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Cardiovasc Revasc Med · Oct 2015
Multicenter Study Comparative Study Clinical TrialPaclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study.
- Stephen Worthley, Randall Hendriks, Matthew Worthley, Alan Whelan, Darren L Walters, Robert Whitbourn, and Ian Meredith.
- Cardiovascular Investigation Unit, Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia. Electronic address: stephen.worthley@adelaide.edu.au.
- Cardiovasc Revasc Med. 2015 Oct 1; 16 (7): 413-7.
BackgroundSeveral studies investigated the combination of bare metal stents in the main branch and drug-eluting balloons in the side branch in bifurcation lesions, but data on the combination of drug-eluting stents and drug-eluting balloons are scarce. We aim to assess the feasibility of provisional stenting with an everolimus-eluting stent in the main branch and a paclitaxel-eluting balloon in the side branch.MethodsIn this prospective, multi-center study conducted in 5 Australian sites, 35 patients with bifurcation lesions were enrolled. Angiographic and intravascular ultrasound assessments were conducted at 9 months; clinical follow-up was conducted until 12 months.ResultsThe primary endpoint, late lumen loss in the side branch measured by quantitative coronary angiography, was 0.10±0.43mm. No binary restenosis was observed. One patient died; 3 myocardial infarctions (one suspected and two in non-target vessels) and one target lesion revascularization occurred. No probable or definite stent thrombosis was observed.ConclusionThe combination of an everolimus-eluting stent in the main branch and a paclitaxel-eluting balloon in the side branch appears to be a safe, effective and novel treatment option for bifurcation lesions.Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.
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