent atrial fibrillation in a randomized trial with 173 patients.

This finding from the first prospective randomized trial to test adding routine left atrial appendage (LAA) electrical isolation to the established catheter-ablation protocol of pulmonary-vein isolation should encourage electrophysiologists to make LAA isolation a more standard part of their approach to treating long-standing, persistent atrial fibrillation (Afib), Dr. Jagmeet P. Singh commented in an interview at the annual congress of the European Society of Cardiology.

“A lot of us have, in the past, been hesitant to ablate the LAA” out of concern that it could render the LAA inert and more likely to become a source of blood clots, noted Dr. Singh, professor of medicine at Harvard Medical School and director of the cardiac resynchronization therapy program at Massachusetts General Hospital in Boston. “This study result provides, for the first time in a randomized fashion, direction on this area of ablation.” Based on the results, Dr. Singh said that in his practice now he would “look for LAA activity” when assessing an Afib patient in the electrophysiology laboratory, “and if the LAA was active I would ablate it,” he said.

The BELIEF (Effect of Empirical Left Atrial Appendage Isolation on Long-Term Procedure Outcome in Patients With Persistent or Long-Standing Persistent Atrial Fibrillation Undergoing Catheter Ablation) trial enrolled 173 patients with long-standing persistent Afib that was refractory to treatment with antiarrhythmic drugs at two U.S. centers and randomized them to receive either conventional pulmonary vein isolation alone, or pulmonary vein isolation and additional point ablations to also produce LAA isolation. The study’s primary endpoint was freedom from Afib episodes at 12 months after treatment.

At 12 months after treatment, freedom from Afib recurrence occurred in 48 of the 85 patients (56%) assigned to LAA isolation and in 25 of the 88 patients (25%) treated with pulmonary vein isolation only, a statistically significant difference, reported Dr. Luigi Di Biasi at the congress. In an analysis that adjusted for patient age, sex, and left atrial diameter the addition of LAA ablation linked with a statistically significant 55% reduction in Afib recurrence, said Dr. Di Biasi, director of the arrhythmia service at Montefiore Medical Center in New York.

Adding LAA isolation to the standard ablation procedure did not result in additional complications, said Dr. Di Biasi, although it did increase procedure time by about 15 minutes. The patients who underwent LAA isolation had no strokes during 2 years of follow-up, and no statistically significant change in the incidence of Afib-related hospitalizations or hospitalizations for heart failure, compared with control patients. One pericardial effusion occurred in each of the study arms during follow-up, and there were no deaths during follow-up in either group. LAA isolation resulted in impaired LAA function in about half of the patients who had the isolation procedure, detected by transesophageal echocardiography after the procedure, but the clinical outcomes indicated that this did not appear to affect patients’ stroke risk.

Dr. Singh has been a consultant to Boston Scientific, St. Jude, Medtronic, Sorin, and Biotronik. Dr. Di Biasi has been a consultant to Biosense Webster, Stereotaxis, and St. Jude, and a speaker for Biotronik, Medtronic, Boston Scientific, and Epi EP.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

LONDON – Aldosterone blockade with oral spironolactone showed a disappointing lack of clinical benefit when initiated in the first hours after an acute MI without heart failure in the large, randomized ALBATROSS trial.

ALBATROSS did, however, flash a silver lining under one wing: A whopping 80% reduction in 6-month mortality in a prespecified subgroup analysis restricted to the 1,229 participants with ST-elevation MI, Dr. Gilles Montalescot reported at the annual congress of the European Society of Cardiology.

Bruce Jancin/Frontline Medical News

Although this finding is intriguing, hypothesis-generating, and definitely warrants a confirmatory study, he continued, mortality was nevertheless merely a secondary endpoint in ALBATROSS (Aldosterone Lethal Effects Blockade in Acute Myocardial Infarction Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up).

In contrast, the primary composite outcome was negative, so the takeaway message is clear: “The results of the ALBATROSS study do not warrant the extension of aldosterone blockade to MI patients without heart failure,” said Dr. Montalescot, professor of cardiology at the University of Paris.

ALBATROSS was a multicenter French trial that randomly assigned 1,603 acute MI patients to standard therapy alone or with added mineralocorticoid antagonist therapy started within the first 2 days of their coronary event. Often the aldosterone antagonist was begun in the ambulance en route to the hospital.

The primary endpoint was a composite of death, resuscitated cardiac arrest, ventricular fibrillation or tachycardia, heart failure, or an indication for an implantable cardioverter defibrillator. There were 194 such events, and they occurred at a similar rate in the patients who got 25 mg/day of spironolactone and those who did not.

The rationale for ALBATROSS was sound, according to the cardiologist. Aldosterone is a stress hormone released in acute MI. It has deleterious cardiac effects, including arrhythmias, heart failure, and a dose-dependent increase in mortality, so it makes good sense to block it as soon as possible in MI patients. In the EPHESUS trial, the aldosterone antagonist eplerenone, when started 3-14 days post MI in patients with early heart failure, significantly reduced mortality (N Engl J Med. 2003 Apr 3;348[14]:1309-2), with the bulk of the benefit occurring in patients in whom the drug was started 3-7 days post MI.

Last year, Dr. Montalescot and his coinvestigators published the REMINDER study, in which 1,012 ST-elevation MI (STEMI) patients without heart failure were randomized to eplerenone or placebo within the first 24 hours. The study showed a significant reduction in levels of brain natriuretic peptide or N-terminal pro-BNP in the eplerenone arm (Eur Heart J. 2014 Sep 7;35[34]:2295-302), but that’s not a clinical endpoint. ALBATROSS was the first study to look at the clinical impact of commencing mineralocorticoid antagonist therapy prior to day 3 post MI.

Discussant Dr. John McMurray, professor of cardiology at the University of Glasgow, said that ALBATROSS was simply underpowered and thus leaves unanswered the clinically important question of whether early initiation of aldosterone blockade post MI in patients without heart failure confers clinical benefit. The investigators projected a total of 269 events in the composite endpoint but got only 194 because the study participants were so well treated and contemporary medical and interventional therapies are quite effective.

He dismissed the sharp reduction seen in 6-month mortality with spironolactone in the STEMI patients as “just implausible – we don’t know of any treatments in medicine that reduce mortality by 80%.”

Noting that there were only 28 deaths in the study, Dr. McMurray asserted that “a subgroup analysis on such a small number of events is never going to give you a reliable result.” Moreover, he added, “subgroup analysis is even more treacherous when the overall trial is underpowered.”

Dr. Montalescot replied that, while he considers the signal of a mortality benefit for aldosterone blockade in STEMI patients worthy of pursuit in a large randomized trial, the prospects for mounting such a study are poor. The medications are now available as generics, so there is no commercial incentive. The French Ministry of Health, which funded ALBATROSS, isn’t prepared to back a follow-up study. The best hope is that eventually one of the pharmaceutical companies developing third-generation aldosterone antagonists, now in phase II studies, will become interested, he said.

Dr. Montalescot said that, while he receives research grants and consulting fees from numerous pharmaceutical companies, these commercial relationships aren’t relevant to the government-funded ALBATROSS trial.

bjancin@frontlinemedcom.com

LONDON – Aldosterone blockade with oral spironolactone showed a disappointing lack of clinical benefit when initiated in the first hours after an acute MI without heart failure in the large, randomized ALBATROSS trial.

ALBATROSS did, however, flash a silver lining under one wing: A whopping 80% reduction in 6-month mortality in a prespecified subgroup analysis restricted to the 1,229 participants with ST-elevation MI, Dr. Gilles Montalescot reported at the annual congress of the European Society of Cardiology.

Bruce Jancin/Frontline Medical News

Although this finding is intriguing, hypothesis-generating, and definitely warrants a confirmatory study, he continued, mortality was nevertheless merely a secondary endpoint in ALBATROSS (Aldosterone Lethal Effects Blockade in Acute Myocardial Infarction Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up).

In contrast, the primary composite outcome was negative, so the takeaway message is clear: “The results of the ALBATROSS study do not warrant the extension of aldosterone blockade to MI patients without heart failure,” said Dr. Montalescot, professor of cardiology at the University of Paris.

ALBATROSS was a multicenter French trial that randomly assigned 1,603 acute MI patients to standard therapy alone or with added mineralocorticoid antagonist therapy started within the first 2 days of their coronary event. Often the aldosterone antagonist was begun in the ambulance en route to the hospital.

The primary endpoint was a composite of death, resuscitated cardiac arrest, ventricular fibrillation or tachycardia, heart failure, or an indication for an implantable cardioverter defibrillator. There were 194 such events, and they occurred at a similar rate in the patients who got 25 mg/day of spironolactone and those who did not.

The rationale for ALBATROSS was sound, according to the cardiologist. Aldosterone is a stress hormone released in acute MI. It has deleterious cardiac effects, including arrhythmias, heart failure, and a dose-dependent increase in mortality, so it makes good sense to block it as soon as possible in MI patients. In the EPHESUS trial, the aldosterone antagonist eplerenone, when started 3-14 days post MI in patients with early heart failure, significantly reduced mortality (N Engl J Med. 2003 Apr 3;348[14]:1309-2), with the bulk of the benefit occurring in patients in whom the drug was started 3-7 days post MI.

Last year, Dr. Montalescot and his coinvestigators published the REMINDER study, in which 1,012 ST-elevation MI (STEMI) patients without heart failure were randomized to eplerenone or placebo within the first 24 hours. The study showed a significant reduction in levels of brain natriuretic peptide or N-terminal pro-BNP in the eplerenone arm (Eur Heart J. 2014 Sep 7;35[34]:2295-302), but that’s not a clinical endpoint. ALBATROSS was the first study to look at the clinical impact of commencing mineralocorticoid antagonist therapy prior to day 3 post MI.

Discussant Dr. John McMurray, professor of cardiology at the University of Glasgow, said that ALBATROSS was simply underpowered and thus leaves unanswered the clinically important question of whether early initiation of aldosterone blockade post MI in patients without heart failure confers clinical benefit. The investigators projected a total of 269 events in the composite endpoint but got only 194 because the study participants were so well treated and contemporary medical and interventional therapies are quite effective.

He dismissed the sharp reduction seen in 6-month mortality with spironolactone in the STEMI patients as “just implausible – we don’t know of any treatments in medicine that reduce mortality by 80%.”

Noting that there were only 28 deaths in the study, Dr. McMurray asserted that “a subgroup analysis on such a small number of events is never going to give you a reliable result.” Moreover, he added, “subgroup analysis is even more treacherous when the overall trial is underpowered.”

Dr. Montalescot replied that, while he considers the signal of a mortality benefit for aldosterone blockade in STEMI patients worthy of pursuit in a large randomized trial, the prospects for mounting such a study are poor. The medications are now available as generics, so there is no commercial incentive. The French Ministry of Health, which funded ALBATROSS, isn’t prepared to back a follow-up study. The best hope is that eventually one of the pharmaceutical companies developing third-generation aldosterone antagonists, now in phase II studies, will become interested, he said.

Dr. Montalescot said that, while he receives research grants and consulting fees from numerous pharmaceutical companies, these commercial relationships aren’t relevant to the government-funded ALBATROSS trial.

bjancin@frontlinemedcom.com

LONDON – Aldosterone blockade with oral spironolactone showed a disappointing lack of clinical benefit when initiated in the first hours after an acute MI without heart failure in the large, randomized ALBATROSS trial.

ALBATROSS did, however, flash a silver lining under one wing: A whopping 80% reduction in 6-month mortality in a prespecified subgroup analysis restricted to the 1,229 participants with ST-elevation MI, Dr. Gilles Montalescot reported at the annual congress of the European Society of Cardiology.

Bruce Jancin/Frontline Medical News

Although this finding is intriguing, hypothesis-generating, and definitely warrants a confirmatory study, he continued, mortality was nevertheless merely a secondary endpoint in ALBATROSS (Aldosterone Lethal Effects Blockade in Acute Myocardial Infarction Treated With or Without Reperfusion to Improve Outcome and Survival at Six Months Follow-up).

In contrast, the primary composite outcome was negative, so the takeaway message is clear: “The results of the ALBATROSS study do not warrant the extension of aldosterone blockade to MI patients without heart failure,” said Dr. Montalescot, professor of cardiology at the University of Paris.

ALBATROSS was a multicenter French trial that randomly assigned 1,603 acute MI patients to standard therapy alone or with added mineralocorticoid antagonist therapy started within the first 2 days of their coronary event. Often the aldosterone antagonist was begun in the ambulance en route to the hospital.

The primary endpoint was a composite of death, resuscitated cardiac arrest, ventricular fibrillation or tachycardia, heart failure, or an indication for an implantable cardioverter defibrillator. There were 194 such events, and they occurred at a similar rate in the patients who got 25 mg/day of spironolactone and those who did not.

The rationale for ALBATROSS was sound, according to the cardiologist. Aldosterone is a stress hormone released in acute MI. It has deleterious cardiac effects, including arrhythmias, heart failure, and a dose-dependent increase in mortality, so it makes good sense to block it as soon as possible in MI patients. In the EPHESUS trial, the aldosterone antagonist eplerenone, when started 3-14 days post MI in patients with early heart failure, significantly reduced mortality (N Engl J Med. 2003 Apr 3;348[14]:1309-2), with the bulk of the benefit occurring in patients in whom the drug was started 3-7 days post MI.

Last year, Dr. Montalescot and his coinvestigators published the REMINDER study, in which 1,012 ST-elevation MI (STEMI) patients without heart failure were randomized to eplerenone or placebo within the first 24 hours. The study showed a significant reduction in levels of brain natriuretic peptide or N-terminal pro-BNP in the eplerenone arm (Eur Heart J. 2014 Sep 7;35[34]:2295-302), but that’s not a clinical endpoint. ALBATROSS was the first study to look at the clinical impact of commencing mineralocorticoid antagonist therapy prior to day 3 post MI.

Discussant Dr. John McMurray, professor of cardiology at the University of Glasgow, said that ALBATROSS was simply underpowered and thus leaves unanswered the clinically important question of whether early initiation of aldosterone blockade post MI in patients without heart failure confers clinical benefit. The investigators projected a total of 269 events in the composite endpoint but got only 194 because the study participants were so well treated and contemporary medical and interventional therapies are quite effective.

He dismissed the sharp reduction seen in 6-month mortality with spironolactone in the STEMI patients as “just implausible – we don’t know of any treatments in medicine that reduce mortality by 80%.”

Noting that there were only 28 deaths in the study, Dr. McMurray asserted that “a subgroup analysis on such a small number of events is never going to give you a reliable result.” Moreover, he added, “subgroup analysis is even more treacherous when the overall trial is underpowered.”

Dr. Montalescot replied that, while he considers the signal of a mortality benefit for aldosterone blockade in STEMI patients worthy of pursuit in a large randomized trial, the prospects for mounting such a study are poor. The medications are now available as generics, so there is no commercial incentive. The French Ministry of Health, which funded ALBATROSS, isn’t prepared to back a follow-up study. The best hope is that eventually one of the pharmaceutical companies developing third-generation aldosterone antagonists, now in phase II studies, will become interested, he said.

Dr. Montalescot said that, while he receives research grants and consulting fees from numerous pharmaceutical companies, these commercial relationships aren’t relevant to the government-funded ALBATROSS trial.

bjancin@frontlinemedcom.com

In cancer patients with acute, symptomatic venous thromboembolisms, daily tinzaparin does not significantly reduce recurrent venous thromboembolisms, overall mortality, or major bleeding compared with warfarin, but does reduce clinically-relevant nonmajor bleeding, according to a 900-patient randomized trial published in JAMA.

Tinzaparin (Innohep) is a low-molecular-weight heparin (LMWH) marketed outside the United States. LMWHs are generally recommended over warfarin to treat acute venous thromboembolism (VTE) in cancer patients, but the recommendation is based mostly on a single trial over a decade old; that might explain why, worldwide, vitamin K antagonists are still heavily used in patients with cancer-associated thrombosis, said the authors, led by Dr. Agnes Lee, of the University of British Columbia (Vancouver).

Courtesy Wikimedia Commons/BruceBlaus/Creative Commons License

To revisit the issue in the modern treatment era, Dr. Lee and her colleagues randomized 449 adults with active cancer and documented deep vein thrombosis or pulmonary embolism to tinzaparin (175 IU/kg) once daily for 6 months, and 451 others to 6 months of conventional therapy with tinzaparin (175 IU/kg) once daily for 5-10 days followed by warfarin dose adjusted to maintain therapeutic range (JAMA. 2015;314[7]:677-86).

The subjects were recruited from 164 centers in Asia, Africa, Europe, Canada, and Central and South America; all had a life expectancy greater than 6 months. The mean age in the study was 59 years, and 60% of the subjects were women. Gynecologic and colorectal cancers were the most common in the study.

Recurrent VTE occurred in 31 patients in the tinzaparin group and 45 in the warfarin group, giving a 6-month cumulative incidence of 7.2% for tinzaparin versus 10.5% for warfarin (hazard ratio [HR] 0.65; 95% CI 0.41-1.03; P = .07).

There was major bleeding in 12 (2.7%) tinzaparin patients and 11 (2.4%) warfarin patients, an insignificant difference (HR 0.89; 95% CI 0.40-1.99; P = .77); 150 tinzaparin patients (33.4%) and 138 warfarin patients (30.6%) died in the trial, also an insignificant difference (HR, 1.08; 95% CI 0.85-1.36; P = .54).

There were 49 (10.9%) clinically relevant but nonmajor bleeds in the tinzaparin group versus 69 (15.3%) among warfarin patients, a difference that was significant (HR 0.58; 95% CI 0.40-0.84; P = .004). Clinically relevant nonmajor bleeding meant nonfatal bleeding outside of a critical area or organ that still required intervention but did not cause a fall in hemoglobin greater than 2 g/dL.

There were fewer than anticipated thrombotic events in the warfarin group. “We had expected a recurrence rate of 12.6% with warfarin; the observed rate was only 10.5%. This potentially affected the power of the trial to detect a benefit associated with tinzaparin.” Also, “a significant reduction in recurrent [VTEs] might be observed with tinzaparin” among patients at higher risk for them than were in the study, the investigators said.

Even so, the trial did demonstrate “that tinzaparin, even when given at a full therapeutic dose for up to 6 months, is safe in a broad oncology population,” they said.

LEO Pharma, makers of tinzaparin, funded the study. The company was involved throughout the trial, including data analysis and approval of the manuscript. Dr. Lee reported honoraria, consulting fees, and research funding from the company. Other authors reported payments from LEO for those or other reasons.

aotto@frontlinemedcom.com

In cancer patients with acute, symptomatic venous thromboembolisms, daily tinzaparin does not significantly reduce recurrent venous thromboembolisms, overall mortality, or major bleeding compared with warfarin, but does reduce clinically-relevant nonmajor bleeding, according to a 900-patient randomized trial published in JAMA.

Tinzaparin (Innohep) is a low-molecular-weight heparin (LMWH) marketed outside the United States. LMWHs are generally recommended over warfarin to treat acute venous thromboembolism (VTE) in cancer patients, but the recommendation is based mostly on a single trial over a decade old; that might explain why, worldwide, vitamin K antagonists are still heavily used in patients with cancer-associated thrombosis, said the authors, led by Dr. Agnes Lee, of the University of British Columbia (Vancouver).

Courtesy Wikimedia Commons/BruceBlaus/Creative Commons License

To revisit the issue in the modern treatment era, Dr. Lee and her colleagues randomized 449 adults with active cancer and documented deep vein thrombosis or pulmonary embolism to tinzaparin (175 IU/kg) once daily for 6 months, and 451 others to 6 months of conventional therapy with tinzaparin (175 IU/kg) once daily for 5-10 days followed by warfarin dose adjusted to maintain therapeutic range (JAMA. 2015;314[7]:677-86).

The subjects were recruited from 164 centers in Asia, Africa, Europe, Canada, and Central and South America; all had a life expectancy greater than 6 months. The mean age in the study was 59 years, and 60% of the subjects were women. Gynecologic and colorectal cancers were the most common in the study.

Recurrent VTE occurred in 31 patients in the tinzaparin group and 45 in the warfarin group, giving a 6-month cumulative incidence of 7.2% for tinzaparin versus 10.5% for warfarin (hazard ratio [HR] 0.65; 95% CI 0.41-1.03; P = .07).

There was major bleeding in 12 (2.7%) tinzaparin patients and 11 (2.4%) warfarin patients, an insignificant difference (HR 0.89; 95% CI 0.40-1.99; P = .77); 150 tinzaparin patients (33.4%) and 138 warfarin patients (30.6%) died in the trial, also an insignificant difference (HR, 1.08; 95% CI 0.85-1.36; P = .54).

There were 49 (10.9%) clinically relevant but nonmajor bleeds in the tinzaparin group versus 69 (15.3%) among warfarin patients, a difference that was significant (HR 0.58; 95% CI 0.40-0.84; P = .004). Clinically relevant nonmajor bleeding meant nonfatal bleeding outside of a critical area or organ that still required intervention but did not cause a fall in hemoglobin greater than 2 g/dL.

There were fewer than anticipated thrombotic events in the warfarin group. “We had expected a recurrence rate of 12.6% with warfarin; the observed rate was only 10.5%. This potentially affected the power of the trial to detect a benefit associated with tinzaparin.” Also, “a significant reduction in recurrent [VTEs] might be observed with tinzaparin” among patients at higher risk for them than were in the study, the investigators said.

Even so, the trial did demonstrate “that tinzaparin, even when given at a full therapeutic dose for up to 6 months, is safe in a broad oncology population,” they said.

LEO Pharma, makers of tinzaparin, funded the study. The company was involved throughout the trial, including data analysis and approval of the manuscript. Dr. Lee reported honoraria, consulting fees, and research funding from the company. Other authors reported payments from LEO for those or other reasons.

aotto@frontlinemedcom.com

In cancer patients with acute, symptomatic venous thromboembolisms, daily tinzaparin does not significantly reduce recurrent venous thromboembolisms, overall mortality, or major bleeding compared with warfarin, but does reduce clinically-relevant nonmajor bleeding, according to a 900-patient randomized trial published in JAMA.

Tinzaparin (Innohep) is a low-molecular-weight heparin (LMWH) marketed outside the United States. LMWHs are generally recommended over warfarin to treat acute venous thromboembolism (VTE) in cancer patients, but the recommendation is based mostly on a single trial over a decade old; that might explain why, worldwide, vitamin K antagonists are still heavily used in patients with cancer-associated thrombosis, said the authors, led by Dr. Agnes Lee, of the University of British Columbia (Vancouver).

Courtesy Wikimedia Commons/BruceBlaus/Creative Commons License

To revisit the issue in the modern treatment era, Dr. Lee and her colleagues randomized 449 adults with active cancer and documented deep vein thrombosis or pulmonary embolism to tinzaparin (175 IU/kg) once daily for 6 months, and 451 others to 6 months of conventional therapy with tinzaparin (175 IU/kg) once daily for 5-10 days followed by warfarin dose adjusted to maintain therapeutic range (JAMA. 2015;314[7]:677-86).

The subjects were recruited from 164 centers in Asia, Africa, Europe, Canada, and Central and South America; all had a life expectancy greater than 6 months. The mean age in the study was 59 years, and 60% of the subjects were women. Gynecologic and colorectal cancers were the most common in the study.

Recurrent VTE occurred in 31 patients in the tinzaparin group and 45 in the warfarin group, giving a 6-month cumulative incidence of 7.2% for tinzaparin versus 10.5% for warfarin (hazard ratio [HR] 0.65; 95% CI 0.41-1.03; P = .07).

There was major bleeding in 12 (2.7%) tinzaparin patients and 11 (2.4%) warfarin patients, an insignificant difference (HR 0.89; 95% CI 0.40-1.99; P = .77); 150 tinzaparin patients (33.4%) and 138 warfarin patients (30.6%) died in the trial, also an insignificant difference (HR, 1.08; 95% CI 0.85-1.36; P = .54).

There were 49 (10.9%) clinically relevant but nonmajor bleeds in the tinzaparin group versus 69 (15.3%) among warfarin patients, a difference that was significant (HR 0.58; 95% CI 0.40-0.84; P = .004). Clinically relevant nonmajor bleeding meant nonfatal bleeding outside of a critical area or organ that still required intervention but did not cause a fall in hemoglobin greater than 2 g/dL.

There were fewer than anticipated thrombotic events in the warfarin group. “We had expected a recurrence rate of 12.6% with warfarin; the observed rate was only 10.5%. This potentially affected the power of the trial to detect a benefit associated with tinzaparin.” Also, “a significant reduction in recurrent [VTEs] might be observed with tinzaparin” among patients at higher risk for them than were in the study, the investigators said.

Even so, the trial did demonstrate “that tinzaparin, even when given at a full therapeutic dose for up to 6 months, is safe in a broad oncology population,” they said.

LEO Pharma, makers of tinzaparin, funded the study. The company was involved throughout the trial, including data analysis and approval of the manuscript. Dr. Lee reported honoraria, consulting fees, and research funding from the company. Other authors reported payments from LEO for those or other reasons.

aotto@frontlinemedcom.com

ESTES PARK, COLO. – Clopidogrel is vastly underutilized in real-world medical management of patients with unstable angina or non–ST-segment elevation MI who don’t undergo coronary revascularization, Dr. Mel L. Anderson said at a conference on internal medicine sponsored by the University of Colorado.

Such patients fall under the umbrella of the so-called CURE indication for clopidogrel, named for the landmark Clopidogrel in Unstable Angina to Prevent Recurrent Events trial. CURE showed that adding clopidogrel to aspirin for an average of 9 months in patients with acute coronary syndrome without ST-segment elevation reduced the major adverse cardiovascular event rate from 11.4% to 9.3% (N Engl J Med. 2001;345[7]:494-502).

Bruce Jancin/Frontline Medical News

Clinical practice has changed enormously since CURE was published in 2001, so a group of investigators decided to see if discharging medically managed ACS patients on clopidogrel is still beneficial in the contemporary setting. They conducted a retrospective observational cohort study of 16,345 Kaiser Permanente Northern California patients with unstable angina or NSTEMI managed medically without percutaneous coronary intervention or coronary artery bypass graft, of whom only 36% were discharged on clopidogrel.

“It’s disappointing that fully two-thirds of patients did not get clopidogrel when they had an indication for it,” commented Dr. Anderson, chief of the hospital medicine section at the Denver VA Medical Center and an internist at the university.

Two-year all-cause mortality was 8.3% in the clopidogrel users, compared with 13% in propensity-matched controls not on clopidogrel, for an adjusted 37% relative risk reduction in favor of the antiplatelet agent (J Am Coll Cardiol. 2014 Jun 3;63[21]:2249-57).

“That’s a number-needed-to-treat of 20. It’s really quite a robust benefit for a drug that’s now generic and has a well-established safety profile,” Dr. Anderson continued.

The 2-year composite outcome of death or MI occurred in 13.5% of the clopidogrel group and 17.4% of controls, for a number-needed-to-treat of about 25. Clopidogrel’s benefit in terms of this composite endpoint achieved significance only among the 65% of participants with NSTEMI, not those with unstable angina.

“Don’t forget the CURE indication for clopidogrel,” the hospitalist concluded.

bjancin@frontlinemedcom.com

ESTES PARK, COLO. – Clopidogrel is vastly underutilized in real-world medical management of patients with unstable angina or non–ST-segment elevation MI who don’t undergo coronary revascularization, Dr. Mel L. Anderson said at a conference on internal medicine sponsored by the University of Colorado.

Such patients fall under the umbrella of the so-called CURE indication for clopidogrel, named for the landmark Clopidogrel in Unstable Angina to Prevent Recurrent Events trial. CURE showed that adding clopidogrel to aspirin for an average of 9 months in patients with acute coronary syndrome without ST-segment elevation reduced the major adverse cardiovascular event rate from 11.4% to 9.3% (N Engl J Med. 2001;345[7]:494-502).

Bruce Jancin/Frontline Medical News

Clinical practice has changed enormously since CURE was published in 2001, so a group of investigators decided to see if discharging medically managed ACS patients on clopidogrel is still beneficial in the contemporary setting. They conducted a retrospective observational cohort study of 16,345 Kaiser Permanente Northern California patients with unstable angina or NSTEMI managed medically without percutaneous coronary intervention or coronary artery bypass graft, of whom only 36% were discharged on clopidogrel.

“It’s disappointing that fully two-thirds of patients did not get clopidogrel when they had an indication for it,” commented Dr. Anderson, chief of the hospital medicine section at the Denver VA Medical Center and an internist at the university.

Two-year all-cause mortality was 8.3% in the clopidogrel users, compared with 13% in propensity-matched controls not on clopidogrel, for an adjusted 37% relative risk reduction in favor of the antiplatelet agent (J Am Coll Cardiol. 2014 Jun 3;63[21]:2249-57).

“That’s a number-needed-to-treat of 20. It’s really quite a robust benefit for a drug that’s now generic and has a well-established safety profile,” Dr. Anderson continued.

The 2-year composite outcome of death or MI occurred in 13.5% of the clopidogrel group and 17.4% of controls, for a number-needed-to-treat of about 25. Clopidogrel’s benefit in terms of this composite endpoint achieved significance only among the 65% of participants with NSTEMI, not those with unstable angina.

“Don’t forget the CURE indication for clopidogrel,” the hospitalist concluded.

bjancin@frontlinemedcom.com

ESTES PARK, COLO. – Clopidogrel is vastly underutilized in real-world medical management of patients with unstable angina or non–ST-segment elevation MI who don’t undergo coronary revascularization, Dr. Mel L. Anderson said at a conference on internal medicine sponsored by the University of Colorado.

Such patients fall under the umbrella of the so-called CURE indication for clopidogrel, named for the landmark Clopidogrel in Unstable Angina to Prevent Recurrent Events trial. CURE showed that adding clopidogrel to aspirin for an average of 9 months in patients with acute coronary syndrome without ST-segment elevation reduced the major adverse cardiovascular event rate from 11.4% to 9.3% (N Engl J Med. 2001;345[7]:494-502).

Bruce Jancin/Frontline Medical News

Clinical practice has changed enormously since CURE was published in 2001, so a group of investigators decided to see if discharging medically managed ACS patients on clopidogrel is still beneficial in the contemporary setting. They conducted a retrospective observational cohort study of 16,345 Kaiser Permanente Northern California patients with unstable angina or NSTEMI managed medically without percutaneous coronary intervention or coronary artery bypass graft, of whom only 36% were discharged on clopidogrel.

“It’s disappointing that fully two-thirds of patients did not get clopidogrel when they had an indication for it,” commented Dr. Anderson, chief of the hospital medicine section at the Denver VA Medical Center and an internist at the university.

Two-year all-cause mortality was 8.3% in the clopidogrel users, compared with 13% in propensity-matched controls not on clopidogrel, for an adjusted 37% relative risk reduction in favor of the antiplatelet agent (J Am Coll Cardiol. 2014 Jun 3;63[21]:2249-57).

“That’s a number-needed-to-treat of 20. It’s really quite a robust benefit for a drug that’s now generic and has a well-established safety profile,” Dr. Anderson continued.

The 2-year composite outcome of death or MI occurred in 13.5% of the clopidogrel group and 17.4% of controls, for a number-needed-to-treat of about 25. Clopidogrel’s benefit in terms of this composite endpoint achieved significance only among the 65% of participants with NSTEMI, not those with unstable angina.

“Don’t forget the CURE indication for clopidogrel,” the hospitalist concluded.

bjancin@frontlinemedcom.com

Adding a mechanical suction technique to local thrombolysis to break up and remove blood clots reduced postthrombotic syndrome (PTS) after deep vein thrombosis (DVT) without causing increased complications, according to a small retrospective study.

Dr. Chun-Yang Huang of the National Yang Ming University (Taipei, Taiwan) and colleagues examined patients diagnosed with acute proximal lower limb DVT. Patients received either thrombolysis alone via a catheter-directed thrombolysis (CDT), or percutaneous mechanical thrombectomy (PMT) by a combination of pharmacologic thrombolysis and suction; both techniques were accompanied by systemic anticoagulation. Though both treatment groups fared well during treatment and for the 12-month follow-up period, the PMT group had a significantly lower incidence of PTS 1 year after treatment (Ann. Vascular Surg. 2015. doi: 10.1016/j.avsg.2015.01.014).

For those with DVT, parenteral anticoagulation prevents propagation of the clot and minimizes risk of pulmonary embolism (PE); however, anticoagulation does not accelerate dissolution of the existing clot. According to study authors, 30%-40% of those with proximal leg DVTs will go on to develop PTS, with the prolonged distal venous stasis from an undisturbed clot causing loss of valvular competence and resultant chronic venous insufficiency. PTS can involve leg swelling, discomfort, skin changes, and ulceration, with significant impact on quality of life and health care costs.

Techniques such as CDT and PMT can increase the rate of clot dissolution, thus restoring patency sooner and minimizing risk for PTS. However, these methods also can carry increased risk of bleeding and infection, considerations that must be balanced against potential benefit.

Investigators reviewed records for 39 patients who were diagnosed with ultrasound- or CT-confirmed acute proximal lower limb DVT and received either CDT or PMT during the period from November 2010 to November 2013. Patients were not randomized to treatment arms but were assigned using clinical judgment and patient preference. During the 12-month follow-up, three participants died of malignancy and two were lost to follow-up. Analysis was completed for the remaining 34 patients.

Overall, patient characteristics did not differ significantly between groups, with mean ages of 62.75 for the PMT group (n = 16) and 64.17 for the CDT group (n = 18). In all, 13/34 participants were female. Patients in both treatment groups fared well, with no 30-day mortality, and no episodes of major bleeding, PE, or renal failure. Ten patients in the PMT group and six in the CDT group required stenting of the common iliac vein to maintain patency, a nonsignificant difference. Just one participant in the CDE group experienced a minor bleeding event.

Turning to outcomes, study authors assessed postprocedure patency, finding improved patency for both procedures (P less than .001 for both, compared with preoperation patency scores), with no significant difference between the two groups post procedure. Thrombus scores were also significantly better for both treatment arms post procedure (P less than .001). Clot burden tended to improve more rapidly over the 12-month follow-up period for the PMT group, though the difference between groups was just short of statistically significant.

At 12 months, though the amount of venous reflux did not differ significantly between groups, those who had received PMT had significantly fewer signs and symptoms of PTS. This assessment used the Villalta scale, a standardized assessment and scoring system for PTS, where higher numbers indicate worse PTS. The PMT group’s Villalta score was 2.06 +/–2.95, compared with 5.06 +/–4.07 for the CDT group (P = .030).

Study limitations included the small study size, retrospective study design, and lack of randomization. Acknowledging these limitations, Dr. Huang and coauthors called for larger, multicenter, randomized controlled studies of PMT. The personal and economic costs of PTS, they argue, warrant exploring whether PMT may help minimize total thrombolysis dose, reduce hospital stays, and decrease costs while minimizing the risks of chronic venous insufficiency post DVT.

Dr. Huang and coauthors reported no conflicts of interest.

Adding a mechanical suction technique to local thrombolysis to break up and remove blood clots reduced postthrombotic syndrome (PTS) after deep vein thrombosis (DVT) without causing increased complications, according to a small retrospective study.

Dr. Chun-Yang Huang of the National Yang Ming University (Taipei, Taiwan) and colleagues examined patients diagnosed with acute proximal lower limb DVT. Patients received either thrombolysis alone via a catheter-directed thrombolysis (CDT), or percutaneous mechanical thrombectomy (PMT) by a combination of pharmacologic thrombolysis and suction; both techniques were accompanied by systemic anticoagulation. Though both treatment groups fared well during treatment and for the 12-month follow-up period, the PMT group had a significantly lower incidence of PTS 1 year after treatment (Ann. Vascular Surg. 2015. doi: 10.1016/j.avsg.2015.01.014).

For those with DVT, parenteral anticoagulation prevents propagation of the clot and minimizes risk of pulmonary embolism (PE); however, anticoagulation does not accelerate dissolution of the existing clot. According to study authors, 30%-40% of those with proximal leg DVTs will go on to develop PTS, with the prolonged distal venous stasis from an undisturbed clot causing loss of valvular competence and resultant chronic venous insufficiency. PTS can involve leg swelling, discomfort, skin changes, and ulceration, with significant impact on quality of life and health care costs.

Techniques such as CDT and PMT can increase the rate of clot dissolution, thus restoring patency sooner and minimizing risk for PTS. However, these methods also can carry increased risk of bleeding and infection, considerations that must be balanced against potential benefit.

Investigators reviewed records for 39 patients who were diagnosed with ultrasound- or CT-confirmed acute proximal lower limb DVT and received either CDT or PMT during the period from November 2010 to November 2013. Patients were not randomized to treatment arms but were assigned using clinical judgment and patient preference. During the 12-month follow-up, three participants died of malignancy and two were lost to follow-up. Analysis was completed for the remaining 34 patients.

Overall, patient characteristics did not differ significantly between groups, with mean ages of 62.75 for the PMT group (n = 16) and 64.17 for the CDT group (n = 18). In all, 13/34 participants were female. Patients in both treatment groups fared well, with no 30-day mortality, and no episodes of major bleeding, PE, or renal failure. Ten patients in the PMT group and six in the CDT group required stenting of the common iliac vein to maintain patency, a nonsignificant difference. Just one participant in the CDE group experienced a minor bleeding event.

Turning to outcomes, study authors assessed postprocedure patency, finding improved patency for both procedures (P less than .001 for both, compared with preoperation patency scores), with no significant difference between the two groups post procedure. Thrombus scores were also significantly better for both treatment arms post procedure (P less than .001). Clot burden tended to improve more rapidly over the 12-month follow-up period for the PMT group, though the difference between groups was just short of statistically significant.

At 12 months, though the amount of venous reflux did not differ significantly between groups, those who had received PMT had significantly fewer signs and symptoms of PTS. This assessment used the Villalta scale, a standardized assessment and scoring system for PTS, where higher numbers indicate worse PTS. The PMT group’s Villalta score was 2.06 +/–2.95, compared with 5.06 +/–4.07 for the CDT group (P = .030).

Study limitations included the small study size, retrospective study design, and lack of randomization. Acknowledging these limitations, Dr. Huang and coauthors called for larger, multicenter, randomized controlled studies of PMT. The personal and economic costs of PTS, they argue, warrant exploring whether PMT may help minimize total thrombolysis dose, reduce hospital stays, and decrease costs while minimizing the risks of chronic venous insufficiency post DVT.

Dr. Huang and coauthors reported no conflicts of interest.

Adding a mechanical suction technique to local thrombolysis to break up and remove blood clots reduced postthrombotic syndrome (PTS) after deep vein thrombosis (DVT) without causing increased complications, according to a small retrospective study.

Dr. Chun-Yang Huang of the National Yang Ming University (Taipei, Taiwan) and colleagues examined patients diagnosed with acute proximal lower limb DVT. Patients received either thrombolysis alone via a catheter-directed thrombolysis (CDT), or percutaneous mechanical thrombectomy (PMT) by a combination of pharmacologic thrombolysis and suction; both techniques were accompanied by systemic anticoagulation. Though both treatment groups fared well during treatment and for the 12-month follow-up period, the PMT group had a significantly lower incidence of PTS 1 year after treatment (Ann. Vascular Surg. 2015. doi: 10.1016/j.avsg.2015.01.014).

For those with DVT, parenteral anticoagulation prevents propagation of the clot and minimizes risk of pulmonary embolism (PE); however, anticoagulation does not accelerate dissolution of the existing clot. According to study authors, 30%-40% of those with proximal leg DVTs will go on to develop PTS, with the prolonged distal venous stasis from an undisturbed clot causing loss of valvular competence and resultant chronic venous insufficiency. PTS can involve leg swelling, discomfort, skin changes, and ulceration, with significant impact on quality of life and health care costs.

Techniques such as CDT and PMT can increase the rate of clot dissolution, thus restoring patency sooner and minimizing risk for PTS. However, these methods also can carry increased risk of bleeding and infection, considerations that must be balanced against potential benefit.

Investigators reviewed records for 39 patients who were diagnosed with ultrasound- or CT-confirmed acute proximal lower limb DVT and received either CDT or PMT during the period from November 2010 to November 2013. Patients were not randomized to treatment arms but were assigned using clinical judgment and patient preference. During the 12-month follow-up, three participants died of malignancy and two were lost to follow-up. Analysis was completed for the remaining 34 patients.

Overall, patient characteristics did not differ significantly between groups, with mean ages of 62.75 for the PMT group (n = 16) and 64.17 for the CDT group (n = 18). In all, 13/34 participants were female. Patients in both treatment groups fared well, with no 30-day mortality, and no episodes of major bleeding, PE, or renal failure. Ten patients in the PMT group and six in the CDT group required stenting of the common iliac vein to maintain patency, a nonsignificant difference. Just one participant in the CDE group experienced a minor bleeding event.

Turning to outcomes, study authors assessed postprocedure patency, finding improved patency for both procedures (P less than .001 for both, compared with preoperation patency scores), with no significant difference between the two groups post procedure. Thrombus scores were also significantly better for both treatment arms post procedure (P less than .001). Clot burden tended to improve more rapidly over the 12-month follow-up period for the PMT group, though the difference between groups was just short of statistically significant.

At 12 months, though the amount of venous reflux did not differ significantly between groups, those who had received PMT had significantly fewer signs and symptoms of PTS. This assessment used the Villalta scale, a standardized assessment and scoring system for PTS, where higher numbers indicate worse PTS. The PMT group’s Villalta score was 2.06 +/–2.95, compared with 5.06 +/–4.07 for the CDT group (P = .030).

Study limitations included the small study size, retrospective study design, and lack of randomization. Acknowledging these limitations, Dr. Huang and coauthors called for larger, multicenter, randomized controlled studies of PMT. The personal and economic costs of PTS, they argue, warrant exploring whether PMT may help minimize total thrombolysis dose, reduce hospital stays, and decrease costs while minimizing the risks of chronic venous insufficiency post DVT.

Dr. Huang and coauthors reported no conflicts of interest.

Endovascular stenting is a safe and effective way to treat iliofemoral obstructions in patients with postthrombotic syndrome, according to Dr. M. Yin of Shanghai (China) JiaoTong University, and associates.

The stenting process was achieved without major complications in 95% of cases. Cumulative primary, assisted primary, and secondary patency rates after 3 years were 69%, 79%, and 92%, respectively. Patients with severe postthrombotic syndrome (PTS) saw a significant drop in their Villalta score, compared with patients treated with elastic compression stockings (ECS) therapy, though scores were similar in patients with moderate PTS in both groups. The 24-month recurrence-free ulcer healing rate was significantly higher in the stenting group (87% vs. 71%).

“ECS therapy shows equal clinical effects with stent placement in patients with moderate PTS,” but the stented patients did not have to wear stockings after the procedure, the researchers wrote.

Find the full study in the European Journal of Vascular & Endovascular Surgery (doi: 10.1016/j.ejvs.2015.03.029).

Endovascular stenting is a safe and effective way to treat iliofemoral obstructions in patients with postthrombotic syndrome, according to Dr. M. Yin of Shanghai (China) JiaoTong University, and associates.

The stenting process was achieved without major complications in 95% of cases. Cumulative primary, assisted primary, and secondary patency rates after 3 years were 69%, 79%, and 92%, respectively. Patients with severe postthrombotic syndrome (PTS) saw a significant drop in their Villalta score, compared with patients treated with elastic compression stockings (ECS) therapy, though scores were similar in patients with moderate PTS in both groups. The 24-month recurrence-free ulcer healing rate was significantly higher in the stenting group (87% vs. 71%).

“ECS therapy shows equal clinical effects with stent placement in patients with moderate PTS,” but the stented patients did not have to wear stockings after the procedure, the researchers wrote.

Find the full study in the European Journal of Vascular & Endovascular Surgery (doi: 10.1016/j.ejvs.2015.03.029).

Endovascular stenting is a safe and effective way to treat iliofemoral obstructions in patients with postthrombotic syndrome, according to Dr. M. Yin of Shanghai (China) JiaoTong University, and associates.

The stenting process was achieved without major complications in 95% of cases. Cumulative primary, assisted primary, and secondary patency rates after 3 years were 69%, 79%, and 92%, respectively. Patients with severe postthrombotic syndrome (PTS) saw a significant drop in their Villalta score, compared with patients treated with elastic compression stockings (ECS) therapy, though scores were similar in patients with moderate PTS in both groups. The 24-month recurrence-free ulcer healing rate was significantly higher in the stenting group (87% vs. 71%).

“ECS therapy shows equal clinical effects with stent placement in patients with moderate PTS,” but the stented patients did not have to wear stockings after the procedure, the researchers wrote.

Find the full study in the European Journal of Vascular & Endovascular Surgery (doi: 10.1016/j.ejvs.2015.03.029).

Venous thromboembolism is common in patients undergoing oxaliplatin, capecitabine, and epirubicin chemotherapy for esophagogastric cancer, according to Dr. Anders Christian Larsen of Aalborg (Denmark) University Hospital and associates.

There were 21 cases of VTE among the 129 patients with esophagogastric cancer, a rate of 16%. Of the VTE cases, 14 were asymptomatic and 7 were symptomatic. Gastric cancer and late-stage cancer were significant VTE risk factors, with odds ratios of 6.4 and 5.2, respectively. The median survival time was 18 months in non-VTE patients and 14 months in VTE patients.

“The extent of treatment-related VTE in upper GI cancer patients (with active cancer) receiving both chemotherapy and curative intended surgery may be greater than previously estimated. … Our data demonstrate the need to address this clinical problem with randomized clinical trials on VTE prophylaxis, particularly in patients undergoing neoadjuvant chemotherapy for resectable cancer disease,” the investigators concluded.

The authors said that there were no conflicts; the study was funded by private foundations.

Find the full study in Thrombosis Research.

lfranki@frontlinemedcom.com

Venous thromboembolism is common in patients undergoing oxaliplatin, capecitabine, and epirubicin chemotherapy for esophagogastric cancer, according to Dr. Anders Christian Larsen of Aalborg (Denmark) University Hospital and associates.

There were 21 cases of VTE among the 129 patients with esophagogastric cancer, a rate of 16%. Of the VTE cases, 14 were asymptomatic and 7 were symptomatic. Gastric cancer and late-stage cancer were significant VTE risk factors, with odds ratios of 6.4 and 5.2, respectively. The median survival time was 18 months in non-VTE patients and 14 months in VTE patients.

“The extent of treatment-related VTE in upper GI cancer patients (with active cancer) receiving both chemotherapy and curative intended surgery may be greater than previously estimated. … Our data demonstrate the need to address this clinical problem with randomized clinical trials on VTE prophylaxis, particularly in patients undergoing neoadjuvant chemotherapy for resectable cancer disease,” the investigators concluded.

The authors said that there were no conflicts; the study was funded by private foundations.

Find the full study in Thrombosis Research.

lfranki@frontlinemedcom.com

Venous thromboembolism is common in patients undergoing oxaliplatin, capecitabine, and epirubicin chemotherapy for esophagogastric cancer, according to Dr. Anders Christian Larsen of Aalborg (Denmark) University Hospital and associates.

There were 21 cases of VTE among the 129 patients with esophagogastric cancer, a rate of 16%. Of the VTE cases, 14 were asymptomatic and 7 were symptomatic. Gastric cancer and late-stage cancer were significant VTE risk factors, with odds ratios of 6.4 and 5.2, respectively. The median survival time was 18 months in non-VTE patients and 14 months in VTE patients.

“The extent of treatment-related VTE in upper GI cancer patients (with active cancer) receiving both chemotherapy and curative intended surgery may be greater than previously estimated. … Our data demonstrate the need to address this clinical problem with randomized clinical trials on VTE prophylaxis, particularly in patients undergoing neoadjuvant chemotherapy for resectable cancer disease,” the investigators concluded.

The authors said that there were no conflicts; the study was funded by private foundations.

Find the full study in Thrombosis Research.

lfranki@frontlinemedcom.com

Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

mbock@frontlinemedcom.com

Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

mbock@frontlinemedcom.com

Rivaroxaban has been recommended by the U.K. National Institute for Health and Care Excellence (NICE) as a treatment option for prevention of blood clots in adults who have had acute coronary syndrome with elevated cardiac biomarkers, the agency announced in a statement.

NICE officials recommended rivaroxaban (Xarelto), in combination with aspirin plus clopidogrel or aspirin alone, as an option for preventing atherothrombotic events in patients who have had a heart attack. Assessment of clinical-effectiveness evidence was based on data from an international, multicenter, randomized controlled trial. An independent appraisal committee considered clinical and cost-effectiveness evidence before making the recommendation.

Rivaroxaban, manufactured by Bayer and marketed by Janssen Pharmaceuticals, is an orally active direct factor Xa inhibitor.

Clinicians should regularly reassess the benefits and risks of continuing treatment with rivaroxaban, the agency recommended, and a decision on continuation of treatment should be made no later than 12 months after starting treatment.

Read the full guideline statement here.

mbock@frontlinemedcom.com