Author + information
- Rajasekhar Durgaprasad1,
- Vanajakshamma Velam1,
- Latheef Kasala1,
- Obul Reddy Gajjala1 and
- Sreedhar Naik Kanavat1
Everolimus-eluting coronary stents are the second generation drug-eluting stents developed to overcome the high rates of restenosis and target lesion revascularization. Everoflex (Sahajanand Medical Technologies Pvt Ltd, Surat, India) is a biodegradable polymer coated everolimus-eluting Cobalt-Chromium (Co-Cr) coronary stent with strut size of 60 μ, whereas Xience Pro (Abbott Vascular, Abbott Park, Illinois) is a permanent polymer coated everolimus-eluting Co-Cr coronary stent system with strut size of 120 μ. In this study, we sought to evaluate safety and efficacy of Everoflex and Xience Pro stents in daily clinical practice at a tertiary care center.
It is a single-center, non-randomized, prospective registry consisting of two cohorts – Everoflex and Xience Pro. Each cohort consisting of 327 consecutive patients who underwent percutaneous coronary intervention with Everoflex and Xience Pro stents respectively between January and December 2015. The primary endpoint was an incidence of cardiac death, myocardial infarction, and target lesion revascularization. The secondary endpoint was composite of device oriented end-points as well as patient-oriented outcomes comprising overall mortality, any myocardial infarction, and repeat revascularization.
The mean age of the Everoflex and Xience Pro groups was 56.7 ± 10.4 years and 55.6 ± 9.7 years (p=NS) respectively. Both the groups were matched in terms of gender, risk factors, ejection fraction, a severity of the disease and infarct-related artery. The average diameter and length of stents were 2.83 ± 0.29 mm and 25.12 ± 8.70 mm in Everoflex group, 2.82 ± 0.31 mm and 19.81 ± 7.61 mm in Xience Pro group. Device related outcomes at 1-year follow-up: Cardiac death, myocardial infarction, target vessel revascularization (TVR) and target lesion revascularization (TLR) were reported in 02 (0.6%), 07 (2.2%), 06 (1.8%) and 06 (1.8%) patients in Everoflex group whereas in Xience Pro group it was 05 (1.5%), 7 (2.1%), 04 (1.2%) and 04 (1.2%) respectively. In Everoflex group, Stent thrombosis was reported in 03 (0.9%) patients, of which 01 (0.3%) was Sub-acute and 02 (0.6%) were late whereas in Xience Pro group it was reported in 02 (0.6%) patients and both were late. In-stent restenosis was found in 03 (0.9%) and 02 (0.6%) patients in Everoflex and Xience Pro groups respectively. At 1-year follow-up, overall mortality was 0.6% and 1.5%; and the survival rate was 99.4% and 98.5% in Everoflex and Xience Pro groups respectively.
At 1-year follow-up, Everoflex and Xience Pro stents are safe with low risk of stent thrombosis, in-stent restenosis and higher survival rates in all-comers patient population. Everoflex group showed a slightly higher mortality benefit than Xience Pro, this finding may be because of thinner strut size and biodegradable polymer used in Everoflex. A larger multicentric study with longer follow-up will be useful to establish these findings.