Randomized Evaluation of Anticoagulation Versus Antiplatelet Therapy After Coronary Stent Implantation in High-Risk Patients

Abstract

Background —Although the association of ticlopidine and aspirin has been shown to be superior to anti–vitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently. Methods and Results —We randomized 350 high-risk patients within 6 hours after stent implantation to receive during 30 days either aspirin 250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and oral anticoagulation (A+OAC group) targeted at an international normalized ratio of 2.5 to 3. The primary composite end point was defined as the occurrence of cardiovascular death, myocardial infarction, or repeated revascularization at 30 days. Patients were eligible if (1) the stent(s) were implanted to treat abrupt closure after PTCA; (2) the angiographic result after implantation was suboptimal; (3) a long segment was stented (>45 mm and/or ≥3 stents); or (4) the largest balloon inflated in the stent had a nominal diameter of ≤2.5 mm. The primary cardiac end point was reached for 10 patients (5.6%) in the A+T group and 19 (11%) in the A+OAC group (relative risk [RR], 1.9; 95% CI, 0.9 to 4.1; P =0.07). Major vascular and bleeding complications were less frequent in the A+T group (3 patients, 1.7%) than in the A+OAC group (12 patients, 6.9%) (RR, 4.1; 95% CI, 1.2 to 14.3; P =0.02). Conclusions —High-risk patients should be treated with A+T rather than A+OAC after coronary stenting because the bleeding and vascular complications are significantly reduced and there is a marked trend suggesting a decrease in cardiac events.