TY - JOUR
T1 - Real-world outcomes of rivaroxaban treatment in elderly Japanese patients with nonvalvular atrial fibrillation
AU - Kitazono, Takanari
AU - Ikeda, Takanori
AU - Ogawa, Satoshi
AU - Nakagawara, Jyoji
AU - Minematsu, Kazuo
AU - Miyamoto, Susumu
AU - Murakawa, Yuji
AU - Cavaliere, Mary
AU - Hayashi, Yasuhiro
AU - Kidani, Yoko
AU - Okayama, Yutaka
AU - Sunaya, Toshiyuki
AU - Sato, Shoichiro
AU - Yamanaka, Satoshi
N1 - Funding Information:
Writing assistance was provided by Michelle L. Jones, PhD, ELS, and publication support was provided by McCann MDS, Inc.
Funding Information:
The author TK was advisory board member for Bayer Yakuhin Ltd. (Bayer) and received research grant from the same. TI received research grant from Daiichi Sankyo (Daiichi), Bristol-Myers Squibb (BMS), Medtronic Japan, St. Jude Medical, Bayer; honoraria from Daiichi, Ono Pharma, Pfizer, Bayer, BMS and was member of advisory board for the last two companies. SO was advisory board member (AB) for Bayer. JN received research grant from Nihon Medi-Physics and AB member for Bayer. KM received honoraria from Bayer, Otsuka Pharma, Boehringer Ingelheim (BI), AstraZeneca, Pfizer, Mitsubishi Tanabe, Stryker, Kowa, Nihon Medi-Physics Co, BMS, Sawai Pharma, Sumitomo Dainippon Pharma, Daiichi, Astellas, Nippon Chemiphar and was member of AB for CSL Behring, Medico’s Hirata, Bayer. SM received research grant from Takeda Pharma, CSL Behring, Meiji Seika Pharma, MSD, Astellas, Eisai, Otsuka Pharma, Carl Zeiss Meditec, Philips Electronics Japan, Sanofi, Siemens Healthcare, Daiichi, Mitsubishi Tanabe, Chugai Pharma, Nihon Medi-Physics, Pfizer, BMS, Brainlab, Mizuho, and Medtronic and was AB member for Bayer. YM received research grant from Bayer, Daiichi, BI; honoraria from Bayer, Daiichi, BI, BMS and was AB member for Bayer. MC, YH, YK, YO, TS, SS, SY are employees of Bayer Yakuhin Ltd.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - Direct oral anticoagulants (DOACs), such as rivaroxaban, reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, it is still unclear whether the stroke reduction benefit outweighs the bleeding risk in elderly Japanese patients with NVAF. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of rivaroxaban in Japanese clinical practice. This sub-analysis evaluated the clinical outcomes of elderly patients aged ≥ 75 years. At the 1-year follow-up, there were 4,685 (48.91%) and 4,893 (51.09%) patients aged ≥ 75 and < 75 years, respectively. Safety and effectiveness outcomes were compared between patients aged ≥ 75 years and those aged < 75 years, and among 3 elderly sub-populations (age ranges: 75–79, 80–84, and ≥ 85 years). Patients aged ≥ 75 years had higher rates of major bleeding [2.22 vs. 1.35 events per 100 patient-years, hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.17–2.28] and composite of stroke (ischemic or hemorrhagic)/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI) (2.41 vs. 1.21 events per 100 patient-years, HR 1.97, 95% CI 1.40–2.77) compared to patients aged < 75 years. Intracranial hemorrhage rates were < 1 event per 100 patient-years in both groups (0.85 vs. 0.59 events per 100 patient-years, HR 1.43, 95% CI 0.85–2.40). Kaplan–Meier curves of major bleeding and stroke/non-CNS SE/MI showed that no significant differences of cumulative event rates were identified among the 3 elderly sub-populations. Stepwise Cox regression analyses revealed that creatinine clearance (CrCl) (<50 mL/min), hepatic impairment, and hypertension were specific predictors for major bleeding and no specific predictors were found for stroke/non-CNS SE/MI in patients aged ≥ 75 years. In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared with those aged < 75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.
AB - Direct oral anticoagulants (DOACs), such as rivaroxaban, reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). However, it is still unclear whether the stroke reduction benefit outweighs the bleeding risk in elderly Japanese patients with NVAF. The Xarelto Post-Authorization Safety and Effectiveness Study in Japanese Patients with Atrial Fibrillation (XAPASS) was a real-world, prospective observational, post-marketing surveillance study on the safety and effectiveness of rivaroxaban in Japanese clinical practice. This sub-analysis evaluated the clinical outcomes of elderly patients aged ≥ 75 years. At the 1-year follow-up, there were 4,685 (48.91%) and 4,893 (51.09%) patients aged ≥ 75 and < 75 years, respectively. Safety and effectiveness outcomes were compared between patients aged ≥ 75 years and those aged < 75 years, and among 3 elderly sub-populations (age ranges: 75–79, 80–84, and ≥ 85 years). Patients aged ≥ 75 years had higher rates of major bleeding [2.22 vs. 1.35 events per 100 patient-years, hazard ratio (HR) 1.63, 95% confidence interval (CI) 1.17–2.28] and composite of stroke (ischemic or hemorrhagic)/non-central nervous system (non-CNS) systemic embolism (SE)/myocardial infarction (MI) (2.41 vs. 1.21 events per 100 patient-years, HR 1.97, 95% CI 1.40–2.77) compared to patients aged < 75 years. Intracranial hemorrhage rates were < 1 event per 100 patient-years in both groups (0.85 vs. 0.59 events per 100 patient-years, HR 1.43, 95% CI 0.85–2.40). Kaplan–Meier curves of major bleeding and stroke/non-CNS SE/MI showed that no significant differences of cumulative event rates were identified among the 3 elderly sub-populations. Stepwise Cox regression analyses revealed that creatinine clearance (CrCl) (<50 mL/min), hepatic impairment, and hypertension were specific predictors for major bleeding and no specific predictors were found for stroke/non-CNS SE/MI in patients aged ≥ 75 years. In conclusion, safety and effectiveness event rates were higher in patients aged ≥ 75 years compared with those aged < 75 years, yet, no distinct differences were observed among the 3 elderly sub-populations.
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U2 - 10.1007/s00380-019-01487-x
DO - 10.1007/s00380-019-01487-x
M3 - Article
C2 - 31492970
AN - SCOPUS:85073978913
VL - 35
SP - 399
EP - 408
JO - Heart and Vessels
JF - Heart and Vessels
SN - 0910-8327
IS - 3
ER -