Necla ÖZER, Hikmet YORGUN, Kudret AYDEMİR, Mehmet Levent ŞAHİNER, Ugur Nadir KARAKULAK, Ergün Barış KAYA, Ali OTO

Evaluation of Effectiveness and Safety of Everolimus Eluting Stent System (XIENCE V) in the Treatment of Coronary Artery Lesions

Objective: Drug eluting stents have become an important component in percutaneous treatment of patients with symptomatic coro nary artery disease. The population in the previous drug eluting stent studies has very risk profile, and therefore not reflects real-world information. Moreover, there are limited data to evaluate risk factors and predictors of intended outcomes. In this study, everolimus eluting stent (XIENCE V) implantations and follow-up results in patients with coronary artery disease were evaluated. Methods: A total of 833 patients who underwent everolimus eluting stent deployment for coronary artery lesions were enrolled. Base line demographic, clinic and angiographic data, procedure-related complications, and outcomes during follow-up were studied. Results: As primary endpoints, all-cause mortality was 1.3% and target lesion failure was 2.3%. As secondary outcomes, cardiac death, target lesion revascularization, target vessel revascularization, myocardial infarction, and stent thrombosis were seen 0.84, 0.8%, 2.2%, 0.6%, and 0.24%, respectively. Premature discontinuation of dual antiplatelet therapy and presentation with acute coronary syndrome were strong predictors for all-cause and cardiac mortality. Conclusion: Despite heterogeneity and high-risk profile of our patients, procedural-related complications and primary and secondary outcomes were very low with high clinical device and procedure success. These results demonstrate effectiveness and safety of the XIENCE V everolimus eluting stent in a highly complex, real-world patient population.

PDF

___

1. Bonaa KH, Mannsverk J, Wiseth R, et al. Drug-eluting or bare-metal stents for coronary artery disease. N Engl J Med. 2016;375:1242- 1252. [CrossRef]
2. Garg S, Serruys PW. Drug-eluting stents: A reappraisal. Heart. 2010;96:489-493. [CrossRef]
3. Krucoff MW, Rutledge DR, Gruberg L, et al. A new era of prospective real-world safety evaluation primary report of XIENCE V USA (XIENCE V Everolimus Eluting Coronary Stent System condition-ofapproval post-market study). JACC Cardiovasc Interv. 2011;4:1298- 1309. [CrossRef]
4. Kedhi E, Joesoef KS, McFadden E, et al. Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice (COMPARE): A randomised trial. Lancet. 2010;375:201-209. [CrossRef]
5. Kalra A, Rehman H, Khera S, et al. New-generation coronary stents: Current data and future directions. Curr Atheroscler Rep. 2017;19:14. [CrossRef]
6. Levine GN, Bates ER, Bittl JA, 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: An update of the 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention, 2011 ACCF/AHA guideline for coronary artery bypass graft surgery, 2012 ACC/AHA/ACP/ AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease, 2013 ACCF/ AHA guideline for the management of ST-elevation myocardial infarction, 2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes, and 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery. Circulation. 2016;134:123-155. [CrossRef]
7. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: A case for standardized definitions. Circulation. 2007;115:2344-351. [CrossRef]
8. Onuma Y, Miquel-Hebert K, Serruys PW, SPIRIT II Investigators. Five-year long-term clinical follow-up of the XIENCE V everolimuseluting coronary stent system in the treatment of patients with de novo coronary artery disease: The SPIRIT II trial. EuroIntervention. 2013;8:1047-1051. [CrossRef]
9. Stone GW, Midei M, Newman W, et al. Comparison of an everolimus-eluting stent and a paclitaxel-eluting stent in patients with coronary artery disease: A randomized trial. JAMA. 2008;299:1903-1913. [CrossRef]
10. Gada H, Kirtane AJ, Newman W, et al. 5-Year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxeleluting stents: Final results from the SPIRIT III trial (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;6:1263-1266. [CrossRef]
11. Stone GW, Rizvi A, Sudhir K, et al. Randomized comparison of everolimus- and paclitaxel-eluting stents. 2-Year follow-up from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) IV trial. J Am Coll Cardiol. 2011;58:19-25. [CrossRef]
12. Ribichini F, Romano M, Rosiello R, et al. A clinical and angiographic study of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with multivessel coronary artery disease: The EXECUTIVE trial (EXecutive RCT: evaluating XIENCE V in a multi vessel disease). JACC Cardiovasc Interv. 2013;6:1012-1022. [CrossRef]
13. Valgimigli M, Cao D, Makkar RR, et al. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021;231:147-156. [CrossRef]
14. Lee MS, Shlofmitz R, Mahmud E, et al. Four-year outcomes of multivessel percutaneous coronary intervention with Xience V Everolimus-Eluting Stents. J Invasive Cardiol. 2019;31:240-246.
15. Spitaleri G, Brugaletta S, Scalone G, et al. Role of ST-segment resolution in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (from the 5-year outcomes of the EXAMINATION [Evaluation of the Xience-V Stent in Acute Myocardial Infarction] Trial). Am J Cardiol. 2018;121:1039-1045. [CrossRef]
16. Hermiller JB, Rutledge DR, Gruberg L, et al. Sustained low clinical event rates in real-world patients receiving everolimus-eluting coronary stent system from a large, prospective, condition of approval study: 2-Year clinical outcomes from the XIENCE V USA Study. J Interv Cardiol. 2012;25:565-575. [CrossRef]
17. Latib A, Ferri L, Ielasi A, et al. Clinical outcomes after unrestricted implantation of everolimus-eluting stents. JACC Cardiovasc Interv. 2009;2:1219-1226. [CrossRef]
18. Grube E, Chevalier B, Smits P, et al. The SPIRIT V study: A clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions. JACC Cardiovasc Interv. 2011;4:168-175. [CrossRef]
19. Naidu SS, Krucoff MW, Rutledge DR, et al. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation: Results from the 8,061-patient XIENCE V United States study. JACC Cardiovasc Interv. 2012;5:626-635. [CrossRef]
20. Silber S, Windecker S, Vranckx P, Serruys PW, RESOLUTE All Comers investigators. Unrestricted randomised use of two new generation drug-eluting coronary stents: 2-Year patient-related versus stentrelated outcomes from the RESOLUTE All Comers trial. Lancet. 2011;377:1241-1247. [CrossRef]
21. Onuma Y, Kukreja N, Piazza N, et al. The everolimus-eluting stent in real-world patients: 6-Month follow-up of the X-SEARCH (Xience V Stent Evaluated at Rotterdam Cardiac Hospital) registry. J Am Coll Cardiol. 2009;54:269-276. [CrossRef]
22. Altun B, Arici M, Nergizoglu G, et al. Prevalence, awareness, treatment and control of hypertension in Turkey (the PatenT study) in 2003. J Hypertens. 2005;23:1817-1823. [CrossRef]
23. Altun B, Suleymanlar G, Utas C, et al. Prevalence, awareness, treatment and control of hypertension in adults with chronic kidney disease in Turkey: Results from the CREDIT study. Kidney Blood Press Res. 2012;36:36-46. [CrossRef]
24. Song JW, Soh S, Shim JK. Dual antiplatelet therapy and noncardiac surgery: Evolving issues and anesthetic implications. Korean J Anesthesiol. 2017;70:13-21. [CrossRef]
25. Eisenberg MJ, Richard PR, Libersan D, Filion KB. Safety of shortterm discontinuation of antiplatelet therapy in patients with drugeluting stents. Circulation. 2009;119:1634-1642. [CrossRef]
26. Watanabe CT, Maynard C, Ritchie JL. Comparison of short-term outcomes following coronary artery stenting in men versus women. Am J Cardiol. 2001;88:848-852. [CrossRef]
27. Lansky AJ, Ng VG, Mutlu H, et al. Gender-based evaluation of the XIENCE V everolimus-eluting coronary stent system: Clinical and angiographic results from the SPIRIT III randomized trial. Catheter Cardiovasc Interv. 2009;74:719-727. [CrossRef]
28. Arnold AM, Mick MJ, Piedmonte MR, Simpfendorfer C. Gender differences for coronary angioplasty. Am J Cardiol. 1994;74:18-21. [CrossRef]