ワーファリンと比較したダビガトランの処置周期の出血および血栓塞栓事件:長期抗凝固療法のランダム化評価 (RE-LY) のランダム化試験の結果
Jeff S Healey1, John Eikelboom, James Douketis
1Population Health Research Institute, McMaster University, Hamilton, Canada. Jeff.Healey@phri.ca
Circulation
|June 16, 2012
まとめ
ダビガトランとワルファリンは,緊急手術を含む侵襲的な処置を受けた患者で,類似した周術出血率を示した. ダビガトランはまた,抗凝固剤の中断期間を短くすることを可能にしました.
科学分野:
- 心臓病学 心臓病学
- 薬理学 薬理学とは
- クリニック・トライアル 臨床試験
背景:
- ウォルファリンは一般的な経口抗凝固剤ですが,ダビガトランは不全性脳卒中のリスクを軽減します.
- 手術中にダビガトランの出血のリスクに関する懸念は,すぐに利用可能な解毒剤の欠如のために存在します.
- RE-LY試験は,これらの抗凝固剤をさまざまな臨床シナリオで比較するための強力なデータセットを提供します.
研究 の 目的:
- 侵襲的処置を受ける患者のダビガトランとワルファリンの間での周辺処置による出血リスクを比較する.
- ダビガトランの抗剤の欠如がワルファリンと比較して出血率に影響するかどうかを評価する.
- 両薬の処置に必要な経口抗凝固剤の中断期間を評価する.
主な方法:
- RE-LY試験で侵襲的な処置を受けた患者の分析.
- 出血率は,処置前の7日から処置後の30日まで評価された.
- ダビガトラン (110mgと150mg) とワルファリン群の主要な周術出血の比較.
主要な成果:
- ダビガトラン (3.8%-5.1%) とワルファリン (4.6%) グループでは,メジャー・ペリ・プロシージャル出血率の有意な差は認められなかった.
- 緊急手術を必要とする患者では,出血率も同様であった:ダビガトラン (17.8%-17.7%) 対 ワルファリン (21.6%)
- ダビガトランを服用した患者は,ワーファリン (114時間) と比較して,経口抗凝固薬の中断期間 (49時間) が著しく短かった.
結論:
- ダビガトランとワルファリンは,緊急の手術の状況でも,類似した手術周辺の出血リスクと関連しています.
- ダビガトランの使用は,処置前に口服抗凝固薬の中断期間を短縮することを可能にします.
- これらの発見は,侵襲的な処置を必要とする患者にダビガトランの使用を支持し,有効性と安全性のバランスをとります.
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