アスピリンと左心房アシスト装置による血液互換性: ARIES-HM3ランダム化臨床試験

Mandeep R Mehra¹, Ivan Netuka², Nir Uriel³

¹Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.

JAMA

|November 11, 2023

まとめ

心不全患者では,左心室補助器具 (LVAD) を用いてアスピリンを服用することは安全で,出血を減少させます. このアプローチは,VKA療法と組み合わせて,アスピリンの使用に劣らず,非手術による出血を減少させます.

科学分野:

心臓病科
医療機器
薬理学について

背景:

左心室補助器 (LVAD) は,進行した心不全の結果を改善します.
非手術による出血は,LVAD患者における重大な合併症です.
現行のガイドラインでは,限られた証拠にもかかわらず,しばしばアスピリンをVKA療法と併用することを義務付けています.

研究の目的:

完全に磁気浮揚されたLVADを持つ患者の抗血栓療法からアスピリンの排除の安全性と有効性を評価する.
血栓塞栓症のリスクを高めることなく,アスピリンを避けた方が出血を減少させるかどうかを判断する.

主な方法:

国際的なランダム化,ダブルブラインド,プラセボ対照試験で,完全に磁気浮揚されたLVADを使用した628人の患者が参加しました.
患者はVKA療法とアスピリン (100 mg/ d) またはプラセボを併用した.
主要エンドポイント: 血液適合性に関連する有害事象 (脳卒中,ポンプ血栓症,大出血,血栓塞栓症) のない12ヶ月の生存率.

主要な成果:

プラセボ群は,無事生存率の非劣化を示した (74% vs 68%).
アスピリンを避けたことで,非手術による出血が有意に減少した (RR 0. 66; P=. 002).
アスピリンを避けたとき,脳卒中やその他の血栓塞栓事件の増加は観察されなかった.

結論:

LVAD患者の治療からアスピリンを排除することは安全で有効です.
アスピリンを避けることは,血栓性の保護を損なうことなく,出血の合併症を軽減します.
この発見は,LVAD受容者のための改訂された抗血栓戦略を支持する.

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