Vol 26, No 5 (2019)
Original articles — Interventional cardiology
Published online: 2018-05-08

open access

Page views 4267
Article views/downloads 1753
Get Citation

Connect on Social Media

Connect on Social Media

Comparison of short-term clinical outcomes between Resolute Onyx zotarolimus-eluting stents and everolimus-eluting stent in patients with acute myocardial infarction: Results from the Korea Acute Myocardial infarction Registry (KAMIR)

Yongcheol Kim1, Sung Sik Oh1, Myung Ho Jeong1, Youngkeun Ahn1, Ju Han Kim1, Young Joon Hong1, Doo Sun Sim1, Min Chul Kim1, Hyo-Soo Kim2, Kyeong Ho Yun3, Seok Kyu Oh3, Chong Jin Kim4, Myeong Chan Cho5
Pubmed: 29745969
Cardiol J 2019;26(5):469-476.

Abstract

Background: There are few studies which compare the efficacy and safety of the Resolute Onyx zotarolimus-eluting stent (O-ZES) and everolimus-eluting stent (EES) in patients with acute myocardial infarction (AMI). Therefore, the present study aimed to compare clinical outcomes of O-ZES and EES in patients with AMI undergoing successful percutaneous coronary intervention (PCI). Methods: From January 2016 to December 2016, the Korea Acute Myocardial Infarction Registry (KAMIR) enrolled 3,364 consecutive patients. Among them, O-ZES was used in 402 patients and EES was used in 1,084 patients. The primary endpoint was target lesion failure (TLF), as defined by composite of cardiac death, target vessel myocardial infarction (TV-MI), and ischemic driven-target lesion revascularization (ID-TLR) at 6 month clinical follow-up. Results: At 6 months, the incidence of TLF was not significantly different between O-ZES and EES group (4.0% vs. 3.9%, adjusted hazard ratio [HR] 1.17, 95% confidential interval [CI] 0.58–2.35, p = 0.665). O-ZES also showed similar results of cardiac death (3.7% vs. 3.4%, adjusted HR 1.25, 95% CI 0.59–2.63, p = 0.560), TV-MI (0.2% vs. 0.6%, adjusted HR 0.56, 95% CI 0.07–4.85, p = 0.600), ID-TLR (0.0% vs. 0.3%, p = 0.524), and definite or probable stent thrombosis (0.2% vs. 0.3%, adjusted HR 0.63, 95% CI 0.06–6.41, p = 0.696) when compared with EES. Conclusions: The present study shows that implantation of O-ZES or EES provided similar clinical outcomes with similar risk at 6-month of TLF and definite/probable ST in patients with AMI undergoing successful PCI.

Article available in PDF format

View PDF Download PDF file

References

  1. Stefanini GG, Holmes DR. Drug-eluting coronary-artery stents. N Engl J Med. 2013; 368(3): 254–265.
  2. Wenaweser P, Daemen J, Zwahlen M, et al. Incidence and Correlates of Drug-Eluting Stent Thrombosis in Routine Clinical Practice. J Am Coll Cardiol. 2008; 52(14): 1134–1140.
  3. Windecker S, Meier B. Late coronary stent thrombosis. Circulation. 2007; 116(17): 1952–1965.
  4. Windecker S, Jüni P. Safety of drug-eluting stents. Nat Clin Pract Cardiovasc Med. 2008; 5(6): 316–328.
  5. Joner M, Finn A, Farb A, et al. Pathology of Drug-Eluting Stents in Humans. J Am Coll Cardiol. 2006; 48(1): 193–202.
  6. Stefanini GG, Taniwaki M, Windecker S. Coronary stents: novel developments. Heart. 2014; 100(13): 1051–1061.
  7. Sarno G, Lagerqvist Bo, Fröbert O, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of 'new-generation' drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J. 2012; 33(5): 606–613.
  8. Räber L, Magro M, Stefanini GG, et al. Very late coronary stent thrombosis of a newer-generation everolimus-eluting stent compared with early-generation drug-eluting stents: a prospective cohort study. Circulation. 2012; 125(9): 1110–1121.
  9. Kang SH, Park KW, Kang DY, et al. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014; 35(17): 1147–1158.
  10. Navarese EP, Tandjung K, Claessen B, et al. Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. BMJ. 2013; 347: f6530.
  11. Palmerini T, Biondi-Zoccai G, Della Riva D, et al. Clinical outcomes with bioabsorbable polymer- versus durable polymer-based drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2014; 63(4): 299–307.
  12. Kim JuH, Chae SC, Oh DJ, et al. Multicenter Cohort Study of Acute Myocardial Infarction in Korea - Interim Analysis of the Korea Acute Myocardial Infarction Registry-National Institutes of Health Registry. Circ J. 2016; 80(6): 1427–1436.
  13. Cutlip DE, Windecker S, Mehran R, et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115(17): 2344–2351.
  14. Stefanini GG, Serruys PW, Silber S, et al. The impact of patient and lesion complexity on clinical and angiographic outcomes after revascularization with zotarolimus- and everolimus-eluting stents: a substudy of the RESOLUTE All Comers Trial (a randomized comparison of a zotarolimus-eluting stent with an everolimus-eluting stent for percutaneous coronary intervention). J Am Coll Cardiol. 2011; 57(22): 2221–2232.
  15. Sen H, Lam MK, Tandjung K, et al. Complex patients treated with zotarolimus-eluting resolute and everolimus-eluting Xience V stents in the randomized TWENTE trial: comparison of 2-year clinical outcome. Catheter Cardiovasc Interv. 2015; 85(1): 74–81.
  16. Di Mario C, Serruys PW, Silber S, et al. Long-term outcomes after Resolute zotarolimus-eluting stent implantation in patients with ST-segment elevation acute myocardial infarction: insights from the RESOLUTE All Comers Trial and the RESOLUTE Global Clinical Trial Program. EuroIntervention. 2016; 12(10): 1207–1214.
  17. Yeh RW, Silber S, Chen L, et al. 5-Year safety and efficacy of resolute zotarolimus-eluting stent: the RESOLUTE global clinical trial program. JACC Cardiovasc Interv. 2017; 10(3): 247–254.
  18. Tam CC, Chan K, Lam S, et al. One-year clinical outcomes of patients implanted with a Resolute Onyx™ zotarolimus-eluting stent. J Int Med Res. 2018; 46(1): 457–463.
  19. Price MJ, Shlofmitz RA, Spriggs DJ, et al. Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: Primary outcome of the RESOLUTE ONYX core trial. Catheter Cardiovasc Interv. 2017 [Epub ahead of print].
  20. Price MJ, Saito S, Shlofmitz RA, et al. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv. 2017; 10(14): 1381–1388.
  21. Costa MA, Angiolillo DJ, Tannenbaum M, et al. STLLR Investigators. Impact of stent deployment procedural factors on long-term effectiveness and safety of sirolimus-eluting stents (final results of the multicenter prospective STLLR trial). Am J Cardiol. 2008; 101(12): 1704–1711.