Long-term follow-up of atrial fibrillation patients in the NASPEAF study. Prospective evaluation of different antiplatelet treatments.

ABSTRACT

INTRODUCTION AND OBJECTIVES: In the NASPEAF (National Study for Prevention of Embolism in Atrial Fibrillation) trial, combination therapy with an anticoagulant and an antiplatelet was more effective than anticoagulation alone in patients with atrial fibrillation. We report long-term follow-up in these patients, including prospective evaluation of different antiplatelet therapies. METHODS: This analysis included 574 atrial fibrillation patients. Standard anticoagulation (international normalized ratio [INR] 2.0-3.0) was used as control therapy to compare with anticoagulation (INR 1.9-2.5) plus either triflusal at 600 mg/day, triflusal at 300 mg/day or aspirin at 100 mg/day. The primary endpoint was ischemic or hemorrhagic stroke, a systemic or coronary ischemic event, or cardiovascular death. The mean follow-up was 4.92 years. RESULTS: Long-term follow-up confirmed that combination therapy with an anticoagulant plus triflusal at 600 mg/day gave significantly better results than anticoagulation alone (hazard ratio [HR]=0.33; 95% confidence interval [CI], 0.14-0.80; P=.014). There was a significantly higher incidence of ischemic events with triflusal at 300 mg/day (P=.031) and of severe bleeding events with aspirin at 100 mg/day (P=.008). The mean INR was similar in the three combination therapy groups. The incidence of severe nongastric bleeding during combination therapy with triflusal was very low (0.3% of patients/year). CONCLUSIONS: Long-term follow-up confirmed that combination antithrombotic therapy with triflusal at 600 mg/day gave significantly better results than anticoagulant monotherapy. The results obtained with combination therapy with triflusal at 300 mg/day and with aspirin at 100 mg/day should be considered provisional because the treatment groups were small and treatment was not randomly assigned.