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Previous Volume 350:232-238 January 15, 2004 Number 3 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Lange, R. A. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention after pretreatment with clopidogrel is unknown.

Methods We enrolled 2159 patients with coronary artery disease who underwent a percutaneous coronary intervention: 1079 patients were randomly assigned in a double-blind manner to receive abciximab and 1080 patients to receive placebo. All patients were pretreated with a 600-mg dose of clopidogrel at least two hours before the procedure. The primary end point of the trial was the composite of death, myocardial infarction, and urgent target-vessel revascularization within 30 days after randomization.

Results The incidence of the primary end point was 4 percent (45 patients) in the abciximab group, as compared with 4 percent (43 patients) in the placebo group (relative risk, 1.05; 95 percent confidence interval, 0.69 to 1.59; P=0.82). Most adverse events were myocardial infarctions: the incidence was 4 percent (40 patients) in the abciximab group and 4 percent (41 patients) in the placebo group (P=0.91). Twelve patients (1 percent) in the abciximab group and eight patients (1 percent) in the placebo group had major bleeding complications (P=0.37). Profound thrombocytopenia occurred in 10 patients (1 percent) in the abciximab group but in none in the placebo group (P=0.002).

Conclusions Our data suggest that in patients at low-to-intermediate risk who undergo elective percutaneous coronary intervention after pretreatment with a high loading dose of clopidogrel, abciximab is associated with no clinically measurable benefit within the first 30 days.

Source Information

From Deutsches Herzzentrum, Munich, Germany (A.K., J.M., H.S., C.V., M.G., A.S.); First Medizinische Klinik rechts der Isar, Munich, Germany (J.D., H.B., A.S.); Medizinische Klinik I, Garmisch-Partenkirchen, Germany (F.D.); St. Antonius Ziekenhuis, Nieuwegein, the Netherlands (J.M.B.); Herz-Zentrum, Bad Krozingen, Germany (F.-J.N.); and the Mayo Clinic, Rochester, Minn. (P.B.B.).

Address reprint requests to Dr. Kastrati at Deutsches Herzzentrum, Lazarettstr. 36, 80636 Munich, Germany, or at kastrati{at}dhm.mhn.de.

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