Clinical safety and performance of a biodegradable polymer-coated sirolimus-eluting stent in an all-comers population: results from the S-FLEX Russia registry

Background: The safety and clinical performance of the Supraflex Cruz sirolimus-eluting stent (SES) have not been explored within a Russian population until now. Aims: The S-FLEX Russia registry was designed to evaluate the clinical safety and performance of the Supraflex Cruz SES in a real-world, all-comers Russian population undergoing percutaneous coronary intervention (PCI). Methods: This was a prospective, multicentre, single-arm, observational registry that included 522 patients who underwent PCI with the Supraflex Cruz SES between August 2021 and February 2022, at five hospitals in Russia. Subgroups prespecified for data analysis included patients with diabetes mellitus, bifurcation lesions, type B2/C lesions and at least one long lesion (>20 mm). The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TVMI) and clinically driven target lesion revascularisation (CD-TLR) at 12-month follow-up. Results: The mean age of the patient population was 64.26±9.46 years. Device and procedural success were 99.4% and 98.9%, respectively. At 12 months, TLF was observed in 16 (3.1%) patients, comprising 8 (1.5%) cardiac deaths, 6 (1.1%) TVMI, and 2 (0.4%) CD-TLR. Only 1 (0.2%) instance of definite stent thrombosis was observed at 12-month follow-up. In the high-risk subgroups, TLF at 12 months was 5.6% in patients with diabetes, 8.5% in bifurcation lesions, 2.8% in complex B2/C lesions, and 1.9% in long lesions (>20 mm). Conclusions: Low rates of TLF and stent thrombosis at 12-month follow-up demonstrate the excellent safety and clinical performance of the Supraflex Cruz SES in a real-world, all-comers Russian population, including prespecified high-risk subgroups.