Helical stent (SUPERA™) and drug-coated balloon (Passeo–18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA

Abstract

Background:

The treatment options for cephalic arch stenosis are limited and standard of care remains at crossroads – none are ideal and there is currently no gold standard. Endovascular techniques are now the preferred primary therapeutic option because they are minimally invasive and better tolerated by haemodialysis patients who have multiple comorbidities. However, conventional plain old balloon angioplasty, bare metal stenting and stent grafts all have their limitations. The aim of this trial is to evaluate whether the helical SUPERA™ stent (Abbott Vascular, Santa Clara, CA, USA), which has a higher degree of flexibility and resistance to compressive forces compared to traditionally laser-cut nitinol stents, combined with a drug-coated balloon (Biotronik Passeo-18 Lux™) to minimize the neointimal hyperplasia effect, can improve patency and reduce reintervention rates.

Methods and results:

Arch V SUPERA-LUX is a pilot investigator-initiated single-centre, single-arm prospective study. Twenty patients with a brachiocephalic fistula within 6 months of initial plain old balloon angioplasty for significant cephalic arch stenosis will be recruited for treatment with SUPERA and drug-coated balloon. The primary objectives are immediate angiographic and procedural success, primary patency and functional fistula at 1 week, 8 weeks, 6 and 12 months. The results from eight patients treated prospectively as proof of concept have shown primary patency of 83.3% at 1 year with 100% technical and procedural success rates. Enrolment for the Arch V SUPERA-LUX study is expected to be completed at the end of 2019.

Conclusion:

The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique.

Trial registration:

This study is registered on ClinicalTrials.gov NCT03891693.

Keywords

Stenting primary patency drug eluting balloon fistuloplasty cephalic arch SUPERA

Get full access to this article

View all access options for this article.

References

Vascular Access Work G. Clinical practice guidelines for vascular access. Am J Kidney Dis 2006; 48(Suppl. 1): S248–S273.

Mousa

Dearing

Aburahma

AF.

Radiocephalic fistula: review and update. Ann Vasc Surg 2013; 27(3): 370–378.

Bennett

Hammes

Blicharski

, et al. Characterization of the cephalic arch and location of stenosis. J Vasc Access 2015; 16(1): 13–18.

Sivananthan

Menashe

Halin

NJ.

Cephalic arch stenosis in dialysis patients: review of clinical relevance, anatomy, current theories on etiology and management. J Vasc Access 2014; 15(3): 157–162.

Daoui

Asif

Cephalic arch stenosis: mechanisms and management strategies. Semin Nephrol 2012; 32(6): 538–544.

Rajan

Clark

Patel

, et al. Prevalence and treatment of cephalic arch stenosis in dysfunctional autogenous hemodialysis fistulas. J Vasc Interv Radiol 2003; 14(5): 567–573.

Davies

Hicks

Haidar

, et al. Outcomes of intervention for cephalic arch stenosis in brachiocephalic arteriovenous fistulas. J Vasc Surg 2017; 66(5): 1504–1510.

Garcia

Rosenfield

Metzger

, et al. SUPERB final 3-year outcomes using interwoven nitinol biomimetic supera stent. Catheter Cardiovasc Interv 2017; 89(7): 1259–1267.

SanNorberto

Fuente

Flota

, et al. Impact of implantation defects on intermediate outcome of supera stent for popliteal artery stenosis. Ann Vasc Surg 2017; 41: 186–195.

10.

Brodmann

Zeller

Christensen

, et al. Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment. J Vasc Bras 2017; 16(4): 276–284.

11.

Shemesh

Goldin

Zaghal

, et al. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg 2008; 48: 1524–1531, 1531.e1–1531.e2.

12.

Miller

Preddie

Savransky

, et al. Use of the Viabahn stent graft for the treatment of recurrent cephalic arch stenosis in hemodialysis accesses. J Vasc Surg 2018; 67(2): 522–528.

13.

Rajan

Falk

A randomized prospective study comparing outcomes of angioplasty versus VIABAHN stent-graft placement for cephalic arch stenosis in dysfunctional hemodialysis accesses. J Vasc Interv Radiol 2015; 26(9): 1355–1361.

14.

D’Cruz

Leong

Syn

, et al. Endovascular treatment of cephalic arch stenosis in brachiocephalic arteriovenous fistulas: a systematic review and meta-analysis. J Vasc Access 2019; 20: 345–355.

15.

de Boer

van den Heuvel

DAF

de Vries-Werson

DAB

, et al. Short-term results of the RAPID randomized trial of the Legflow paclitaxel-eluting balloon with supera stenting vs supera stenting alone for the treatment of intermediate and long superficial femoral artery lesions. J Endovasc Ther 2017; 24(6): 783–792.

16.

Yan Wee

Yap

Hsien Ts’ung

, et al. A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis. J Vasc Surg 2019; 70(3): 970–979.e3.

Helical stent (SUPERA™) and drug-coated balloon (Passeo–18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA–LUX Study