Key result
Ultrathin strut S-SES demonstrates a ~2.4% TLF rate at 12 months post-PCI.
Why the study?
To prospectively evaluate the safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent in a real-world patient population requiring PCI.
Observational (n=469)
Yes
The ultrathin strut biodegradable polymer-coated sirolimus-eluting stent demonstrated a low incidence of target lesion failure at 12 months in a real-world PCI population.
Supports real-world use of Supraflex in PCI; leaves open comparative efficacy versus established DES.
OBJECTIVE: To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in 'real world' patient population requiring percutaneous coronary intervention (PCI). METHODS: National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months-overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE-composite of cardiac death, MI, emergent or repeat revascularisation). RESULTS: At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%). CONCLUSIONS: The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.
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Choudhury et al. (2019) conducted an observational in Coronary artery disease requiring percutaneous coronary intervention (n=469). Supraflex sirolimus-eluting stent (S-SES) was evaluated on Target lesion failure (TLF) at 12 months. The ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent demonstrated a 2.4% rate of target lesion failure at 12 months in patients undergoing PCI.
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