1. A Randomized, Multicenter, Single-Blinded Trial Comparing Paclitaxel-Coated Balloon Angioplasty With Plain Balloon Angioplasty in Drug-Eluting Stent Restenosis
- Author
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Matthias Waliszewski, Ole-A. Breithardt, Marc Ohlow, Andreas Brugger, Ralf Birkemeyer, Anil-M. Sinha, Johannes Brachmann, Stefan Zimmermann, The-Vinh Nguyen, Harald Rittger, Moritz von Cranach, Jochen Wöhrle, Werner G. Daniel, Volkhard Kurowski, Martin Schmidt, Sandra Lonke, and Holger Thiele
- Subjects
medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Stent ,medicine.disease ,Balloon ,Surgery ,Catheter ,Restenosis ,Drug-eluting stent ,Angioplasty ,medicine ,Clinical endpoint ,Myocardial infarction ,Radiology ,Cardiology and Cardiovascular Medicine ,business - 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 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 )
- Published
- 2012
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