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


CONCLUSIONS
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.
Cardiovascular Investigation Unit, Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia. Electronic address: stephen.worthley@adelaide.edu.au.
Stephen
S
Worthley
Cardiology Research Centre, Fremantle Hospital, Fremantle, Australia.
Randall
R
Hendriks
Cardiovascular Investigation Unit, Royal Adelaide Hospital and University of Adelaide, Adelaide, Australia.
Matthew
M
Worthley
Cardiology Research Centre, Fremantle Hospital, Fremantle, Australia.
Alan
A
Whelan
Department of Cardiology, Prince Charles Hospital, Brisbane, Australia and University of Queensland, Brisbane Australia.
Darren L
DL
Walters
Department of Cardiology, St Vincent's Hospital, Melbourne, Fitzroy, Australia.
Robert
R
Whitbourn
Cardiovascular Research Centre, Monash Medical Centre, Clayton, Australia.
Ian
I
Meredith
D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D002317:Cardiovascular Agents / Q000008:administration & dosage* / Q000009:adverse effects; D020099:Coated Materials, Biocompatible; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000175:diagnosis / Q000628:therapy*; D023903:Coronary Restenosis / Q000209:etiology; D054855:Drug-Eluting Stents; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D062645:Percutaneous Coronary Intervention / Q000009:adverse effects / Q000295:instrumentation*; D010865:Pilot Projects; D011446:Prospective Studies; D011474:Prosthesis Design; D013997:Time Factors; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional; D062666:Vascular Access Devices
D002317:Cardiovascular Agents; D020099:Coated Materials, Biocompatible; D000068338:Everolimus; D017239:Paclitaxel
Bifurcation lesion; Drug-coated balloon; Drug-eluting balloon; Provisional stenting