著者

Eiji Hiraoka Kengo Tanabe Shinichiro Izuta Tadao Kubota Shun Kohsaka Amane Kozuki Kazuhiro Satomi Hiroki Shiomi Toshiro Shinke Toshiyuki Nagai Susumu Manabe Yasuhide Mochizuki Taku Inohara Mitsuhiko Ota Tetsuma Kawaji Yutaka Kondo Yumiko Shimada Yohei Sotomi Tomofumi Takaya Atsushi Tada Tomohiko Taniguchi Kazuya Nagao Kenichi Nakazono Yukiko Nakano Kazuhiko Nakayama Yuichiro Matsuo Takashi Miyamoto Yoshinao Yazaki Kazuyuki Yahagi Takuya Yoshida Kohei Wakabayashi Hideki Ishii Minoru Ono Akihiro Kishida Takeshi Kimura Tetsuro Sakai Yoshihiro Morino on behalf of the Japanese Society Joint Working Group

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-22-0609, (Released:2023-08-10)

参考文献数

439

被引用文献数

7

著者

Tomoaki Kobayashi Yohei Sotomi Akio Hirata Yasushi Sakata Atsushi Hirayama Yoshiharu Higuchi

出版者

The Japanese Circulation Society

雑誌

Circulation Reports (ISSN:24340790)

巻号頁・発行日

vol.2, no.6, pp.289-296, 2020-06-10 (Released:2020-06-10)

参考文献数

16

被引用文献数

9

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Background:The association between direct oral anticoagulant (DOAC) dose and clinical outcomes when used with antiplatelets still remains to be investigated.Methods and Results:We conducted a prospective registry of non-valvular atrial fibrillation (AF) patients with DOAC: the DIRECT registry (n=2,216; follow-up, 407±388 days). We analyzed patients taking standard dose (n=907) and off-label reduced dose (n=338) DOAC in this sub-analysis. These patients were further stratified by add-on antiplatelets. Because DOAC dose was not randomly selected, potential confounding factors were eliminated through a propensity score-matching technique. The primary endpoint was clinically significant bleeding. The secondary endpoint was major adverse cardiovascular events (MACE; composite of all-cause death, all myocardial infarction, and stroke/systemic embolism). In patients with DOAC only/DOAC+antiplatelets, we successfully matched 212/62 patients who received off-label reduced dose DOAC with 212/62 standard dose patients. Off-label DOAC dose reduction did not have a significant impact on bleeding (HR, 1.123; 95% CI: 0.730–1.728, P=0.596) or MACE (HR, 1.107; 95% CI: 0.463–2.648, P=0.819) in patients with DOAC only, whereas in patients with add-on antiplatelets, off-label dose reduction significantly reduced bleeding (HR, 0.429; 95% CI: 0.212–0.868, P=0.019) without increasing MACE (HR, 2.205; 95% CI: 0.424–11.477, P=0.348).Conclusions:Reduced DOAC dose in combination with antiplatelet agents was associated with fewer bleeding complications than standard-dose therapy with no reduction in efficacy.

著者

Yuma Hamanaka Yohei Sotomi Akio Hirata Tomoaki Kobayashi Yasuhiro Ichibori Nobuhiko Makino Takaharu Hayashi Yasushi Sakata Atsushi Hirayama Yoshiharu Higuchi

出版者

The Japanese Circulation Society

雑誌

Circulation Journal (ISSN:13469843)

巻号頁・発行日

pp.CJ-19-1006, (Released:2020-02-11)

参考文献数

21

被引用文献数

8 17

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Background:This study investigated the impact of systemic inflammation on bleeding risk in non-valvular atrial fibrillation (NVAF) patients treated with direct oral anticoagulants (DOAC).Methods and Results:We conducted a single-center prospective registry of 2,216 NVAF patients treated with DOAC: the DIRECT registry (UMIN000033283). High-sensitivity C-reactive protein (hsCRP) was measured ≤3 months before (pre-DOAC hsCRP) and 6±3 months after initiation of DOAC (post-DOAC hsCRP). Multivariate logistic regression model was used to assess the influence of systemic inflammation and conventional bleeding risk factors on major bleeding according to International Society on Thrombosis and Haemostasis criteria. Based on the findings, we created a new bleeding risk assessment score: the ORBIT-i score, which included post-DOAC hsCRP >0.100 mg/dL and all components of the ORBIT score. A total of 1,848 patients had both pre- and post-DOAC hsCRP data (follow-up duration, 460±388 days). Post-DOAC hsCRP was associated with major bleeding (OR, 2.770; 95% CI: 1.687–4.548, P<0.001). Patients with post-DOAC hsCRP >0.100 mg/dL more frequently had major bleeding than those without (log-rank test, P<0.001). ORBIT-i score had the highest C-index of 0.711 (95% CI, 0.654–0.769) compared with the ORBIT and HAS-BLED scores.Conclusions:Persistent systemic inflammation was associated with major bleeding risk. ORBIT-i score had a higher discriminative performance compared with the conventional bleeding risk scores.