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

Abstract

Background: Diabetic patients undergoing percutaneous coronary intervention (PCI) frequently have complex coronary artery disease (CAD) and suboptimal outcomes with drug-eluting stents (DES). Sirolimus-coated balloons (SCB) have recently been introduced, but comparative data versus DES in diabetic patients with de novo CAD are lacking.

Methods: The SIMPLE-DM study is a pooled analysis of five observational registries including all-comer diabetic patients undergoing PCI for de novo CAD. Patients in the SCB cohort were treated with the phospholipid nanocarrier Magic Touch SCB, while those in the DES cohort received current-generation DES. Propensity score (PS) adjustment was used to balance clinical and angiographic characteristics. The primary endpoint was the 2-year cumulative incidence of target lesion failure (TLF), defined as the composite of cardiac death, target vessel MI (TV-MI), or target lesion revascularization (TLR).

Results: A total of 1838 patients were included, 599 treated with SCB-based PCI and 1239 with DES-only PCI. At 2 years, TLF occurred in 9.1% of SCB and 9.9% of DES patients (adj. hazard ratio HR 0.88, 95% confidence interval CI 0.43-1.81, p = 0.736). No significant differences were found in cardiac death, TV-MI or TLR. SCB-based PCI was associated with more favourable outcomes in patients with chronic kidney disease (p for interaction = 0.042) and long lesions (p for interaction = 0.003), whereas DES-only PCI performed better in those with short lesions.

Conclusions: 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.