Abstract 3244: Abciximab Effect on Clinical and Angiographic Restenosis in High-Risk Patients with Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention. Results of the ISAR-REACT 2 Trial
Restenosis remains an important limitation of percutaneous coronary interventions (PCI). Adjunctive abciximab therapy has been shown to reduce restenosis risk in some, but not all PCI studies. Recently, we showed in the ISAR-SWEET trial that abciximab reduces the risk of restenosis in stable diabetic patients undergoing coronary implantation of bare metal stents after pre-treatment with a 600 mg loading dose of clopidogrel.
Hypothesis: Whether abciximab reduces the risk of restenosis after PCI in patients with acute coronary syndromes.
Methods: The randomized, double-blind, placebo-controlled ISAR-REACT 2 trial studied the value of abciximab in 2022 patients with acute coronary syndromes (unstable angina plus troponin > 0.03 μg/l and/or ST-segment depression) undergoing PCI after pre-treatment with 600 mg of clopidogrel. The primary end point was the composite of death, myocardial infarction or urgent vessel revascularization at 30 days after PCI. The present analysis will focus on clinical (target vessel revascularization) and angiographic restenosis.
Results: Of 2022 patients enrolled, 1012 were assigned to abciximab and 1010 to placebo. Of the total study population, 498 patients (25%) were women and 536 patients (27%) had diabetes mellitus. Arterial hypertension was presented in 1281 patients (63%) and hypercholesterolemia in 1232 patients (61%). Almost 75% of the patients had multivessel disease. About 50% of the patients received drug-eluting stents. The primary end point was reached in 90 patients (8.9%) assigned to abciximab vs 120 patients (11.9%) assigned to placebo, a 25% reduction in risk with abciximab (relative risk, 0.75; 95% CI, 0.58 – 0.97; P = .03). The 30-day results of the trial have been published previously. The data about clinical and angiographic restenosis will be available at the end of October 2006 and presented during the meeting in November.
Conclusions: It will be the first report from a randomized trial on the impact of abciximab on restenosis in the drug-eluting stent era.