Bivalirudin Anticoagulation in PCI Has Benefits

October 2009

By Mary Ann Moon
Elsevier Global Medical News

The use of bivalirudin during primary percutaneous coronary intervention yielded superior outcomes as long as 1 year later, compared with the use of standard anticoagulant therapy, according to a report published in Lancet.

Bivalirudin, a direct thrombin inhibitor, substantially reduced the rates of major bleeding, net adverse clinical events, all-cause mortality, cardiac mortality, and reinfarction for a full year following the procedure, compared with heparin plus a glycoprotein IIb/IIIa inhibitor, said Dr. Roxana Mehran of the division of cardiology at Columbia University, New York, and her associates in the HORIZONS-AMI clinical trial.

Almost all of bivalirudin's long-term benefits were attributed to its inhibition of major bleeding.

"These results, now replicated in three consecutive prospective trials in more than 23,000 patients, suggest that the prevention of early bleeding complications reduces the occurrence of both late and early mortality," the investigators wrote.

Dr. Mehran and her colleagues previously published the 30-day results of the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial, which showed that patients who received bivalirudin during primary PCI had lower 1-month rates of bleeding and thrombocytopenia, higher rates of survival, and similar rates of ischemic events as did those who received heparin plus either abciximab or eptifibatide. This latest report comes from the results of 1-year follow-up among 3,398 patients treated at 123 medical centers in this international, open-label study funded by Boston Scientific Corp. and the Medicines Company.

Patients randomly assigned to receive bivalirudin during PCI had a lower rate of major bleeding (5.8%) 1 year later than did those assigned to receive standard anticoagulation (9.2%), and a resulting lower rate of net adverse clinical events (15.6% vs. 18.3%).

The 1-year rates of cardiac mortality (2.1%) and all-cause mortality (3.5%) also were significantly lower than those with standard anticoagulant therapy (3.8% and 4.8%, respectively).

"The difference in survival between study groups widened between 30 days and 1 year, with approximately 17 cardiac deaths and 13 all-cause deaths prevented per 1,000 patients (number needed to treat to prevent 1 cardiac death and 1 all-cause death approximately 59 and 77 patients, respectively)."

These beneficial effects were independent of the type of stent placed during PCI.

The mortality benefit "might be attributable to the prevention of iatrogenic hemorrhagic complications. The rates of all-cause mortality, cardiac mortality, and stroke were all five times higher in patients who had major bleeding than in those who did not. Additionally, the rate of reinfarction in patients who had major bleeding was twice the rate in those without major bleeding," Dr. Mehran and her associates wrote (Lancet 2009 [doi:10.1016/S0140-6736(09)61484-7]).

"Early bleeding might lead to late mortality through a variety of mechanisms, including long-lasting adverse effects from transfusions and the discontinuation of antiplatelet agents, beta-blockers, and angiotensin-converting enzyme inhibitors, which might not be restarted," they said.

The researchers previously had found that stent thrombosis within the first 24 hours of PCI was more frequent in patients assigned to bivalirudin than to those assigned to standard anticoagulation therapy. "However, between 24 hours and 1 year, stent thrombosis was more frequent in the heparin-plus-GPI group than in the bivalirudin group. As a result, at the end of 1-year follow-up, the rate of stent thrombosis was similar in the two groups," they added.

Dr. Mehran reported receiving lecture fees from Boston Scientific and the Medicines Company.

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