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Previous Volume 344:1888-1894 June 21, 2001 Number 25 Next

	Full Text PDF Editorial by Throckmorton, D. C. Editorial by Boden, W. E. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background In the setting of percutaneous coronary revascularization, agents in the class known as platelet glycoprotein IIb/IIIa inhibitors have significantly reduced the incidence of death or nonfatal myocardial infarction at 30 days. We assessed whether there are differences in safety or efficacy between two such inhibitors, tirofiban and abciximab.

Methods Using a double-blind, double-dummy design at 149 hospitals in 18 countries, we randomly assigned patients to receive either tirofiban or abciximab before undergoing percutaneous coronary revascularization with the intent to perform stenting. The primary end point was a composite of death, nonfatal myocardial infarction, or urgent target-vessel revascularization at 30 days. The trial was designed and statistically powered to demonstrate the noninferiority of tirofiban as compared with abciximab.

Results The primary end point occurred more frequently among the 2398 patients in the tirofiban group than among the 2411 patients in the abciximab group (7.6 percent vs. 6.0 percent; hazard ratio, 1.26; one-sided 95 percent confidence interval of 1.51, demonstrating lack of equivalence, and two-sided 95 percent confidence interval of 1.01 to 1.57, demonstrating the superiority of abciximab over tirofiban; P=0.038). The magnitude and the direction of the effect were similar for each component of the composite end point (hazard ratio for death, 1.21; hazard ratio for myocardial infarction, 1.27; and hazard ratio for urgent target-vessel revascularization, 1.26), and the difference in the incidence of myocardial infarction between the tirofiban group and the abciximab group was significant (6.9 percent and 5.4 percent, respectively; P=0.04). The relative benefit of abciximab was consistent regardless of age, sex, the presence or absence of diabetes, or the presence or absence of pretreatment with clopidogrel. There were no significant differences in the rates of major bleeding complications or transfusions, but tirofiban was associated with a lower rate of minor bleeding episodes and thrombocytopenia.

Conclusions Although the trial was intended to assess the noninferiority of tirofiban as compared with abciximab, the findings demonstrated that tirofiban offered less protection from major ischemic events than did abciximab.

Source Information

From the Cleveland Clinic Foundation, Cleveland (E.J.T., D.J.M.); the University of Pennsylvania Medical Center, Philadelphia (H.C.H.); the University of Virginia School of Medicine, Charlottesville (E.R.P.); William Beaumont Hospital, Royal Oak, Mich. (C.L.G.); Beth Israel Deaconess Hospital, Boston (D.J.C.); Sunnybrook and Women's College Health Sciences Centre, Toronto (E.A.C.); Hôpital Cardiologique, Lille, France (M.B.); Medizinische Klinik der Technischen Universität München, Munich, Germany (F.-J.N.); Lenox Hill Hospital, New York (G.W.S.); and Merck, West Point, Pa. (P.M.D., L.D.).

Other authors were Steven J. Yakubov, M.D. (Riverside Methodist Hospital, Columbus, Ohio), and Paul T. DeLucca, Ph.D. (Merck, West Point, Pa.).

Address reprint requests to Dr. Topol at the Department of Cardiology, Desk F25, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, OH 44195, or at topole{at}ccf.org.

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