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.
Highlights
Cardiovascular disease (CVD) is one of the leading causes of mortality in India [1]
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 sirolimus-eluting coronary stent (SES) from February 2012 to February 2015 and mean follow-up period of those patients was 3.6 ± 0.6 years
The primary endpoint of the study was to determine the rate of major adverse cardiac event (MACE); which is defined as the aggregate of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) procedure during the follow-up period after the index procedure
Summary
Cardiovascular disease (CVD) is one of the leading causes of mortality in India [1]. According to the World Health demography 2008 report, global deaths from CVD will extend from 17.1 million in 2004 to 23.4 million in 2030, predetermined CVD is the leading cause of morbidity and mortality worldwide [2]. Drug eluting stent (DES) has established for the treatment for coronary artery disease (CAD) over the past decade by effectively reducing in-stent restenosis and for the target vessel revascularization (TVR) [3] [4] [5]. DES such as MetaforTM (CE approved) sirolimus-eluting coronary stent (SES) system (Meril Life Sciences Pvt. Ltd., Vapi, India) has been developed with an objective to reduce the adverse effects of existing DES. The Metafor SES (Meril Life Sciences Pvt. Ltd., Vapi, India) uses L605 cobalt chromium alloy as its stent platform which is coated with a biodegradable and biocompatible polymer to deliver sirolimus. The primary aim of this retrospective study was to evaluate clinical performance of the Metafor SES sirolimus-eluting coronary stent in the treatment of patients enrolled in every day practice at the Apollo Hospitals, Hyderabad, Telangana, India. Stent thrombosis (ST) was analyzed at respective follow-up period
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