A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access

Objective The comparison between paclitaxel-coated balloon (PCB) angioplasty and plain balloon angioplasty (PBA) for hemodialysis (HD) access stenosis or occlusion has not been well investigated. The objectives of this systematic review and meta-analysis were to compare all-cause mortality, HD access primary patency, and circuit primary patency after endovascular maintenance procedures using PCB angioplasty vs PBA. Methods MEDLINE, Embase, and Cochrane Databases were systematically searched to identify all the relevant studies on paclitaxel-coated devices for stenosis or thrombosis of HD access. A random effects model was applied to pool the effect measures. Dichotomous data were presented using an odds ratio (OR). Effect data were presented using pooled hazard ratio (HR) with 95% confidence interval (CI). Results A total of 16 studies were included in this meta-analysis, 12 randomized controlled trials and 4 cohort studies involving 1086 patients who underwent endovascular treatment for HD access stenosis or occlusion. All-cause mortality rates at 6, 12, and 24 months after intervention were similar between the PCB and PBA groups (6 months: OR, 1.06 [95% CI, 0.38-2.96; P = .907; I2 = 19.2%]; 12 months: OR, 1.20 [95% CI, 0.66-2.16; P = .554; I2 = 0%]; 24 months: OR, 1.43 [95% CI, 0.83-2.45; P = .195; I2 = 0%]). There was a significant improvement of primary patency in the PCB group compared with the PBA group (HR, 0.47; 95% CI, 0.33-0.69; P < .001; I2 = 67.3%). This benefit was consistent with the analysis of randomized controlled trials, whereas cohort studies were excluded. Further subgroup analysis of target lesions demonstrated that primary patency was significantly higher in the PCB group than in the PBA group, not only for arteriovenous fistula (HR, 0.54; 95% CI, 0.30-0.98; P = .041; I2 = 76.8%) but also for central venous stenosis (HR, 0.39; 95% CI, 0.22-0.71; P = .002; I2 = 0%). The PCB group was associated with higher 6-month (OR, 0.40; 95% CI, 0.27-0.59; P < .001) and 24-month lesion primary patency (OR, 0.28; 95% CI, 0.11-0.72; P = .009) than PBA and was marginally associated with 12-month lesion primary patency (OR, 0.52; 95% CI, 0.26-1.03; P = .06). Circuit primary patency analysis showed a marginal trend toward better outcome in the PCB group (HR, 0.63; 95% CI, 0.40-1.00) but no statistical significance (P = .052). Conclusions This systematic review and meta-analysis demonstrated that PCB angioplasty is associated with significantly improved primary patency of arteriovenous fistula and central venous stenosis for HD access maintenance, with no evidence of increasing all-cause mortality based on short-term and midterm follow-up. Further large cohort study is needed to investigate long-term mortality.