Drug-coated balloons and hybrid strategies versus drug-eluting stents in chronic total occlusions: a systematic review and meta-analysis.

INTRODUCTION AND

OBJECTIVES

Implantation of drug-eluting stents (DES) is currently the standard of care in chronic total occlusion percutaneous coronary intervention (CTO-PCI). However, drug-coated balloons (DCB) have emerged as a promising alternative, providing antiproliferative drug delivery while avoiding permanent scaffolding. This meta-analysis compared the effectiveness of DCB and hybrid strategies vs DES in CTO-PCI.

METHODS

Studies comparing DCB with and without hybrid strategies and DES in CTO-PCI were identified through PubMed/MEDLINE and Web of Science up to February 2025. The primary outcome was target lesion revascularization. Secondary outcomes included major adverse cardiac events, cardiovascular mortality, target vessel revascularization, and target vessel myocardial infarction.

RESULTS

Six observational studies, including 2221 patients, met the inclusion criteria. After a median follow-up of 2.8 years, target lesion revascularization occurred in 9.9% of DCB-treated patients and 9.7% of DES-treated patients (HR, 0.81; 95%CI, 0.57-1.13; P=.22). Subgroup analysis showed no significant differences between de-novo and in-stent CTOs. The rates of secondary outcomes were comparable between the DCB and DES groups. On meta-regression analysis, advanced lesion preparation (with cutting balloons, intravascular lithotripsy, or rotational atherectomy) was associated with lower rates of target lesion revascularization (P=.02).

CONCLUSIONS

This meta-analysis comparing DCB and DES in CTO-PCI found no significant differences in target lesion revascularization or other clinical outcomes, supporting the potential role of DCB strategies in selected CTO-PCI cases. These findings support the potential role of stentless revascularization and provide a rationale for further randomized trials to validate DCB-based strategies in complex CTO anatomies. Registered at PROSPERO ID: CRD42025642790.