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

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.

Antithrombotic therapy in elderly patients with atrial fibrillation: effects and bleeding complications: a stratified analysis of the NASPEAF randomized trial.

AIMS: Atrial fibrillation patients with prior embolism have a high risk of vascular events in spite of anticoagulant therapy and elderly patients carry an additional risk. We analysed and compared vascular events-rate between older and younger than 75 years atrial fibrillation patients randomized to anticoagulant-alone or combined antiplatelet plus moderate-level anticoagulant therapy. METHODS AND RESULTS: A total of 967 patients stratified by age and the history of prior embolism were randomized to therapeutic doses of anticoagulant-alone or combined antithrombotic therapy. Primary events were fatal and non-fatal ischaemic or haemorrhagic stroke/transient ischaemic attack, systemic embolism and myocardial infarction, sudden death and death from bleeding. The elderly, compared with the younger patients, had higher event-rate [hazard ratio 2.31 (95% confidence interval 1.37-3.90), P < 0.003]. The elderly suffered higher severe bleeding event-rate during anticoagulant therapy. The combined, compared with the anticoagulant therapy, reduced the vascular events-rate in the elderly (P = 0.012) and caused less intracranial haemorrhages and less bleeding mortality, although more non-fatal gastric bleeding. CONCLUSION: The elderly with AF had a higher event-rate than the younger patients. A higher severe bleeding event-rate was also registered in elderly patients receiving anticoagulant therapy. Combined, compared with anticoagulant therapy, significantly reduced vascular events and bleeding mortality in elderly patients.

Seguimiento a largo plazo de enfermos con fibrilación auricular del estudio NASPEAF. Control prospectivo de otros tratamientos antiplaquetarios / Long-term follow-up of atrial fibrillation patients in the NASPEAF study. Prospective evaluation of different antiplatelet treatments

Introducción y objetivos. En el estudio NASPEAF, el tratamiento combinado anticoagulante más antiplaquetario fue más beneficioso que la anticoagulación sola en los enfermos con fibrilación auricular. Presentamos el seguimiento a largo plazo de los enfermos de este estudio, controlando de forma prospectiva otros tratamientos antiplaquetarios alternativos. Métodos. Se ha incluido en este análisis a 574 pacientes con fibrilación auricular. El tratamiento anticoagulante estándar (INR 2,0-3,0) se utilizó como control frente a la anticoagulación (INR 1,9-2,5) más triflusal 600 mg/día, triflusal 300 mg/día o ácido acetilsalicílico 100 mg/día. El evento primario fue ictus isquémico/hemorrágico, accidente isquémico sistémico/coronario y muerte cardiovascular. La media de tiempo de seguimiento fue 4,92 años. Resultados. El seguimiento a largo plazo confirmó el beneficio significativo del tratamiento combinado anticoagulante más triflusal 600 mg/día frente a la anticoagulación sola (hazard ratio [HR] = 0,33; intervalo de confianza [IC] del 95%, 0,14-0,80; p = 0,014). Se observó una mayor tasa de accidentes isquémicos durante el uso de triflusal 300 mg/día (p = 0,031) y de hemorragias severas con ácido acetilsalicílico 100 mg/día (p = 0,008). El valor medio del INR fue muy similar en los tres grupos que recibieron tratamiento combinado. La tasa de hemorragias no gástricas severas durante el tratamiento combinado con triflusal fue muy baja (0,3% pacientes/año). Conclusiones. El seguimiento a largo plazo ha confirmado el beneficio del tratamiento antitrombótico combinado con triflusal 600 mg/día frente a la monoterapia anticoagulante. Los resultados del tratamiento combinado con triflusal 300 mg/día y ácido acetilsalicílico 100 mg/ día deben considerarse preliminares, por ser grupos de pequeño tamaño y no haber sido aleatorizados (AU)

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/d, triflusal at 300 mg/d, or aspirin at 100 mg/d. 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/d (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/d gave significantly better results than anticoagulant monotherapy. The results obtained with combination therapy with triflusal at 300 mg/d and with aspirin at 100 mg/d should be considered provisional because the treatment groups were small and treatment was not randomly assigned (AU)