- 著者
- Nobuhiro Murata Yasuo Okumura Katsuaki Yokoyama Naoya Matsumoto Eizo Tachibana Keiichiro Kuronuma Koji Oiwa Michiaki Matsumoto Toshiaki Kojima Shoji Hanada Kazumiki Nomoto Ken Arima Fumiyuki Takahashi Tomobumi Kotani Yukitoshi Ikeya Seiji Fukushima Satoru Itoh Kunio Kondo Masaaki Chiku Yasumi Ohno Motoyuki Onikura Atsushi Hirayama for the SAKURA AF Registry Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- vol.83, no.4, pp.727-735, 2019-03-25 (Released:2019-03-25)
- 参考文献数
- 27
- 被引用文献数
- 61
Background: Off-label dosing of direct oral anticoagulants (DOACs) is encountered clinically among patients with atrial fibrillation (AF), although data on the clinical outcomes of over- and under-dosing are lacking in Japan. Methods and Results: We examined the clinical outcomes of off-label DOAC dosing using the SAKURA AF Registry, a prospective multicenter registry in Japan. Among 3,237 enrollees, 1,676 under any of the 4 DOAC regimens were followed up for a median of 39.3 months: 746 (45.0%), appropriate standard-dose; 477 (28.7%), appropriate low-dose; 66 (4.0%), over-dose; and 369 (22.2%) under-dose. Compared with the standard-dose group, patients in the under- and over-dose groups were significantly older and had a higher stroke risk. After multivariate adjustment, stroke/systemic embolism (SE) and death events were equivalent between the standard- and under-dose groups, but major bleeding events tended to be lower in the under-dose group (hazard ratio [HR] 0.474, P=0.0739). Composite events (stroke/SE, major bleeding, or death) were higher in the over-dose than in the standard-dose group (HR 2.714, P=0.0081). Conclusions: Clinical outcomes were not worse for under-dose than for standard-dose users among patients with different backgrounds. Over-dose users, however, were at higher risk for all clinical events and required careful follow-up. Further studies are needed to clarify the safety and effectiveness of off-label DOAC dosing in Japan.
- 著者
- Nobuhiro Murata Yasuo Okumura Katsuaki Yokoyama Naoya Matsumoto Eizo Tachibana Keiichiro Kuronuma Koji Oiwa Michiaki Matsumoto Toshiaki Kojima Shoji Hanada Kazumiki Nomoto Ken Arima Fumiyuki Takahashi Tomobumi Kotani Yukitoshi Ikeya Seiji Fukushima Satoru Itoh Kunio Kondo Masaaki Chiku Yasumi Ohno Motoyuki Onikura Atsushi Hirayama for the SAKURA AF Registry Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-18-0991, (Released:2019-02-05)
- 参考文献数
- 27
- 被引用文献数
- 61
Background: Off-label dosing of direct oral anticoagulants (DOACs) is encountered clinically among patients with atrial fibrillation (AF), although data on the clinical outcomes of over- and under-dosing are lacking in Japan. Methods and Results: We examined the clinical outcomes of off-label DOAC dosing using the SAKURA AF Registry, a prospective multicenter registry in Japan. Among 3,237 enrollees, 1,676 under any of the 4 DOAC regimens were followed up for a median of 39.3 months: 746 (45.0%), appropriate standard-dose; 477 (28.7%), appropriate low-dose; 66 (4.0%), over-dose; and 369 (22.2%) under-dose. Compared with the standard-dose group, patients in the under- and over-dose groups were significantly older and had a higher stroke risk. After multivariate adjustment, stroke/systemic embolism (SE) and death events were equivalent between the standard- and under-dose groups, but major bleeding events tended to be lower in the under-dose group (hazard ratio [HR] 0.474, P=0.0739). Composite events (stroke/SE, major bleeding, or death) were higher in the over-dose than in the standard-dose group (HR 2.714, P=0.0081). Conclusions: Clinical outcomes were not worse for under-dose than for standard-dose users among patients with different backgrounds. Over-dose users, however, were at higher risk for all clinical events and required careful follow-up. Further studies are needed to clarify the safety and effectiveness of off-label DOAC dosing in Japan.
- 著者
- Yasuo Okumura Katsuaki Yokoyama Naoya Matsumoto Eizo Tachibana Keiichiro Kuronuma Koji Oiwa Michiaki Matsumoto Toshiaki Kojima Shoji Hanada Kazumiki Nomoto Ken Arima Fumiyuki Takahashi Tomobumi Kotani Yukitoshi Ikeya Seiji Fukushima Satoru Itou Kunio Kondo Masaaki Chiku Yasumi Ohno Motoyuki Onikura Atsushi Hirayama for the SAKURA AF Registry Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- vol.82, no.10, pp.2500-2509, 2018-09-25 (Released:2018-09-25)
- 参考文献数
- 20
- 被引用文献数
- 55
Background: Although direct oral anticoagulants (DOACs) are widely used in Japanese patients with atrial fibrillation (AF), large-scale investigations into their use, with suitable follow-up times and rates, are lacking. Methods and Results: The SAKURA AF Registry is a prospective multicenter registry created to investigate therapeutic outcomes of oral anticoagulant (OAC) use in Japanese AF patients. We conducted a study involving 3,237 enrollees from 63 institutions in the Tokyo area being treated with any of 4 DOACs (n=1,676) or warfarin (n=1,561) and followed-up for a median of 39.3 months (range 28.5–43.6 months). Analyses of 1- and 2-year follow-up data available for 3,157 (97.5%) and 2,952 (91.2%) patients, respectively, showed no significant differences in rates of stroke or systemic embolism (SE), major bleeding, and all-cause mortality for DOAC vs. warfarin users (1.2 vs. 1.8%/year, 0.5 vs. 1.2%/year, and 2.1 vs. 1.7%/year, respectively). Under propensity score matching, the incidence of stroke or SE (P=0.679) and all-cause death (P=0.864) remained equivalent, but the incidence of major bleeding was significantly lower (P=0.014) among DOAC than warfarin users. Conclusions: A high follow-up rate allowed us to obtain reliable data on the status of OAC use and therapeutic outcomes among AF patients in Japan. Warfarin and DOACs appear to yield equivalent 3-year stroke and all-cause mortality rates, but DOACs appear to reduce the risk of major bleeding.
- 著者
- Yasuo Okumura Katsuaki Yokoyama Naoya Matsumoto Eizo Tachibana Keiichiro Kuronuma Koji Oiwa Michiaki Matsumoto Toshiaki Kojima Shoji Hanada Kazumiki Nomoto Ken Arima Fumiyuki Takahashi Tomobumi Kotani Yukitoshi Ikeya Seiji Fukushima Satoru Itou Kunio Kondo Masaaki Chiku Yasumi Ohno Motoyuki Onikura Atsushi Hirayama for the SAKURA AF Registry Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-18-0535, (Released:2018-08-04)
- 参考文献数
- 20
- 被引用文献数
- 55
Background:Although direct oral anticoagulants (DOACs) are widely used in Japanese patients with atrial fibrillation (AF), large-scale investigations into their use, with suitable follow-up times and rates, are lacking.Methods and Results:The SAKURA AF Registry is a prospective multicenter registry created to investigate therapeutic outcomes of oral anticoagulant (OAC) use in Japanese AF patients. We conducted a study involving 3,237 enrollees from 63 institutions in the Tokyo area being treated with any of 4 DOACs (n=1,676) or warfarin (n=1,561) and followed-up for a median of 39.3 months (range 28.5–43.6 months). Analyses of 1- and 2-year follow-up data available for 3,157 (97.5%) and 2,952 (91.2%) patients, respectively, showed no significant differences in rates of stroke or systemic embolism (SE), major bleeding, and all-cause mortality for DOAC vs. warfarin users (1.2 vs. 1.8%/year, 0.5 vs. 1.2%/year, and 2.1 vs. 1.7%/year, respectively). Under propensity score matching, the incidence of stroke or SE (P=0.679) and all-cause death (P=0.864) remained equivalent, but the incidence of major bleeding was significantly lower (P=0.014) among DOAC than warfarin users.Conclusions:A high follow-up rate allowed us to obtain reliable data on the status of OAC use and therapeutic outcomes among AF patients in Japan. Warfarin and DOACs appear to yield equivalent 3-year stroke and all-cause mortality rates, but DOACs appear to reduce the risk of major bleeding.