経口抗凝固薬を受けている慢性冠動脈症候群患者のアスピリン
Gilles Lemesle1,2,3,4, Romain Didier5,6,7, Philippe Gabriel Steg4,8,9,10
1Heart and Lung Institute, University Hospital of Lille, Centre Hospitalier Universitaire (CHU) Lille, Lille, France.
The New England journal of medicine
|September 1, 2025
まとめ
高リスクの慢性冠動脈症候群の患者では,口服抗凝固薬にアスピリンを加えることで,死亡と重度の出血のリスクが増加しました. この併用治療は安全性上の懸念から推奨されません.
科学分野:
- 心臓病科
- 薬理学について
- 臨床試験
背景:
- 慢性冠動脈症候群 (CCS) の患者で,長期の経口抗凝固薬 (OAC) を服用している場合の最適な抗凝固薬策は未定義です.
- この患者群では,先程のステントの導入が一般的です.
研究 の 目的:
- 高リスクのCCS患者において,OACにアスピリンを加える効果と安全性を評価する.
- この特定の患者群の最適の抗血栓治療法を決定する.
主な方法:
- 多センター,ダブルブラインド,ランダム化,プラセボ対照試験が行われました.
- 872人のCCS患者,既往のステント移植,高血小板血栓症リスク,および長期のOACは,アスピリン (100 mg/ 日) またはプラセボ,継続的なOACにランダムに (1: 1) 割り当てられました.
- 主要有効性アウトカム: 心血管疾患による死亡,心臓発作,脳卒中,栓塞,再血管化,または急性肢体缺血の複合. 安全性に関する重要な結果: 大量の出血.
主要な成果:
- アスピリン群の全因死亡率が高かったため,試験は早期に中止された.
- アスピリン群 (16. 9%) とプラセボ群 (12. 1%) で,主効性アウトカムイベントがより頻繁に発生しました.
- すべての原因による死亡 (13. 4% 対 8. 4%) と大出血 (10. 2% 対 3. 4%) は,アスピリン添加で有意に高かった.
結論:
- 高リスクのCCS患者でOACにアスピリンを追加すると,重大な心血管不良事件,あらゆる原因による死亡,および重大な出血のリスクが著しく増加します.
- リスク・ベネフィット・プロファイルが好ましくないため,この患者群ではアスピリンをOACに追加すべきではないことを示唆している.
- 代替の抗血栓剤の戦略を探るにはさらなる研究が必要である.
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