Safety and performance of the ultrathin sirolimus-eluting coronary stent in an all-comer patient population: the S-FLEX UK-II registry.

OBJECTIVE

We evaluated the clinical safety and performance of the ultrathin strut biodegradable polymer-coated Supraflex Cruz (Sahajanand Medical TechnologiesLtd., Surat, India) sirolimus-eluting stent (SES) in an all-comer patient population requiring coronary stent implantation.

STUDY DESIGN

The study was a prospective, observational, multicentre, single-arm registry.

STUDY SETTINGS

The study was conducted at 19 NHS Hospitals across the UK, from March 2020 to September 2021.

STUDY PARTICIPANTS

A total of 1904 patients with symptomatic coronary artery disease (age ≥18 years) who underwent percutaneous coronary intervention with at least one Supraflex Cruz SES were enrolled.

PRIMARY AND SECONDARY OUTCOMES MEASURE

The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically indicated target lesion revascularisation (CI-TLR), at 12 months. Safety endpoints were stent thrombosis, all-cause death and any MI. Prespecified subgroups analysis included patients with diabetes mellitus, bifurcation lesion, type B2/C lesion defined as per ACC/AHA (American College of Cardiology/American Heart Association) lesion classification and long coronary lesions (>20 mm).

RESULTS

A total of 2973 Supraflex Cruz SES were implanted in 1835 patients (mean age: 65.20±11.03 years). Of these, 404 patients had diabetes mellitus (491 lesions), 271 had bifurcation lesions (293 lesions), 1541 had type B2/C lesions (1832 lesions) and 985 had long coronary lesions (>20 mm, 1139 lesions). Among the overall population, device success was achieved in 98.2% of lesions. TLF occurred in 12 (0.7%) patients (0.3% cardiac death, 0.2% TV-MI, 0.2% CI-TLR) at 30 days and in 43 (2.3%) patients (0.8% cardiac death, 0.8% TV-MI, 0.8% CI-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3% in the overall population at 12 months. The incidence of TLF and stent thrombosis was 6.2% and 1% in the diabetic, 1.8% and none in bifurcation lesion, 2.5% and 0.3% in type B2/C lesion, and 2.7% and 0.3% in long coronary lesions (>20 mm) subgroups, respectively. at 12 months follow-up.

CONCLUSION

The S-FLEX UK-II registry confirms the clinical safety and performance of the ultrathin Supraflex Cruz SES in an all-comer population with complex coronary artery disease, demonstrating low rates of TLF and stent thrombosis.

TRIAL REGISTRATION NUMBER

ISRCTN39751665 (https://doi.org/10.1186/ISRCTN39751665).