The trial was stopped early after enrollment of only 157 patients because of excessive hemorrhage in the group receiving uindione plus aspirin.103 No con- clusion can be drawn regarding ef cacy for preven- tion of stroke or MI because there were so few events during a short duration of follow-up. There is direct evidence from a nonrandomized comparison of patients enrolled in the SPORTIF trials that combination therapy (with warfarin [INR 2.0-3.0] plus aspirin) is associated with a nearly two- fold greater risk of major bleeding compared with warfarin alone, with no signi cant reduction in stroke or MI.104 Patients receiving aspirin were different from those not receiving aspirin (eg, those receiving aspirin more often had diabetes, coronary artery dis- ease, and previous stroke or TIA). Although the analy- ses were adjusted for baseline differences in patient characteristics, there remains a high risk for bias. A similar nonrandomized comparison of patients enrolled in the RE-LY trial reported that rates (likely unadjusted) of major bleeding were roughly 2 times higher for patients receiving aspirin in www.chestpubs.org CHEST / 141 / 2 / FEBRUARY, 2012 SUPPLEMENT e561S bene t compared with dual antiplatelet therapy for patients at high risk of stroke (eg, CHADS2 score of 2), whereas the net bene t at lower levels of stroke risk is uncertain. The duration of triple therapy should be kept as brief as possible given the associ- ated increase in bleeding risk. Because the risk of stent thrombosis falls signi cantly after 30 days with bare-metal stents and 3 to 6 months after drug-eluting stents, triple therapy should be continued only dur- ing this high-risk period and only among patients at higher risk of stroke. 