Angiographic and functional assessment after paclitaxel or sirolimus drug-coated balloons for de novo coronary artery disease in small vessels: PICCOLETO VI study.

Abstract

Background: Paclitaxel-coated balloons (PCB) have strong supporting evidence for use in small coronary vessels, while sirolimus-coated balloons (SCB) have shown variable angiographic results, raising questions about their overall effectiveness.

Aims: The PICCOLETO VI study aimed to compare the angiographic and physiological outcomes of various PCB and SCB technologies in treating de novo coronary artery disease.

Methods: This international, multicentre study included patients who underwent percutaneous coronary intervention and had elective angiographic follow-up 5-9 months later. Angiographic and physiological assessments were performed by a core laboratory, including Murray law-based quantitative flow ratio (μFR).

Results: Based on a cohort of 293 patients, 227 lesions treated either with a PCB (n=148) or an SCB (n=79) were included. No differences in terms of baseline clinical or angiographic characteristics were reported between the two cohorts. PCB showed lower late lumen loss (-0.05±0.56 mm vs +0.10±0.59 mm; p=0.05) and a higher prevalence of late lumen enlargement (58.1% vs 40.5%; p=0.01). The primary endpoint of late functional loss was not statistically different, with a trend in favour of PCB (-0.01±0.15 vs +0.03±0.13; p=0.09). There was no difference in terms of target lesion failure, with a higher rate of ischaemia-inducing vessels at follow-up in the SCB group (14.9% vs 26.6%; p=0.03). A μFR <=0.86 following drug-coated balloon (DCB) treatment emerged as a reliable cutoff for predicting follow-up ischaemia, with an accuracy of 80%, whereas no significant interaction was observed for a post-DCB angiographic degree of stenosis >=30%.

Conclusions: In this direct comparison between two classes of DCB, late functional loss was comparable between PCB and SCB, with PCB confirming superior angiographic performance.