HOKUSAI-VTE
Edoxaban versus Warfarin for the Treatment of Symptomatic Venous Thromboembolism
Doente / População Intervenção / Exposição Comparação Desfecho
In 8,240 patients with acute venous thromboembolism after initial heparin, once-daily edoxaban was non-inferior for recurrent symptomatic venous thromboembolism and caused less clinically relevant bleeding than warfarin.
N
8240
Desenho
Double-blind, double-dummy non-inferiority RCT
Desfecho
Recurrent symptomatic venous thromboembolism
Relevância
2
Resultado3.2 % vs 3.5 % (HR 0.89; 95 % CI 0.70–1.13; p<0.001 for non-inferiority). Major or clinically relevant bleeding 8.5 % vs 10.3 % (HR 0.81; 95 % CI 0.71–0.94; p=0.004). In PE with right-ventricular dysfunction, recurrence 3.3 % vs 6.2 % (HR 0.52).
The Hokusai-VTE Investigators. N Engl J Med. 2013;369(15):1406-1415. 10.1056/NEJMoa1306638
Discussão e crítica
A heparin lead-in is mandatory, so this is not a single-drug regimen. Its double-blind design, high-quality warfarin comparator and the pre-specified right-ventricular-dysfunction subgroup make it the strongest DOAC evidence in the sicker end of the PE spectrum.