6/29/23, 1:12 AM ROCKET AF Pathway Feedback Search Clinical Topics Home Studies ROCKET AF ROCKET AF Disease Disease Disease Acute ischemic stroke Atrial fibrillation Transient Trial question Is rivaroxaban noninferior to warfarin in patients with nonvalvular AF who are at an increased risk for stroke? Study design Multi-center Double blinded RCT Population Characteristics of study participants 40.0% female N = 14264 60.0% male 14264 patients (5663 female, 8601 male) Inclusion criteria: patients with nonvalvular AF who are at increased risk for stroke Key exclusion criteria: prosthetic heart valve, planned cardioversion, active endocarditis, active internal bleeding or increased risk of bleeding, platelet count < 90,000/uL, or sustained uncontrolled hypertension Interventions N=7131 rivaroxaban (at a daily dose of 20 mg) N=7133 warfarin (adjusted-dose to target INR 2.0-3.0) Primary outcome https://web.pathway.md/studies/rec2HYnuL6iEOeNnv 1/2 6/29/23, 1:12 AM ROCKET AF Pathway Incidence of stroke or systemic embolism 2.2 % / y 2.2 1.7 1.7 % / y 1.1 % / y Difference not exceeding nonferiority margin 0.6 % / y 0.0 % / y Rivaroxaban Warfarin Difference not exceeding nonferiority margin in the incidence of stroke or systemic embolism (1.7% / y vs. 2.2% / y; HR 0.79, 95% CI 0.66 to 0.96) Secondary outcomes No significant difference in the incidence of myocardial infarction (0.9% / y vs. 1.1% / y; HR 0.81, 95% CI 0.63 to 1.06) No significant difference in the incidence of death (1.9% / y vs. 2.2% / y; HR 0.85, 95% CI 0.7 to 1.02) Safety outcomes No significant difference in major and clinically relevant nonmajor bleeding and major bleeding. Significant difference in intracranial hemorrhage (0.8% vs. 1.2%) and fatal bleeding (0.4% vs. 0.8%). Conclusion In patients with nonvalvular AF who are at increased risk for stroke, rivaroxaban was noninferior to warfarin with respect to the incidence of stroke or systemic embolism. Reference Patel MR, Mahaffey KW, Garg J et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. Open reference URL https://web.pathway.md/studies/rec2HYnuL6iEOeNnv 2/2