NEW YORK (Reuters Health) – Compared with unfractionated heparin, bivalirudin used for anticoagulation in unselected patients undergoing percutaneous coronary intervention is associated with less bleeding after 1 month and 1 year, and with no greater risk of major adverse cardiac events (MACE). The findings are reported in the American Journal of Cardiology online September 10.
“It confirms, in a real-world setting, the impressive results obtained in the large-scale randomized trials of bivalirudin for elective and urgent coronary stenting procedures,” senior author Dr. Frederic Resnic told Reuters Health.
“On the basis of the large randomized trials, I believe that bivalirudin has become the standard of care for most patients undergoing coronary interventional procedures if they present with an acute coronary syndrome such as unstable angina or a non ST segment elevation myocardial
infarction (NSTEMI),” he added.
Dr. Resnic, with Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, and colleagues studied 3367 consecutive patients who underwent PCI over a 40-month period. Two-thirds (2228) received unfractionated heparin and one-third (1139) received bivalirudin.
“In a propensity-score matched analysis, bivalirudin-based anticoagulation strategy was associated with lower bleeding complications at 30 days (7.0% vs 13.7%, p=0.001) and 1 year (12.7% vs 18.9%, p=0.013),” according to the report.
On the other hand, MACE rates were no worse with bivalirudin than UFH at 30 days (6.4% vs 8.3%; p=0.103) and at 1 year (9.4% vs 10.9%; p=0.449).
Dr. Resnic said these results indicate that the benefits seen in clinical trials can also be expected “in an ‘all-comers’ clinical practice, which did not have the restrictions of inclusion and exclusion criteria like a randomized trial always has in place.”
Are there any circumstances where bivalirudin is contraindicated? “We are cautious when using it as the only anticoagulant in someone with a major heart attack (STEMI), and make sure that the patients are adequately treated with anti-platelet drugs,” Dr. Resnic said. “We excluded STEMI patients from our analysis, though subsequent review has certainly not shown any problems in this group.”
He added, “We also do not use bivalirudin when we are concerned about bleeding around the heart, which has an increased chance of happening when we try to open an artery that has been completely blocked for months or years. For these “chronic total occlusions” we tend to use unfractionated heparin which can be easily and quickly reversed using protamine.”
Overall, he and his conclude in their paper, “The 1-year findings of our study presented in this report validate the durable efficacy of bivalirudin in routine clinical practice.”
Am J Cardiol 2010
