Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials

Abstract

Background: Restenosis remains a significant problem in endovascular therapy for hemodialysis vascular access. Drug-coated balloon (DCB) angioplasty decreases restenosis in peripheral and coronary artery diseases. The aim of this systematic review and meta-analysis is to assess the patency outcomes following DCB angioplasty, as compared to conventional balloon (CB) angioplasty for the stenosis of hemodialysis vascular access.

Methods: A comprehensive search in the MEDLINE, EMBASE, and CENTRAL databases was conducted in order to identify eligible randomized controlled trials evaluating DCB angioplasty for hemodialysis vascular access dysfunction. The primary endpoint was the 6-month target lesion primary patency and the secondary endpoints were 12-month target lesion primary patency and procedure-related complications. Risk ratios (RR) were pooled and relevant subgroups were analyzed separately.

Results: Eleven randomized controlled trials comprised of 487 patients treated with DCB angioplasty and 489 patients treated with CB angioplasty were included. There were no significant differences in the target lesion primary patency at 6 months [RR, 0.75; 95% confidence interval (CI), 0.56, 1.01; p = 0.06] and at 12 months (RR 0.89; 95% CI, 0.79, 1.00; p = 0.06). The absence of benefit for the DCB group remained, even in the arteriovenous fistula subgroup or the subgroup of studies excluding central vein stenosis. The risk of procedure-related complication did not differ between the two groups (RR 1.00; 95% CI 0.98, 1.02; p = 0.95).

Conclusion: DCB angioplasty did not demonstrate significant patency benefit for the treatment of hemodialysis vascular access dysfunction. Wide variations in patency outcomes across studies were noted. Further studies focusing on specific types of access or lesions are warranted to clarify the value of DCB for hemodialysis vascular access. (PROSPERO Number CRD42019119938).

Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1. Flow chart for the selection of studies.

Abbreviations: AVG, arteriovenous graft; AVF, arteriovenous fistula; PCB, paclitaxel-coated balloon; DEB, drug-eluting balloon; DCB, drug-coated balloon; RCT, randomized controlled study.

Fig 2

Risk of bias assessments for included studies A. Risk of bias graph B. Risk of bias summary.

Fig 3

Forest plot of (A) 6-month and (B) 12-month primary patency of target lesion in DCB arm and CB arm. Abbreviations: DCB, drug-coated balloon; CB, conventional balloon;

Fig 4

Forest plot of (A) 6-month and (B) 12-month target lesion primary patency of AVF only subgroup, non-central venous stenosis subgroup, and AVF and non-central venous stenosis subgroup. Abbreviations: DCB, drug-coated balloon; CB, conventional balloon; CVS, central venous stenosis and non-central venous stenosis and AVF only.

Fig 5

Forest plot of (A) 6-month and (B) 12-month primary patency of access circuit in the DCB arm and the CB arm. Abbreviations: DCB, drug-coated balloon; CB, conventional balloon.

Fig 6. Forest plot of complications in the DCB arm and CB arm.

Abbreviations: DCB, drug-coated balloon; CB, conventional balloon;

Fig 7. Funnel plot of publication bias.

A. 6-month primary patency B. 12-month primary patency.