BABILON: Drug-Eluting Balloon a Risky Choice for Treating Bifurcation Lesions

PARIS, France—In treating bifurcation lesions, use of a paclitaxel-eluting balloon (PEB) rather than an everolimus-eluting stent (EES) appears to double the amount of late lumen loss at 9 months and triple the need for repeat revascularization at 24 months. However, the observed differences, from the randomized BABILON trial presented Tuesday, May 20, 2014, at EuroPCR, failed to reach statistical significance.

Study investigator José R. López-Mínguez, MD, PhD, of Infanta Cristina University Hospital (Badajoz, Spain), said in his presentation that due to slow enrollment, BABILON was stopped early after enrolling only 108 out of 190 planned patients.

Dr. López-Mínguez and colleagues randomized patients to receive sequential main and side branch dilatation with plain balloons followed by 1 of 2 strategies:

  • Sequential main and side branch dilatation with PEB followed by provisional T-stenting of the main branch with BMS (n = 52)
  • Provisional T-stenting of the main branch with EES (n = 56)

Procedures concluded with final kissing balloon at operator discretion. Recommended duration of dual antiplatelet therapy was 3 months in the DEB arm and 12 months in the EES arm.

More Late Lumen Loss, Repeat Revascularization

Baseline characteristics were similar between the groups apart from PEB cases having less frequent use of final kissing balloon (15.7% vs 35.7%; P = .019) and a trend toward longer lesions in the main branch (20.22 ± 7.90 mm vs 17.04 ± 5.71 mm; P = .055) than EES-treated patients.

Among the 86 patients with complete angiographic follow-up through 9 months, in-segment percent diameter stenosis of the main branch was greater and late lumen loss numerically higher for PEB (table 1).

Table 1. Angiographic Outcomes at 9 Months

 

PEB
(n = 43)

EES
(n = 43)

P Value

Diameter Stenosis, %
Main Branch In-Segment
Main Branch In-Stent
Side Branch

 
46.17 ± 16.02
37.94 ± 17.05
35.00 ± 13.02

 
38.65 ± 16.21
31.24 ± 17.38
33.29  ± 12.77

 
.046
.078
.570

Late Lumen Loss, mm
Main Branch In-Segment
Main Branch In-Stent
Side Branch

 
0.31 ± 0.48
0.35 ± 0.46
-0.04 ± 0.76

 
0.16 ± 0.38
0.27 ± 0.47
-0.03 ± 0.51

 
.150
.426
.983


At 24 months, the rate of MACE occurring after hospitalization was 17.3% with PEB and 7.1% with EES (P = .125). PEB use increased main branch restenosis (13.5% vs 1.8%; P = .027), resulting in higher need for TVR (17.3% vs 3.6%; P = .018) and TLR (15.4% vs 3.6%; P = .045). Global restenosis also was more common in the PEB group (17.3% vs 5.4%; P = .048).

For Now, No Advantage to Side-Branch PEB

“At the present time, in daily practice and with the strategy described in our study, there is no advantage of using PEB in the side branch,” Dr. López-Mínguez concluded. “Future studies with dedicated DES respecting the ostium of the side branch (without displacing the carina of the bifurcation) might show an advantage of using PEB in the side branch.”

Panelist Miodrag Ostojic, MD, PhD, of the Institute for Gerontology and Palliative Care (Belgrade, Serbia), asked why PEB would be used instead of a DES, particularly in the challenging subset of bifurcation lesions. “What is the rationale in your everyday practice for using drug-eluting balloons instead of stents?... Is this [only] an investigational study, or do you really use that?”

Dr. López-Mínguez said that the evidence base for weighing the options is slim.

 


Source:
López-Mínguez JR. Prospective randomised study of the paclitaxel-coated balloon catheter in bifurcated coronary lesions (BABILON trial): 24-month clinical and angiographic results. Presented at: EuroPCR; May 20, 2014; Paris, France.

 

 

Related Stories:

Disclosures
  • Dr. López-Mínguez reports receiving institutional grant/research support from BBRAUN.

Comments