51293
document
Rivaroxaban versus warfarin in nonvalvular atrial fibrillation . 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 , NCT00403767 . ) .
51294
Intervention_Pharmacological
Rivaroxaban
51295
Intervention_Pharmacological
warfarin
51296
Intervention_Pharmacological
warfarin
51297
Intervention_Pharmacological
Rivaroxaban
51298
Intervention_Pharmacological
warfarin
51299
Intervention_Pharmacological
rivaroxaban
51300
Intervention_Pharmacological
warfarin
51301
Intervention_Pharmacological
rivaroxaban
51302
Intervention_Pharmacological
warfarin
51303
Intervention_Pharmacological
rivaroxaban
51304
Intervention_Pharmacological
warfarin
51305
Intervention_Pharmacological
rivaroxaban
51306
Intervention_Pharmacological
rivaroxaban
51307
Intervention_Pharmacological
warfarin
51308
Intervention_Pharmacological
rivaroxaban
51309
Intervention_Pharmacological
warfarin
51310
Intervention_Pharmacological
rivaroxaban
51311
Intervention_Pharmacological
rivaroxaban
51312
Intervention_Pharmacological
rivaroxaban
51313
Outcome_Physical
rate of ischemic stroke
51314
Outcome_Physical
stroke or systemic embolism
51315
Outcome_Physical
Major and nonmajor clinically relevant bleeding
51316
Outcome_Physical
intracranial hemorrhage
51317
Outcome_Physical
fatal bleeding
51318
Outcome_Physical
major bleeding
51319
Outcome_Physical
intracranial and fatal bleeding
51320
Participant_Condition
nonvalvular atrial fibrillation .
51321
Participant_Sample-size
14,264 patients