Masatsugu Hori1, Masayasu Matsumoto2, Norio Tanahashi3, Shin-Ichi Momomura4, Shinichiro Uchiyama5, Shinya Goto6, Tohru Izumi7, Yukihiro Koretsune8, Mariko Kajikawa9, Masaharu Kato9, Mary Cavaliere9, Kazuma Iekushi9, Satoshi Yamanaka9. 1. Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. Electronic address: hori-ma@mc.pref.osaka.jp. 2. Department of Clinical Neuroscience and Therapeutics, Hiroshima University, Hiroshima, Japan. 3. Department of Neurology, Saitama Medical University International Medical Center, Saitama, Japan. 4. Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, Saitama, Japan. 5. Clinical Research Center for Medicine, International University of Health and Welfare, Tokyo, Japan; Center for Brain and Cerebral Vessels, Sanno Hospital and Sanno Medical Center, Tokyo, 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.
Abstract
BACKGROUND: Results from the J-ROCKET AF study revealed that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcomes in patients with non-valvular atrial fibrillation. This subgroup analysis evaluated whether non-major clinically relevant bleeding (NMCRB) could be a predictive factor for major bleeding (MB). Other predictive factors for MB were also obtained in both rivaroxaban and warfarin treatment groups. METHODS: The temporal incidence of MB was compared between the rivaroxaban and warfarin treatment groups. Assessment was made whether MB events were often preceded by NMCRB. Univariate and multivariate analyses were carried out to identify any independent predictive factors for MB in both treatment groups. RESULTS: The incidences of MB and NMCRB were 18.04% (138/639 patients) in the rivaroxaban arm, and 16.42% in the warfarin arm (124/639 patients). NMCRB preceded MB in only four patients in each treatment group (rivaroxaban: 4/117 and warfarin: 4/98). Multivariate analysis identified predictive factors for bleeding events: anemia with warfarin treatment and concomitant use of antiplatelet agents with rivaroxaban treatment. CONCLUSIONS: Results from this subgroup analysis, particularly the fact that there was no repeated or sequential pattern between NMCRB and MB occurrences in both treatment groups, suggests that NMCRB might not be a predictive factor for MB. On the contrary, anemia and concomitant use of antiplatelet therapy were likely predictive factors for bleeding with warfarin and rivaroxaban treatment, respectively.
BACKGROUND: Results from the J-ROCKET AF study revealed that rivaroxaban was non-inferior to warfarin with respect to the principal safety outcomes in patients with non-valvular atrial fibrillation. This subgroup analysis evaluated whether non-major clinically relevant bleeding (NMCRB) could be a predictive factor for major bleeding (MB). Other predictive factors for MB were also obtained in both rivaroxaban and warfarin treatment groups. METHODS: The temporal incidence of MB was compared between the rivaroxaban and warfarin treatment groups. Assessment was made whether MB events were often preceded by NMCRB. Univariate and multivariate analyses were carried out to identify any independent predictive factors for MB in both treatment groups. RESULTS: The incidences of MB and NMCRB were 18.04% (138/639 patients) in the rivaroxaban arm, and 16.42% in the warfarin arm (124/639 patients). NMCRB preceded MB in only four patients in each treatment group (rivaroxaban: 4/117 and warfarin: 4/98). Multivariate analysis identified predictive factors for bleeding events: anemia with warfarin treatment and concomitant use of antiplatelet agents with rivaroxaban treatment. CONCLUSIONS: Results from this subgroup analysis, particularly the fact that there was no repeated or sequential pattern between NMCRB and MB occurrences in both treatment groups, suggests that NMCRB might not be a predictive factor for MB. On the contrary, anemia and concomitant use of antiplatelet therapy were likely predictive factors for bleeding with warfarin and rivaroxaban treatment, respectively.
Authors: Nicole Hanna-Rivero; Samuel J Tu; Adrian D Elliott; Bradley M Pitman; Celine Gallagher; Dennis H Lau; Prashanthan Sanders; Christopher X Wong Journal: BMC Cardiovasc Disord Date: 2022-05-04 Impact factor: 2.174