Context Abciximab, a potent inhibitor of the platelet glycoprotein IIb/IIIa
receptor, reduces thrombotic complications in patients undergoing percutan
eous coronary intervention (PCI), Because of its potent inhibition of plate
let 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, r
andomized trials (EPIC, CAPTURE, EPILOG, and EPISTENT) conducted between No
vember 1991 and October 1997 at a total of 257 academic and community hospi
tals in the United States and Europe.
Patients A total of 8555 patients undergoing PCI with or without stent depl
oyment for a variety of indications were randomly assigned to receive a bol
us and infusion of abciximab (n=5476) or matching placebo (n=3079). One tre
atment group in EPIC received a bolus of abciximab only.
Main Outcome Measure Risk of hemorrhagic and nonhemorrhagic stroke within 3
0 days of treatment among abciximab and placebo groups.
Results No significant difference in stroke rate was observed between patie
nts 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 str
okes (0.30%) among 3023 patients who received placebo and 15 (0.32%) in 468
0 patients treated with abciximab bolus plus infusion, a difference of 0.02
% (95% confidence interval [Cl], -0.23% to 0.28%), The rate of nonhemorrhag
ic stroke was 0.17% in patients treated with abciximab and 0.20% in patient
s treated with placebo (difference, -0.03%; 95% Cl, -0.23% to 0.17%), and t
he rates of hemorrhagic stroke were 0.15% and 0.10%, respectively (differen
ce, 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 h
eparin 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.