TITLE:
Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes
AUTHORS:
Sridhar Kasturi, Srinivas Polasa, Shailender Singh, Vijay Kumar Reddy, Kondal Rao, Ganesh Mathan, Shiva Kumar Bandimida, Manikandhar Pendyala, Chandrashekar Challa
KEYWORDS:
Biodegradable Polymer, Percutaneous Coronary Intervention, Everolimus-Eluting
JOURNAL NAME:
World Journal of Cardiovascular Diseases,
Vol.6 No.12,
December
19,
2016
ABSTRACT: Introduction: Tetrilimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) is a recently-introduced biodegradable-polymer coated everolimus-eluting cobalt-chromium coronary stent system with an ultra-thin strut thickness. We aimed to evaluate the clinical outcomes with Tetrilimus coronary stents in “real-world” patients with coronary artery disease. Methods: In this retrospective, single-arm, open-label, multi-center registry, all consecutive patients who received Tetrilimus stents between July-2015 and April-2016 at two tertiary-care centers in India were analyzed. Primary endpoint was 30-day incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, and target vessel revascularization. The Academic Research Consortium (ARC)-defined stent thrombosis was assessed as additional safety endpoint. Results: During the study period, 280 Tetrilimus stents (1.4 ± 0.5 stent/patient) were implanted to treat 252 coronary lesions (1.1 ± 0.3 stent/lesion) in 208 patients (age: 57.5 ± 11.9 years). Of study population, 65.9% were males, 46.6% were hypertensives, 25% were diabetics, 36.5% were alcoholics, 29.3% were smokers, 13.9% were tobacco chewers, 5.3% had previous revascularization, and 45.2% displayed multi-vessel disease. Of treated lesions, 67.5% were complex and 18.7% had total occlusion. Average length and diameter of implanted stents were 25.5 ± 8.8 mm and 2.9 ± 0.3 mm respectively. Subsequently, 30-day MACE were reported in 2 (0.96%) patients; both cases owing to in-hospital cardiac deaths. Events of stent thrombosis or noncardiac death were not reported in any patient. Conclusion: Low MACE rates and absence of stent thrombosis at early 30-day follow-up indicates that Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected “real-world” patients with coronary artery disease.