A costly drug frequently used to treat patients with heart disease may offer no greater benefit than standard medications, say Yale researchers. Their study calls into question widespread use of the drug bivalirudin (Angiomax) during stent procedures.
Principal investigator Dr. Behnood Bikdeli and his co-authors at Yale and McMaster University in Canada conducted one of the largest meta-analyses of bivalirudin trials, involving more than 40,000 cardiac patients.
They reviewed outcomes for patients treated with ''percutaneous coronary intervention'' - a common procedure that involves placing a stent in blood vessels of the heart 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 either bivalirudin or other standard anti-coagulants, most commonly the drug heparin.
The researchers found that although patients on bivalirudin had lower risk of bleeding, that benefit came at the cost of increased risk of clots in the stents (stent thrombosis). They also found no difference in the rates of heart attack or mortality from any cause.
''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,'' says Bikdeli.
''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.''
The study published early online this month in Thrombosis Research.