A novel biolimus drug-coated balloon was shown to be safe and effective in patients with small-vessel coronary artery disease compared to plain balloon angioplasty, a new first-in-man (FIM) trial reports. The findings, reported Saturday at Transcatheter Cardiovascular Therapeutics (TCT) 2021 in Orlando, Florida, come from the BIO-RISE CHINA study – an FIM trial to confirm the safety and effectiveness of a biolimus-coated balloon to reduce restenosis after coronary angioplasty in patients with small-vessel coronary artery disease. Speaking on Saturday, Kai Xu, MD, site private investigator from the General Hospital of Northern Theater Command in Shenyang, China, noted that while coronary stent technology has evolved beyond the use of paclitaxel, with devices like the BioFreedom biolimus A9 coated stent, almost all coronary drug-coated balloons still utilize paclitaxel. “Biolimus is already used as a stent coating and has shown excellent safety and efficacy in multiple RCTs, including LEADERS, LEADERS FREE and ONYX ONE,” he noted. "The availability of a biolimus-coated balloon will provide doctors and patients with a completely new therapeutic option for the invasive management of small vessel coronary artery disease.” Trial details The FIM randomized controlled trial set out to confirm the safety and effectiveness of a biolimus-coated balloon to reduce restenosis after coronary angioplasty in patients with small vessel coronary artery disease. Xu noted that the primary endpoint for the trial was in-segment late lumen loss (LLL) at 9 months, assessed by an independent core laboratory blinded to treatment assignment, adding that the study was powered to show superiority of the biolimus-coated balloon over plain balloon angioplasty but that the study was not powered for clinical outcomes. “The biolimus-coated balloon was superior to plain balloon angioplasty,” said Xu, noting that in the per-protocol population, the incidence of LLL was 0.16 mm vs 0.30 mm (difference: 0.14 mm; 95% confidence interval [CI]: -0.23 to -0.05; p=0.001). He noted that incidence was similar in the full analysis set, at 0.17 mm versus 0.29 mm, for the biolimus-coated balloon versus plain balloon angioplasty, respectively (difference: 0.13 mm; 95% CI: -0.21 to -0.02; p=0.0034) He added that the study also found that there were more patients with late lumen enlargement in the biolimus-coated balloon group compared with the control group (29.7% vs 9.7%; p=0.0007), adding that there were no significant differences between the two groups for clinical outcomes at 12 months, including target lesion failure. "This first-in-man randomized controlled trial has confirmed the safety and efficacy of a biolimus-coated balloon in patients with small-vessel coronary artery disease compared to plain balloon angioplasty," said Xu, noting that late lumen enlargement was 3 times more common with the biolimus-coated balloon than with plain balloon angioplasty. New device: Pivotal trial underway Xu noted that the novel device is made by Biosensors International Group, the same company behind the BioFreedom biolimus-coated stent and the BioStream paclitaxel-eluting balloon for coronary interventions. “It's the same drug as used in BioFreedom stents,” he noted. In August 2020, Biosensors announced the enrollment of the first patient in its pivotal REFORM Trial; a prospective, randomized, non-inferiority trial to determine the safety and efficacy of the biolimus A9 drug-coated balloon for the treatment of in-stent restenosis. The ongoing trial is targeting CE-mark approval for the biolimus A9 drug-coated balloon and will include 34 sites in Germany, Italy, Ireland, Spain, the United Kingdom and South Korea. “The REFORM trial is testing the first-ever Biolimus A9 coated balloon and builds on the success of the LEADERS and LEADERS FREE trials, which demonstrated the excellent safety and efficacy of Biolimus A9 eluting coronary stents,” commented trial leader Professor Robert Byrne from Mater Private Hospital and RCSI University, Dublin. “If successful, this new drug-coated balloon will expand the treatment options for patients with in-stent restenosis undergoing repeat PCI,” said Byrne.