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

Abstract

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.

Comparative efficacy of five balloons for treating autogenous arteriovenous fistula stenosis: a Bayesian network meta-analysis

“…Four studies investigating the effect of DEB (21)(22)(23)(24) and nine studies investigating the effect of DCB were included in our NMA (12,(15)(16)(17)(18)(19)(20)(21)29). The results demonstrated that both DEB and DCB had a statistically higher patency rate compared with PBA at all time points, which was consistent with the results of several recently published studies (40,41). Meanwhile, both these studies demonstrated that the use of DCB did not cause a significant increase in patient mortality, indicating the high safety of DCB compared with PBA.…”

Longitudinal micro‐incision creation prior to balloon angioplasty for treatment of arteriovenous access dysfunction in a real‐world patient population: 6‐month cohort analysis

“…There have been recent meta-analyses that pool results of multiple randomized control trials (RCTs) that assess outcomes of stand-alone PTA to treat dysfunctional AV access. 6,[19][20][21][22] Ng et al reviewed seven studies that reported a cumulative 1147 subjects (867 AVGs, 280 AVFs) with a range of target lesion patency at 6 months of 8%-34% for subjects treated with PTA. 20 Liao et al conducted a meta-analysis of 11 RCTs PTA in AVF that pooled 976 subjects and reported 6-month patency of 51.7% (236/489) for a PTA cohort.…”

“…6 A study by Hu et al conducted a meta-analysis of 18 RCTs of DCB versus PTA in AVF that pooled 1898 subjects with the PTA cohort associated with a 6-month primary patency of 58.6% (499/851). 21 Supporting Information Table S1 summarizes the literature comparison results. 6,[20][21][22][23] The observation of comparable target lesion primary patency in the FLEX-AV registry relate to those reported by RCTs is remarkable given that inclusion criteria for RCTs are more stringent than those for this allcomers registry.…”

“…21 Supporting Information Table S1 summarizes the literature comparison results. 6,[20][21][22][23] The observation of comparable target lesion primary patency in the FLEX-AV registry relate to those reported by RCTs is remarkable given that inclusion criteria for RCTs are more stringent than those for this allcomers registry. Thus, the results provide reinforcement for the benefit of FLEX VP prior to PTA for vascular access treatment.…”

“…Target lesion primary patency for AVG subjects ( n = 42) was 52.4%. There have been recent meta‐analyses that pool results of multiple randomized control trials (RCTs) that assess outcomes of stand‐alone PTA to treat dysfunctional AV access 6,19–22 . Ng et al reviewed seven studies that reported a cumulative 1147 subjects (867 AVGs, 280 AVFs) with a range of target lesion patency at 6 months of 8%–34% for subjects treated with PTA 20 .…”