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Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT--a double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary inte

Abstract：

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 (> or = 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.

journal_name

Am Heart J

journal_title

American heart journal

authors

Schühlen H,Kastrati A,Mehilli J,Hausleiter J,Dirschinger J,Dotzer F,Bollwein H,Schömig A

doi

10.1016/j.ahj.2005.08.002

subject

Has Abstract

pub_date

2006-06-01 00:00:00

pages

1248-54

issue

eissn

0002-8703

issn

1097-6744

pii

S0002-8703(05)00785-4

journal_volume

151

pub_type

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Abciximab and angiographic restenosis after coronary stent placement. Analysis of the angiographic substudy of ISAR-REACT--a double-blind, placebo-controlled, randomized trial evaluating abciximab in patients undergoing elective percutaneous coronary inte