title: Paclitaxel-coated balloon in combination with bare metal stent for treatment of de novo coronary lesions: an optical coherence tomography first-in-human randomised trial, balloon first vs. stent first.
abstract: OBJECTIVE
  To test the efficacy of sequential application of drug-coated balloon (DCB) and bare metal stent (BMS) for treatment of de novo coronary lesions, comparing the sequence of application (DCB first vs. BMS first).
  
  
  RESULTS
  In a multicentre pilot trial, 26 patients with de novo coronary lesions were randomised to receive a paclitaxel-coated balloon application followed by BMS implantation (DCB first) or vice versa (BMS first). Quantitative coronary angiography (QCA) and optical coherence tomography (OCT) were performed post-procedure and at six months, with OCT % neointimal volume obstruction as primary endpoint. Longitudinal geographical miss was only observed in DCB first (23.1 vs. 0.0%, p=0.220). Implantation of BMS first resulted in fewer malapposed struts (p=0.013) but similar coverage at six months. No significant difference was found regarding the primary endpoint (25.5 vs. 24.9%, p=0.922), mean thickness of coverage (261 vs. 225 µm, p=0.763), late loss (0.53 vs. 0.45 mm, p=0.833), binary restenosis (27.3 vs. 16.7% in-segment, p=0.640) or clinical endpoints.
  
  
  CONCLUSIONS
  Sequential application of DCB and not pre-mounted BMS for treatment of de novo coronary lesions results in efficient inhibition of neointimal hyperplasia. The sequence of application (DCB first vs. BMS first) does not seem to influence the outcome, except for better apposition in BMS first.
authors: Thoraxcenter, Erasmus MC, Rotterdam, The Netherlands.
authors: Juan Luis
authors: JL
authors: Gutiérrez-Chico
authors: Robert Jan
authors: RJ
authors: van Geuns
authors: Karel T
authors: KT
authors: Koch
authors: Jacques J
authors: JJ
authors: Koolen
authors: Henricus
authors: H
authors: Duckers
authors: Evelyn
authors: E
authors: Regar
authors: Patrick W
authors: PW
authors: Serruys
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000295:instrumentation*; D002317:Cardiovascular Agents / Q000008:administration & dosage*; D016009:Chi-Square Distribution; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000628:therapy*; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000209:etiology / Q000473:pathology / Q000517:prevention & control*; D004867:Equipment Design; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D008670:Metals; D008875:Middle Aged; D009426:Netherlands; D017239:Paclitaxel / Q000008:administration & dosage*; D010865:Pilot Projects; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D011474:Prosthesis Design; D015607:Stents; D013997:Time Factors; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
chemical_list: D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D008670:Metals; D017239:Paclitaxel