ReoPro abciximab: Phase IV data

Researchers at Deutsches Herzzentrum and colleagues reported data from the double-blind, international Phase IV ISAR-REACT 4 trial in 1,721 patients with acute with non-ST-segment-elevation myocardial infarction (NSTEMI) undergoing PCI showing that ReoPro plus unfractionated heparin missed the primary endpoint of significantly reducing a composite of death, MI, urgent TVR and major bleeding at 30 days vs. bivalirudin (10.9% vs. 11%, p=0.94). ReoPro plus heparin also missed the secondary endpoint of significantly reducing a composite of death, MI and urgent TVR vs. bivalirudin (12.8% vs. 13.4%, p=0.76). Additionally, the rate of major bleeding was significantly higher for ReoPro plus heparin vs. bivalirudin (4.6% vs. 2.6%, p=0.02). All patients received aspirin and clopidogrel prior to receiving the study drugs. Data were presented at the American Heart Association meeting in Orlando and published in the New England Journal of Medicine. The Nycomed unit of Takeda Pharmaceutical Co. Ltd. (Tokyo:4502, Osaka, Japan), which was a former distributor of bivalirudin in Europe, funded the trial. ...