This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Pieper, K. S. Articles by Harrington, R. A. Search for Related Content PubMed PubMed Citation Articles by Pieper, K. S. Articles by Harrington, R. A.

(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

This article has been cited by other articles:

				R. P. Giugliano, J. A. White, C. Bode, P. W. Armstrong, G. Montalescot, B. S. Lewis, A. van `t Hof, L. G. Berdan, K. L. Lee, J. T. Strony, et al. Early versus Delayed, Provisional Eptifibatide in Acute Coronary Syndromes N. Engl. J. Med., May 21, 2009; 360(21): 2176 - 2190. [Abstract] [Full Text] [PDF]

				C. W. Hamm, H. Möllmann, J.-P. Bassand, and F. van de Werf CHAPTER 16 Acute Coronary Syndromes ESC Textbook of Cardiovascular Medicine, January 1, 2009; 2(1): med-9780199566990-chapter - med-9780199566990-chapter. [Abstract] [Full Text] [PDF]

				A. V Hernandez, C. M Westerhout, E. W Steyerberg, J. P A Ioannidis, H. Bueno, H. White, P. Theroux, D. J Moliterno, P. W Armstrong, R. M Califf, et al. The authors' reply: Heart, October 1, 2007; 93(10): 1293 - 1293. [Full Text] [PDF]

				Authors/Task Force Members, J.-P. Bassand, C. W. Hamm, D. Ardissino, E. Boersma, A. Budaj, F. Fernandez-Aviles, K. A.A. Fox, D. Hasdai, E. M. Ohman, et al. Guidelines for the diagnosis and treatment of non-ST-segment elevation acute coronary syndromes: The Task Force for the Diagnosis and Treatment of Non-ST-Segment Elevation Acute Coronary Syndromes of the European Society of Cardiology Eur. Heart J., July 1, 2007; 28(13): 1598 - 1660. [Full Text] [PDF]

				K. W. Mahaffey and R. A. Harrington Optimal Timing for Use of Glycoprotein IIb/IIIa Inhibitors in Acute Coronary Syndromes: Questions, Answers, and More Questions JAMA, February 14, 2007; 297(6): 636 - 639. [Full Text] [PDF]

				P. W. Armstrong, W.-C. Chang, L. Wallentin, P. Goldstein, C. B. Granger, K. Bogaerts, T. Danays, F. Van de Werf, and for the ASSENT-3 and ASSENT-3 PLUS Investigators Efficacy and safety of unfractionated heparin versus enoxaparin: a pooled analysis of ASSENT-3 and -3 PLUS data. Can. Med. Assoc. J., May 9, 2006; 174(10): 1421 - 1426. [Abstract] [Full Text] [PDF]

				R. Glaser, H. A. Glick, H. C. Herrmann, and S. E. Kimmel The Role of Risk Stratification in the Decision to Provide Upstream Versus Selective Glycoprotein IIb/IIIa Inhibitors for Acute Coronary Syndromes: A Cost-Effectiveness Analysis J. Am. Coll. Cardiol., February 7, 2006; 47(3): 529 - 537. [Abstract] [Full Text] [PDF]

				SYNERGY Trial Investigators Enoxaparin vs Unfractionated Heparin in High-Risk Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Managed With an Intended Early Invasive Strategy: Primary Results of the SYNERGY Randomized Trial JAMA, July 7, 2004; 292(1): 45 - 54. [Abstract] [Full Text] [PDF]

				J. L. Petersen, K. W. Mahaffey, V. Hasselblad, E. M. Antman, M. Cohen, S. G. Goodman, A. Langer, M. A. Blazing, A. Le-Moigne-Amrani, J. A. de Lemos, et al. Efficacy and Bleeding Complications Among Patients Randomized to Enoxaparin or Unfractionated Heparin for Antithrombin Therapy in Non-ST-Segment Elevation Acute Coronary Syndromes: A Systematic Overview JAMA, July 7, 2004; 292(1): 89 - 96. [Abstract] [Full Text] [PDF]