A randomized, multicenter, single-blinded trial comparing paclitaxel-coated balloon angioplasty with plain balloon angioplasty in drug-eluting stent restenosis: the PEPCAD-DES study
Harald Rittger, Johannes Brachmann, Anil-M Sinha, Matthias Waliszewski, Marc Ohlow, Andreas Brugger, Holger Thiele, Ralf Birkemeyer, Volkhard Kurowski, Ole-A Breithardt, Martin Schmidt, Stefan Zimmermann, Sandra Lonke, Moritz von Cranach, The-Vinh Nguyen, Werner G Daniel, Jochen Wöhrle, Harald Rittger, Johannes Brachmann, Anil-M Sinha, Matthias Waliszewski, Marc Ohlow, Andreas Brugger, Holger Thiele, Ralf Birkemeyer, Volkhard Kurowski, Ole-A Breithardt, Martin Schmidt, Stefan Zimmermann, Sandra Lonke, Moritz von Cranach, The-Vinh Nguyen, Werner G Daniel, Jochen Wöhrle
Abstract
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 ± 0.61 mm versus 1.03 ± 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]; NCT00998439).
Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed