- 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
- Makoto Watanabe Kazutaka Aonuma Toyoaki Murohara Yasuo Okumura Takeshi Morimoto Sadanori Okada Sunao Nakamura Shiro Uemura Koichiro Kuwahara Tadateru Takayama Naofumi Doi Tamio Nakajima Manabu Horii Kenichi Ishigami Kazumiki Nomoto Daisuke Abe Koji Oiwa Kentaro Tanaka Terumasa Koyama Akira Sato Tomoya Ueda Tsunenari Soeda Yoshihiko Saito PREVENT CINC-J Investigators
- 出版者
- The Japanese Circulation Society
- 雑誌
- Circulation Journal (ISSN:13469843)
- 巻号頁・発行日
- pp.CJ-21-0869, (Released:2022-04-22)
- 参考文献数
- 37
- 被引用文献数
- 2
Background: Previous studies have reported that high-dose strong statin therapy reduces the incidence of contrast-induced nephropathy (CIN) in statin naïve patients; however, the efficacy of high-dose strong statins for preventing CIN in real-world clinical practice remains unclear. The aim of this study was to evaluate the efficacy of strong statin therapy in addition to fluid hydration for preventing CIN after cardiovascular catheterization.Methods and Results: This prospective, multicenter, randomized controlled trial included 420 patients with chronic kidney disease who underwent cardiovascular catheterization. They were assigned to receive high-dose pitavastatin (4 mg/day × 4 days) on the day before and of the procedure and 2 days after the procedure (Statin group, n=213) or no pitavastatin (Control group, n=207). Isotonic saline hydration combined with a single bolus of sodium bicarbonate (20 mEq) was scheduled for administration to all patients. In the control group, statin therapy was continued at the same dose as that before randomization. CIN was defined as a ≥0.5 mg/dL increase in serum creatinine or ≥25% above baseline at 48 h after contrast exposure. Before randomization, 83% of study participants were receiving statin treatment. The statin group had a higher incidence of CIN than the control group (3.0% vs. 0%, P=0.01). The 12-month rate of major adverse cardiovascular events was similar between the 2 groups.Conclusions: High-dose pitavastatin increases the incidence of CIN in this study population.
- 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.