47 Stroke and Systemic Embolization by Center Proportion of INR in Therapeutic Range in ROCKET AF RivaroxabanWarfarin Rivaroxaban vs.
{"Image DocumentName": "Rivaroxaban vs. Warfarin", "Image ImageDescription": "Stroke and Systemic Embolization by Center Proportion of INR in Therapeutic Range in ROCKET AF. Rivaroxaban. Warfarin. Rivaroxaban vs. Warfarin. Center TTR\u2021 Total. Event Rate. (100 Pt Yrs)\u00a7 Hazard Ratio. (95% CI)II % 45/1735 (2.59) /1689 (3.67) (0.48, 1.03) 50.7%-58.5% 53/1746 (3.04) /1807 (3.49) (0.62, 1.29) % 54/1734 (3.11) /1758 (3.53) (0.62, 1.28) % 37/1676 (2.21) /1826 (3.01) (0.49, 1.12) Table 5 N Engl J Med Sep 8;365(10): Epub 2011 Aug 10. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC,Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Collaborators (1236) Source Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 27705, USA. BACKGROUND: The use of warfarin reduces the rate of ischemic stroke in patients with atrial fibrillation but requires frequent monitoring and dose adjustment. Rivaroxaban, an oral factor Xa inhibitor, may provide more consistent and predictable anticoagulation than warfarin. METHODS: In a double-blind trial, we randomly assigned 14,264 patients with nonvalvular atrial fibrillation who were at increased risk for stroke 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. RESULTS: In the primary analysis, the 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) (hazard ratio in the rivaroxaban group, 0.79; 95% confidence interval [CI], 0.66 to 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) (hazard ratio, 0.88; 95% CI, 0.74 to 1.03; P<0.001 for noninferiority; P=0.12 for superiority). Major and nonmajor clinically relevant bleeding occurred in 1475 patients in the rivaroxaban group (14.9% per year) and in 1449 in the warfarin group (14.5% per year) (hazard ratio, 1.03; 95% CI, 0.96 to 1.11; P=0.44), with significant reductions in intracranial hemorrhage (0.5% vs. 0.7%, P=0.02) and fatal bleeding (0.2% vs. 0.5%, P=0.003) in the rivaroxaban group. CONCLUSIONS: In patients with atrial fibrillation, rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism. There was no significant between-group difference in the risk of major bleeding, although intracranial and fatal bleeding occurred less frequently in the rivaroxaban group. (Funded by Johnson & Johnson and Bayer; ROCKET AF ClinicalTrials.gov number, NCT ). Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. N Engl J Med Sep 8;365(10): Epub 2011 Aug 10. PMID: N=7061 rivaroxaban N=7082 warfarin. P value for interaction= Time in therapeutic range-2-3 inclusive. \u2021Center TTR calculated using total INR values in target range from all warfarin subjects within center, divided by total INR values from all warfarin subjects within center. \u00a7Number of events per 100 patient-years of follow-up. II Hazard ratio from Cox proportional hazard model with treatment as a covariate. Patel MR, et al. N Engl J Med Sep 8;365(10): Pub Med PMID:", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}