Rivaroxaban versus warfarin in Japanese patients with non-valvular atrial fibrillation in relation to hypertension: a subgroup analysis of the J-ROCKET AF trial.
The majority of the patients enrolled in the rivaroxaban vs. warfarin in Japanese patients with atrial fibrillation (J-ROCKET AF) trial had hypertension. In this subgroup analysis, we investigated differences in the safety and efficacy of rivaroxaban and warfarin in subjects with and without hypertension. The baseline blood pressure (BP) measurements of patients with hypertension in the rivaroxaban and warfarin groups were 130/77 mm Hg and 131/77 mm Hg, respectively, whereas those of patients without hypertension were 123/74 mm Hg and 124/73 mm Hg, respectively. The incidence rates of the principal safety outcomes in the rivaroxaban and warfarin groups were 18.39% per year and 16.81% per year, respectively, among patients with baseline hypertension (hazard ratio (HR): 1.10; 95% confidence interval (CI): 0.84-1.45) and 16.71% per year and 15.00% per year, respectively, among patients without hypertension at baseline (HR: 1.14; 95% CI: 0.66-1.97), indicating no significant interaction (P=0.933). The incidence rates of the primary efficacy endpoints in the rivaroxaban group and the warfarin group were 0.54% per year and 2.24% per year, respectively, in patients without baseline hypertension (HR: 0.25; 95% CI: 0.03-2.25), and 1.45% per year and 2.71% per year, respectively, in patients with baseline hypertension (HR: 0.54; 95% CI: 0.25-1.16), indicating no significant interaction (P=0.509). In conclusion, the safety and efficacy profile of rivaroxaban was similar to that of warfarin, independent of baseline hypertensive status.
Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan.
Masayasu
M
Matsumoto
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan.
Masatsugu
M
Hori
Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan.
Norio
N
Tanahashi
Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan.
Shin-Ichi
S
Momomura
Department of Neurology, Tokyo Women's Medical University, Tokyo, Japan.
Shinichiro
S
Uchiyama
Department of Medicine (Cardiology), Tokai University School of Medicine, Tokyo, Japan.
Shinya
S
Goto
Department of Cardio-Angiology, Kitasato University School of Medicine, Sagamihara City, Kanagawa, Japan.
Tohru
T
Izumi
Institute for Clinical Research, Osaka National Hospital, Osaka, Japan.
Yukihiro
Y
Koretsune
Bayer Yakuhin Limited, Osaka, Japan.
Mariko
M
Kajikawa
Bayer Yakuhin Limited, Osaka, Japan.
Masaharu
M
Kato
Bayer Yakuhin Limited, Osaka, Japan.
Hitoshi
H
Ueda
Bayer Yakuhin Limited, Osaka, Japan.
Kazuma
K
Iekushi
Bayer Yakuhin Limited, Osaka, Japan.
Satoshi
S
Yamanaka
Bayer Yakuhin Limited, Osaka, Japan.
Masahiro
M
Tajiri
D000368:Aged; D044466:Asian People; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy*; D004311:Double-Blind Method; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000188:drug therapy*; D007564:Japan; D008297:Male; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014859:Warfarin / Q000009:adverse effects / Q000627:therapeutic use*
D065427:Factor Xa Inhibitors; D005343:Fibrinolytic Agents; D009025:Morpholines; D013876:Thiophenes; D014859:Warfarin; D000069552:Rivaroxaban