COVID-19で入院した患者に対する治療対予防抗凝固薬 (ACTION):オープン・マルチセンター・ランダム化・制御試験
Renato D Lopes1, Pedro Gabriel Melo de Barros E Silva2, Remo H M Furtado3
1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil.
Lancet (London, England)
|June 7, 2021
まとめ
治療的抗凝固薬は,D-ダイマー値が上昇し,出血のリスクが増加した,入院したCOVID-19患者のアウトカムを改善しませんでした. 特定の指示がない限り,リバロキサバンおよび類似薬の治療用投与は避けるべきです.
科学分野:
- 内科 医学
- 心臓病科
- 感染症
背景:
- COVID-19 (新型コロナウイルス感染症 2019) は,前血栓状態と関連しており,臨床結果を悪化させる可能性があります.
- 入院したCOVID-19患者の治療における抗凝固薬の有効性は不明である.
研究 の 目的:
- D-ダイマー値が上昇した入院COVID-19患者における治療対予防抗凝固剤の有効性と安全性を比較する.
主な方法:
- プラグマティックでオープンな多センターのランダム化制御試験で,D-ダイマー値が上昇した入院COVID-19患者615人が参加した.
- 患者は,治療用抗凝固薬 (リバロキサバンまたはエノキサパリン,その後リバロキサバン) または予防用抗凝固薬 (エノキサパリンまたは未分化ヘパリン) のいずれかにランダムに分けられました.
- 主要な有効性評価は,死亡,入院期間,または酸素投与期間を階層的に組み合わせたものであった. 主要な安全性評価は,重症または臨床的に重要な非重症出血であった.
主要な成果:
- 治療用抗凝固薬は,予防用抗凝固薬と比較して,主効性評価を有意に改善しなかった (勝率0. 86; p=0. 40).
- 治療用抗凝固剤群 (8%) と予防用群 (2%) で重大または臨床的に重要な非重大出血が有意に多く発生した (RR 3. 64; p=0. 0010).
結論:
- D-ダイマー値が上昇した入院COVID-19患者では,入院治療の抗凝固薬が臨床結果を改善しなかった.
- 治療用抗凝固剤は,この患者群で,予防用抗凝固剤と比較して,出血のリスクを有意に増加させた.
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