Association Between Direct Oral Anticoagulant Score and Bleeding Events in Patients With Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: A Retrospective Multicenter Cohort Study

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[Released on 21/11/2024]

Authors: Yoshihiro Harano MD , Masanori Yamamoto MD, PhD , Tetsuro Shimura MD , Munenori Okubo MD , Yutaka Koyama MD , Ryo Yamaguchi MD , Ai Kagase MD , Takahiro Tokuda MD , Fumiaki Yashima MD , Shinichi Shirai MD , Norio Tada MD , Toru Naganuma MD, PhD , Masahiro Yamawaki MD , Futoshi Yamanaka MD , Kazuki Mizutani MD , Masahiko Noguchi MD , Hiroshi Ueno MD , Kensuke Takagi MD , Yohei Ohno MD , Masaki Izumo MD , Hidetaka Nishina MD , Masahiko Asami MD , Toshiaki Otsuka MD , Yusuke Watanabe MD , Kentaro Hayashida MD , the OCEAN‐TAVI investigators , Kentaro Hayashida , Makoto Tanaka , Hikaru Tsuruta , Tetsuya Saito , Yusuke Kobari , Toshinobu Ryuzaki , Tatsuo Takahashi , Shinichi Goto , Shohei Imaeda , Shingo Sakata , Yoshinori Katsumata , Kohsuke Shirakawa , Juri Iwata , Keitaro Shinada , Akiyoshi Kajino , Jungo Kato , Ryo Arita , Tomonari Moriizumi , Masanori Yamamoto , Mitsuru Sago , Tatsuya Tsunaki , Ryo Yamaguchi , Junji Yanagisawa , Yuki Okubo , Ai Kagase , Takahiro Tokuda , Yuki Nakashima , Toshihiro Kobayashi , Kenichi Shibata , Ryoutaku Kawahata , Hiroto Nishio , Yuki Kondo , Tomofumi Nakamura , Hiroshi Tsunamoto , Tetsuro Shimura , Yutaka Koyama , Munenori Okubo , Shunsuke Imai , Tokuya Sakakura , Yoshihiro Harano , Masahiro Inagaki , Hirooki Higami , Yoji Kuze , Takashi Nagai , Azusa Kurita , Shinichi Shirai , Akihiro Isotani , Kenichi Ishizu , Masato Fukunaga , Hiroyuki Tabata , Toru Morofuji , Hiroyuki Kono , Maiko Kuroda , Ko Euihong , Norihisa Miyawaki , Kenji Nakano , Katsunori Miyahara , Ko Yamamoto , Koumei Onuki , Yasuo Tsuru , Tomohiro Suenaga , Akira Otani , Yusuke Watanabe , Taiga Katayama , Hirofumi Hioki , Junichi Nishikawa , Yosei Iseki , Yasuyuki Tsuchida , Kento Kito , Joe Omiya , Masataka Arakawa , Maki Okamoto , Masafumi Saito , Mizuki Miura , Toru Naganuma , Toru Ouchi , Haruhito Yuki , Masahiro Yamawaki , Norio Tada , Yusuke Enta , Masaki Nakashima , Makoto Saigan , Yoshiko Munehisa , Masaki Miyasaka , Natsuko Satomi , Yuta Kobayashi , Daishi Tazawa , Yun Teng , Futoshi Yamanaka , Shingo Mizuno , Koki Shishido , Tomoki Ochiai , Tsuyoshi Yamabe , Noriaki Moriyama , Takashi Matsumoto , Hirokazu Miyashita , Yoichi Sugiyama , Kunihiko Shimizu , Daisuke Sato , Yuka Murakami , Masahiko Noguchi , Nahoko Kato , Joji Ito , Makio Muraishi , Yuta Azumi , Minoru Tabata , Kunihiko Yoshino , Tetsuya Kobayashi , Hiroki Sakai , Hiroshi Ueno , Nobuyuki Fukuda , Shuhei Tanaka , Hiroshi Onoda , Toshio Doi , Mitsuo Sobajima , Yohei Ueno , Teruhiko Imamura , Ryuichi Ushijima , Yuki Hida , Kazuya Nakashima , Yohei Ohno , Junichi Miyamoto , Tsutomu Murakami , Kimiaki Okada , Sho Torii , Makoto Natsumeda , Shigemitu Tanaka , Takeshi Ijichi , Hitomi Horinouchi , Kazuki Aihara , Katsuaki Sakai , Shingo Matsumoto , Norihiko Kamioka , Norihito Nakamura , Takafumi Saito , Satoshi Noda , Yu Sato , Masaki Izumo , Daisuke Miyahara , Shingo Kuwata , Masashi Koga , Toshiki Kaihara , Takumi Higuma , Kei Honda , Yoshikuni Kobayashi , Risako Murata , Kenichi Sasaki , Daisuke Togashi , Takahiko Kai , Taishi Okuno , Toshiya Yoshida , Keita Sone , Karin Terauchi , Kazumasa Yamasaki , Hiroki Bota , Tomoyuki Tani , Mamoru Miyazaki , Yuki Katagiri , Hidetaka Nishina , Akimune Kuwayama , Daiki Akiyama , Kazuya Shinouchi , Maiko Ishikawa , Hiroto Suzuyama , Kazuhisa Kodama , Hideharu Okamatsu , Tomohiro Sakamoto , Yoko Horibata , Yutaka Konami , Masahiro Yamada , Eiji Horio , Mika Maeda , Satoko Hasegawa , Megumi Koga , Mikiko Ohara , Shota Fukushige , Yasushi Fuku , Akihiro Ikuta , Shunsuke Matsushita , Satoki Oka , Naoya Inoue , Gakuto Bando , Kensuke Takagi , Makoto Amaki , Takeshi Kitai , Atsushi Okada , Tasuku Hada , Shoko Nakagawa , Marina Arai , Yuki Irie , Takahiro Sakamoto , Shinichi Kurashima , Masahiko Asami , Jun Tanaka , Yu Horiuchi , Naoki Hosoda , Yuki Gonda , Yohei Nishimura , Asahi Oshima , Fumiaki Yashima , Kenichi Hashizume , Hiroaki Nishida , Nobuhiro Yoshijima , Masatoshi Sato , Gaku Nakazawa , Masakazu Yasuda , Kosuke Fujita , Tatsuya Miyoshi , Naoko Soejima , Masahiro Maruyama , Motohide Tanaka , Takayuki Kawamura , Honoka Kanno , Ayano Yoshida , Kyohei Onishi , Nobuhiro Yamada , Hiroki Matsuzoe , Daisuke Hachinohe , Ken Kobayashi , Umihiko Kaneko , Kazuki Mizutani , Hidemasa Shitan , Ryo Horita , Ryo Otake

Abstract

Background The Direct Oral Anticoagulant (DOAC) Score can predict bleeding risk in patients with atrial fibrillation taking DOACs; however, it lacks external validation. Therefore, this study aimed to assess the association between the DOAC Score and bleeding events in patients with atrial fibrillation who underwent transcatheter aortic valve replacement.
Methods and Results This retrospective multicenter cohort study included patients with atrial fibrillation who underwent transcatheter aortic valve replacement, as registered in a Japanese multicenter registry. The primary end point was the incidence of bleeding. Patients were categorized based on their DOAC Score: low and moderate‐ (7 points), high‐ (8–9 points), and very high‐risk (10 points) groups. Among 1230 patients (mean age 84.6±5.1 years; 457 men), 465 (37.8%) received a vitamin K antagonist, and the remaining patients received DOACs. The low and moderate‐, high‐, and very high‐risk groups included 380 (30.1%), 497 (40.4%), and 353 patients (28.7%), respectively. The 3‐year cumulative incidence of all bleeding events was significantly different among the 3 groups (low and moderate risk: 6.6%, high risk: 6.9%, and very high risk: 14.0%; P<0.01). Multivariable Cox regression analysis revealed that significant increments in the DOAC Score were associated with a risk of all bleeding events at 3 years in the overall cohort (hazard ratio [HR], 1.22 [95% CI, 1.08–1.38]; P<0.01), in the DOAC cohort (HR, 1.20 [95% CI, 1.01–1.42]; P=0.04), and in the vitamin K antagonist cohort (HR, 1.25 [95% CI, 1.04–1.50]; P=0.02).
Conclusions The DOAC Score was significantly associated with bleeding events in patients with atrial fibrillation after transcatheter aortic valve replacement, aiding in clinical decision‐making for anticoagulant management.
Registration URL: https://center6.umin.ac.jp/cgi&open&bin/ctr_e/c...; Unique identifier: UMIN000020423.

Keywords: atrial fibrillation; bleeding; DOAC Score; transcatheter aortic valve replacement.

Nonstandard Abbreviations and Acronyms

  • DOAC
  • direct oral anticoagulant
  • OAC
  • oral anticoagulant
  • TAVR
  • transcatheter aortic valve replacement
  • VKA
  • vitamin K antagonist

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Association Between Direct Oral Anticoagulant Score and Bleeding Events in Patients With Atrial Fibrillation Following Transcatheter Aortic Valve Replacement: A Retrospective Multicenter Cohort Study

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Abstract

Background The Direct Oral Anticoagulant (DOAC) Score can predict bleeding risk in patients with atrial fibrillation taking DOACs; however, it lacks external validation. Therefore, this study aimed to assess the association between the DOAC Score and bleeding events in patients with atrial fibrillation who underwent transcatheter aortic valve replacement.
Methods and Results This retrospective multicenter cohort study included patients with atrial fibrillation who underwent transcatheter aortic valve replacement, as registered in a Japanese multicenter registry. The primary end point was the incidence of bleeding. Patients were categorized based on their DOAC Score: low and moderate‐ (7 points), high‐ (8–9 points), and very high‐risk (10 points) groups. Among 1230 patients (mean age 84.6±5.1 years; 457 men), 465 (37.8%) received a vitamin K antagonist, and the remaining patients received DOACs. The low and moderate‐, high‐, and very high‐risk groups included 380 (30.1%), 497 (40.4%), and 353 patients (28.7%), respectively. The 3‐year cumulative incidence of all bleeding events was significantly different among the 3 groups (low and moderate risk: 6.6%, high risk: 6.9%, and very high risk: 14.0%; P<0.01). Multivariable Cox regression analysis revealed that significant increments in the DOAC Score were associated with a risk of all bleeding events at 3 years in the overall cohort (hazard ratio [HR], 1.22 [95% CI, 1.08–1.38]; P<0.01), in the DOAC cohort (HR, 1.20 [95% CI, 1.01–1.42]; P=0.04), and in the vitamin K antagonist cohort (HR, 1.25 [95% CI, 1.04–1.50]; P=0.02).
Conclusions The DOAC Score was significantly associated with bleeding events in patients with atrial fibrillation after transcatheter aortic valve replacement, aiding in clinical decision‐making for anticoagulant management.
Registration URL: https://center6.umin.ac.jp/cgi&open&bin/ctr_e/c...; Unique identifier: UMIN000020423.

Keywords: atrial fibrillation; bleeding; DOAC Score; transcatheter aortic valve replacement.

Nonstandard Abbreviations and Acronyms

  • DOAC
  • direct oral anticoagulant
  • OAC
  • oral anticoagulant
  • TAVR
  • transcatheter aortic valve replacement
  • VKA
  • vitamin K antagonist

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