Drug-Coated Balloon-Based Angioplasty for Chronic Total Occlusions: The PICCOLETO X Study

Area of Science:

• Cardiology
• Interventional Cardiology
• Vascular Medicine

Background:

• Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) traditionally involves extensive metal stenting.
• Stent implantation may negatively impact vascular function and increase late adverse events.
• Drug-coated balloons (DCB) offer stent-sparing alternatives, but their efficacy in CTO is not well-established.

Purpose of the Study:

• To assess the real-world clinical outcomes of DCB-based revascularization strategies in a large CTO patient cohort.
• To compare the efficacy and safety of DCB-only versus DCB-plus-stent treatments for CTO PCI.
• To evaluate target vessel failure at 12 months as the primary endpoint.

Main Methods:

• The PICCOLETO X registry included 938 consecutive CTO PCI patients from 21 international centers.
• Patients received at least one DCB, with analysis of DCB-only versus DCB-plus-stent groups.
• A propensity score matching model was used to adjust for baseline differences between treatment groups.

Main Results:

• No significant differences in in-hospital outcomes like acute kidney injury or myocardial infarction were observed between strategies.
• At 12 months, target vessel failure occurred in 9.5% of patients overall, with no significant difference between DCB-only (10.6%) and DCB-plus-stent (8.4%) groups.
• Propensity score matching also showed no significant difference in target vessel failure rates between the DCB-only (6.2%) and blended (8.8%) arms.

Conclusions:

• DCB-based strategies, alone or with stents, are associated with favorable 1-year clinical outcomes in real-world CTO PCI.
• No significant differences in efficacy or safety were found between DCB-only and DCB-plus-stent treatments for CTO.
• These findings support the use of DCB strategies in CTO PCI to potentially reduce stent burden.