Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis

Abstract

Purpose: To compare the effectiveness and safety outcomes of drug-coated balloon angioplasty (DCBA) vs conventional balloon angioplasty (BA) for arteriovenous fistula (AVF) stenosis. Materials and Methods: A systematic review was conducted of PubMed and Embase databases from 1966 to May 2019 to identify English-language articles evaluating DCBA vs BA for the treatment of AVF stenosis. Data extracted from each study were synthesized to evaluate target lesion revascularization (TLR), technical success, and mortality for the 2 approaches. Meta-analyses were performed on these outcomes using random effects models to estimate the odds ratios (ORs) and 95% confidence intervals (CIs). Subgroup and sensitivity analyses were performed. Results: Twelve studies [6 randomized controlled trials (RCTs) and 6 cohort studies] comprising 979 patients were included in this meta-analysis. The pooled results showed that AVFs treated with DCBA had significantly fewer TLRs at 6 months (OR 0.31, 95% CI 0.14 to 0.69, p=0.004) and 12 months (OR 0.45, 95% CI 0.21 to 0.97, p=0.04) than BA. The 2 approaches had similar technical success rates (OR 0.22, 95% CI 0.03 to 1.43, p=0.11). Additionally, the pooled OR of 12-month mortality was 0.71 (95% CI 0.20 to 2.51, p=0.60), indicating no significant difference between DCBA and BA. Subgroup analysis based on study design showed the superiority of DCBA to BA in cohort studies but not RCTs, which had high heterogeneity. Significant publication bias was found in the cohort studies. Conclusion: In de novo or recurrent AVF stenosis, DCBA appears to be an effective procedure associated with lower 6- and 12-month TLR compared with BA. However, larger and randomized controlled studies are warranted to draw definitive conclusions.

Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

“…The results based on pooled data of over 4500 patients showed an increased mortality rate at 2 and 5 years, following the application of paclitaxel balloons or stents compared to non-drug devices in the femoro-popliteal artery region. However, this trend has never been shown in the AVF circuit from either the meta-analysis data [ 9 ] or from the larger RCTs [ 10 ] and registries [ 21 ]. If the current trend continues, paclitaxel devices may be ultimately consigned to the past [ 13 ] and this will be a setback for progress as many vascular specialists perceive CBA and bare metal stents to be basic technologies with poorer outcomes.…”

“…Our group has recently published a systematic review and meta-analysis showing that in patients with dialysis access stenosis, DCB angioplasty was a safe alternative to CBA, offering superior patency rates at both 6 (71.0% vs 49.2%) and 12 months (44.2% vs 20.6%) [ 8 ]. This has been borne out in a more recent meta-analysis focusing on AVF per se showing DCB angioplasty to be an effective procedure associated with lower 6- and 12-month target lesion revascularization compared with CBA [ 9 ]. However, this was not reflected in the largest RCT to date of DCB vs CBA in AVF with no superior target lesion patency demonstrated at six months and at one and two years follow-up [ 10 ].…”

“…However, this was not reflected in the largest RCT to date of DCB vs CBA in AVF with no superior target lesion patency demonstrated at six months and at one and two years follow-up [ 10 ]. Furthermore, recent attention has been drawn to a possible increase in late mortality signal [ 11 ] and lower amputation free survival [ 12 ] in patients receiving DCB treatment with paclitaxel for peripheral arterial disease, although this suggestion has not been demonstrated in the data of DCB within the fistula circuit either at 1 or 2 years [ 9 , 10 ]. In light of these concerns, attention has turned away recently from paclitaxel-based technologies to sirolimus coated platforms [ 13 ].…”

Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

“…There have been eight systematic reviews with meta-analyses; improved outcomes with DCBs were reported in seven [32][33][34][35][36][37][38], while similar outcomes between DCB and conventional balloon were reported in one [39]. Even the three most recently published meta-analyses of 2020 have reported contradictory findings [36][37][38][39]. A meta-analysis of 10 studies (five randomized controlled trials and five cohort studies) by Yuan et al included 861 stenoses in AVFs that were treated using DCBs (48.8%) and conventional balloons (51.2%).…”

“…Another meta-analysis of 12 studies (six randomized controlled trials and six cohort studies) by Cao et al included 979 stenoses in AVFs that were treated with DCBs (47.9%) and conventional balloons (52.1%). Their pooled results revealed that AVFs treated with DCBs had significantly fewer incidences of target lesion revascularization at 6 months (odds ratio (OR), 0.31; 95% CI, 0.14-0.69, p = 0.004) and 12 months (OR, 0.45; 95% CI 0.21-0.97, p = 0.04) than did those treated with conventional balloons [36]. Chen et al summarized 16 studies (12 RCTs and four cohort studies) involving 1086 patients, and they observed a significantly better primary patency in the DCB group than the conventional balloon group (HR, 0.47; 95% CI, 0.33-0.69; p < 0.001; I 2 = 67.3%) [38].…”