A clinical trial comparing three antithrombotic drug regimens after coronary-artery stenting

Background Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of th ree ant ithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspiri n and ticlopidine - after coronary stenting. Methods Of 1965 patients who underwent coronary stenting at 50 centers, 165 3 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (5 57 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidi ne (546 patients). All clinical events reflecting stent thrombosis were inc luded in the prespecified primary end point: death, revascularization of th e target lesion, angiographically evident thrombosis, or myocardial infarct ion within 30 days. Results The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive as pirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and tic lopidine (P = 0.001 for the comparison of all three groups). Hemorrhagic co mplications occurred in 10 patients (1.8 percent) who received aspirin alon e, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all th ree groups); the incidence of vascular surgical complications was 0.4 perce nt (2 patients), 2.0 percent(ll patients), and 2.0 percent (11 patients), r espectively (P = 0.02). There were no significant differences in the incide nce of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) amo ng the three treatment groups. Conclusions As compared with aspirin alone and a combination of aspirin and warfarin, treatment with, aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications th an with aspirin alone. After coronary stenting, aspirin and ticlopidine sho uld be considered for the prevention of the serious complication of stent t hrombosis. (N Engl J Med 1998;339:1665-71.) (C)1998, Massachusetts Medical Society.