Korean Circ J.  2019 Aug;49(8):709-720. 10.4070/kcj.2019.0018.

Effectiveness and Safety of Zotarolimus-Eluting Stent (Resoluteâ„¢ Integrity) in Patients with Diffuse Long Coronary Artery Disease

Affiliations
  • 1Division of Cardiology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Korea.
  • 2Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea. cecilyk@hanmail.net
  • 3Division of Cardiology, Department of Internal Medicine, Gyeongsang National University Hospital, Jinju, Korea.
  • 4Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Hospital Gumi, Gumi, Korea.
  • 5Division of Cardiology, Presbyterian Medical Center, Jeonju, Korea.
  • 6Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Korea.
  • 7Division of Cardiology, Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea.
  • 8Division of Cardiology, Department of Internal Medicine, Dong-A University Hospital, Busan, Korea.
  • 9Division of Cardiology, Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.
  • 10Division of Cardiology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea.
  • 11Division of Cardiology, Daegu Fatima Hospital, Daegu, Korea.
  • 12Division of Cardiology, Kwangju Christian Hospital, Gwangju, Korea.
  • 13Division of Cardiology, Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea.
  • 14Division of Cardiology, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
  • 15Division of Cardiology, St. Carollo Hospital, Suncheon, Korea.
  • 16Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.
  • 17Division of Cardiology, Department of Internal Medicine, Chonbuk National University Hospital, Jeonju, Korea.
  • 18Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea.
  • 19Division of Cardiology, Gwangju Veterans Hospital, Gwangju, Korea.
  • 20Division of Cardiology, Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
  • 21Division of Cardiology, Department of Internal Medicine, Inje University Haeundae Paik Hospital, Busan, Korea.

Abstract

BACKGROUND AND OBJECTIVES
Diffuse long coronary artery disease (DLCAD) still has unfavorable clinical outcomes after successful percutaneous coronary intervention (PCI). Therefore, we aimed to evaluate the effectiveness and safety of Resoluteâ„¢ zotarolimus-eluting stent (R-ZES; Resoluteâ„¢ Integrity) for patients with DLCAD.
METHODS
From December 2011 to December 2014, 1,011 patients who underwent PCI using R-ZES for CAD with longer than 25 mm lesion were prospectively enrolled from 21 hospitals in Korea. We assessed the clinical outcome of major adverse cardiac events (MACE) defined as the composite of cardiac death, non-fatal myocardial infarction (MI), and clinically-driven target vessel revascularization at 12 months.
RESULTS
Mean age was 63.8±10.8 years, 701 (69.3%) patients were male, 572 (87.0%) patients had hypertension, 339 (33.8%) patients had diabetes, 549 (54.3%) patients diagnosed with acute MI and 545 (53.9%) patients had multi-vessel disease (MVD). A total of 1,697 stents were implanted into a total of 1,472 lesions. The mean diameter was 3.07±0.38 mm and the length was 28.27±6.97 mm. Multiple overlapping stents were performed in 205 (13.8%) lesions. A 12-month clinical follow-up was available in 1,004 patients (99.3%). The incidences of MACE and definite stent thrombosis at 12-month were 3.0% and 0.3% respectively. On multivariate Cox-regression analysis, multiple overlapping stents implantation, previous congestive heart failure, MVD, and age ≥75 years were independent predictors of one-year MACE.
CONCLUSIONS
Our study shows that R-ZES has an excellent 1-year clinical outcome in Korean patients with DLCAD.

Keyword

Drug-eluting stents; Coronary artery disease; Treatment outcome

MeSH Terms

Coronary Artery Disease*
Coronary Vessels*
Death
Drug-Eluting Stents
Follow-Up Studies
Heart Failure
Humans
Hypertension
Incidence
Korea
Male
Myocardial Infarction
Percutaneous Coronary Intervention
Prospective Studies
Stents*
Thrombosis
Treatment Outcome

Figure

  • Figure 1 Kaplan-Meier survival curves for MACE among subgroups. Cumulative incidences of MACE according to (A) sex, (B) the presence of DM, (C) presentation with AMI, (D) performance of post-dilatation, (E) use of IVUS, and (F) the presence of multiple overlapping stents implantation. AMI = acute myocardial infarction; DM = diabetes mellitus; IVUS = intravascular ultrasound MACE = major adverse cardiac events.


Cited by  1 articles

Diffuse Long Coronary Artery Disease is Still an Obstacle for Percutaneous Coronary Intervention in the Second-Generation Drug-Eluting Stent Era?
Pyung Chun Oh, Seung Hwan Han
Korean Circ J. 2019;49(8):721-723.    doi: 10.4070/kcj.2019.0150.


Reference

1. Kastrati A, Schömig A, Elezi S, et al. Predictive factors of restenosis after coronary stent placement. J Am Coll Cardiol. 1997; 30:1428–1436.
Article
2. Kobayashi Y, De Gregorio J, Kobayashi N, et al. Stented segment length as an independent predictor of restenosis. J Am Coll Cardiol. 1999; 34:651–659.
Article
3. Claessen BE, Smits PC, Kereiakes DJ, et al. Impact of lesion length and vessel size on clinical outcomes after percutaneous coronary intervention with everolimus- versus paclitaxel-eluting stents pooled analysis from the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. JACC Cardiovasc Interv. 2011; 4:1209–1215.
4. Banerjee S. The resolute™ integrity zotarolimus-eluting stent in coronary artery disease: a review. Cardiol Ther. 2013; 2:17–25.
Article
5. Yeung AC, Leon MB, Jain A, et al. Clinical evaluation of the Resolute zotarolimus-eluting coronary stent system in the treatment of de novo lesions in native coronary arteries: the RESOLUTE US clinical trial. J Am Coll Cardiol. 2011; 57:1778–1783.
6. Qiao S, Chen L, Chen S, Wang W, Zhu G. One-year outcomes from an all-comers chinese population of patients implanted with the resolute zotarolimus-eluting stent. Am J Cardiol. 2014; 113:613–620.
Article
7. Richardt G, Leschke M, Abdel-Wahab M, et al. Clinical outcomes of the Resolute zotarolimus-eluting stent in patients with in-stent restenosis: 2-year results from a pooled analysis. JACC Cardiovasc Interv. 2013; 6:905–913.
8. 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; 10:247–254.
9. Park KW, Lee JM, Kang SH, et al. Safety and efficacy of second-generation everolimus-eluting Xience V stents versus zotarolimus-eluting resolute stents in real-world practice: patient-related and stent-related outcomes from the multicenter prospective EXCELLENT and RESOLUTE-Korea registries. J Am Coll Cardiol. 2013; 61:536–544.
10. Taniwaki M, Stefanini GG, Silber S, et al. 4-year clinical outcomes and predictors of repeat revascularization in patients treated with new-generation drug-eluting stents: a report from 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. 2014; 63:1617–1625.
11. Raungaard B, Christiansen EH, Bøtker HE, et al. Comparison of durable-polymer zotarolimus-eluting and biodegradable-polymer biolimus-eluting coronary stents in patients with coronary artery disease: 3-year clinical outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017; 10:255–264.
12. von Birgelen C, Kok MM, van der Heijden LC, 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; 388:2607–2617.
Article
13. Kastrati A, Elezi S, Dirschinger J, Hadamitzky M, Neumann FJ, Schömig A. Influence of lesion length on restenosis after coronary stent placement. Am J Cardiol. 1999; 83:1617–1622.
Article
14. Choi IJ, Koh YS, Lim S, et al. Impact of the stent length on long-term clinical outcomes following newer-generation drug-eluting stent implantation. Am J Cardiol. 2014; 113:457–464.
Article
15. Lee M, Hiremath S, Zambahari R, et al. One-year outcomes of percutaneous coronary intervention with the 38-mm Resolute zotarolimus-eluting stent. Am J Cardiol. 2013; 112:1335–1341.
Article
16. Bahuleyan CG, Krishna Kumar VV, Babu S. Prospective study to evaluate safety and efficacy of Zotarolimus Eluting Stent (PSEZES) in patients with long coronary artery lesions. Indian Heart J. 2015; 67:233–238.
Article
17. Ahn JM, Park DW, Kim YH, et al. Comparison of resolute zotarolimus-eluting stents and sirolimus-eluting stents in patients with de novo long coronary artery lesions: a randomized LONG-DES IV trial. Circ Cardiovasc Interv. 2012; 5:633–640.
18. Im E, Kim BK, Ko YG, et al. Comparison of 3-year clinical outcomes between Resolute™ zotarolimus- and sirolimus-eluting stents for long coronary artery stenosis. J Interv Cardiol. 2013; 26:378–383.
Article
19. Patra S, Chakraborty RN, Pande A, et al. Zotarolimus-eluting Resolute Integrity versus everolimus-eluting Xience Xpedition stents in the management of very long (>30mm) de novo coronary artery stenosis. Cardiovasc Revasc Med. 2017; 18:160–164.
20. Kereiakes DJ, Wang H, Popma JJ, et al. Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials. J Am Coll Cardiol. 2006; 48:21–31.
21. Dawkins KD, Grube E, Guagliumi G, et al. Safety and efficacy of multiple, overlapping polymer-based paclitaxel-eluting stents. EuroIntervention. 2007; 3:213–221.
Article
22. Räber L, Jüni P, Löffel L, et al. Impact of stent overlap on angiographic and long-term clinical outcome in patients undergoing drug-eluting stent implantation. J Am Coll Cardiol. 2010; 55:1178–1188.
Article
23. Park KH, Jeong MH, Kim JM, et al. The impact of triple anti-platelet therapy for endothelialization and inflammatory response at overlapping bioabsorbable polymer coated drug-eluting stents in a porcine coronary model. Int J Cardiol. 2013; 168:1853–1858.
Article
24. Kitabata H, Loh JP, Pendyala LK, et al. Safety and efficacy outcomes of overlapping second-generation everolimus-eluting stents versus first-generation drug-eluting stents. Am J Cardiol. 2013; 112:1093–1098.
Article
25. Durante A, Foglia Manzillo G, Burzotta F, et al. Long term follow-up of “full metal jacket” of de novo coronary lesions with new generation zotarolimus-eluting stents. Int J Cardiol. 2016; 221:1008–1012.
Article
Full Text Links
  • KCJ
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr