A Randomized, Multicenter, Single-Blinded Trial Comparing Paclitaxel-Coated Balloon Angioplasty With Plain Balloon Angioplasty in Drug-Eluting Stent Restenosis: The PEPCAD-DES Study

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• 作者：Harald Rittger ; MD^?/sup> ; ^{rittger@arcor.de} ; Johannes Brachmann ; MD^&dagger ; ; Anil-M. Sinha ; MD ; DPhil^&Dagger ; ; Matthias Waliszewski ; MD^§ ; ; Marc Ohlow ; MD^?/sup> ; Andreas Brugger ; MD^¶ ; ; Holger Thiele ; MD^# ; Ralf Birkemeyer ; MD^?? ; Volkhard Kurowski ; MD^&dagger ; &dagger ; ; Ole-A. Breithardt ; MD^?/sup> ; Martin Schmidt ; MD^&Dagger ; &Dagger ; ; Stefan Zimmermann ; MD^?/sup> ; Sandra Lonke^?/sup> ; Moritz von Cranach^?/sup> ; The-Vinh Nguyen^§ ; § ; ; Werner G. Daniel ; MD^?/sup> ; Jochen Wö ; hrle ; MD^§ ; § ;
• 关键词：balloon angioplasty ; drug-coated balloon ; drug-eluting stent ; in-stent restenosis
• 刊名：Journal of the American College of Cardiology
• 出版年：2012
• 出版时间：10 April, 2012
• 年：2012
• 卷：59
• 期：15
• 页码：1377-1382
• 全文大小：494 K

文摘

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Objectives

This study sought to define the impact of paclitaxel-coated balloon angioplasty for treatment of drug-eluting stent restenosis compared with uncoated balloon angioplasty alone.

Background

Drug-coated balloon angioplasty is associated with favorable results for treatment of bare-metal stent restenosis.

Methods

In this prospective, single-blind, multicenter, randomized trial, the authors randomly assigned 110 patients with drug-eluting stent restenoses located in a native coronary artery to paclitaxel-coated balloon angioplasty or uncoated balloon angioplasty. Dual antiplatelet therapy was prescribed for 6 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was late lumen loss. The secondary clinical endpoint was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization.

Results

There was no difference in patient baseline characteristics or procedural results. Angiographic follow-up rate was 91 % . Treatment with paclitaxel-coated balloon was superior to balloon angioplasty alone with a late loss of 0.43 ¡À 0.61 mm versus 1.03 ¡À 0.77 mm (p < 0.001), respectively. Restenosis rate was significantly reduced from 58.1 % to 17.2 % (p < 0.001), and the composite clinical endpoint was significantly reduced from 50.0 % to 16.7 % (p < 0.001), respectively.

Conclusions

Paclitaxel-coated balloon angioplasty is superior to balloon angioplasty alone for treatment of drug-eluting stent restenosis. (PEPCAD DES-Treatment of DES-In-Stent Restenosis With SeQuent? Please Paclitaxel Eluting PTCA Catheter [PEPCAD-DES]; )