Paclitaxel-eluting balloon and everolimus-eluting stent for provisional stenting of coronary bifurcations: 12-month results of the multicenter BIOLUX-I study

Cardiovasc Revasc Med. 2015 Oct-Nov;16(7):413-7. doi: 10.1016/j.carrev.2015.07.009. Epub 2015 Aug 10.

Abstract

Background: Several 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.

Methods: In 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.

Results: The 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.

Conclusion: The 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.

Keywords: Bifurcation lesion; Drug-coated balloon; Drug-eluting balloon; Provisional stenting.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Australia
  • Cardiovascular Agents / administration & dosage*
  • Cardiovascular Agents / adverse effects
  • Coated Materials, Biocompatible*
  • Coronary Angiography
  • Coronary Artery Disease / diagnosis
  • Coronary Artery Disease / therapy*
  • Coronary Restenosis / etiology
  • Drug-Eluting Stents*
  • Everolimus / administration & dosage*
  • Everolimus / adverse effects
  • Feasibility Studies
  • Female
  • Humans
  • Male
  • Middle Aged
  • Paclitaxel / administration & dosage*
  • Paclitaxel / adverse effects
  • Percutaneous Coronary Intervention / adverse effects
  • Percutaneous Coronary Intervention / instrumentation*
  • Pilot Projects
  • Prospective Studies
  • Prosthesis Design
  • Time Factors
  • Treatment Outcome
  • Ultrasonography, Interventional
  • Vascular Access Devices*

Substances

  • Cardiovascular Agents
  • Coated Materials, Biocompatible
  • Everolimus
  • Paclitaxel