To evaluate the efficacy and safety of the combination of antiplatelet and moderate-intensity anticoagulation therapy in patients with atrial fibrillation associated with recognized risk factors or mitral stenosis.
- Aspirin (stroke prevention) Drug
Intervention Desc: Antiplatelet agent; inhibits thromboxane A2
- Warfarin (Coumadin®)Drug
Other Names: Coumadin; Acenocoumarol Intervention Desc: Anticoagulant (Vitamin K antagonist)
Prospective, multicenter, randomized open-label study.
Patients were divided in two groups: the high-risk group included nonvalvular plus prior embolism and patients with mitral stenosis with and with-out prior embolism and consisted of 495 patients (with a median follow-up 1,075 days); and the intermediate-risk group with 714 patients included patients with risk factors or over 60 years of age with a median follow-up 965 days. In the intermediate risk group 242 received the cyclooxygenase inhibitor triflusal, 237 received acenocumarol, and 235 received a combination of both. In the high risk group, 259 received anticoagulants and 236 received the combined therapy.
|Type||Measure||Time Frame||Safety Issue|
|Primary||A composite of vascular mortality, transient ischemic attack (TIA), and nonfatal stroke or systemic embolism, whichever came first.|
|Secondary||Severe bleeding, MI, nonvascular mortality, and non-severe bleeding. The composite of primary outcomes and severe bleeding was jointly analyzed to evaluate the benefit-to-risk ratio.|