TITLE:
Clinical Performance of the Cobalt-Chromium Biodegradable Polymer Coated Sirolimus-Eluting Stent in an Unselected Real-World Population
AUTHORS:
Prakash Chandwani, Atul D. Abhyankar, Jayesh S. Prajapati, Sanjay C. Porwal, Ashok S. Thakkar
KEYWORDS:
Coronary Artery Disease; Biodegradable Polymer; Sirolimus-Eluting Stent
JOURNAL NAME:
International Journal of Clinical Medicine,
Vol.5 No.5,
March
18,
2014
ABSTRACT:
OBJECTIVE: The primary objective of the S-CORE
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: S-CORE 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.