title: Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease.
abstract: BACKGROUND
  Percutaneous coronary intervention with stent implantation is limited by the occurrence of re-stenosis and the risk of stent thromboses.
  
  
  OBJECTIVE
  To define the impact of paclitaxel-coated balloon angioplasty plus endothelial progenitor cell capturing (EPC) stent implantation in de novo coronary artery disease. This combination may reduce neointimal proliferation within the EPC stent and address the risk of stent thrombosis by facilitating rapid endothelialisation.
  
  
  METHODS
  In this prospective single-blind multicentre randomised trial, 120 patients with a de novo lesion in a native coronary artery were randomly assigned to undergo treatment with paclitaxel-coated balloon plus EPC stent or EPC stent alone. Dual antiplatelet therapy was prescribed for 3 months. Angiographic follow-up was scheduled at 6 months. The primary endpoint was in-stent late lumen loss. The secondary clinical endpoint was a composite of death from a cardiac cause, myocardial infarction attributed to the target vessel or target lesion revascularisation.
  
  
  RESULTS
  There was no difference in patient baseline characteristics or procedural results. The angiographic follow-up rate was 96%. Treatment with paclitaxel-coated balloon plus EPC stent was superior to EPC stent alone, with an in-stent late loss of 0.34±0.45 mm versus 0.88±0.48 mm (p<0.001). The re-stenosis rate was reduced from 23.2% to 5.1% (p=0.006) and the clinical endpoint was reduced from 17.2% to 4.8% (p=0.039). There was no definite or probable stent thrombosis.
  
  
  CONCLUSIONS
  Paclitaxel-coated balloon plus EPC stent implantation is superior to EPC stent implantation alone for treatment of de novo coronary artery disease.
  
  
  BACKGROUND
  NCT00732953.
authors: Clinic of Internal Medicine II, University of Ulm, Germany. jochen.woehrle@uniklinik-ulm.de
authors: Jochen
authors: J
authors: Wöhrle
authors: Ralf
authors: R
authors: Birkemeyer
authors: Sinisa
authors: S
authors: Markovic
authors: The-Vinh
authors: TV
authors: Nguyen
authors: Anil
authors: A
authors: Sinha
authors: Tomislav
authors: T
authors: Miljak
authors: Jochen
authors: J
authors: Spiess
authors: Wolfgang
authors: W
authors: Rottbauer
authors: Harald
authors: H
authors: Rittger