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COVID-19 のアウトプット患者における血栓性イベント,入院,死亡の予防のためのリバロキサバン:ランダム化臨床試験
Gregory Piazza1, Alex C Spyropoulos2,3,4, Judith Hsia5,6
1Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (G.P.).
Circulation
|May 8, 2023
まとめ
予防的なリバロキサバンは,入院していないCOVID-19患者における主要な血栓性イベント,入院,または死亡を減少させなかった. PREVENT- HD試験は,低症例率と入学困難のため,早期に中止されました.
科学分野:
- 心臓病科
- 感染症
- 血液学
背景:
- COVID-19は静脈と動脈の血栓や呼吸不全のリスクを高めます.
- 病院に入院していないCOVID-19患者の予防性抗凝固効果の評価は極めて重要です.
研究 の 目的:
- リバロキサバンによる血液凝固抑制薬が,高リスクの,入院していないCOVID-19患者の血栓形成,入院,または死亡を減少させるかどうかを評価する.
主な方法:
- PREVENT-HD試験は,入院していないCOVID-19患者1284人を対象とした二重盲検,プラセボ対照試験でした.
- 患者は35日間,毎日口服リバロキサバン (10 mg) またはプラセボを投与された.
- 主なアウトカム: 血栓性イベント,入院,または死亡; 安全性: 臨界部位または致死性出血.
主要な成果:
- 研究は,入学困難と低発生率のために早期に終了されました.
- リバロキサバン群: 3. 4%のイベント率; プラセボ群: 3. 0%のイベント率 (HR,1. 16; P=0. 63).
- 臨界部位または致死性出血は発生しなかったが,リバロキサバン群では大きな出血が1回発生した.
結論:
- リバロキサバンは,血栓形成のリスクのある,入院していないCOVID-19患者の複合エンドポイントを有意に低下させなかった.
- 裁判の早期終了は 決定的な結論を制限しました
- この集団における抗凝固剤の役割を明らかにするために,さらなる研究が必要になる可能性があります.
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