Results from the BIOLUX randomised control trial, which were presented at EuroPCR 2016, indicate that the Pantera Lux drug-coated balloon (Biotronik) is angiographically non-inferior to stenting with the latest-generation drug-eluting stents at six months for the treatment of in-stent restenosis. The study, according to a press release, is only one of a few randomised controlled trials to compare a latest generation coronary drug-eluting stent to drug-coated balloon in this indication.
In the study, patients with either a bare metal stent or a drug-eluting stent in-stent restenosis were randomised to receive the Pantera Lux drug-coated balloon (157 patients) or the latest generation drug-eluting stent (72). The trial’s primary endpoint was in-stent late lumen loss at six months; patients treated with a drug-coated balloon had an average late lumen loss of 0.05±0.44mm as compared to 0.18 ± 0.69mm for the control drug-eluting stent treated patients (p-value for non-inferiority = 0.0004). Additionally, patients in the trial’s Pantera Lux arm experienced a similarly low rate of target lesion failure at 12 months: 17.1% vs. 14% for patients in the control arm.
Christoph Naber, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany, says: “These results confirm positive data from earlier single-arm trials and establish Pantera Lux as a viable approach to in-stent restenosis. Treatment with drug-coated balloons offers patients the added advantage of not leaving another implant behind.”