TITLE:
Safety and Performance of Sirolimus-Eluting Coronary Stent System with Biodegradable Polymer: A Retrospective Analysis in Real-World Patient Population
AUTHORS:
Vithala Surya Prakasa Rao, A. S. V. Narayana Rao, Pannala Lakshmi Narasimha Kapardhi, Priyen Kantilal Shah, Revanur Viswanath, Satyajit Govindrao Mehetre, Avanindra Kumar Srivastava
KEYWORDS:
Biodegradable Polymer, Cobalt-Chromium, Metafor SES, Sirolimus-Eluting Stent, Stent Thrombosis
JOURNAL NAME:
World Journal of Cardiovascular Diseases,
Vol.7 No.5,
May
27,
2017
ABSTRACT: Background and Aim: Newer generation coronary stent systems with low profile metallic frame, biodegradable polymer coating and potent but safe anti-restenosis drug from “limus family” are emerging as safe and effective stents. To evaluate the safety and performance of Metafor SES (Meril life Sciences Pvt. Ltd., Vapi, India) in consecutive patients in a real-world population. Methods: The study was a retrospective, non-randomized, single-center study which evaluated the data of 127 patients who underwent percutaneous coronary intervention (PCI) treated with Metafor SES from February 2012 to February 2015 and mean follow-up period of those patients was 3.6 ± 0.6 years. The primary endpoint was a major adverse cardiac event (MACE) including cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). In addition, Stent thrombosis (ST) was analyzed at respective follow-up period. Results: A total of 127 patients (mean age: 53.70 ± 8.41 years and 99 males) were included. Among those 80 (63%) patients had hypertension and 58 (45.7%) patients with diabetes mellitus.At follow-up, MACE in form of TLR was observed in 2 (1.6%) patients only. No cardiac death or stent thrombosis was reported in any patient. A total of 169 lesions were treated with the Metafor SES (1.3 stents per lesion). The 38.4% of patients treated with the Metafor SES with lesion length ≥24 mm, and the procedural success was 100%. Conclusions: The lower incidence of MACE in uncontrolled and real world population at long term follow-up clearly depicts the prolonged safety and performance of the Metafor SES.