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

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 1101,0 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 BM S 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. 2251.1m, 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.