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Original article
Prospective randomised trial evaluating a paclitaxel-coated balloon in patients treated with endothelial progenitor cell capturing stents for de novo coronary artery disease
  1. Jochen Wöhrle1,
  2. Ralf Birkemeyer2,
  3. Sinisa Markovic1,
  4. The-Vinh Nguyen1,
  5. Anil Sinha3,
  6. Tomislav Miljak2,
  7. Jochen Spiess1,
  8. Wolfgang Rottbauer1,
  9. Harald Rittger3
  1. 1Clinic of Internal Medicine II, University of Ulm, Ulm, Germany
  2. 2Innere Medizin III Kardiologie, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany
  3. 3Medizinische Klinik II, Klinikum Coburg, Coburg, Germany
  1. Correspondence to Dr Jochen Wöhrle, Department of Internal Medicine II, University of Ulm, Albert-Einstein-Allee 23, 89081 Ulm, Germany; jochen.woehrle{at}uniklinik-ulm.de

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.

Trial registration NCT00732953.

  • Stents
  • restenosis
  • endothelialization
  • paclitaxel
  • coronary intervention
  • coronary stenting
  • coronary artery disease (cad)
  • clinical trials

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Footnotes

  • JW, RB and HR contributed equally.

  • Funding Supported in part by an unrestricted grant from OrbusNeich Medical GmbH, Wiesbaden, Germany and B Braun, Melsungen, Germany.

  • Patient consent Obtained.

  • Ethics approval This study was conducted with the approval of the ethics committee, University of Ulm, Germany.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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