Author + information
- Rajasekhar Durgaprasad,
- Vanajakshamma Velam,
- Vasudeva Chetty Pakala,
- Vamsidhar Akkulagari,
- Latheef Kasala,
- Sowjenya Gopal and
- Sreedhar Naik Kanavat
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 primary objective of this 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 318 consecutive patients who underwent percutaneous coronary intervention with Everoflex coronary stents between 1st January and 31st December, 2015. 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. Patients who were not on regular follow-ups to the hospital were contacted telephonically for study specific events. Median follow-up duration was 9 months (range: 4-16 months).
The mean age of the study group was 56.5 ± 10.6 years, 236 (74.2%) were male, 106 (33.3%) were diabetic and 134 (42.1%) were hypertensive. Majority (62.3%) had single vessel disease. Left anterior descending artery (66.4%) was the most common revascularized coronary artery. A total number of 420 Everoflex coronary stents (average of 1.32 stents/patient) were implanted in the study population. The average diameter and length of stents were 2.83 ± 0.29 mm and 25.47 ± 8.83 mm respectively. Device related outcomes at 9-months median follow up -- Cardiac death, myocardial infarction, target vessel revascularization and target lesion revascularization were reported in 01 (0.3%), 05 (1.6%), 05 (1.6%) and 05 (1.6%) patients respectively. Stent thrombosis was reported in 02 (0.6%) patients, of which 01 (0.3%) was subacute and 1 (0.3%) was late and both were definite stent thrombosis. Overall mortality at 9-months median follow-up was 0.3%. The event-free survival at 9-months median follow-up after Everoflex coronary stent implantations was 99.7%.
This study shows that the use of Everolimus stent is safe on median 9-months follow-up with low risk of early and late stent thrombosis and higher survival rates in all-comers patient populations.