Anticlotting Therapies Similarly Effective in Patients Undergoing PCI

Orlando—Two commonly used anticlotting regimens—abciximab with unfractionated heparin and bivalirudin—were similarly effective in preventing death, subsequent myocardial infarction (MI), or need for further revascularization in patients with non–ST-segment elevation MI (non-STEMI) undergoing percutaneous coronary intervention (PCI), according to Adnan Kastrati, MD, lead researcher for the ISAR-REACT 4 (Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment) study. The findings were presented at the AHA meeting and reported in the New England Journal of Medicine [2011;365(21):1980-1989]. In this randomized, double-blind, active-controlled, multicenter efficacy study, immediately before PCI, researchers randomized 1721 patients with acute non-STEMI to receive abciximab plus heparin (n=861) or bivalirudin (n=860) to determine which of these 2 medications is more effective to prevent thrombotic and bleeding complications in patients suffering from a heart attack and undergoing PCI. Of the abciximab plus heparin group, 69.7% had hypercholesterolemia, 86.5% had arterial hypertension, and 29.8% had diabetes. In the bivalirudin group, 67.4% had hypercholesterolemia, 84.5% had arterial hypertension, and 28.3% had diabetes. The primary composite end point was death, large recurrent MI, urgent target-vessel revascularization (TVR), or major bleeding within 30 days. Secondary end points included safety and efficacy based on primary outcomes. The primary end point occurred in 10.9% of the patients (n=94) taking abciximab and heparin and in 11.0% of patients (n=95) taking bivalirudin (relative risk [RR] with abciximab, 0.99; 95% confidence interval [CI], 0.74-1.32; P=.94). The secondary efficacy end point of death, any recurrent MI, or urgent TVR occurred in 12.8% of patients (n=110) taking abciximab plus heparin and 13.4% of patients (n=115) taking bivalirudin (RR, 0.96; 95% CI, 0.74-1.25; P=.76). As for major bleeding, 4.7% of patients (n=40) taking abciximab and heparin experienced this complication, compared with 2.6% of patients (n=22) taking bivalirudin (RR, 1.84; 95% CI, 1.10-3.07; P=.02). Dr. Kastrati explained that the results indicate patients receiving the abciximab plus heparin combination faced about an 80% greater relative risk of bleeding. “Understanding which treatment works better is important because non-STEMI heart attack patients are in danger of further cardiovascular problems,” said Dr. Kastrati. “The results of PCI in these patients are strongly dependent on the efficacy and safety of the anticlotting drugs used during the procedure.” In conclusion, abciximab and heparin, as compared with bivalirudin, failed to reduce the rate of the primary end point and increased the risk of bleeding among patients with non-STEMI undergoing PCI. “These findings...show that bivalirudin might be the preferred drug in patients undergoing PCI for an acute MI, with or without ST-segment elevation,” Dr. Kastrati said.