The S-FLEX UK-II Registry was designed to evaluate the safety and performance of the ultrathin Supraflex Cruz sirolimus-eluting stents (SES) in a diverse population of patients with coronary artery disease
Sahajanand Medical Technologies (SMT), healthcare company in India with a focus on patient care in the cardiovascular sector has announced promising data from its study, the Prospective S-FLEX UK-II Registry.
The S-FLEX UK-II Registry was designed to evaluate the safety and performance of the ultrathin Supraflex Cruz sirolimus-eluting stents (SES) in a diverse population of patients with coronary artery disease. This multicenter, single-arm study involved 19 sites across UK, with a total of 1835 patients enrolled between March 2020 and September 2021.
Study highlights:
- Study design: Prospective, observational, multicenter, single-arm study
- Primary objective: To evaluate the safety and performance of the ultrathin Supraflex Cruz SES in patients with coronary artery disease.
- Patient population: All-comers patients requiring PCI (Stent implantation)
- Follow-up/total duration: 12 months (data presented at TCT 2023, San Francisco, October 23-26, 2023)
- Primary endpoint: Target Lesion Failure (TLF), a composite of cardiac death, target vessel MI (TV-MI), and clinically driven target lesion revascularisation (CD-TLR), at 12 months.
Prof. Azfar Zaman, Freeman Hospital, Newcastle Upon Tyne, United Kingdom Principal Investigator of the study stated, “The overall study results show consistently low clinical event rates with Supraflex Cruz in a real-world all-comers population from the United Kingdom. Importantly, the safety of Supraflex Cruz was once again confirmed in a high-risk subset of patients and lesion types.”
The study demonstrated, in the overall population, that TLF occurred in 0.7 per cent of patients (0.3 per cent cardiac death, 0.2 per cent TV-MI, 0.2 per cent CD-TLR) at 30 days and in 2.4 per cent of patients (0.8 per cent cardiac death, 0.8 per cent TV-MI, 0.9 per cent CD-TLR) at 12 months follow-up. The rate of definite stent thrombosis was 0.3 per cent in the overall population at 12 months. The incidence of TLF and stent thrombosis in pre-specified subgroups were-6.5 per cent and 1 per cent in patients with diabetes, 1.9 per cent and none in bifurcation lesions, 2.6 per cent and 0.3 per cent in type B2/C lesions, and 2.8 per cent and 0.3 per cent in long lesions (>20 mm) respectively. at 12 months follow-up.
Dr Krishna Sudhir, Chief Medical Officer, SMT commented, “This study adds to a convincing body of clinical evidence from several registries and two major randomised trials confirming the benefits of using Supraflex Cruz in patients with complex coronary artery disease.”