RE-LY
Randomized Evaluation of Long-term Anticoagulation Therapy
Paziente / Popolazione Intervento / Esposizione Confronto Esito
In 18,113 patients with non-valvular AF, dabigatran 150 mg twice daily reduced stroke or systemic embolism compared with warfarin, with similar major bleeding.
N
18.113
Disegno
Open-label (PROBE), 2 yr
Esito
Stroke or systemic embolism
Rilevanza
1
Risultato1.11 %/yr vs 1.69 %/yr (RR 0.66). 110 mg dose non-inferior with less bleed.
Connolly SJ, et al. N Engl J Med. 2009;361(12):1139-1151. 10.1056/NEJMoa0905561
Discussione e critica
First NOAC win. Open-label design and dyspepsia signal. Renal clearance is dominant — avoid in CrCl < 30.