A prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results.
OBJECTIVE
Paclitaxel drug-eluting balloons (pDEB) could be an attractive option to minimise side branch (SB) restenosis in bifurcated coronary lesions. We compared angiographic and clinical outcomes with pDEB plus bare metal stent (BMS) versus drug-eluting stents (DES) in de novo bifurcated lesions.


RESULTS
This multicentre randomised trial included 108 patients. Sequential main branch (MB)/SB dilatation with pDEB, with provisional T-stenting with BMS in the MB was performed in the pDEB group, and with everolimus DES in the DES group. The primary endpoint was late lumen loss (LLL) at nine months. The secondary endpoint was the incidence of major adverse cardiac events (MACE: death, myocardial infarction, or target lesion revascularisation). In-segment MB LLL was 0.31±0.48 mm in the pDEB group, and 0.16±0.38 mm in the DES group (p=0.15); mean difference was 0.15 mm (upper limit one-sided 95% CI: 0.27 mm; p=0.001; non-inferiority test). LLL in SB was -0.04±0.76 mm in the pDEB group and -0.03±0.51 mm in the DES group (p=0.983). MACE and TLR were higher in the pDEB group (17.3% vs. 7.1%; p=0.105, and 15.4% vs. 3.6%; p=0.045), due to higher MB restenosis (13.5% vs. 1.8%; p=0.027).


CONCLUSIONS
pDEB bifurcation pretreatment with BMS implantation in MB showed greater LLL (ns) and increased incidence of MACE compared to everolimus DES. Both strategies showed similar results in the SB.
Hospital Universitario Infanta Cristina, Badajoz, Spain.
José Ramón
JR
López Mínguez
Juan Manuel
JM
Nogales Asensio
Luis Javier
LJ
Doncel Vecino
Jorge
J
Sandoval
Sebastián
S
Romany
Pedro
P
Martínez Romero
José Antonio
JA
Fernández Díaz
Javier
J
Fernández Portales
Reyes
R
González Fernández
Ginés
G
Martínez Cáceres
Antonio
A
Merchán Herrera
Fernando
F
Alfonso Manterola
D000368:Aged; D000787:Angina Pectoris / Q000209:etiology / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D001241:Aspirin / Q000627:therapeutic use; D000077144:Clopidogrel; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000517:prevention & control*; D023921:Coronary Stenosis / Q000150:complications / Q000628:therapy*; D054855:Drug-Eluting Stents; D000068338:Everolimus; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000627:therapeutic use*; D010975:Platelet Aggregation Inhibitors / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives / Q000627:therapeutic use; D015607:Stents; D013988:Ticlopidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D016896:Treatment Outcome; D050257:Tubulin Modulators / Q000627:therapeutic use*
D007166:Immunosuppressive Agents; D010975:Platelet Aggregation Inhibitors; D050257:Tubulin Modulators; D000068338:Everolimus; D000077144:Clopidogrel; D013988:Ticlopidine; D017239:Paclitaxel; D001241:Aspirin; D020123:Sirolimus