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(Circulation. 2004;109:641-646.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Differential Treatment Benefit of Platelet Glycoprotein IIb/IIIa Inhibition With Percutaneous Coronary Intervention Versus Medical Therapy for Acute Coronary Syndromes

Exploration of Methods

Karen S. Pieper, MS; Anastasios A. Tsiatis, PhD; Marie Davidian, PhD; Vic Hasselblad, PhD; Neal S. Kleiman, MD; Eric Boersma, PhD; Wei-Ching Chang, PhD; Jeffrey Griffin, MS; Paul W. Armstrong, MD; Robert M. Califf, MD; Robert A. Harrington, MD

From the Duke Clinical Research Institute and Departments of Medicine (K.S.P., J.G., R.M.C., R.A.H.) and Genomics and Biostatistics (V.H.), Duke University Medical Center, Durham, NC; Department of Statistics (A.A.T., M.D.), North Carolina State University, Raleigh, NC; Baylor College of Medicine/Texas Medical Center (N.S.K.), Houston, Tex; Erasmus Medical Center (E.B.), Rotterdam, the Netherlands; and the University of Alberta (W-C.C., P.W.A.), Edmonton, Alberta, Canada.

Correspondence to Karen S. Pieper, MS, Duke Clinical Research Institute, PO Box 17969, Durham, NC 27715. E-mail karen.pieper{at}duke.edu

Received June 23, 2003; revision received October 23, 2003; accepted October 31, 2003.

Background— Although many believe that platelet glycoprotein IIb/IIIa inhibitors should be used only in acute coronary syndrome patients undergoing percutaneous coronary intervention, supporting data from randomized clinical trials are tenuous. The assumption that these agents are useful only in conjunction with percutaneous coronary intervention is based primarily on inappropriate subgroup analyses performed across the glycoprotein IIb/IIIa inhibitor trials.

Methods and Results— We describe the problems with these analytical techniques and demonstrate that different approaches to the question can result in opposing answers.

Conclusions— Clinical-practice decisions and practice guidelines should be based on overall trial results and not analyses of post-randomization subgroups.

Key Words: trials • glycoproteins • coronary disease

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