Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials

BACKGROUND: Arteriovenous fistulas, a major treatment for end-stage kidney disease, frequently require endovascular reinterventions to maintain haemodialysis function. Drug-coated angioplasty balloons (DCBs) were developed with the intention of reducing reintervention rates. The aim of this study was to perform a systematic review and meta-analysis of DCBs in the treatment of failing haemodialysis access. METHODS: Electronic databases were searched systematically to identify all relevant RCTs and any follow-up studies from RCTs. Pooled estimates of dichotomous outcomes were calculated using the odds ratio (OR) and 95 per cent confidence interval. Effect data are presented as summary hazard ratio and 95 per cent confidence interval. RESULTS: Some 19 studies from 18 RCTs and comprising 1898 patients were included in the meta-analysis. Compared with plain balloon angioplasty (PBA), DCB use was associated with higher target-lesion primary patency (HR 0.60, 95 per cent c.i. 0.45 to 0.79), access-circuit primary patency (HR 0.67, 0.56 to 0.80), and less target-lesion revascularization (TLR) within 6 months (OR 0.33, 0.23 to 0.47). No difference was observed between DCB and PBA in 12-month TLR (OR 0.62, 0.28 to 1.37). Mortality after DCB use was similar to that associated with PBA use at 6 months (OR 1.20, 0.65 to 2.21) and 12 months (OR 0.99, 0.66 to 1.49), and was higher at 24 months (23.1 versus 16.6 per cent), although the difference was not statistically significant (OR 1.53, 0.92 to 2.53). CONCLUSION: Drug-coated balloon angioplasty of haemodialysis fistulas is associated with higher patency rates and lower rates of reintervention in the short to mid term. Although mortality rates appeared to be higher with drug-coated angioplasty at 24 months, this did not reach statistical significance.