Document Type : Original Article(s)
Professor, Department of Cardiology, KLE Academy of Higher Education & Research, Belagavi, Karnataka, India
Head, Department of Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi, Gujarat, India
BACKGROUND: Evermine 50™ (Meril Life Sciences Pvt. Ltd., India) everolimus-eluting stent system (EES) is a novel ultrathin strut (50 µm) cobalt-chromium coronary drug-eluting stent (DES) platform with biodegradable polymer coating. The Evermine 50 EES-KLES study aimed to evaluate the Evermine 50 EES in terms of 24-month clinical safety and performance in patients with coronary artery disease (CAD).METHODS: This retrospective study consisted of 171 patients (258 lesions) implanted with Evermine 50 EES for managing CAD. We analyzed the major adverse cardiac events (MACE) incidence, defined as a composite of cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization (ID-TLR) at 6-, 12-, and 24-month follow-up.RESULTS: A total of 171 patients were included with a mean age of 57.85 ± 10.05 years, of which, 139 (81.29%) were men, 69 (40.35%) were hypertensive, and 70 (40.94%) were diabetic. The incidence of MACE was 1 (0.58%), 3 (1.81%), and 4 (2.42%) at 6-, 12-, and 24-month follow-up, respectively. There were three cases (1.82%) of cardiac death and one case (0.61%) of ID-TLR up to 24 months. None of the patients was presented with definite or probable stent thrombosis (ST).CONCLUSION: This study demonstrated that implantation of ultrathin strut Evermine 50 EES resulted in a low rate of incidence of MACE, indicating a favourable clinical safety and performance profile of Evermine 50 EES in patients with CAD [Clinical Trials Registry-India (CTRI) Number: CTRI/2017/09/009939)].
- von Birgelen C, Kok MM, van der Heijden LC, Danse PW, Schotborgh CE, Scholte M, et al. Very thin strut biodegradable polymer everolimus-eluting and sirolimus-eluting stents versus durable polymer zotarolimus-eluting stents in allcomers with coronary artery disease (BIO-RESORT): A three-arm, randomised, non-inferiority trial. Lancet 2016; 388(10060): 2607-17.
- Koskinas KC, Chatzizisis YS, Antoniadis AP, Giannoglou GD. Role of endothelial shear stress in stent restenosis and thrombosis: Pthophysiologic mechanisms and implications for clinical translation. J Am Coll Cardiol 2012; 59(15): 1337-49.
- Dangas GD, Serruys PW, Kereiakes DJ, Hermiller J, Rizvi A, Newman W, et al. Meta-analysis of everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease: Final 3-year results of the SPIRIT clinical trials program (Clinical Evaluation of the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Patients with De Novo Native Coronary Artery Lesions). JACC Cardiovasc Interv 2013; 6(9): 914-22.
- Park KW, Chae IH, Lim DS, Han KR, Yang HM, Lee HY, et al. Everolimus-eluting versus sirolimus-eluting stents in patients undergoing percutaneous coronary intervention: The EXCELLENT (Efficacy of Xience/Promus Versus Cypher to Reduce Late Loss After Stenting) randomized trial. J Am Coll Cardiol 2011; 58(18): 1844-54.
- de Winter RJ, Katagiri Y, Asano T, Milewski KP, Lurz P, Buszman P, et al. A sirolimus-eluting bioabsorbable polymer-coated stent (MiStent) versus an everolimus-eluting durable polymer stent (Xience) after percutaneous coronary intervention (DESSOLVE III): A randomised, single-blind, multicentre, non-inferiority, phase 3 trial. Lancet 2018; 391(10119): 431-40.
- Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, et al. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol 2011; 58(24): e44-122.
- Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease: a report of the American college of cardiology/American heart association task force on clinical practice guidelines. J Am Coll Cardiol 2016; 68(10): 1082-115.
- Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA, et al. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation 2007; 115(17): 2344-51.
- Lemos PA, Chandwani P, Saxena S, Ramachandran PK, Abhyankar A, Campos CM, et al. Clinical outcomes in 995 unselected real-world patients treated with an ultrathin biodegradable polymer-coated sirolimus-eluting stent: 12-month results from the FLEX Registry. BMJ Open 2016; 6(2): e010028.
- Haude M, Ince H, Abizaid A, Toelg R, Lemos PA, von Birgelen C, et al. Safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de-novo coronary artery lesions (BIOSOLVE-II): 6 month results of a prospective, multicentre, non-randomised, first-in-man trial. Lancet 2016; 387(10013): 31-9.
- Jimenez VA, Iniguez A, Baz JA, Valdes M, Ortiz A, Vuilliomenet A, et al. A randomized comparison of novel bioresorbable polymer sirolimus-eluting stent and durable polymer everolimus-eluting stent in patients with acute coronary syndromes: The CENTURY II high risk ACS substudy. Cardiovasc Revasc Med 2016; 17(6): 355-61.
- Zhang H, Wang X, Deng W, Wang S, Ge J, Toft E. Randomized clinical trial comparing abluminal biodegradable polymer sirolimus-eluting stents with durable polymer sirolimus-eluting stents: Nine months angiographic and 5-year clinical outcomes.
- Medicine (Baltimore) 2016; 95(38): e4820.
- Bangalore S, Toklu B, Patel N, Feit F, Stone GW. Newer-generation ultrathin strut drug-eluting stents versus older second-generation thicker strut drug-eluting stents for coronary artery disease. Circulation 2018; 138(20): 2216-26.
- Milewski K, Gasior P, Samborski S, Buszman PP, Blachut A, Wojtaszczyk A, et al. Evaluation of safety and efficacy of NexGen - an ultrathin strut and hybrid cell design cobalt-chromium bare metal stent implanted in a real life patient population-the Polish NexGen Registry. Postepy Kardiol Interwencyjnej 2016; 12(3): 217-23.
- Patted SV, Patted AS, Turiya PK, Thakkar AS. Clinical Outcomes of World's Thinnest (50 mumr) Strut Biodegradable Polymer Coated Everolimus-Eluting Coronary Stent System in Real-World Patients. Cardiol Res 2018; 9(6): 370-7.
- Pilgrim T, Heg D, Roffi M, Tuller D, Muller O, Vuilliomenet A, et al. Ultrathin strut biodegradable polymer sirolimus-eluting stent versus durable polymer everolimus-eluting stent for percutaneous coronary revascularisation (BIOSCIENCE): A randomised, single-blind, non-inferiority trial. Lancet 2014; 384(9960): 2111-22.
- Kastrati A, Mehilli J, Dirschinger J, Dotzer F, Schuhlen H, Neumann FJ, et al. Intracoronary stenting and angiographic results: Strut thickness effect on restenosis outcome (ISAR-STEREO) trial. Circulation 2001; 103(23): 2816-21.
- Otikunta AN, Hosad UK, Reddy YVS, Eruvaram S, Srinivas R, Garg R, et al. Analysis of 12 months clinical outcomes associated with implantation of ultrathin (60 mum) bare metal stent in an
- unselected real-world population with coronary artery disease. J Clin Diagn Res 2017; 11(5): OC12-OC16.
- Wijns W, Suttorp MJ, Zagozdzon L, Morice MC, McClean D, Stella P, et al. Evaluation of a crystalline sirolimus-eluting coronary stent with a bioabsorbable polymer designed for rapid dissolution: Two-year outcomes from the DESSOLVE I and II trials. EuroIntervention 2015; 11(5): 20150307-02.
- Raber L, Kelbak H, Taniwaki M, Ostojic M, Heg D, Baumbach A, et al. Biolimus-eluting stents with biodegradable polymer versus bare-metal stents in acute myocardial infarction: two-year clinical results of the COMFORTABLE AMI trial. Circ Cardiovasc Interv 2014; 7(3): 355-64.
- Natsuaki M, Kozuma K, Morimoto T, Shiomi H, Kimura T. Two-year outcome of a randomized trial comparing second-generation drug-eluting stents using biodegradable or durable polymer. JAMA 2014; 311(20): 2125-7.
- Kok MM, Zocca P, Buiten RA, Danse PW, Schotborgh CE, Scholte M, et al. Two-year clinical outcome of all-comers treated with three highly dissimilar contemporary coronary drug-eluting stents in the randomised BIO-RESORT trial. EuroIntervention 2018; 14(8): 915-23.
- Buiten RA, Ploumen EH, Zocca P, Doggen CJ, Jessurun GA, Schotborgh CE, et al. Thin composite-wire-strut zotarolimus-eluting stents versus ultrathin-strut sirolimus-eluting stents in BIONYX at 2 years. JACC Cardiovasc Interv 2020; 13(9): 1100-9.