CLINICAL STUDIES
Reduction in complications of angioplasty with abciximab occurs largely independently of baseline lesion morphology
Stephen G. Ellis, MD*,
A. Michael Lincoff, MD*,
Dave Miller, MS ,
James E. Tcheng, MD ,
Neal S. Kleiman, MD ,
Dean Kereiakes, MD||,
Robert Califf, MD ,
Eric J. Topol, MD* for the EPIC and EPILOG Investigators
* Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Department of Biostatistics, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
Department of Cardiology, Duke University Medical Center, Durham, North Carolina, USA
University of Texas, Houston, Texas, USA
|| The Christ Hospital, Cincinnati, Ohio, USA
Manuscript received March 17, 1998;
revised manuscript received July 7, 1998,
accepted July 24, 1998.
Address for correspondence: Dr. Stephen G. Ellis, The Cleveland Clinic Foundation, 9500 Euclid Avenue, F-25, Cleveland, Ohio 44195 elliss{at}cesmtp.ccf.org
Objectives. We investigated the hypothesis that abciximab might lead to a differential effect among patients with different lesion morphologies; hence, its cost/benefit ratio would be optimized if it were used selectively on the basis of baseline angiographic findings.
Background. Major complications of coronary angioplasty occur in 4% to 9% of patients. In the Evaluation of 7E3 for the Prevention of Ischemic Complications (EPIC) and Evaluation of PTCA To Improve Long-term Outcome with abciximab GPIIb/IIIa Receptor Blockade (EPILOG) trials, abciximab decreased the ischemic complications after intervention by 35% to 56%. However, the cost of this agent is appreciable, and there remain concerns about the safety of its readministration.
Methods. There were 1,362 patients in EPIC and 2,792 patients in EPILOG randomized to either bolus plus an infusion of abciximab or placebo, administered with aspirin and heparin at the time of the coronary intervention. Data from these studies were combined, and a differential effect of abciximab in relation to baseline lesion morphology on 30-day risk of death, myocardial infarction or urgent intervention was investigated using the Breslow Day test for statistical interaction.
Results. Abciximab consistently reduced the relative risk of complications across all lesion morphologies studied, with the possible exception of patients treated with degenerated saphenous vein grafts (risk with placebo 16.3% vs. risk with abciximab 18.6%, Breslow Day test for interaction, p = 0.08). However, the absolute reduction of risk was somewhat greater in patients with more complex B2 or C lesions (7.6% and 5.8%, respectively) than in patients with morphologically simpler A or B1 lesions (3.7% and 3.2%, respectively).
Conclusions. The reduction of early adverse ischemic events associated with angioplasty by abciximab occurs largely independent of pretreatment morphology.
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Abbreviations and Acronyms
| | ACC/AHA | = American College of Cardiology/American Heart Association | | ACT | = activated clotting time | | EPIC | = Evaluation of 7E3 for the Prevention of Ischemic Complications (trial) | | EPILOG | = Evaluation of PTCA To Improve Long-term Outcome by c7E3 GPIIb/IIIa Receptor Blockade (trial) | | GP | = glycoprotein |
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