Risk of stroke associated with abciximab among patients undergoing percutaneous coronary intervention

Context Abciximab, a potent inhibitor of the platelet glycoprotein IIb/IIIa receptor, reduces thrombotic complications in patients undergoing percutaneous coronary intervention (PCI), Because of its potent inhibition of platelet aggregation, the effect of abciximab on risk of stroke is a concern. Objective To determine whether abciximab use among patients undergoing PCI is associated with an increased risk of stroke. Design Combined analysis of data from 4 double-blind, placebo-controlled, randomized trials (EPIC, CAPTURE, EPILOG, and EPISTENT) conducted between November 1991 and October 1997 at a total of 257 academic and community hospitals in the United States and Europe. Patients A total of 8555 patients undergoing PCI with or without stent deployment for a variety of indications were randomly assigned to receive a bolus and infusion of abciximab (n=5476) or matching placebo (n=3079). One treatment group in EPIC received a bolus of abciximab only. Main Outcome Measure Risk of hemorrhagic and nonhemorrhagic stroke within 30 days of treatment among abciximab and placebo groups. Results No significant difference in stroke rate was observed between patients assigned abciximab (n=22 [0.40%]) and those assigned placebo (n=9 [0.29%]; P=.46). Excluding the EPIC abciximab bolus-only group, there were 9 strokes (0.30%) among 3023 patients who received placebo and 15 (0.32%) in 4680 patients treated with abciximab bolus plus infusion, a difference of 0.02% (95% confidence interval [Cl], -0.23% to 0.28%), The rate of nonhemorrhagic stroke was 0.17% in patients treated with abciximab and 0.20% in patients treated with placebo (difference, -0.03%; 95% Cl, -0.23% to 0.17%), and the rates of hemorrhagic stroke were 0.15% and 0.10%, respectively (difference, 0.05%; 95% CI, -0.11% to 0.21%), Among patients treated with abciximab, the rate of hemorrhagic stroke in patients receiving standard-dose heparin in EPIC, CAPTURE, and EPILOG was higher than in those receiving low-dose heparin in the EPILOG and EPISTENT trials (0.27% vs 0.04%; P=.057). Conclusions Abciximab in addition to aspirin and heparin does not increase the risk of stroke in patients;undergoing PCI, Patients undergoing PCI and treated with abciximab should receive low-dose, weight-adjusted heparin.