Patients with diabetes who undergo percutaneous coronary intervention (PCI) frequently present with complex coronary artery disease (CAD) and may experience less favorable outcomes after implantation of drug-eluting stents (DES). Sirolimus-coated balloons (SCB) have recently emerged as an alternative PCI strategy, but comparative evidence in individuals with diabetes and de novo CAD remains limited. A pooled analysis from the SIMPLE-DM study, published in Cardiovascular Diabetology, evaluated outcomes associated with SCB-based PCI compared with DES-only PCI in this population.

The analysis combined data from five observational registries, including 1,838 all-comer patients with diabetes undergoing PCI for de novo CAD. Of these, 599 patients received SCB-based PCI using the phospholipid nanocarrier Magic Touch sirolimus-coated balloon, while 1,239 patients underwent PCI with contemporary DES. Propensity score adjustment was applied to balance clinical and angiographic characteristics between the two treatment groups. The primary endpoint was target lesion failure (TLF) at 2 years, defined as the composite of cardiac death, target-vessel myocardial infarction (TV-MI), or target lesion revascularization (TLR).

At two years, TLF occurred in 9.1% of patients treated with SCB and 9.9% of those treated with DES (adjusted HR 0.88; 95% CI 0.43-1.81; p=0.736). Rates of cardiac death, TV-MI, and TLR were comparable between strategies. Interaction analyses indicated that SCB-based PCI showed more favorable outcomes in patients with chronic kidney disease and in those with long coronary lesions, whereas DES-only PCI demonstrated better results in short lesions. 

Overall, SCB-based PCI showed similar two-year outcomes to DES-only PCI in patients with diabetes undergoing PCI for de novo CAD.