Nanocarrier SIroliMus-coated balloon-based percutaneous coronary intervention (PCI) versus drug-eluting stent (DES)-onLy PCI in patients with diabetes mellitus

Gitto, M; Filiberti, G; Leone, PP; Chiarito, M; Gurgoglione, FL; Tartaglia, F; Frazzetto, M; Calamita, G; Rossi, ML; Bernardini, V; Reimers, B; Regazzoli, D; Mangieri, A; Gasparini, G; Briguori, C; Latib, A; Stefanini, GG; Godino, C; Sardella, G; Cortese, B; Colombo, A

doi:10.1186/s12933-026-03110-6

Type 2 & other diabetes

Nanocarrier SIroliMus-coated balloon-based percutaneous coronary intervention (PCI) versus drug-eluting stent (drug-eluting stents (DES))-onLy PCI in patients with diabetes mellitus

Cardiovasc DiabetolPublished 4 Mar 2026Pooled analysis of five observational registries

Pooled result · Target lesion failureResultAdjusted hazard ratio 0.88 95% CI 0.43–1.81

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Authors' conclusion

In diabetic patients undergoing PCI for de novo CAD, an SCB-based strategy was associated with comparable 2-year outcomes to DES-only PCI, with signals of potential benefit in the highest clinical and anatomical risk subsets.

Study context

Population: All-comer patients with DM undergoing PCI for de novo coronary artery disease
Participants: 1,838 patients

Comparison: Sirolimus-coated balloons (SCB)-based PCI vs DES-only PCI
SCBn = 599
DESn = 1,239reference
Outcome: Target lesion failure: composite of cardiac death, target vessel MI or target lesion revascularization
Follow-up: 2 years

Methodological detailspropensity score adjustment, all-comer

Propensity score adjustment
All-comer

Pooled result

Target lesion failure

Adjusted hazard ratio

0.88

95% CI 0.43–1.81

P = 0.736

By group

SCB9.1%

DES9.9%

SCBvs DES

adjusted HR 0.88 (95% CI 0.43–1.81); P = 0.736

As reported in the abstract

Further pooled results

Outcome	P value
TLF by subgroup (CKD, lesion length)SCB vs DES · CKD subgroup; more favourable outcomes with SCB	P for interaction = 0.042
TLF by subgroup (CKD, lesion length)SCB vs DES · long lesions; more favourable outcomes with SCB	P for interaction = 0.003

Cardiac death, target vessel MI, target lesion revascularization

No significant differences in cardiac death, target vessel MI (TV-MI) or target lesion revascularization (TLR)

Target lesion failure (TLF) by subgroup (CKD, lesion length)

DES-only PCI performed better in short lesions

Original publication

Nanocarrier SIroliMus-coated balloon-based percutaneous coronary intervention (PCI) versus drug-eluting stent (DES)-onLy PCI in patients with diabetes mellitus. Cardiovasc Diabetol. Published 4 March 2026. doi:10.1186/s12933-026-03110-6

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