New Biolimus-Coated Balloon Is No Inferior to Paclitaxel Devices

All PCI patients were randomly assigned to receive BCB or PCB. BCB patients were treated with the new Biolimus A9 Coated BioAscend balloon. The Biolimus A9 (BA9) coating was developed by Biosensor International.

“BA9, a modified sirolimus analogue with increased lipophilicity, is designed to optimize local drug delivery from stents and balloons,” the authors wrote. “Unlike sirolimus, BA9 is a crystalline drug that loses less drug during delivery and has 10 times greater lipophilic solubility than sirolimus. This allows for rapid tissue uptake while minimizing exposure loss, resulting in greater efficacy in inhibiting intravascular hyperplasia and reducing late lumen loss.”

All PCB patients were treated with the popular SeQuent Please NEO drug-coated balloon from B. Braun Melsungen AG.

Before randomization, patients were given aspirin in addition to clopidogrel or ticagrelor before PCI. They were told to continue dual antiplatelet therapy for at least 1 month after the procedure and to continue taking aspirin.

Overall, the study’s primary endpoint—mean late segment lumen loss at nine months—was 0.23 mm for the BCB group and 0.25 mm for the PCB group. The researchers also used optical coherence tomography (OCT) to track the neointimal area at nine months, which was 2.32 mm² for the BCB group and 2.37 mm² for the PCB group.

At one year, the group added, target lesion failure (13.3% vs. 9.5%) and revascularization (22.2% vs. 13.2%) were higher in the BCB group. These differences were not found to be statistically significant, but Chen and colleagues emphasized that larger studies with longer follow-up periods are needed to “provide a more comprehensive understanding of this issue.”

After analyzing these findings, the authors ultimately concluded that BCB was noninferior to PCB for the treatment of patients undergoing PCI with a drug-coated balloon.

“These results demonstrate the potential of BCB to improve clinical outcomes in the treatment of coronary in-stent restenosis,” they wrote.

Read the full study here.