Long-term outcomes of drug-coated balloons vs. drug-eluting stents in coronary chronic total occlusion angioplasty: the SPARTAN-CTO study

Aim: The role of drug coated balloon (DCB)-only strategy in de novo chronic total occlusion (CTO) percutaneous coronary intervention (PCI) remains uncertain. We compared DCB with drug eluting stent (DES) strategies in patients undergoing CTO angioplasty.

Methods: We retrospectively analysed 170 patients with de novo CTO undergoing PCI between 2013 and 2019. Patients were treated with either DCB-only (n=85) or DES-only (n=85) strategies. The primary endpoint was target vessel revascularisation (TVR); secondary endpoints included all-cause mortality, cardiovascular death, target vessel-myocardial infarction (TV-MI), any MI and a composite of all-cause mortality, MI and TVR. Median follow-up was 3.67 years.

Results: TVR occurred in 11 (12.9%) DCB vs 5 (5.9%) DES patients (HR 2.33, 95% CI 0.81–6.74, p=0.118). All-cause mortality (7.1% vs 12.9%; HR 0.56, p=0.262) and the composite endpoint (21.2% vs 20.0%; HR 1.15, p=0.686) did not differ significantly. After adjustment for creatinine, J-CTO score, and vessel diameter, outcomes remained comparable between groups. Creatinine was independently associated with mortality and composite endpoint. No acute vessel closure or thrombosis occurred within 30 days. During follow-up, no target lesion thrombosis was observed in the DCB group, while one late stent thrombosis (1.2%) occurred in the DES group.

Conclusion: In this single-centre study, a DCB-only strategy for de novo CTO PCI demonstrated long-term efficacy and safety outcomes comparable to DES, supporting DCB as a potential alternative.