AIMS: 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). METHODS AND 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.
RCT Entities:
AIMS: 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). METHODS AND 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: Francesco Burzotta; Marta Francesca Brancati; Carlo Trani; Giancarlo Pirozzolo; Gianluigi De Maria; Antonio Maria Leone; Giampaolo Niccoli; Italo Porto; Francesco Prati; Filippo Crea Journal: Heart Vessels Date: 2015-04-12 Impact factor: 2.037
Authors: Franz X Kleber; Harald Rittger; Klaus Bonaventura; Uwe Zeymer; Jochen Wöhrle; Raban Jeger; Benny Levenson; Sven Möbius-Winkler; Leonhard Bruch; Dieter Fischer; Christian Hengstenberg; Tudor Pörner; Detlef Mathey; Bruno Scheller Journal: Clin Res Cardiol Date: 2013-08-28 Impact factor: 5.460
Authors: Francesco Burzotta; Marta Francesca Brancati; Carlo Trani; Italo Porto; Antonella Tommasino; Gianluigi De Maria; Giampaolo Niccoli; Antonio Maria Leone; Valentina Coluccia; Giovanni Schiavoni; Filippo Crea Journal: Trials Date: 2012-05-06 Impact factor: 2.279
Authors: Juan Luis Gutiérrez-Chico; Eduardo Alegría-Barrero; Rodrigo Teijeiro-Mestre; Pak Hei Chan; Hiroto Tsujioka; Ranil de Silva; Nicola Viceconte; Alistair Lindsay; Tiffany Patterson; Nicolas Foin; Takashi Akasaka; Carlo di Mario Journal: Eur Heart J Cardiovasc Imaging Date: 2012-02-13 Impact factor: 6.875
Authors: In Ho Chae; Chang Hwan Yoon; Jin Joo Park; Il Young Oh; Jung Won Suh; Young Seok Cho; Tae Jin Youn; Dong Ju Choi Journal: J Korean Med Sci Date: 2017-06 Impact factor: 2.153