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Abciximab Adds No Benefit to Clopidogrel in Low- and Intermediate-Risk PCI

Routine use of platelet glycoprotein IIb/IIIa inhibitors during percutaneous coronary intervention (PCI) has shown the greatest benefits in patients with high risk for complications and in those with inadequate platelet antagonism. Now, in a partially industry-supported, multicenter, double-blind trial, researchers randomized 2159 low- and intermediate-risk patients (>95% in Europe) to placebo or the GPIIb/IIIa inhibitor abciximab. Among the exclusion criteria were recent MI, unstable angina, troponin T elevation, visible thrombus, and insulin-dependent diabetes. All subjects received a 600-mg loading dose of clopidogrel at least 2 hours before elective PCI; heparin was administered in fixed, weight-based doses.

Incidence of the primary endpoint (death, MI, or urgent target-vessel revascularization by 30 days) was similar in the two groups (about 4% in each), as were incidences of the endpoint components. Age, sex, and diabetes status did not affect the findings. The two groups had similar rates of both major and minor bleeding, although severe thrombocytopenia occurred only with abciximab (incidence, 1%). Transfusions also were more common with abciximab (2%) than with placebo (1%).

Comment: These data suggest that patients with low or intermediate risk for PCI complications derive no additional benefit from abciximab beyond that provided by a 600-mg loading dose of clopidogrel administered at least 2 hours before the intervention. Unfortunately, as the editorialists note, as many as two thirds of patients who undergo PCI in the U.S. would be considered at higher risk than the patients in this study. Furthermore, most U.S. patients undergo PCI immediately after diagnostic angiography; therefore, a long delay to administer clopidogrel would be impractical. Further study limitations are a wide 95% confidence interval for the primary endpoint and heparin use that was not guided by the activated clotting time.

— Howard C. Herrmann, MD

Published in Journal Watch Cardiology December 31, 2004

Citation(s):

Kastrati A et al. for the Intracoronary Stenting and Antithrombotic Regimen-Rapid Early Action for Coronary Treatment (ISAR-REACT) Study Investigators. A clinical trial of abciximab in elective percutaneous coronary intervention after pretreatment with clopidogrel. N Engl J Med 2004 Jan 15; 350:232-8.

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• Medline abstract (Free)

Lange RA and Hillis LD. Antiplatelet therapy for ischemic heart disease. N Engl J Med 2004 Jan 15; 350:277-80.

• Original article (Subscription may be required)
• Medline abstract (Free)