Stents (Bare-metal, Drug-eluting)
Clinical Evaluation of Everoshine Everolimus Eluting Coronary Stent in Coronary Artery Lesions
Sridhar Kasturi1, Shailender Singh1, Vijay Kumar Reddy Shanivaram1
Sunshine Hospital, India1
The development of coronary drug-eluting stents has included the use of new metal alloys, changes in stent architecture, and the use of bioresorbable polymers. New-generation drug-eluting stents (DES) represent the current standard of care in patients undergoing percutaneous coronary intervention (PCI). Biodegradable polymer DES (BP-DES) was recently developed to overcome the current limitations of newer-generation durable polymer DES(DP-DES) attributed to sustained inflammatory responses induced by permanent polymers. The Everoshine DES (Kamal Encon Industries Limited - Kamal Medtech, Faridabad, Haryana) is a novel thin-strut cobalt-chromium everolimus-eluting stent with a biodegradable polymer that features some of the latest developments in DES technology.
Thestudy population included a registry of 200 patients who underwent single ormulti-vessel revascularization with clinical presentations such as stableangina and acute coronary syndrome in the period between October 2020 and August2021 and who completes a one-year follow-up period. All the patients enrolledwere implanted with at least one Everoshine DES (Kamal Medtech, Faridabad, Haryana) stent and responded to follow-up. The endpoint of the study was the incidence of majoradverse cardiac events (MACE) defined as cardiac death, re-infarction, repeat coronaryrevascularization, and stent thrombosis.Clinical, telephonic follow-up was performed and MACE was analyzed at 30days, and 12 months.
Overall193 patients were responded with 310 lesions treated with 260 Everoshine stents were enrolled in the study with a mean age of 57.8± 11.01 years among them 73.6% males were reported. And hypertensive, diabeticprevalence of 47.4% and 35.2% found respectively. The mean lesion length was26.77 ± 9.78mm with mean stent diameter 2.91 ± 0.39mm. At 12 months follow up, the efficacy endpoint MACEoccurred in 5 (2.6%) of 193 patients, consisting of 3 (1.5%) cardiac deaths, 2(0.7%) MI, 2 (0.5%) target lesion failures and stent thrombosis (ST) was observed in 2 (1.3%) patients.
| Parameter || 1 month || 12 months |
| All-cause mortality || 4 (2.07) || 5 (2.6) |
| Cardiac Death || 2 (1.03) || 3 (1.5) |
| MI || 2 (1.03) || 2 (1.03) |
| TLF || 2 (1.03) || 2 (1.03) |
| Stent Thrombosis || 2 (1.03) || 2 (1.03) |
| MACE || 4 (2.07) || 5 (2.6) |
The outperformance ofthe bioresorbable polymer everolimus-eluting stent system over the durablepolymer everolimus-eluting stent in a complex patient population undergoingpercutaneous coronary intervention suggests a new direction in improving nextgeneration drug-eluting stent technology.