Mortality After Paclitaxel-Coated Device Use in Dialysis Access: A Systematic Review and Meta-Analysis

Abstract

Purpose: To report the risk of all-cause mortality in patients who underwent dialysis access treatment using paclitaxel-coated devices compared with percutaneous transluminal angioplasty (PTA) with an uncoated balloon. Materials and Methods: A systematic review and meta-analysis of randomized controlled trials were performed to investigate the mortality outcomes associated with paclitaxel-coated devices in the treatment of patients with a failing dialysis access (last search date February 28, 2019). The primary endpoint was all-cause mortality. This analysis included 8 studies comparing paclitaxel-coated balloon (PCB) angioplasty (n=327) and PTA (n=331) in the treatment of failing dialysis access. None investigated paclitaxel-coated stents. Mortality data were pooled using a random effects model. Statistical heterogeneity was evaluated with a chi-square test and the I2 statistic. Summary statistics are expressed as relative risk ratios (RR) with a 95% confidence interval (CI). Results: At the pooled mean follow-up of 13.5 months (median 12, range 6–24) all-cause mortality was similar in the PCB group (13.8%) compared with PTA (11.2%; RR 1.26, 95% CI 0.85 to 1.89, p=0.25; I2=0%). Subgroup analysis, stratified according to length of follow-up, confirmed that there were no statistically significant differences in mortality at short- and midterm follow-up [6-month (8 studies): 5.2% vs 4.8%, RR 1.24, 95% CI 0.62 to 2.47, p=0.55; 12-month (6 studies): 6.3% vs 6.0%, RR 1.06, 95% CI 0.43 to 2.63, p=0.90; and 24-month (3 studies): 19.0% vs 13.5%, RR 1.38, 95% CI 0.90 to 2.12, p=0.14). Conclusion: The analysis found no difference in short- to midterm mortality among patients treated with a drug-coated balloon compared with PTA. With proven benefit and no evidence of harm, the authors recommend ongoing use of PCB for the failing dialysis access.

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

“…Patients who suffer from ESRD have a high risk of death and also a high chance of repeated interventions. Regarding DCB angioplasty of hemodialysis vascular access, a recent meta-analysis showed that there was no increase in mortality rate for up to 2 years [26]. Further studies are needed to investigate the long-term safety within this high-risk population.…”

Use of Paclitaxel Eluting Stents in Arteriovenous Fistulas: A Pilot Study

“…With primary and assisted primary access circuit patencies of 44% and 78%, our results are comparable to those obtained following the use of other methods of endovascular salvage. Finally, a recent study conducted by Dinh et al [26] showed no increased risk for all-cause mortality in patients treated with DEB angioplasty compared to those treated with PTA for dialysis access dysfunction during short-term and mid-term follow up.…”

Paclitaxel-Coated Balloon versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous Fistulas: A Prospective Randomized Controlled Trial

“…A recent review drew attention to a possible increase in late mortality in patients undergoing DBA for peripheral arterial disease ( 37 ). However, the first meta-analysis investigating mortality following DCB use in the treatment of dysfunctional dialysis access circuits found no increased risk of all-cause mortality following DBA as compared to PBA at short- and mid-term follow-up ( 38 ).…”