Comparison of the efficacy and safely of aspirin alone with coumadin plus aspirin after provisional coronary stenting: Final and follow-up results ofa randomised study

Background The antithrombotic benefit of the conventional treatment with co umadin after coronary stenting is limited by bleeding complications. Howeve r, the superiority of an antiplatelet therapy with aspirin alone compared w ith coumadin plus aspirin has not been proven by randomized studies. The ef ficacy and safety of treatment with aspirin alone in comparison to coumadin plus aspirin were evaluated in this randomized study. Methods out of 164 patients aged 59.7 +/- 9.2 years, 79 patients were rando mly assigned to receive 100 mg aspirin daily (group A) and 85 patients rand omly assigned to coumadin plus aspirin (group CA) after provisional coronar y stenting with a high-pressure technique. The primary end point was define d as the absence of death, subacute closure of the target vessel, myocardia l infarction, urgent coronary bypass surgery, repeated coronary angioplasty , and peripheral vascular complications requiring transfusion or surgery. H igh-pressure inflation technique was used, but ultrasound guidance was not. Results During hospitalization (median 8 days), 135 patients (82.3%) were f ree of events (A, 84.8%; CA, 80.8%; P = .42). Eleven (6.7%) subacute closur es occurred (A, 10.1%; CA, 3.5%; P = .09); 2 of them were lethal in the asp irin group. Emergency bypass surgery was performed in patient in each group . peripheral vascular complications were observed in 13 patients (7.9%) (A, 1.3%; CA, 14.1%; P < .01). At 3-month follow-up, 15 (9.1%) elective revasc ularization procedures (A, 7.6%; CA, 10.6%; P = .51) were performed. Conclusion Aspirin a one at the low dose of 100 mg administered or the comb ination of coumadin and aspirin after high-pressure coronary stenting does not prevent adverse clinical events when ultrasound guidance is not used.