SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

Suh Chien Pang, Ru Yu Tan, Edward Choke, Jackie Ho, Kiang Hiong Tay, Apoorva Gogna, Farah G Irani, Kun Da Zhuang, Luke Toh, Shaun Chan, Pradesh Krishnan, Kristen A Lee, Sum Leong, Richard Lo, Ankur Patel, Bien Soo Tan, Chow Wei Too, Jasmine Chua, Ren Kwang Alvin Tng, Tjun Yip Tang, Siew Ping Chng, Tze Tec Chong, Hsien Ts'ung Tay, Hao Yun Yap, Julian Wong, Rajesh Babu Dharmaraj, Jun Jie Ng, Anil Gopinathan, Eu Kuang Loh, Shao Jin Ong, Gary Yoong, Jia Sheng Tay, Kay Yuan Chong, Chieh Suai Tan, Suh Chien Pang, Ru Yu Tan, Edward Choke, Jackie Ho, Kiang Hiong Tay, Apoorva Gogna, Farah G Irani, Kun Da Zhuang, Luke Toh, Shaun Chan, Pradesh Krishnan, Kristen A Lee, Sum Leong, Richard Lo, Ankur Patel, Bien Soo Tan, Chow Wei Too, Jasmine Chua, Ren Kwang Alvin Tng, Tjun Yip Tang, Siew Ping Chng, Tze Tec Chong, Hsien Ts'ung Tay, Hao Yun Yap, Julian Wong, Rajesh Babu Dharmaraj, Jun Jie Ng, Anil Gopinathan, Eu Kuang Loh, Shao Jin Ong, Gary Yoong, Jia Sheng Tay, Kay Yuan Chong, Chieh Suai Tan

Abstract

Background: Percutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied.

Methods/design: This is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical.

Discussion: This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients.

Trial registration: ClinicalTrials.gov NCT04409912 . Registered on 1 June 2020.

Keywords: Dialysis access dysfunction; Drug-coated balloon; Hemodialysis; Sirolimus.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the study based on the Consolidated Standards for Reporting of Trials
Fig. 2
Fig. 2
Schedule of enrollment, interventions, and assessments according to the SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials.* The clinically driven fistulogram may be used in lieu of the 6-month follow-up ultrasound if it is performed within the window period of the scheduled 6-month ultrasound. The same rule applies to those patients who fall into the window period of the scheduled 12-month ultrasound

References

    1. Campos RP, Do Nascimento MM, Chula DC, Do Nascimento DE, Riella MC. Stenosis in hemodialysis arteriovenous fistula: evaluation and treatment. Hemodial Int. 2006;10(2):152–161. doi: 10.1111/j.1542-4758.2006.00087.x.
    1. Roy-Chaudhury P, Arend L, Zhang J, Krishnamoorthy M, Wang Y, Banerjee R, Samaha A, Munda R. Neointimal hyperplasia in early arteriovenous fistula failure. Am J Kidney Dis. 2007;50(5):782–790. doi: 10.1053/j.ajkd.2007.07.019.
    1. Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol. 2006;17(4):1112–1127. doi: 10.1681/ASN.2005050615.
    1. Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther. 2012;19(2):263–272. doi: 10.1583/11-3690.1.
    1. Kitrou PM, Spiliopoulos S, Katsanos K, Papachristou E, Siablis D, Karnabatidis D. Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial. J Vasc Interv Radiol. 2015;26(3):348–354. doi: 10.1016/j.jvir.2014.11.003.
    1. Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S, Holden A, IN.PACT AV Access Investigators Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med. 2020;383(8):733–742. doi: 10.1056/NEJMoa1914617.
    1. Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D, et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs sham in recurrent native dialysis fistula stenoses. J Vasc Access. 2019;20(3):260–269. doi: 10.1177/1129729818801556.
    1. Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF. Drug coated balloon angioplasty in failing AV fistulas: a randomized controlled trial. Clin J Am Soc Nephrol. 2018;13(8):1215–1224. doi: 10.2215/CJN.14231217.
    1. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc. 2018;7(24):e011245. doi: 10.1161/JAHA.118.011245.
    1. Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis. J Vasc Interv Radiol. 2019;30(4):483–94.e1. doi: 10.1016/j.jvir.2019.01.012.
    1. Haskal ZJ, Saad TF, Hoggard JG, Cooper RI, Lipkowitz GS, Gerges A, et al. Prospective, randomized, concurrently-controlled study of a stent graft versus balloon angioplasty for treatment of arteriovenous access graft stenosis: 2-year results of the RENOVA Study. J Vasc Interv Radiol. 2016;27(8):1105–14.e3. doi: 10.1016/j.jvir.2016.05.019.
    1. Haskal ZJ, Trerotola S, Dolmatch B, Schuman E, Altman S, Mietling S, Berman S, McLennan G, Trimmer C, Ross J, Vesely T. Stent graft versus balloon angioplasty for failing dialysis-access grafts. N Engl J Med. 2010;362(6):494–503. doi: 10.1056/NEJMoa0902045.
    1. Kouvelos GN, Spanos K, Antoniou GA, Vassilopoulos I, Karathanos C, Matsagkas MI, et al. Balloon angioplasty versus stenting for the treatment of failing arteriovenous grafts: a meta-analysis. Eur J Vasc Endovasc Surg. 2018;55(2):249–256. doi: 10.1016/j.ejvs.2017.11.011.
    1. Vesely T, DaVanzo W, Behrend T, Dwyer A, Aruny J. Balloon angioplasty versus Viabahn stent graft for treatment of failing or thrombosed prosthetic hemodialysis grafts. J Vasc Surg. 2016;64(5):1400–10.e1. doi: 10.1016/j.jvs.2016.04.035.
    1. Jim MH, Fung RC, Yiu KH. Angiographic result of sirolimus-eluting balloon in de novo small coronary artery lesion (ARSENAL) Int J Cardiol. 2016;222:992–994. doi: 10.1016/j.ijcard.2016.08.133.
    1. Verheye S, Vrolix M, Kumsars I, Erglis A, Sondore D, Agostoni P, Cornelis K, Janssens L, Maeng M, Slagboom T, Amoroso G, Jensen LO, Granada JF, Stella P. The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): angiographic results and 1-year clinical outcomes. JACC Cardiovascular interventions. 2017;10(20):2029–2037. doi: 10.1016/j.jcin.2017.06.021.
    1. Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, et al. KDOQI Clinical Practice Guideline for Vascular Access: 2019 update. Am J Kidney Dis. 2020;75(4 Suppl 2):S1–s164. doi: 10.1053/j.ajkd.2019.12.001.
    1. Gray RJ, Sacks D, Martin LG, Trerotola SO. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol. 2003;14(9 Pt 2):S433–S442. doi: 10.1097/01.RVI.0000094618.61428.58.
    1. Tan CW, Tan RY, Pang SC, Tng ARK, Tang TY, Zhuang KD, Chua JME, Tay KH, Chong TT, Tan CS. Single-center prospective pilot study of sirolimus drug-coated balloon angioplasty in maintaining the patency of thrombosed arteriovenous graft. J Vasc Interv Radiol. 2021;32(3):369–375. doi: 10.1016/j.jvir.2020.11.010.
    1. Tang TY, Soon SXY, Yap CJQ, Chan SL, Tan RY, Pang SC, Lee SQW, Yap HY, Choke ETC, Tan CS, Chong TT. Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial. PLoS One. 2020;15(10):e0241321. doi: 10.1371/journal.pone.0241321.
    1. Renaud CJ, Francois M, Nony A, Fodil-Cherif M, Turmel-Rodrigues L. Comparative outcomes of treated symptomatic versus non-treated asymptomatic high-grade central vein stenoses in the outflow of predominantly dialysis fistulas. Nephrol Dial Transplant. 2012;27(4):1631–1638. doi: 10.1093/ndt/gfr506.
    1. Irani FG, Teo TKB, Tay KH, Yin WH, Win HH, Gogna A, Patel A, Too CW, Chan SXJM, Lo RHG, Toh LHW, Chng SP, Choong HL, Tan BS. Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty. Radiology. 2018;289(1):238–247. doi: 10.1148/radiol.2018170806.
    1. Valente JF, Hricik D, Weigel K, Seaman D, Knauss T, Siegel CT, Bodziak K, Schulak JA. Comparison of sirolimus vs. mycophenolate mofetil on surgical complications and wound healing in adult kidney transplantation. American Journal of Transplantation. 2003;3(9):1128–1134. doi: 10.1034/j.1600-6143.2003.00185.x.
    1. Hofma SH, van der Giessen WJ, van Dalen BM, Lemos PA, McFadden EP, Sianos G, et al. Indication of long-term endothelial dysfunction after sirolimus-eluting stent implantation. European heart J. 2006;27(2):166–170. doi: 10.1093/eurheartj/ehi571.
    1. Zbinden R, Eshtehardi P, Cook S. Coronary aneurysm formation in a patient early after everolimus-eluting stent implantation. J Invasive Cardiol. 2008;20(5):E174–E175.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe