Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population

Abstract

OBJECTIVE: The primary objective of the SCORE registry was to assess the safety and efficacy of the Supralimus-Core ® sirolimus-eluting stent deployment for the treatment of coronary artery disease and event-free survival of patients treated with this coronary stent. METHODS: SCORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multicenter registry in which 562 patients undergoing single-or multi-vessel percutaneous coronary intervention were enrolled. The pre-specified primary outcome was the rate of major adverse cardiac events (MACE), defined as the composite of cardiac death, myocardial infarction (MI), target lesion revascularisation (TLR) and target vessel revascularisation (TVR) at 12-month post-procedure. Stent thrombosis (ST) served as the safety endpoint. RESULTS: A total of 640 lesions were treated in 562 enrolled patients (mean age 57.4 ± 10.7 years) with average stent length of 25.0 ± 9.0 mm. Stent delivery was successful in 99% cases. A total of 554 (98.6%) patients have been followed up to 12 months. The incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%) respectively. The composite rate of MACE at a 12-month clinical follow-up was 19 (3.4%), consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. The long-term follow-up of this registry is going on to confirm safety and efficacy profiles. CONCLUSIONS: This multicenter registry demonstrated satisfactory safety and efficacy profiles, as evidenced by low rates of major adverse cardiac events up to 12 months, for the cobalt-chromium biodegradable polymer-based sirolimus-eluting Supralimus-Core ® stent in a "real-world" setting.

Nine-Months Clinical Outcome of Biodegradable Polymer Coated Sirolimus-eluting Stent System: A Multi-Centre “Real-World” Experience

“…In another registry, which aimed at evaluating safety and efficacy of biodegradable polymer coated SES, MACE was found to be 12 (2.1%) with TLR as low as 3 (0.5%) at 6-months follow-up [18]. The results of our study are quite comparable with this registry and delineate safety and efficacy of the Indolimus.…”

Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry

“…The Supralimus-Core (Sahajanand Medical Technologies) is a clinically proven sirolimus-eluting coronary stent and its safety and efficacy has demonstrated in real-life patients. 24 25 The Supraflex SES is a further improved version of the Supralimus-Core SES with replacement of the rigid interlink/joint of the Supralimus-Core SES with a highly flexible 'S-link', which increases flexibility and deliverability of the Supraflex SES. Additionally, in the S-CORE Registry (multicentre registry of Supralimus-Core biodegradable polymer SES), which enrolled 562 'realworld' patients, the incidence of MACE at 30 days and 6 months was 7 (1.2%) and 12 (2.1%), respectively.…”

“…Findings of this S-CORE Registry showed satisfactory safety and efficacy for the Co-Cr biodegradable polymer-based sirolimus-eluting Supralimus-Core stent in a 'real-world' setting as seen from low rates of MACE up to 12 months. 25 Usually, randomised controlled trials or first-in-man studies enrol a low-risk population (clinically stable or straightforward lesions), and thus results of such studies cannot be extrapolated to 'real-world' patients with higher risk or with complex coronary anatomy. Accurate post-market surveillance may provide valuable data of a more real population treated in a true clinical setting.…”

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

“…Studies assessing the Supralimus-Core (previous version of the S-SES with the same strut thickness, polymer and drug concentration) reported reassuring vessel healing properties by optical coherence tomography at 4 months,26 along with satisfactory 1-year TLR of 1.1% along with MACE of 3.4% in real-world patients 17…”

“…The sample size of subjects was selected to be similar to the patient numbers enrolled in the S-CORE registry 17. Data are presented using descriptive statistical methods.…”