Background: ISAR-REACT was a trial designed to evaluate whether the glycoprotein IIb/IIIa inhibitor abciximab is beneficial in patients undergoing elective percutaneous coronary intervention(PCI) with stent placement after pretreatment with a 600 mg loading dose of clopidogrel. Objective for the angiographic substudy was to determine the impact of abciximab on angiographic restenosis after coronary stent placement. Previous analyses have suggested a reduction in the incidence of restenosis after the administration of abciximab. Methods: The angiographic substudy comprises 1885 of 2159 patients enrolled in ISAR-REACT: 994 patients were randomly assigned to abciximab and 941 patients to placebo. All patients were scheduled for a routine angiographic follow-up after 6 months(performed in 80%of eligible patients). End points for the angiographic substudy were the rates of angiographic restenosis(≥50%diameter stenosis) and target lesion revascularization. Results: The incidence of angiographic restenosis was 27%in the abciximab group and 29%in the placebo group(relative risk 0.92, 95%CI 0.79-1.06, P=.27). Late angiographic lumen loss was 0.95±0.68 and 0.99±0.70 mm, respectively(P=.25). Similar results were obtained in a subgroup analysis focusing on high-risk subsets. The rate of target lesion revascularization procedures was 22%in the abciximab group and 23%in the placebo group(relative risk 0.94, 95%CI 0.79-1.12, P=.52). Conclusions: In low-to intermediate-risk patients who undergo elective PCI after pretreatment with a high loading dose of clopidogrel >2 hours before PCI, the additional administration of the glycoprotein IIb/IIIa inhibitor abciximab is not associated with a significant reduction in angiographic restenosis.
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