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
12

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
12

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 Koichi Nagashima Masaru Arai Ryuta Watanabe Katsuaki Yokoyama Naoya Matsumoto Takayuki Otsuka Shinya Suzuki Akio Hirata Masato Murakami Mitsuru Takami Masaomi Kimura Hidehira Fukaya Shiro Nakahara Takeshi Kato Wataru Shimizu Yu-ki Iwasaki Hiroshi Hayashi Tomoo Harada Ikutaro Nakajima Ken Okumura Junjiroh Koyama Michifumi Tokuda Teiichi Yamane Yukihiko Momiyama Kojiro Tanimoto Kyoko Soejima Noriko Nonoguchi Koichiro Ejima Nobuhisa Hagiwara Masahide Harada Kazumasa Sonoda Masaru Inoue Koji Kumagai Hidemori Hayashi Kazuhiro Satomi Yoshinao Yazaki Yuji Watari on behalf of the AF Ablation Frontier Registry
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
pp.CJ-19-0602, (Released:2019-10-16)
参考文献数
27

Background:The safety of discontinuing oral anticoagulant (OAC) after ablation for atrial fibrillation (AF) in Japanese patients has not been clarified.Methods and Results:A study based on the Atrial Fibrillation registry to Follow the long-teRm Outcomes and use of aNTIcoagulants aftER Ablation (AF Frontier Ablation Registry) was conducted. Data were collected from 3,451 consecutive patients (74.1% men; age, 63.3±10.3 years) who had undergone AF ablation at any of 24 cardiovascular centers in Japan between August 2011 and July 2017. During a 20.7-month follow-up period, OAC therapy was discontinued in 1,836 (53.2%) patients; 51 patients (1.5%) suffered a stroke/transient ischemic attack (TIA), 71 (2.1%) suffered major bleeding, and 36 (1.0%) died. Patients in whom OAC therapy was discontinued were significantly younger than those in whom OACs were continued, and their CHA2DS2-VASc scores were significantly lower. The incidences of stroke/TIA, major bleeding, and death were significantly lower among these patients. Upon multivariate adjustment, stroke events were independently associated with relatively high baseline CHA2DS2-VASc scores but not with OAC status.Conclusions:Although the incidences of stroke/TIA, major bleeding, and death were relatively low among patients for whom OAC therapy was discontinued, stroke/TIA occurrence was strongly associated with a high baseline stroke risk rather than with OAC status. Thus, discontinuation of OAC therapy requires careful consideration, especially in patients with a high baseline stroke risk.
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
27

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 Koichi Nagashima Masaru Arai Ryuta Watanabe Katsuaki Yokoyama Naoya Matsumoto Takayuki Otsuka Shinya Suzuki Akio Hirata Masato Murakami Mitsuru Takami Masaomi Kimura Hidehira Fukaya Shiro Nakahara Takeshi Kato Wataru Shimizu Yu-ki Iwasaki Hiroshi Hayashi Tomoo Harada Ikutaro Nakajima Ken Okumura Junjiroh Koyama Michifumi Tokuda Teiichi Yamane Yukihiko Momiyama Kojiro Tanimoto Kyoko Soejima Noriko Nonoguchi Koichiro Ejima Nobuhisa Hagiwara Masahide Harada Kazumasa Sonoda Masaru Inoue Koji Kumagai Hidemori Hayashi Kazuhiro Satomi Yoshinao Yazaki Yuji Watari on behalf of the AF Ablation Frontier Registry
出版者
The Japanese Circulation Society
雑誌
Circulation Journal (ISSN:13469843)
巻号頁・発行日
vol.83, no.12, pp.2418-2427, 2019-11-25 (Released:2019-11-25)
参考文献数
27

Background:The safety of discontinuing oral anticoagulant (OAC) after ablation for atrial fibrillation (AF) in Japanese patients has not been clarified.Methods and Results:A study based on the Atrial Fibrillation registry to Follow the long-teRm Outcomes and use of aNTIcoagulants aftER Ablation (AF Frontier Ablation Registry) was conducted. Data were collected from 3,451 consecutive patients (74.1% men; age, 63.3±10.3 years) who had undergone AF ablation at any of 24 cardiovascular centers in Japan between August 2011 and July 2017. During a 20.7-month follow-up period, OAC therapy was discontinued in 1,836 (53.2%) patients; 51 patients (1.5%) suffered a stroke/transient ischemic attack (TIA), 71 (2.1%) suffered major bleeding, and 36 (1.0%) died. Patients in whom OAC therapy was discontinued were significantly younger than those in whom OACs were continued, and their CHA2DS2-VASc scores were significantly lower. The incidences of stroke/TIA, major bleeding, and death were significantly lower among these patients. Upon multivariate adjustment, stroke events were independently associated with relatively high baseline CHA2DS2-VASc scores but not with OAC status.Conclusions:Although the incidences of stroke/TIA, major bleeding, and death were relatively low among patients for whom OAC therapy was discontinued, stroke/TIA occurrence was strongly associated with a high baseline stroke risk rather than with OAC status. Thus, discontinuation of OAC therapy requires careful consideration, especially in patients with a high baseline stroke risk.
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
27

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
Ichiro Watanabe Yasuo Okumura Rikitake Kogawa Naoko Sasaki Kimie Ohkubo Masayoshi Kofune Koichi Nagashima Kazumasa Sonoda Hiroaki Mano Atsushi Hirayama
出版者
一般社団法人 インターナショナル・ハート・ジャーナル刊行会
雑誌
International Heart Journal (ISSN:13492365)
巻号頁・発行日
vol.53, no.6, pp.375-382, 2012 (Released:2012-12-18)
参考文献数
22
被引用文献数
1 4

Catheter ablation of persistent/long-persistent atrial fibrillation (AF) has been shown to be less effective by pulmonary vein isolation (PVI) and additional left atrial (LA) complex fractionated atrial electrograms and long linear lesions are often required. Recent reports have demonstrated right atrial (RA) ablation increases the success rate of maintaining sinus rhythm in persistent/long-persistent AF. The aim of this study was to investigate whether effective RA linear lesions can terminate AF and render it noninducible in a canine model of rapid atrial pacing-induced sustained AF. Sustained AF was induced by rapid atrial pacing in 20 dogs. AF duration was 21-126 days (median, 50 days). Four RA linear lesions (superior vena cava-inferior vena cava, septal line, transverse line, and cavo-tricuspid line) were created with the use of 1 of 3 different ablation catheters (large-tip [8-mm tip], coil-tip, and cooled-tip catheters). AF was terminated with the large-tip catheter in 4/7 dogs (1 dog died of ventricular fibrillation [VF]), with the coil-tip catheter in 3/7 dogs (1 dog died of VF), and with the cooled-tip catheter in 1/6 dogs. In 6 dogs in which AF could not be terminated acutely by RA ablation, AF terminated spontaneously at 7-78 days (median, 14 days) after ablation. RA linear ablation terminated AF with limited success in our dog model of rapid atrial pacing-induced AF, but late AF termination was noted in the surviving dogs. Therefore, RA linear lesions in addition to the PVI and LA lesions may have additional effects on the catheter ablation for the persistent AF.