The bleeding with antithrombotic therapy study 2: Rationale, design, and baseline characteristics of the participants
The bleeding with antithrombotic therapy study 2: Rationale, design, and baseline characteristics of the participants
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DOI：
10.1177/2396987320960618
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发表时间：
2020-09
影响因子：
6.1
通讯作者：
Masahito Takagi;Kanta Tanaka;K. Miwa;M. Sasaki;M. Koga;T. Hirano;K. Kamiyama;Y. Yagita;Y. Nagakane;H. Hoshino;T. Terasaki;Y. Yakushiji;K. Kudo;M. Ihara;S. Yoshimura;Y. Yamaguchi;M. Shiozawa;K. Toyoda
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文献类型：
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作者：
Masahito Takagi;Kanta Tanaka;K. Miwa;M. Sasaki;M. Koga;T. Hirano;K. Kamiyama;Y. Yagita;Y. Nagakane;H. Hoshino;T. Terasaki;Y. Yakushiji;K. Kudo;M. Ihara;S. Yoshimura;Y. Yamaguchi;M. Shiozawa;K. Toyoda
目前的抗血栓策略在临床环境中的出血风险，包括最近开发的药物，需要澄清。方法和设计在一项由促凝剂启动的、前瞻性、多中心、观察性研究中，纳入了正在服用口服抗血小板或抗凝剂的脑血管或心血管疾病患者。在基线时采集强制性多模态磁共振图像，以评估脑小血管疾病。将进行为期两年的6个月随访。主要结局是国际血栓与止血学会定义的大出血。结果2016年10月至2019年3月期间，入组了5306例患者（71.7 ± 11.2岁，1762例女性）。181例患者（3.4%）记录了既往颅内出血，5006例患者（94.3%）记录了需要抗血栓治疗的脑血管疾病（包括无症状），1061例患者（20.0%）记录了房颤。入组时，3726例患者（70.2%）单独使用抗血小板药物，包括551例（10.4%）使用双重抗血小板药物，1317例（24.8%）单独使用抗凝剂，其余263例（5.0%）同时使用两种药物。主要的抗血小板药物是氯吡格雷（2014例患者），主要的双联抗血小板药物组合是氯吡格雷加阿司匹林（362例）。直接口服抗凝剂的使用（1029例患者，19.4%）超过华法林的使用（554例，10.4%）。2020年4月，关键性出血事件数量超过200起。结论本研究有望提供临床实践中近期口服抗血栓药物的出血并发症发生率，并确定其与潜在小血管疾病和其他生物标志物的相关性。基于研究结果，将能够创建出血风险的新型风险分层模型。
Aims The bleeding risk of current antithrombotic strategies in clinical settings, including recently developed agents, needs to be clarified. Methods and Design In an investigator-initiated, prospective, multicentre, observational study, patients with cerebrovascular or cardiovascular diseases who were taking oral antiplatelet or anticoagulant agents were enrolled. Compulsory multimodal magnetic resonance images were acquired at baseline to assess cerebral small vessel disease. Six-month follow-up will be performed for two years. The primary outcome is major bleeding as defined by the International Society on Thrombosis and Hemostasis. Results Between October 2016 and March 2019, 5306 patients (71.7 ± 11.2 years old, 1762 women) were enrolled. Previous intracranial haemorrhage was documented in 181 patients (3.4%), cerebrovascular disease (including asymptomatic) requiring antithrombotic therapy in 5006 patients (94.3%), and atrial fibrillation in 1061 patients (20.0%). At entry, 3726 patients (70.2%) were taking antiplatelet agents alone, including 551 (10.4%) using dual antiplatelet agents, 1317 (24.8%) taking anticoagulants alone, and the remaining 263 (5.0%) taking both. The leading antiplatelet agent was clopidogrel (2014 patients), and the leading combination of dual antiplatelet medication was clopidogrel plus aspirin (362). Use of direct oral anticoagulants (1029 patients, 19.4%) exceeded warfarin use (554, 10.4%). The number of pivotal bleeding events exceeded 200 in April 2020. Conclusions This study is expected to provide the incidence of bleeding complications of recent oral antithrombotics in clinical practice and identify their associations with underlying small vessel disease and other biomarkers. Novel risk stratification models for bleeding risk will be able to be created based on the study results.