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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