Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry

Abstract

ObjectiveTo 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).MethodsNational, 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).ResultsAt 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%).ConclusionsThe 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.

Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review

“…The FLEX registry included 995 patients (1242 lesions) in nine Indian centres and reported a low rate (3.7%) of MACE at 1-year follow-up (3.7%) [36]. The S-FLEX UK registry was conducted across different U.K. centres and showed a low rate of TLF (2.4%) and no definite stent thrombosis among 469 patients undergoing PCI with the Supraflex SES [37]. The TALENT trial randomly compared the Supraflex SES with the Xience EES among 1430 patients.…”

Thin, very thin, or ultrathin-strut biodegradable or durable polymer-coated drug-eluting stents

“…The single-arm S-FLEX UK registry is another study that established the clinical safety and efficacy of the Supraflex stent. The study assessed a total of 469 'real-world' patients and found at 1-year followup a TLF rate of 2.4% [29].…”