経皮冠動脈干渉 (REGULATE- PCI) の後の結果に対するREG1抗凝固システムの効果: ランダム化臨床試験
A Michael Lincoff1, Roxana Mehran2, Thomas J Povsic3
1Cleveland Clinic Coordinating Center for Clinical Research (C5Research), Cleveland, OH, USA.
Lancet (London, England)
|November 9, 2015
まとめ
抗凝固剤であるREG1は,PCI患者におけるビヴァリルジンと比較して,不血症または出血を減少させなかった. 重度のアレルギー反応により,臨床試験は早期に終了し,統計的効果は制限された.
科学分野:
- 心血管医学
- 薬理学について
- 臨床試験
背景:
- REG1はペグニバコギン (因子IXa阻害剤) とアニバマーセン (逆転剤) を含む新しい抗凝固剤です.
- 仮説: REG1は,ビヴァリルジンと比較して,皮膚経冠動脈干渉 (PCI) の際に出血を増加させずに,血性イベントを減少させる.
研究 の 目的:
- PCIを受ける患者におけるREG1とビヴァリルジンの有効性と安全性を比較する.
- REG1が不血症および出血の合併症を軽減するかどうかを評価する.
主な方法:
- ランダム化され,オープンで, 活性制御され, 多中心の優位性試験です.
- 患者13,200人がPCIを予定しており,REG1またはビヴァリルジンに1対1で割り当てられました.
- 3232人の患者が重度のアレルギー反応を起こしたため,試験は早期に終了した.
主要な成果:
- REG1とビヴァリルジン (OR1. 05, p=0. 72) の間では,主効性エンドポイント (死亡,心筋梗塞,脳卒中,再血管化) で有意な差異はありません.
- 重度の出血率は類似したが,REG1では重度の出血または軽度の出血が増加した (p=0. 002).
- 重度のアレルギー反応は,REG1患者の1%とビヴァリルジン患者の< 1%で発生しました.
結論:
- 現在のREG1の配列は重度のアレルギー反応と関連しています.
- 早期終止は統計的効果を限ったが,REG1が不血症や出血を軽減する上でビヴァリルジンより優れているという証拠はない.
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