What is the clinical evidence from this study?

Study design: Observational. Population: Adults undergoing percutaneous coronary intervention for de novo coronary chronic total occlusion (n=170). Intervention: Drug-coated balloon-only percutaneous coronary intervention vs. Drug-eluting stent-only percutaneous coronary intervention. Primary outcome: Target vessel revascularization (TVR) (HR 2.33, 95% CI 0.81–6.74, p=0.118).

What question did this study set out to answer?

The study aims to evaluate the long-term outcomes of drug-coated balloons versus drug-eluting stents in patients with chronic total occlusion undergoing angioplasty.

February 14, 2026Open Access

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

Key Result

Drug-coated balloon-only PCI resulted in a target vessel revascularization rate of 12.9% versus 5.9% with drug-eluting stents (HR 2.33, 95% CI 0.81–6.74, p=0.118) with no significant difference in long-term outcomes for de novo CTO patients.

Key Points

The study aims to evaluate the long-term outcomes of drug-coated balloons versus drug-eluting stents in patients with chronic total occlusion undergoing angioplasty.
Retrospective analysis of 170 patients with de novo CTO undergoing PCI.
Patients were treated with either DCB-only (n = 85) or DES-only (n = 85) strategies.
Primary endpoint was target vessel revascularization; secondary endpoints included mortality and myocardial infarction.
Median follow-up duration was 3.67 years.
Target vessel revascularization occurred in 12.9% of DCB patients vs. 5.9% of DES patients.
All-cause mortality was 7.1% in DCB and 12.9% in DES patients.
Outcomes remained comparable after adjusting for key factors like creatinine and J-CTO score.
No acute vessel closure or thrombosis occurred within 30 days; one late stent thrombosis in the DES group.

Study Design

Type

Observational (n=170)

Multicenter

Structured PICO

Does a drug-coated balloon-only strategy improve or maintain comparable target vessel revascularization rates compared to drug-eluting stents in patients undergoing de novo chronic total occlusion PCI?

Population

170 patients with de novo chronic total occlusion (CTO) undergoing percutaneous coronary intervention (PCI), mean age ~65, 84-85% male, UK-based. Excluded: patients presenting with cardiac arrest, intubation and ventilation, or cardiogenic shock.

Intervention

Drug-coated balloon (DCB)-only strategy using paclitaxel-coated devices (SeQuent Please, SeQuent Please NEO, and Falcon)

Comparator

Drug-eluting stent (DES)-only strategy using contemporary stent platforms

Outcome

Target vessel revascularization (TVR) at a median follow-up of 3.67 yearshard clinical

A drug-coated balloon-only strategy for de novo chronic total occlusion PCI demonstrated long-term efficacy and safety comparable to drug-eluting stents, supporting it as a viable 'leave nothing behind' alternative.

Main Result

Effect estimate: HR 2.33 (95% CI 0.81–6.74)

Absolute Event Rate: 12.9% vs 5.9%

p-value: p=0.118

Limitations

Retrospective, single-center observational design limiting generalizability and potential for bias
Non-randomized treatment assignment at operator discretion introducing selection bias
Gradual increase in experience with DCB strategy over study period
Potential unmeasured confounding factors
Use of only paclitaxel-coated DCBs limiting applicability to other DCB platforms

Abstract

Abstract 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 analyzed 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 revascularization (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 the 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-center 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. Graphical Abstract

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