Riwaroksaban versus warfaryna w niezastawkowym migotaniu przedsionków – wyniki badania ROCKET AF Na podstawie: ROCKET AF Investigators: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation

Abstract

On one hand the anticoagulant therapy with warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation (AF). On the other hand it requires frequent monitoring of coagulation and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, is thought to provide more consistent and predictable anticoagulation than warfarin. In double-blind study ROCKET AF 14 264 increased risk for stroke patients with non-valvular AF were randomly assigned to receive either rivaroxaban (at a daily dose of 20 mg) or dose-adjusted warfarin. The per-protocol, as-treated primary analysis was designed to determine whether rivaroxaban was noninferior to warfarin for the primary end point of stroke or systemic embolism. In the primary analysis primary end point occurred in 188 patients in the rivaroxaban group (1.7% per year) and in 241 in the warfarin group (2.2% per year) (HR 0.79; 95% CI: 0.66–0.96; p < 0.001 for noninferiority). In the intention-to-treat analysis, the primary end point occurred in 269 patients in the rivaroxaban group (2.1% per year) and in 306 patients in the warfarin group (2.4% per year) (HR 0.88; 95% CI: 0.74-1.03; p < 0.001 for noninferiority; p = 0.12 for superiority). There were no significant differences in the rate of major and nonmajor clinically relevant bleeding in both study groups (HR 1.03; 95% CI: 0.96–1.11; p = 0.44). In the rivaroxaban group significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, p = 0.02) and fatal bleeding (0.2% vs. 0.5%, p = 0.003) were observed. In patients with non-valvular AF rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant difference between warfarin and rivaroxaban in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group.