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Yale Study Questions Benefit of Anticlotting Drug Bivalirudin (Angiomax)

Reduced risk of major bleeds comes with increased risk of stent thrombosis

A costly drug often used to treat patients with heart disease may offer no greater benefit than standard medications, according to Yale researchers. Their study calls into question the widespread use of bivalirudin (Angiomax) during stent procedures.

Principal investigator Dr. Behnood Bikdeli and his co-authors at Yale and McMaster University in Canada analyzed the results from 25 trials of bivalirudin involving a total of 41,243 cardiac patients. They focused on outcomes for patients receiving percutaneous coronary intervention — a common procedure used to open narrowed arteries or to treat a blood clot in the setting of an acute heart attack. Patients who were prescribed medications and blood thinners received bivalirudin or other standard anticoagulants, most commonly heparin.

The researchers found that although patients receiving bivalirudin had a lower risk of bleeding compared with the control group, that benefit came at the cost of an increased risk of stent thrombosis. They also found no difference in the rates of heart attack or mortality from any cause.

Overall, the use of bivalirudin compared with an active control was associated with a significantly increased risk of definite stent thrombosis (11 trials; 16,864 patients; risk ratio [RR], 1.73; P < 0.001); a similar risk of acute myocardial infarction (22 trials; 40,578 patients; RR, 1.00; P = 0.96); a significantly decreased risk of major bleeding (25 trials; 41,243 patients; RR, 0.59; P < 0.001); and a decreased risk of cardiac death (six trials; 6,956 patients; RR, 0.72; P = 0.05), but no change in all-cause mortality (24 trials; 41,058 patients; RR, 0.96; P = 0.69).

“The take-home message is that, essentially, we didn’t find a net benefit with bivalirudin. In our extensive analyses, we could not identify any patient subgroups that had less bleeding but no increase in the risk of clots, or stent thrombosis,” Bikdeli said. “This expensive medication, which is being used in a widespread manner, is not doing a slam-dunk better job. We might need more studies to see if a select minority of patients could potentially fare better with it.”

Sources: Yale University; June 25, 2015; and Thrombosis Research; June 6, 2015.


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