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CLINICAL STUDY: GENDER ISSUE AND CAD

Is glycoprotein IIb/IIIa antagonism as effective in women as in men following percutaneous coronary intervention?

Lessons from the ESPRIT study

Laura S. Fernandes, MD^*, James E. Tcheng, MD, FACC, J. Conor O’Shea, MD, Bonnie Weiner, MD, FACC, Todd J. Lorenz, MD, Cindy Pacchiana, MS, Lisa G. Berdan, PA-C, Kelly J. Maresh, RN^*, Diane Joseph, BS, Mina Madan, MD^||, Tift Mann, MD, FACC^¶, Rakhi Kilaru, MS, Judith S. Hochman, MD, FACC^**, Neal S. Kleiman, MD, FACC^*,* ESPRIT Investigators

^* Baylor College of Medicine and the Methodist DeBakey Heart Center, Houston Texas, USA
Duke Clinical Research Institute, Durham, North Carolina, USA
University of Massachusetts, Worcester, Massachusetts, USA
COR Therapeutics, South San Francisco, California, USA
^|| Sunnybrook and Women’s College Health Sciences Centre, Toronto, Ontario, Canada
^¶ Wake Heart Associates, Raleigh, North Carolina, USA
^** Columbia University and St. Luke’s Roosevelt Hospital, New York, New York, USA

Manuscript received October 24, 2001; revised manuscript received June 5, 2002, accepted June 12, 2002.

^* Reprint requests and correspondence: Dr. Neal S. Kleiman, The Methodist Hospital, 6565 Fannin Street, F-1090, Houston, Texas 77030, USA.
nkleiman{at}bcm.tmc.edu

OBJECTIVES: The study was done to determine whether eptifibatide, a platelet glycoprotein (GP) IIb/IIIa antagonist, prevents ischemic complications following percutaneous coronary interventions (PCIs) in women as well as in men.

BACKGROUND: Eptifibatide reduces ischemic complications after nonurgent coronary stent interventions.

METHODS: We compared outcomes in women (n = 562) and men (n = 1,502) enrolled in the Enhanced Suppression of the Platelet GP IIb/IIIa Receptor with Integrilin Therapy (ESPRIT) trial of double-bolus eptifibatide during PCI.

RESULTS: Women in the ESPRIT trial were older, and more frequently had hypertension, diabetes mellitus, or acute coronary syndromes, but were less likely to have prior PCI or coronary artery bypass graft surgery. The primary end point, a composite at 48 h of death, myocardial infarction (MI), urgent target vessel revascularization (TVR), and unplanned GP IIb/IIIa use, occurred in 10.5% of women and 7.9% of men (p = 0.082). The composite of death, MI, or TVR after one year occurred in 24.5% of women compared with 18% of men (p = 0.0008). At 48 h, eptifibatide reduced the composite of death, MI, and TVR from 14.5% to 6.0% in women versus 9.0% to 6.8% in men. At one year, these differences persisted: 28.9% versus 20.0% for women and 19.5% versus 16.6% for men. No statistical interaction existed between treatment and gender at either 48 h (p = 0.063) or one year (p = 0.2). Bleeding occurred more commonly in women (5.5% vs. 2.6%, p = 0.002), and was more common in eptifibatide-treated women. After adjustment for age, weight, and hypertension, no interaction between treatment and gender was present.

CONCLUSIONS: Eptifibatide is effective to prevent ischemic complications of PCI in women and may eliminate gender-related differences in PCI outcomes.

Abbreviations and Acronyms   CABG   coronary artery bypass graft surgery   CI   confidence interval   ESPRIT   Enhanced Suppression of the Platelet GP IIb/IIIa Receptor with Integrilin Therapy   GP   glycoprotein   HR   hazards ratio   MI   myocardial infarction   OR   odds ratio   PCI   percutaneous coronary intervention   PTCA   percutaneous transluminal coronary angioplasty   PURSUIT   Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Integrilin Therapy   TIMI   Thrombolysis In Myocardial Infarction trial   TVR   target vessel revascularization

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