(Circulation. 1999;99:1951-1958.)
© 1999 American Heart Association, Inc.
Clinical Investigation and Reports |
Sustained Suppression of Ischemic Complications of Coronary Intervention by Platelet GP IIb/IIIa Blockade With Abciximab
One-Year Outcome in the EPILOG Trial
From the Departments of Cardiology or Biostatistics and Epidemiology, The Cleveland Clinic Foundation, Cleveland, Ohio (A.M.L., J.E.B., C.B., E.J.T.); the Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, NC (J.E.T., R.M.C.); Christ Hospital, Cincinnati, Ohio (D.J.K.); Moses Cone Memorial Hospital, Greensboro, NC (T.A.K.); William Beaumont Hospital, Royal Oak, Mich (G.C.T.); Baylor College of Medicine and the Methodist Hospital, Houston, Tex (N.S.K.); and Centocor, Malvern, Pa (C.F.C., K.M.A., H.F.W.).
Correspondence to A. Michael Lincoff, MD, Department of Cardiology, Desk F25, The Cleveland Clinic Foundation, Cleveland, OH 44195.
Background—Blockade of the platelet glycoprotein IIb/IIIa receptor with the monoclonal antibody fragment abciximab was shown in a placebo-controlled randomized trial to reduce the incidence of acute ischemic complications within 30 days among a broad spectrum of patients undergoing percutaneous coronary revascularization. The durability of clinical benefit in this setting has not been established.
Methods and Results—A total of 2792 patients enrolled in the Evaluation in PTCA to Improve Long-term Outcome with abciximab GP IIb/IIIa blockade (EPILOG) trial were followed with maintenance of double-blinding for 1 year. Patients had been assigned at the time of their index coronary interventional procedure to receive placebo with standard-dose, weight-adjusted heparin (100 U/kg initial bolus), abciximab with standard-dose, weight-adjusted heparin, or abciximab with low-dose, weight-adjusted heparin (70 U/kg initial bolus). The primary outcome was the composite of death, myocardial infarction, or urgent repeat revascularization by 30 days; this composite end point and its individual components were also assessed at 6 months and 1 year. Rates of any repeat revascularization (urgent or elective), target vessel revascularization, and a composite of death, myocardial infarction, or any repeat revascularization were also reported. Follow-up at 1 year was 99% complete for survival status and 97% complete for other end points. By 1 year, the incidence of the primary composite end point was 16.1% in the placebo group, 9.6% in the abciximab with low-dose heparin group (P<0.001), and 9.5% in the abciximab with standard-dose heparin group (P<0.001). Each of the components of this composite end point was reduced to a similar extent. Nonurgent or target vessel repeat revascularization rates were not significantly decreased by abciximab therapy. Mortality rates over 1 year increased with increasing levels of periprocedural creatine kinase MB fraction elevation.
Conclusions—Acute reductions in ischemic events after percutaneous coronary intervention by abciximab are sustained over follow-up to at least 1 year. Early periprocedural myocardial infarctions suppressed by this therapy are associated with long-term mortality rates.
Key Words: angioplasty • glycoproteins • receptors • revascularization • thrombosis • platelets
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