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

Juan Luis Gutiérrez-Chico, Robert Jan van Geuns, Karel T. Koch, Jacques J. Koolen, Henricus Duckers, Evelyn Regar, Patrick W. Serruys

Research output: Contribution to journalArticleAcademicpeer-review

44 Citations (Scopus)

Abstract

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). 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. 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
Original languageEnglish
Pages (from-to)711-722
JournalEurointervention
Volume7
Issue number6
DOIs
Publication statusPublished - 2011

Cite this