Original ResearchPaclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease final 5-year results of a randomized prospective multicenter trialSeeger, Julia; Markovic, Sinisa; Birkemeyer, Ralf; Rittger, Harald; Jung, Werner; Brachmann, Johannes; Rottbauer, Wolfgang; Wöhrle, JochenAuthor Information aDepartment of Internal Medicine II and Cardiology, University of Ulm bHerzklinik Ulm, Ulm cKlinikum Fürth, Fürth dDepartment of Internal Medicine III, Schwarzwald-Baar Klinikum, Villingen-Schwenningen eDepartment of Internal Medicine II, Klinikum Coburg, Coburg, Germany Correspondence to Jochen Wöhrle, FESC, Department of Internal Medicine II, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany Tel: +49 731 500 45047; fax: +49 731 500 45029; e-mail: [email protected] Received July 14, 2015 Received in revised form September 3, 2015 Accepted September 24, 2015 Coronary Artery Disease: March 2016 - Volume 27 - Issue 2 - p 84-88 doi: 10.1097/MCA.0000000000000314 Buy Metrics Abstract Background The PERfECT Stent Study compared paclitaxel-coated balloon (PCB) angioplasty plus bare-metal stent (BMS) implantation with BMS alone in de-novo lesions in native coronary artery disease. Angiographic follow-up after 6 months showed the superiority of the additional PCB. We evaluated a potential late catch-up phenomenon with the use of PCB. Methods and results In the prospective, multicenter, single-blind, randomized PERfECT Stent trial, 120 patients were assigned to either PCB angioplasty plus BMS implantation or BMS alone. For BMS, the endothelial progenitor cell capturing stent was used. Dual antiplatelet therapy was recommended for 3 months. The clinical endpoint for 5-year follow-up was a composite of cardiac death, myocardial infarction attributed to the target vessel, or target lesion revascularization. The follow-up rate after 5 years was 97%. Baseline and procedural characteristics did not differ. At the 5-year follow-up, clinically driven target lesion revascularization was 23.2% in the BMS group versus 15% with PCB plus BMS (P=0.26). The clinical endpoint (major adverse cardiac event) was 30.4% with BMS and with 23.5% lower with PCB plus BMS. No definite or probable stent thrombosis was found in either group with a dual antiplatelet therapy for 3 months for the total period. Conclusion PCB angioplasty plus BMS was superior to BMS alone for the treatment of de-novo lesions. The combined clinical endpoint was lower with PCB plus BMS at 6 months and remained lower after 5 years. There was no late catch-up phenomenon (http://www.clinicaltrials.gov; NCT 00732953). Copyright © 2016 Wolters Kluwer Health, Inc. All rights reserved.