アブルミナル生物分解性ポリマーバイオリムス放出ステントと耐久性ポリマーエベロリムス放出ステント (COMPARE II):ランダム化され,制御され,劣等性のない試験
Pieter Cornelis Smits1, Sjoerd Hofma, Mario Togni
1Department of Cardiology, Maasstad Ziekenhuis, Rotterdam, Netherlands. smitsp@maasstadziekenhuis.nl
Lancet (London, England)
|February 5, 2013
まとめ
生物分解性ポリマー・バイオリムス・エリューテーション・ステントは,皮膚経由の冠動脈介入を受けた患者において,耐久性ポリマー・エヴォーリムス・エリューテーション・ステントと比べて,安全性と有効性が同等であることが示された. 長期のステント栓塞のリスクを評価するために,より長いフォローアップが必要である.
科学分野:
- 心臓病学 心臓病学
- バイオメディカルエンジニアリング
- 介入性心臓病学 介入性心臓病学
背景:
- 薬剤排出ステント (DES) は,初期の世代に見られる血栓形成のリスクを軽減します.
- 生物分解性および耐久性の高いポリマーは,現代のDESで使用されています.
- 生物分解性ポリマーバイオリムス放出ステント (BP-BES) と耐久性ポリマーエベロリムス放出ステント (DP-EES) の比較は極めて重要です.
研究 の 目的:
- BP-BESとDP-EESの安全性と有効性を比較する.
- 12ヶ月で心臓死,心筋梗塞,または標的血管再血管化のプライマリエンドポイントを評価するために.
主な方法:
- オープンレーベル,前向き,ランダム化,制御,非劣等性試験,欧州12カ国で実施.
- 2707人の冠動脈疾患の患者は,BP-BES (Nobori) またはDP-EES (Xience/Promus) にランダムに (2:1) 割り当てられました.
- 主要エンドポイントは,治療の意図によって分析され,患者は12ヶ月の二重抗血小板治療を受けた.
主要な成果:
- 主要エンドポイントは,BP-BES患者の5.2%とDP-EES患者の4.8%で発生した (RR 1.07,95%CI 0.75-1.52).
- 非劣等性は満たされた (p<0.0001).
- BP-BESグループでは,ステントが割り当てられていない患者が多くなった (5.9%対2.1%,p<0.0001).
結論:
- 生物分解性ポリマーバイオリムス放出ステントは,耐久性の高いポリマーエベロリムス放出ステントの安全性と有効性において劣らない.
- BP-BESが,1年後のステント血栓形成のリスクを減らすかどうかを判断するために,より長期のフォローアップが必要である.
- この研究は,BP-BESを現在のDP-EES標準の実行可能な代替案として支持しています.
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