利伐沙班 vs.华法林用于非瓣膜性心房颤动患者的净临床收益：J-ROCKET AF试验的亚组分析结果
Net Clinical Benefit of Rivaroxaban versus Warfarin in Japanese Patients with Nonvalvular Atrial Fibrillation: A Subgroup Analysis of J-ROCKET AF
Background
The risk factors that have been identified for bleeding events with rivaroxaban are predominantly the same as those predicting thromboembolic ones in patients with atrial fibrillation (AF). Our aim was to determine the net clinical benefit (NCB) from the results of the J-ROCKET AF trial, in which rivaroxaban was compared with warfarin in Japanese patients with AF.
Methods
Two strategies were adopted to quantify the NCB. First, the NCB was calculated as the number of ischemic strokes avoided with anticoagulation minus the number of excess intracranial hemorrhage (ICH) with a weight of 1.5. Second, the composite end point of major bleeding events and secondary efficacy end points (stroke, noncentral nervous system systemic embolism, myocardial infarction and death) to ascertain the NCB were established. Subgroup analysis by CHADS2 score or creatinine clearance was also performed.
Results
The adjusted NCB, which was given a weight of 1.5 for ICH, was nominally significant in favor of rivaroxaban therapy (difference in incidence rate −2.13; 95% confidence interval [CI]: −.26 to −3.99). Furthermore, the event rate of the composite end point tended to be lower in patients treated with rivaroxaban than in those treated with warfarin (rivaroxaban: 4.97% per year, warfarin: 6.11% per year; difference in incidence rate: −1.14; 95% CI: −3.40 to 1.12). The event rate of the composite end point tended to be consistently low in patients treated with rivaroxaban in the subanalysis by CHADS2 score and renal function.
Conclusion
Analysis of the NCB supports that rivaroxaban therapy provides clinical benefit for Japanese patients with AF.
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