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CLINICAL STUDIES

Clinical benefit of glycoprotein IIb/IIIa blockade with abciximab is independent of gender

Pooled analysis from EPIC, EPILOG and EPISTENT trials

Leslie Cho, MD^a, Eric J. Topol, MD, FACC^a, Craig Balog, BA^a, Joanne M. Foody, MD^a, Joan E. Booth, RN^a, Catherine Cabot, MD^*, Neal S. Kleiman, MD, FACC, James E. Tcheng, MD, FACC, Robert Califf, MD, FACC and A. Michael Lincoff, MD, FACC^a

^a Department of Cardiology, The Cleveland Clinic Foundation, Cleveland, Ohio, USA
^* Centocor Incorporated, Cleveland, Ohio, USA
Baylor College of Medicine, Houston, Texas, USA
Duke Clinical Research Institute, Duke University, Durham, North Carolina, USA

Manuscript received August 13, 1999; revised manuscript received February 11, 2000, accepted March 30, 2000.

Reprint requests and correspondence to: Dr. A. Michael Lincoff, Desk F25, The Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, Ohio 44195
lincofa{at}ccf.org

OBJECTIVES

We sought to determine the efficacy and safety of platelet glycoprotein IIb/IIIa receptor (GP IIb/IIIa) blockade with abciximab in women undergoing percutaneous coronary intervention.

BACKGROUND

Although gender differences in response to platelet glycoprotein IIb/IIIa receptor blockade have been described, there have been no large clinical studies to assess these differences.

METHODS

Outcomes were determined using meta-analysis technique.

RESULTS

In the pooled analysis, the primary end point of death, myocardial infarction (MI) or urgent revascularization within 30 days was reduced from 11.3% to 5.8% (p < 0.001) in men and from 12.7% to 6.5% (p < 0.001) in women treated with abciximab. At six months, death, MI or urgent revascularization was reduced from 14.1% to 8.3% (p < 0.001) in men and 16.0% to 9.9% (p < 0.001) in women receiving abciximab. At one year, mortality was reduced from 2.7% to 1.9% (p = 0.06) in men and 4.0% to 2.5% (p = 0.03) in women treated with abciximab. Major bleeding events occurred in 2.9% versus 3.0% (p = 0.96) of women and 2.7% versus 1.3% (p = 0.003) of men treated with placebo versus abciximab, respectively. Minor bleeding events occurred in 4.7% versus 6.7% (p = 0.01) of women and 2.3% versus 2.2% (p = 0.94) of men treated with placebo versus abciximab, respectively.

CONCLUSIONS

This pooled analysis demonstrated no gender difference in protection from major adverse outcomes with GP IIb/IIIa inhibition with abciximab. Although women had higher rates of both major and minor bleeding events with abciximab compared with men, major bleeding in women was similar with and without abciximab. There was a small increased risk of minor bleeding with abciximab in women.

Abbreviations and Acronyms   ACC/AHA = American College of Cardiology/American Heart Association   ACT = activated clotting time   CABG = coronary artery bypass graft   CHF = congestive heart failure   EPIC = Evaluation of 7E3 for the Prevention of Ischemic Complications trial   EPILOG = Evaluation of Percutaneous Transluminal Coronary Angioplasty to Improve Long-Term Outcome with Abciximab Glycoprotein IIb/IIIa Blockade trial   EPISTENT = Evaluation of Platelet IIb/IIIa Inhibitor for Stenting trial   GP IIb/IIIa = Glycoprotein IIb/IIIa receptor   MI = myocardial infarction   PCI = percutaneous coronary intervention   PTT = partial thromboplastin time

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