Paclitaxel-eluting balloon versus plain balloon angioplasty for dysfunctional dialysis access: a prospective double-blinded randomized controlled trial. 6-month result shows promising outcome in DEB group

Abstract Description

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Authors (including presenting author) :

Pang SYC(1) Liu GYL(1) Au Yeung KCL(1) Tse ROH(1) Lai D(2) Leung WKW(2) Lo SHK(3) Mo KL (3) Hui EKL(4) Yien RLC(1) Tang CN(1)

Affiliation :

(1) Department of Surgery, Pamela Youde Nethersole Eastern Hospital (2) Department of Radiology, Pamela Youde Nethersole Eastern Hospital (3) Department of Medicine, Pamela Youde Nethersole Eastern Hospital (4) Department of Surgery, Ruttonjee Hospital

Introduction :

Dysfunctional renal vascular access is a significant problem amongst renal patients, often requiring insertion of temporary lines and angioplasty intervention in order for HD to be re-established. Current literature suggests that while effective in the short term, long term results of angioplasty with plain balloon are poor with significant restenosis rate. Growing evidence from overseas have suggested benefit in terms of higher patency rates in using paclitaxel-eluting balloon rather than plain balloon.

Objectives :

To compare the target lesion primary patency rate at 12 months between paclitaxel-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of the dysfunctional vascular access

Methodology :

This non-sponsored randomized trial enrolled 40 patients with dysfunctional dialysis access at single centre at Pamela Youde Nethersole Eastern Hospital. Patient with previous metallic stent, stent-graft placement in the access circuit, limited life expectancy or vascular access circuit place in lower extremities were excluded. Patients were randomized into In.Pact Admiral Paclitaxel eluting balloon or plain balloon after lesion crossing in regardless the type of lesion. High pressure balloon and bailout stenting are reserved as adjuncts to both arms. Patients will be followed-up clinically and under surveillance protocol in our vascular laboratory. Patients, staff at haemodialysis centre and sonographer are blinded to the treatment arms.

Result & Outcome :

40 patients (12 arteriovenous graft and 28 arteriovenous fistula) were included in this study. The mean length of target lesion in both group is similar, 45.8 +/- 38.4mm in BA and 50.2 +/- 33.54mm in DEB. 5 patients with AVG allocated in BA group and 7 patients with AVG allocated in DEB group. 100% and 97.5% technical and clinical success were achieved. The primary patency in 3 month in drug balloon group is 95% and 80% in plain balloon group (p=0.21). Patients in drug balloon group performed significantly better in term of primary patency in 6 month 85% versus 55% (p= 0.007).