Korean Circ J.  2021 May;51(5):441-451. 10.4070/kcj.2020.0420.

Korean Multicenter Registry Study of EPIC Stents for the Treatment of Iliac Artery Disease: K-EPIC Registry

• Kim DY
• Ko YG
• Lee SJ
• Ahn CM
• Rha SW
• Choi CU
• Park JK
• Yoon CH
• Choi SH
• Min PK
• Bae JW
• Han JK
• Park SH
• Choi D

• KMID: 2515769
• DOI: http://doi.org/10.4070/kcj.2020.0420

Abstract

Background and Objectives
The EPIC™ stent is a self-expanding, nitinol stent that has been designed to enhance flexibility and provide expansion within vessels. The aim of the present study was to investigate the clinical efficacy and safety of the EPIC™ stent when used to treat iliac artery diseases in a prospective Korean multicenter registry.
Methods
A total of 138 patients with iliac artery diseases who received endovascular treatment with EPIC™ stents at 9 Korean sites were enrolled in a prospective cohort and followed for 1 year. The primary endpoint was the 1-year freedom from target lesion revascularization (TLR). The secondary endpoints were 1-year clinical patency and freedom from major adverse events (MAEs).
Results
The mean age of the study subjects was 66.8±8.5 years and most subjects were male (86.2%). The most frequent lesion type was Trans-Atlantic Inter-Society Consensus B (43.5%) and the majority (56.5%) of the target lesions were located in the common iliac artery. Procedural success was obtained in 99.3% of patients. The freedom from TLR and the clinical patency at 1-year follow-up were 94.9% and 92.3%, respectively. The 1-year rate of MAEs was 5.1%. Combined coronary artery disease (hazard ratio [HR], 5.91; 95% confidence interval [CI], 1.13–30.89; p=0.035) and smaller stent diameter (HR, 0.38; 95% CI, 0.17–0.88; p=0.023) were identified as independent risk factors of TLR after EPIC™ stent implantation.
Conclusions
The EPIC™ stents demonstrated excellent immediate and 1-year efficacy and safety outcomes in iliac artery lesions in this multicenter, prospective, registry-based study.

Keyword

Iliac artery; Nitinol; Self expandable metallic stent; Vascular patency; Peripheral artery disease

Figure

• 

  Figure 1 Patient flowchart.

• 

  Figure 2 Kaplan-Meier curves for clinical outcomes of all patients.MAE = major adverse event; PTA = percutaneous transluminal angioplasty; TLR = target lesion revascularization.

• 

  Figure 3 Kaplan-Meier curves for clinical outcomes in patients with TASC A/B and C/D.PTA = percutaneous transluminal angioplasty; TASC = Trans-Atlantic Inter-Society Consensus; TLR = target lesion revascularization.

• 

  Figure 4 Rutherford class at baseline as well as post-procedure, 6 months, and 12 months after endovascular treatment for aortoiliac occlusive diseases.

Reference

1. Norgren L, Hiatt WR, Dormandy JA, et al. Inter-society consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007; 45(Suppl S):S5–67. PMID: 17223489.

2. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on clinical practice guidelines. J Am Coll Cardiol. 2017; 69:e71–126. PMID: 27851992.

3. Aboyans V, Ricco JB, Bartelink ME, et al. 2017 ESC guidelines on the diagnosis and treatment of peripheral arterial diseases, in collaboration with the European Society for Vascular Surgery (ESVS): Document covering atherosclerotic disease of extracranial carotid and vertebral, mesenteric, renal, upper and lower extremity arteries. Endorsed by: the European Stroke Organization (ESO). The Task Force for the Diagnosis and Treatment of Peripheral Arterial Diseases of the European Society of Cardiology (ESC) and of the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018; 39:763–816. PMID: 28886620.

4. Ko YG, Ahn CM, Min PK, et al. Baseline characteristics of a retrospective patient cohort in the Korean vascular intervention society endovascular therapy in lower limb artery diseases (K-VIS ELLA) registry. Korean Circ J. 2017; 47:469–476. PMID: 28765738.

5. Ye W, Liu CW, Ricco JB, Mani K, Zeng R, Jiang J. Early and late outcomes of percutaneous treatment of TransAtlantic Inter-Society Consensus class C and D aorto-iliac lesions. J Vasc Surg. 2011; 53:1728–1737. PMID: 21609804.

6. Kim TI, Schneider PA. Bare metal stenting of the iliac arteries. J Cardiovasc Surg (Torino). 2016; 57:325–335.

7. Higashiura W, Kichikawa K, Kubota Y, et al. Does stent affect the configuration of the iliac artery in flexion of the hip joint? Jpn J Endovasc Interv. 2004; 5:22–24.

8. Tsujimura T, Iida O, Fujita M, et al. Two-year clinical outcomes post implantation of Epic^TM self-expanding nitinol stents for the aortoiliac occlusive disease in patients with peripheral arterial disease. J Atheroscler Thromb. 2018; 25:344–349. PMID: 28978866.

9. Lee JH, Cho KI, Spertus J, Kim SM. Cross-cultural adaptation and validation of the Peripheral Artery Questionnaire: Korean version for patients with peripheral vascular diseases. Vasc Med. 2012; 17:215–222. PMID: 22653880.

10. Ponec D, Jaff MR, Swischuk J, et al. The Nitinol SMART stent vs Wallstent for suboptimal iliac artery angioplasty: CRISP-US trial results. J Vasc Interv Radiol. 2004; 15:911–918. PMID: 15361558.

11. Stoeckel D, Pelton A, Duerig T. Self-expanding nitinol stents: material and design considerations. Eur Radiol. 2004; 14:292–301. PMID: 12955452.

12. Burket MW, Brodmann M, Metzger C, Tan K, Jaff MR. Twelve-month results of the nitinol astron stent in iliac artery lesions. J Vasc Interv Radiol. 2016; 27:1650–1656.e1. PMID: 27542591.

13. Clair DG, Adams J, Reen B, et al. The EPIC nitinol stent system in the treatment of iliac artery lesions: one-year results from the ORION clinical trial. J Endovasc Ther. 2014; 21:213–222. PMID: 24754280.

14. Krankenberg H, Zeller T, Ingwersen M, et al. Self-expanding versus balloon-expandable stents for iliac artery occlusive disease: the randomized ICE trial. JACC Cardiovasc Interv. 2017; 10:1694–1704. PMID: 28838480.

15. de Donato G, Bosiers M, Setacci F, et al. 24-month data from the BRAVISSIMO: A large-scale prospective registry on iliac stenting for TASC A & B and TASC C & D lesions. Ann Vasc Surg. 2015; 29:738–750. PMID: 25733220.

16. Bechter-Hugl B, Falkensammer J, Gorny O, Greiner A, Chemelli A, Fraedrich G. The influence of gender on patency rates after iliac artery stenting. J Vasc Surg. 2014; 59:1588–1596. PMID: 24548520.

17. van Kuijk JP, Flu WJ, Welten GM, et al. Long-term prognosis of patients with peripheral arterial disease with or without polyvascular atherosclerotic disease. Eur Heart J. 2010; 31:992–999. PMID: 20037181.

18. Gutierrez JA, Mulder H, Jones WS, et al. Polyvascular disease and risk of major adverse cardiovascular events in peripheral artery disease: a secondary analysis of the EUCLID trial. JAMA Netw Open. 2018; 1:e185239. PMID: 30646395.