慢性完全閉塞の治療のための皮膚経冠動脈介入を評価するランダム化試験

Seung-Whan Lee¹, Pil Hyung Lee¹, Jung-Min Ahn¹

¹Department of Cardiology (S-W.L., P.H.L., J.-M.A., D.-W.P., H.K., S.-J.K., Y.-H.K., C.W.L., S.-W.P., S.-J.P.), Center for Medical Research and Information, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.

Circulation

|March 1, 2019

まとめ

慢性完全閉塞 (CTO-PCI) の経皮動脈介入は高い成功率で実行可能である. しかし,この研究では,CTO- PCIとCTO- PCI戦略の間の主要な心血管疾患の有意な違いが見つかりませんでした.

科学分野:

心臓病科
介入心臓科
臨床試験

背景:

慢性完全閉塞 (CTO) の経皮冠動脈介入 (PCI) は進歩しており,より完全な再血管化の傾向があります.
CTO-PCIを支持する証拠は主に観察研究と小規模な試験から得られており,さらなる調査が必要である.

研究の目的:

CTO-PCIの有効性と安全性を評価し,適格な患者にCTO-PCIを施さない戦略と比較する.
CTO-PCIが36ヶ月間にわたる健康関連の生活の質に与える影響を評価する.

主な方法:

834人の患者が参加した無作為化された非劣等性試験です
患者はCTO- PCIまたはCTO- PCIのいずれかに割り当てられ,CTO以外の病変のPCIの選択肢が与えられました.
主要エンドポイントは,死亡,心筋梗塞,脳卒中,またはリバスカライゼーションの組み合わせであり,生活の質も評価された.

主要な成果:

CTO- PCIの成功率は90. 6%で,3人の患者に重篤な合併症がありました.
CTO-PCI (22. 3%) とCTO-PCI (22. 4%) グループ間のプライマリエンドポイントの発生率は,平均4. 0年の追跡期間において有意な差異はなかった.
2つの戦略は,疾患特有の健康状態の比較可能な改善を示し,グループ間の有意な差異はなかった.

結論:

CTO-PCIは高い成功率で実行可能な手順です.
この研究は,CTO- PCIとCTO- PCIなしの主要な心血管疾患の有意な違いを示さなかった.
制限は,臨床的エンドポイントの低い統計力と,グループ間の高いクロスオーバー率を含む.

キーワード:

動脈閉塞性疾患結果経皮冠動脈介入ランダム化制御試験

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