Author + information
- Rajasekhar Durgaprasad1,
- Velam Vanajakshamma1,
- Vamsidhar Akkulagari1,
- Latheef Kasala1,
- Sreedhar Naik Kanavat1 and
- Pathakota Sudhakar Reddy1
Everoflex is a biodegradable everolimus-eluting Cobalt-Chromium coronary stent system with thin struts (60μ) developed by Sahajanand Medical Technologies Pvt Ltd (Surat, Gujarat, India). The aim of the study is to evaluate and collect the safety and performance data for an all-comers patient population treated with Everoflex coronary stents within daily clinical practice.
It is a single-center, non-randomized, prospective registry of 335 consecutive patients who underwent percutaneous coronary intervention with Everoflex stents between 1st January, 2015 and 10th January, 2016. Twelve cases lost follow-up and 323 cases were included. The primary end-point of this study was incidence of cardiac death, myocardial infarction and target lesion revascularization. Secondary endpoint was composite of device oriented end-points as well as patient oriented outcomes comprising overall mortality, any myocardial infarction and repeat revascularization. This study was approved by the institutional ethics committee of our institute.
The mean age of the study group was 56.6±10.6 years, 242 (75.2%) were male, 107 (33.1%) were diabetic and 135 (41.8%) were hypertensive. Majority (61.3%) had single vessel disease. Left anterior descending artery (66.9%) was the most common revascularized coronary artery. 431 Everoflex coronary stents (average of 1.3 stents/patient) were implanted in the study population. The average diameter and length of stents were 2.8±0.3 mm and 25.6±8.8 mm respectively. Device related outcomes at 11-months median follow up: Cardiac death, myocardial infarction, target vessel revascularization and target lesion revascularization were reported in 02 (0.6%), 07 (2.2%), 06 (1.8%) and 06 (1.8%) patients respectively. Stent thrombosis (ST) was reported in 03 (0.9%) patients, of which 01 (0.3%) was sub acute and 02 (0.6%) were late and all were definite ST. Three (0.9%) patients had instent restenosis. Overall mortality and event-free survival at 11-months median follow-up was 0.62% and 99.38% respectively.
At intermediate follow-up, Everoflex stent is safe with low risk of stent thrombosis, instent restenosis and higher survival rates in all-comers patient population.
CORONARY: Stents: Drug-Eluting.