隔離された遠隔深静脈血栓症 (ONCO DVT研究) がん患者の12ヶ月対3ヶ月間のエドキサバン:オープンラベル,マルチセンター,ランダム化臨床試験
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まとめ
この要約は機械生成です。隔離されたディスタル深静脈血栓症のがん患者では,12ヶ月のエドキサバン治療は,3ヶ月の治療と比較して重発性静脈血栓栓症 (VTE) の発生を著しく減少させ,大出血率も同様であった.
科学分野
- 血液学
- 腫瘍学
- 臨床試験
背景
- がん患者の孤立した遠隔深静脈血栓症 (DVT) の最適の抗凝固治療期間は不明である.
- 長期にわたる治療は血栓形成を予防するが,出血のリスクを増加させる.
研究 の 目的
- 癌患者の隔離された遠隔 DVTに対する12ヶ月対3ヶ月間のエドキサバン治療の有効性と安全性を比較する.
- 再発性静脈血栓塞栓症 (VTE) または12ヶ月のVTE関連死亡のプライマリエンドポイントを評価する.
主な方法
- 601人の腫瘍患者で 隔離された先頭部DVTを対象とした多中心のランダム化臨床試験です
- 患者は12ヶ月または3ヶ月エドキサバン治療を受けた.
- 主要エンドポイント: 症状のある再発性VTEまたはVTE関連死亡の複合体; 二次エンドポイント: 大量の出血.
主要な成果
- 12ヶ月のエドキサバンは,症状の再発性VTEまたはVTEに関連する死亡を著しく減少させた (1. 0% 対 7. 2%; OR, 0. 13; 95% CI, 0. 03- 0. 44).
- 12ヶ月 (9. 5%) と3ヶ月 (7. 2%) のグループでは重度の出血率が類似していた (OR,1. 34;95%CI,0. 75~2. 41).
結論
- 12ヶ月のエドキサバン治療は,隔離された静脈動脈腫患者における再発性VTEまたはVTE関連死亡の予防に3ヵ月以上有効です.
- エドキサバンによる長期抗凝固治療は,この患者群では安全である.
関連する概念動画
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