Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes
Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes作者机构：Sunshine Heart Institute Secunderabad India Chalmeda Anandrao Institute of Medical Sciences Karimnagar India
出 版 物：《World Journal of Cardiovascular Diseases》 (心血管病（英文）)
年 卷 期：2016年第6卷第12期
页 面：458-467页
学科分类：1002[医学-临床医学] 100201[医学-内科学(含：心血管病、血液病、呼吸系病、消化系病、内分泌与代谢病、肾病、风湿病、传染病)] 10[医学]
主 题：Biodegradable Polymer Percutaneous Coronary Intervention Everolimus-Eluting
摘 要：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.
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