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Net clinical benefit of rivaroxaban versus warfarin in Japanese patients with nonvalvular atrial fibrillation: a subgroup analysis of J-ROCKET AF.

Author(s): Uchiyama S(1), Hori M(2), Matsumoto M(3), Tanahashi N(4), Momomura S(5), Goto S(6), Izumi T(7), Koretsune Y(8), Kajikawa M(9), Kato M(9), Ueda H(9), Iekushi K(9), Yamanaka S(9), Tajiri M(9); J-ROCKET AF Study Investigators.

Affiliation(s): Author information: (1)Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan. Electronic address: suchiyam@nij.twmu.ac.jp. (2)Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. (3)Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan. (4)Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan. (5)Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan. (6)Department of Medicine (Cardiology), Tokai University School of Medicine, Tokyo, Japan. (7)Department of Cardio-angiology, Kitasato University School of Medicine, Sagamihara City, Kanagawa, Japan. (8)Institute for Clinical Research, Osaka National Hospital, Osaka, Japan. (9)Bayer Yakuhin Ltd, Osaka, Japan.

Publication date & source: 2014, J Stroke Cerebrovasc Dis. , 23(5):1142-7

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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