Three year clinical outcomes after treatment of coronary atherosclerosis with Sirolimus coated balloon

Aim:

We sought to evaluate the performance of Magictouch Sirolimus coated balloon (SCB) (Concept Medical) incorporating a proprietary Nanolute technology in patients with de-novo and restenotic lesions in coronary arteries.

Methods:

NANOLUTE is multi-centre, prospective and real world study. The measured endpoint was MACE (major adverse cardiac event) at 1 year. MACE component encompassed target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and cardiac death. To derive the device performance in long run, we calculated MACE at extended follow-up at 2 years and 3 years.

Results:

450 patients were included in the study, with 479 lesions, all treated with SCB. Of 475 lesions, 47.0% lesions were in-stent restenotic lesion and de-novo accounted for 53.0% lesions. Among those 53.0% de-novo lesions, 80.7% lesions were located in small coronary vessels (RVD ≤ 2.75mm). MACE rates were 3.9%, 4.7% and 4.7% at 1 year, 2 years and 3 years respectively. MACE rates were driven by TLR (3.32%) followed by TV-MI (0.2%) and cardiac death (0.5%). The follow up for the rest of the patients is yet to come as it is on-going registry. There was no increment in MACE at 2 and 3 years follow up.

Conclusion:

SCB proved a valid revascularization strategy in an all-comers population of patients with ISR and de-novo lesions in small vessels, with an acceptable rate of cardiac events up to long term follow-up of 3 years.