AIM: S-CORE is the post-marketing surveillance multicenter registry that demonstrated satisfactory clinical outcomes of a cobalt- chromium biodegradable polymer coated sirolimus-eluting stent (Supralimus-Core®, Sahajanand Medical Technologies Pvt. Ltd., Surat, India) for the treatment of patients in routine clinical practice.
METHODS: S-CORE Registry is an observational, single-arm, non-randomized, post-marketing surveillance multi-center registry in which 562 patients, underwent 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-months 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 12-months clinical follow-up was 19, consisting of 12 (2.1%) cardiac deaths, 0 (0%) MI, 6 (1.1%) TLR and 1 (0.2%) TVR. 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.
