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選択的皮経冠動脈介入 (ALPHEUS) のチカグレル対クロピドグレル:ランダム化,オープンラベル,フェーズ3b試験
Johanne Silvain1, Benoit Lattuca2, Farzin Beygui3
1Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.
Lancet (London, England)
|November 17, 2020
まとめ
選択性皮経冠状動脈干渉 (PCI) の際に,チカグレロはクロピドグレルを上回らなかった. クロピドグレルは標準治療法であり,チカグレロは軽度の出血を増加させた.
科学分野:
- 心臓病科
- 介入心臓科
- 薬理学について
背景:
- 経皮冠動脈干渉 (PCI) に関する筋髄腫は,患者の予後に影響を与える一般的な合併症です.
- クロピドグレルと比較して,選択的なPCI設定におけるチカグレロの有効性は,これまで評価されていなかった.
- PCIを患っている患者にとって,手術周辺の不血症合併症を減らすことは極めて重要です.
研究 の 目的:
- 高リスクの選択性PCIを受けている安定した冠動脈疾患の患者において,チカグレロがクロピドグレルより優れているかどうかを評価する.
- この患者集団におけるチカグレロールとクロピドグレルの安全性プロフィールを比較する.
主な方法:
- 3b相,ランダム化,オープンラベル試験 (ALPHEUS) で,49の病院で1910人の患者が参加した.
- 安定した冠動脈疾患と高リスク特性を有する患者は,30日間チカグレロまたはクロピドグレルにランダムに割り当てられました.
- 主なアウトカムは,PCIに関連した心筋梗塞または48時間以内の心筋損傷の複合体であり,主要な出血は主な安全性アウトカムでした.
主要な成果:
- チカグレロ (35%) は,プライマリ複合アウトカム (OR 0. 97, p=0. 75) の減少においてクロピドグレル (36%) を上回らなかった.
- 重度の出血事件の有意な違いは観察されなかった.
- 軽度の出血は30日後にクロピドグレル (8%) と比較してチカグレル (11%) でより頻繁であった (OR1. 54, p=0. 0070).
結論:
- 選択性PCI後の心筋縮の減少において,チカグレロはクロピドグレルよりも優れていることは示されなかった.
- 重度の出血を増加させなかったが,チカグレロは軽度の出血の頻度が高かった.
- これらの発見は,選択性PCIの標準治療としてクロピドグレルの継続的な使用を支持する.
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