血液透析中の心房細動の患者に対するアピキサバン: 多中心のランダム化試験

Sean D Pokorney¹, Glenn M Chertow², Hussein R Al-Khalidi¹

¹Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).

Circulation

|November 6, 2022

まとめ

RENAL- AF試験では,心房細動 (AF) の血液透析患者における脳卒中予防におけるアピキサバンとワルファリンの比較に十分なデータが見つかりませんでした. 抗凝固剤のリスクと効果に関するさらなる研究が必要となった.

科学分野:

心臓病科
腎臓科
薬理学について

背景:

ヘモダイアリスを受けている心房細動 (AF) の患者の脳卒中予防におけるアピキサバンの安全性と有効性に関するランダム化データは限られている.
末期腎臓病 (ESKD) の患者で,血液透析を受けている患者は,血栓塞栓症および出血合併症のリスクが高い集団です.

研究の目的:

血液透析中のAF患者の脳卒中予防におけるアピキサバンとワルファリンの安全性と有効性を比較する.
この特定の患者コホートにおける出血,脳卒中,死亡率,およびアピキサバンの薬理学を評価する.

主な方法:

予期的なランダム化オープンRENAL- AF試験には,血液透析中のAF患者154名,CHA 2 DS 2 - VAScスコア≥2が登録されました.
患者はアピキサバン (5 mg BID,または2. 5 mg BID) または投与量調整されたワルファリンを投与された.
主なアウトカムは重症または臨床的に重要な非重症出血までの時間であり,次要アウトカムは脳卒中および死亡率であった.

主要な成果:

アピキサバンとワルファリンの間の出血率を比較するのに不十分なパワーをもたらした.
1年間の重大または臨床的に重要な非重大出血率は32% (アピクサバン) と26% (ワルファリン) であり,脳卒中/全身栓塞率はそれぞれ3. 0%であった.
血液出血の結果に関係なく,薬理学分析では,薬剤濃度が重なり合っていることが示された.

結論:

RENAL- AF試験では,血液透析中のAF患者でアピキサバンとワルファリンの間の出血リスクの違いについて結論付けることができなかった.
臨床的に重要な出血事件は脳卒中より有意に頻繁であり,この集団における抗凝固リスクと利益に関する将来の研究の必要性を強調した.

キーワード:

抗凝固剤アピキサバン心房細動腎不全,慢性腎透析ウォルファリン

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