Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population

Sandeep Basavarajaiah; Vinoda Sharma; Alessandro Sticchi; Gianluca Caiazzo; Filiberto Fausto Mottola; Bhagya Harindi Loku Waduge; Sampath Athukorala; Mazaya Fawazy; Luca Testa; Antonio Colombo

doi:10.1002/ccd.31244

Use of sirolimus-coated balloon in de novo coronary lesions; long-term clinical outcomes from a multi-center real-world population

Catheter Cardiovasc Interv. 2024 Oct 3. doi: 10.1002/ccd.31244. Online ahead of print.

Affiliations

¹ Heartlands Hospital, University Hospital Birmingham, Birmingham, UK.
² Department of Cardiology, Birmingham City Hospital, Birmingham, UK.
³ Department of Cardiology, Humanitas Hospital, Milan, Italy.
⁴ Department of Cardiology, Presidio Ospedaliero San Giuseppe Moscati, Aversa, Italy.
⁵ Department of Cardiology, San Donato Hospital, Milan, Italy.

PMID: 39359183
DOI: 10.1002/ccd.31244

Abstract

Background: Sirolimus-coated balloon (SCB), a relatively novel technology appears attractive due to the drug properties (safety and efficacy) and sirolimus remains the drug of choice in stents. However, there is limited data long-term data on SCB. In this study, we have explored the clinical outcomes following the use of SCB in de-novo lesions from a real-world practice.

Aims: To report long-term clinical outcomes following the use of Siroliumus coated balloon in de novo lesions.

Methods and results: We analyzed all patients treated with an SCB in de novo lesions between 2016 and 2023 at four high-volume centers in UK and Italy. The outcomes measured included cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularization (TLR) and major adverse cardiac events (MACE). During the study period, 771 patients had SCB in de novo lesions. Diabetes mellitus was noted in 36% of patients (n = 280), of which 14% (n = 108) were insulin dependent. Fifteen percent (n = 117) had chronic kidney disease, Fifty-two percent (n = 398) of cases were in the setting acute coronary syndrome (ACS) and of which 51 cases (7%) were ST-segment elevation myocardial infarction. Small vessels (<3.0 mm) accounted for 78% (n = 601) of cases and 76% (n = 584) were long lesions ( $\geq$ 20 mm). The mean diameter of SCB was 2.6 ± 0.4 mm and the mean length was 25 ± 10.39 mm. Bailout stenting following SCB was required in 9% lesions (n = 67). During the median follow-up 640 days, total death occurred in 39 (5%) patients and of which, cardiac death occurred in 10 patients (1.3%). TVMI occurred in 20 patients (2.6%). TLR and TVR were 5.6% and 5.8% respectively. The overall MACE rate was 8%. We had no documented case of acute vessel closure.

Conclusions: The results from this long-term follow-up in a real-world population are encouraging with low rates of hard endpoints and acceptable rates of TLR and MACE despite a complex group of patients. Our data suggest that SCBs are safe in coronary intervention with good clinical outcomes in the long term.

Keywords: de‐novo lesions; in‐stent restenosis; paclitaxel‐coated balloon; sirolimus‐coated balloon.