Polymer Free Nanocarrier Eluting Sirolimus Coated Balloon Catheter - A First Sirolimus Delivering Balloon

Background: Use of drug coated balloon (DCB) is an option to treat small vessels (SV), in-stent restenosis (ISR) and bifurcation lesions (BL). Available choice of treatment is limited to paclitaxel coated balloon (PCB). We report a novel sirolimus coated balloon (SCB) with nanocarrier could be superior in lower in-transit loss, better drug retention, acute drug transfer, targeted drug delivery, reduced drug rejection ratio, controlled drug delivery and improved bio-availability. We aimed to observe and evaluate performance of sirolimus coated balloon (SCB) in the treatment various coronary indications.

Methods: A total 329 SCB were used 277 patients to treat 299 lesions. The inclusion criteria were real-world all comers. Patients were clinically followed up at 1, 3, 6 and 12 months post-procedure. The primary endpoint was procedural success and MACE at 6 months evaluated by quantitative coronary angiography. Major adverse cardiac events (MACE); defined as composite of cardiac death, non-cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR).

Results: Out of the total 299 lesions, ISR, bifurcation and small vessels were 44.48%, 8.70% and 63.88% respectively. Mean balloon length and diameter (average±SD) was 22.4±6.48 mm and 2.70±0.46 mm respectively. Of the total 186 patient follow-up at 12 month, overall MACE was 5.38% (n=10) which included one non-cardiac death (0.53%)and TLR/TVR 4.84% (n=9).

Conclusion: A SCB delivers satisfactory clinical outcome at 12 months for new hope in treatment of treatment in CAD for patients with in-stent restenosis and small vessels.