PARIS, France and BUELACH, Switzerland, May 19, 2016 – BIOTRONIK has announced that the BIOLUX RCT study was presented at EuroPCR. The trial compared the Pantera Lux drug-coated balloon (DCB) to a latest generation sirolimus-eluting stent (DES) in treatment of in-stent restenosis, the main indication for DCB. Study investigators found that Pantera Lux is angiographically non-inferior to stenting with the latest generation DES at six months.“BIOLUX RCT is one of very few randomized controlled trials to compare a latest generation coronary DES to DCB in this challenging indication,” commented principal investigator Dr. Christoph Naber, Contilia Heart and Vascular Center, Elisabeth Krankenhaus, Essen, Germany. “These results confirm positive data from earlier single-arm trials1,2, and establish Pantera Lux as a viable approach to in-stent restenosis. Treatment with DCB offers patients the added advantage of not leaving another implant behind.”BIOLUX RCT was randomized in a 2:1 fashion (DCB:DES) in patients with either bare metal stent or DES in-stent restenosis. 157 patients received Pantera Lux DCB and 72 received the latest generation DES. The trial’s primary endpoint was in-stent late lumen loss (LLL) at six months; patients treated with DCB had an average LLL of 0.05±0.44mm as compared to 0.18 ± 0.69mm for the control DES 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 (TLF) at 12 months: 17.1 percent vs. 14.0 percent for patients in the control arm.“While Pantera Lux had already established itself in single-arm clinical trials as a safe and effective treatment for in-stent restenosis, BIOLUX RCT provides a higher degree of clinical proof,” stated Dr. Alexander Uhl, Vice President Marketing, BIOTRONIK Vascular Intervention. “These encouraging results show that the Pantera Lux DCB continues to be an excellent option for treating in-stent restenosis.”
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