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Eric J. Topol, MD; James J. Ferguson, MD; Harlan F. Weisman, MD; James E. Tcheng, MD; Stephen G. Ellis, MD; Neal S. Kleiman, MD; Russell J. Ivanhoe, MD; Ann L. Wang; David P. Miller, MS; Keaven M. Anderson, PhD; Robert M. Califf, MD

JAMA. 1997;278(6):479-484.

Abstract
Context.
—Avciximab,lonal antibody fragment against the platelet receptor _llbβ₃ integrin, prevents platelet aggregation. A randomized, placebo-controlled study showed that abciximab improves outcomes for patients undergoing percutaneous coronary angioplasty at 30 days and at 6 months.

Objective.
—to determine whether abciximab improves outcomes 3 years after coronary angioplasty.

Design.
—Double-blind, placebo-controlled, randomized trial.

Setting.
—A total of 56 academic and community hospitals in the United States.

Patients.
—A total of 2099 high-risk patients undergoing coronary angioplasty were randomized. Sufficient time elapsed for 2.5 years of follow-up among 2001 patients and for 3 years of follow-up among 1599 patients.

Intervention.
—Abciximab bolus of 0.25 mg/kg followed by infusion at 10 µg/min for 12 hours; abciximab bolus of 0.25 mg/kg followed by placebo infusion; or placebo bolus followed by placebo infusion.

Main Outcomes Measures.
—The primary outcome was the composite of death, myocardial infarction, or coronary revascularization. Secondary outcomes were death, myocardial infarction, or coronary revascularization individually. Subgroups having refractory unstable angina or evolving myocardial infarction and having different elevations of creatine kinase during initial angioplasty were analyzed.

Results.
—At 3 years, composite end points occurred in 41.1% of those receiving abciximab bolus plus infusion; 47.4% of those receiving abciximab bolus only; and 47.2% of those receiving placebo only (for abciximab bolus plus infusion vs placebo, P=.009). Death occurred in 6.8%, 8.0%, and 8.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.20); myocardial infarction in 10.7%, 12.2%, and 13.6%, respectively (for abciximab bolus plus infusion vs placebo, P=.08); and revascularization in 34.8%, 38.6%, and 40.1%, respectively (for abciximab bolus plus infusion vs placebo, P=.02). Among those with refractory unstable angina or evolving myocardial infarction, death occurred in 5.1%, 9.2%, and 12.7%, respectively (for abciximab bolus plus infusion vs placebo, P=.01). Death rates increased as periprocedural creatine kinase levels increased.

Conclusions.
—Adciximab bolus with infusion given at the time of coronary angioplasty improves outcomes as long as 3 years after the procedure.

Author Affiliations
for the EPIC Investigator Group

From the Department of Cardiology, Cleveland Clinic Foundation, Cleveland, Ohio (Drs Topol and Ellis and Mr Miller); Baylor College of Medicine (Dr Kleiman) and the Division of Cardiology, Texas Heart Institute (Dr Ferguson), Houston; Florida Heart Group, Orlando (Dr Ivanhoe); Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, NC (Drs Tcheng and Califf); and Centocor, Malvern, Pa (Drs Weisman and Anderson and Ms Wang).

Footnotes
A complete list of the Evaluation of Platelet llb/llla Inhibition for Prevention of Ischemic Complication (EPIC) Investigator Group can be found in Lancet. 1994;343: 881-886.

Reprints: Eric J. Topol, MD, Desk F25, Department of Cardiology, Cleveland Clinic Foundation, Cleveland, OH 44195 (e-mail: topole@cesmtp.ccf.org).

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