Comparative efficacy and safety of four common balloon angioplasty techniques for an arteriovenous fistula or graft stenosis: a systematic review and network meta-analysis of randomized controlled trials

Introduction

Currently, several different guidelines recommend arteriovenous fistula (AVF) or arteriovenous graft (AVG) as the preferred vascular access for patients with kidney failure requiring hemodialysis; however, vascular access dysfunction remains a major cause of morbidity and hospitalization in patients with end-stage renal disease (ESRD) (1,2). The most common cause of vascular access dysfunction is venous stenosis caused by neointimal hyperplasia (3-5), which results from the response to vascular trauma initiated by angioplasty used to repair the injured vessel walls (6).

Updated Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines (2) suggest percutaneous transluminal angioplasty (PTA) as the first choice for the treatment of vascular access dysfunction. Although it is fast and convenient, the primary patency rate of this technique at 12 months is relatively low, ranging from 26% to 62% (7-10). In order to further enhance the durability of therapy, a variety of balloon angioplasty strategies have been explored, such as cutting balloon angioplasty (CtBA), high-pressure balloon angioplasty (HBA), and drug-coated balloon angioplasty (DcBA) (11,12). Currently, there is no consensus on the comparative safety and efficacy of existing balloon angioplasty techniques.

Even though some head-to-head meta-analyses for AVF/AVG treatment have been published (13-18), they were not designed to identify the optimal treatment among various treatment options. A recent network meta-analysis has investigated the comparative therapeutic effects of different endovascular accesses in treating patients suffering from failing autogenous AVFs with outflow vein stenosis (19). Unfortunately, that network meta-analysis incorrectly incorporated standard- and high-pressure balloons into an individual intervention and enrolled a cohort (20) study into the final analysis. It also missed an eligible study (21) that compared CtBA with conventional balloon angioplasty (CBA).

In addition, several eligible studies (22-24) have also been recently published following the previous network meta-analysis. It is therefore essential to perform a more comprehensive network meta-analysis to ascertain the best treatment option. Therefore, we present the following article in accordance with the PRISMA NMA reporting checklist (available at https://atm.amegroups.com/article/view/10.21037/atm-22-381/rc) (25,26).

Methods

Study registry

This updated network meta-analysis complied with the Cochrane handbook for reviewer of systematic review (27); however, its protocol has not been publicly registered. No institutional ethical approval or patients’ informed consent was required as this was a network meta-analysis of published data.

Literature search

A recent network meta-analysis was identified after initially searching PubMed; therefore, an updated literature search strategy was developed. Two independent reviewers conducted an updated electronic search of PubMed and Embase (via Ovid) for potentially eligible studies published between January 2020 and July 2021. The strategies used for PubMed and Embase are summarized in Table S1. Eligible studies from published meta-analyses were also detected. Moreover, two independent reviewers manually checked the reference lists of the included studies. Finally, the same reviewers double-checked all the results. Conflicts between two reviewers were solved by consulting a third reviewer.

Selection criteria

The following selection criteria, which refer to patients, intervention, control, outcome, and study design, were developed according to the previous network meta-analysis with the PICOS methodology: (I) patients with stenotic AVF or AVG for hemodialysis, regardless of de novo or recurrent condition; (II) common balloon angioplasty techniques, including CBA, HBA, CtBA, and DcBA, were compared with each other in a randomized controlled trial (RCT); (III) reported at least one of the following outcomes, including target lesion primary patency (TLPP) at 6 and 12 months of follow-up and the rate of complications; (IV) full-text could be accessed.

The study was excluded if at least one of the following criteria was met: (I) patients were confirmed with central vein stenosis; (II) repeated study with poor methodological quality and relatively fewer data; (III) abstract without sufficient information; or (IV) studies with ineligible design such as observational studies, animal studies, and letters to the editor.

Study selection

Following the requirements proposed by the Cochrane Handbook, study selection was independently conducted by two reviewers. The whole progress included five following steps: (I) records first identified from the target databases were imported into the EndNote software, after which the repeated records were removed; (II) ineligible records were initially excluded through screening of the titles and abstracts; (III) the full-texts of the potentially eligible studies were accessed to confirm their eligibility; (IV) full-texts of the studies that have been included in previous meta-analyses were also accessed and checked for eligibility; (V) the reference lists of all included studies were manually checked to identify additional eligible studies. Discrepancies between the two reviewers were solved through a consultation with a third reviewer.

Definition of outcomes

Three outcomes were evaluated in this network meta-analysis to determine the comparative effectiveness and safety of common balloon angioplasty techniques. TLPP at 6 and 12 months of follow-up were regarded as primary outcomes, and the incidence of complications was considered the secondary outcome. TLPP had to be defined using recognized criteria and clearly reported in the eligible studies.

Data extraction

Two reviewers independently extracted data. The sample size was extracted after randomization as the intention-to-treat analysis was preferable to a full-analysis-set analysis and per-protocol analysis.

The following data were extracted: reference identifiers including the first author’s name and publication year; characteristics of the patients including sample size, the proportion of male patients, mean age of the patient, type of target lesion, the definition of the primary outcome; characteristics of the intervention regimens, including the type of balloon, paclitaxel dose, and follow-up duration. The corresponding authors were also contacted when additional data were needed. Conflicts between two reviewers were solved by consulting a third reviewer.

Construction of the evidence network

The current status of the available evidence in terms of all outcomes was displayed by constructing an evidence network using Stata 14.0 (Stata Corp LP, College Station, Texas, USA). The circle size was weighted according to the accumulated sample size, and the width of the line directly connecting two interventions was weighted using accumulated numbers of eligible studies.

Methodological quality assessment

The risk of bias in the included studies was assessed using the Cochrane risk of bias assessment tool (28) from the following seven items: random sequence generation, allocation concealment, blinding of participants and personnel, blinding of outcome assessment, incomplete outcome data, and selective reporting. Each item was labeled with a “high”, “unclear”, or “low” risk of bias depending on the criteria. Moreover, the overall level of methodological quality was determined according to the proportion of “unclear” and “high” risk of bias.

Statistical analysis

A direct random-effects meta-analysis was first performed by using RevMan version 5.3 (Copenhagen: The Nordic Cochrane Centre, the Cochrane Collaboration, 2014). All outcomes were dichotomous variables; thus, the odds ratio (OR) with a 95% confidence interval (CI) was used to express the pooled results. Before performing quantitative synthesis, statistical heterogeneity was evaluated across studies using the chi-square test (29) and I² statistics to quantify heterogeneity (30).

Next, the aggregate data drug information system (ADDIS) 1.16.8 software (Groningen, the Netherlands, https://www.drugis.org/) was used to perform a network meta-analysis, which was based on the Markov Chain Monte Carlo (MCMC) simulation. Results from the network meta-analysis were expressed as OR, accompanied by a 95% credible interval (CrI). Before conducting quantitative synthesis, the split node method was first used to explore the possibility of inconsistency between direct and indirect effects (31,32), which was performed using Stata 14.0 (Stata Corp LP, College Station, Texas, USA). Direct and indirect effects were considered consistent if the 95% CI contained 0, with a P value >0.05. A number of chains was set to 4, tuning iterations to 2,000, simulation iterations to 50,000, thinning interval to 10, inference samples to 10,000, and variance scaling factor to 2.5 in order to achieve good convergence (33), which was evaluated by using potential proportional reduction factor (PRF) (34,35). We also separately investigated the comparative effectiveness and safety of four available balloon angioplasty techniques in patients with AVFs.

After completing the network meta-analysis, Stata 14.0 (Stata Corp LP, College Station, Texas, USA) was used to draw a comparison-adjusted funnel plot to evaluate the robustness of pooled results when the accumulated numbers of eligible studies were >10 (36).

Finally, the surface under the cumulative ranking curve (SUCRA) values were calculated to rank all targeted balloon angioplasty techniques by estimating the possibility of a certain ranking (37).

Results

Identification and selection of study

Among 46 records that were identified from the updated search, 16 repeated records were removed. After checking out the titles and abstracts, 19 ineligible records were excluded. After checking the full texts of 11 unique records, 8 studies met our selection criteria, and 3 ineligible studies were excluded due to language (n=1) and abstract with insufficient information (n=2). Moreover, 15 potentially eligible studies were initially identified from published meta-analyses. Then, 12 eligible studies were judged to meet the selection criteria after excluding 3 ineligible studies from repeated studies (n=2) and ineligible design (n=1). Finally, 20 eligible studies (21-24,38-53) were included in this network meta-analysis. There was no conflict regarding study selection between the two independent reviewers. The PRISMA flow chart of the literature search is shown in Figure 1.

Figure 1 PRISMA flow chart of identification and selection of studies.

Studies’ characteristics

Table 1 summarizes the characteristics of the eligible studies. Among the 20 studies, 2 (21,50) compared CtBA with CBA; 2 (38,48) compared CtBA with HBA; 8 (39,41,44,45,47,49,51,53) compared DcBA with CBA; and 8 (22-24,40,42,43,46,52) compared DcBA with HBA. There were 12 studies (22-24,38,39,41,43,45,48,50,51,53) that enrolled patients with target lesion of AVF; 2 (21,44) enrolled patients with AVG, and 6 (40,42,46,47,49,52) enrolled patients with mixed target lesions including AVF and AVG. The follow-up duration of the studies ranged from 6 to 42 months.

Assessment of study quality

Except for one study (41), all the others used appropriate methods to produce the random sequence. Meanwhile, all but two (46,49) of the 18 studies (21-24,38-45,47,48,50-53) concealed allocation. Only 7 studies (22,23,39,41,44,47,49) stated to avoid performance bias; however, 12 studies (22,23,39,40,42,44,45,47,48,51-53) avoided detection bias through blinding outcome assessors. The results in 6 studies could be adversely affected by attrition bias; however, only 2 studies encountered a reporting bias. Moreover, ten studies (38,39,41-45,47-49) were judged with a high risk of bias due to insufficient sample size. There were no conflicts regarding the risk of bias assessment between the two independent reviewers. Table 2 summarizes the details of the risk of bias in each eligible study.

Evidence structure

All studies reported TLPP at 6 months follow-up and the incidence of complications; however, TLPP at 12 months was missing from 2 studies. Based on these results, the evidence networks of the three outcomes were constructed and displayed in Figure 2.

Figure 2 Evidence structure plots of primary patency at 6 (A) and 12 (B) months, and the risk of complications (C). The accumulated sample size weighted the size of the circle size, and the accumulated number of eligible studies weighted the width of the line. CBA, conventional balloon angioplasty; CtBA, cutting balloon angioplasty; HBA, high-pressure balloon angioplasty; DcBA, drug-coated balloon angioplasty.

Inconsistency examination

Inconsistency examination suggested that direct and indirect effects were consistent in terms of TLPP at 6 [inconsistent factor (IF), 0.229; 95% CI: 0.00 to 2.98; P=0.797] and 12 (IF, 0.415; 95% CI: 0.00 to 3.02; P=0.463) months; however, the direct and indirect effects were inconsistent in terms of the incidence of complications (IF, 1.288; 95% CI: 0.00 to 6.42; P<0.001).

Meta-analysis of TLPP at 6 months

Two studies compared CtBA with CBA, and a direct meta-analysis indicated that patients receiving CtBA had higher TLPP at 6 months of follow-up compared with patients receiving CBA (OR, 1.91; 95% CI: 1.27 to 2.86; P=0.002); however, remaining comparisons did not reach statistical significance (Figure S1A). Unfortunately, the significant results in the direct meta-analysis were not confirmed in the network meta-analysis (OR, 1.81; 95% CrI: 0.40 to 8.19) (Figure 3A). Ranking based on probability suggested that CtBA was the optimal treatment option (55.0%), followed by HBA (36.0%), DcBA (38.0%), and CBA (51.0%) (Figure 3A).

Figure 3 Pooled results and rankings of primary patency at 6 (A) and 12 (B) months, and the risk of complications (C). Data are shown as OR (95% CrI). A bold numerical value indicates statistical significance. TLPP, target lesion primary patency; CBA, conventional balloon angioplasty; CtBA, cutting balloon angioplasty; HBA, high-pressure balloon angioplasty; DcBA, drug-coated balloon angioplasty; n.a., not applicable; OR, odds ratio; CrI, credible interval.

Meta-analysis of TLPP at 12 months

Among 2 studies that compared CtBA with CBA, only one reported TLPP at 12 months of follow-up. The direct meta-analysis indicated a higher TLPP at 12 months of follow-up related to the CBA (OR, 1.56; 95% CI: 1.13 to 2.15; P=0.006) (Figure S1B); however, the remaining comparisons did not reach statistical significance (Figure S1B). Unfortunately, the network meta-analysis did not detect all comparisons as statistically significant (Figure 3B). Ranking based on probability suggested that CtBA was the optimal treatment option (53.0%), followed by HBA (37.0%), DcBA (37.0%), and CBA (55.0%) (Figure 3B).

Meta-analysis of complications

All 20 studies reported the incidence of complications after receiving balloon angioplasty. Direct meta-analysis revealed no significant differences among the available comparisons (Figure S2). Network meta-analysis found that CtBA was associated with increased incidence of complications compared with CBA (OR, 8.95; 95% CrI: 1.77, 64.79), HBA (OR, 27.94; 95% CrI: 1.44, 1,511.80), and DcBA (OR, 0.05; 95% CrI: 0.00, 0.83) (Figure 3C). The remaining comparisons, including DcBA versus CBA, DcBA versus HBA, and HBA versus CBA, did not reach significant differences (Figure 3C). Ranking based on probability suggested that HBA was the optimal treatment option (70.0%), followed by DcBA (66.0%), CBA (72.0%), and CtBA (99.0%) (Figure 3B).

Sensitivity analysis of TLPP

For meta-analysis of TLPP, substantial statistical heterogeneity across studies was detected. Therefore, we conducted the sensitivity analysis for comparisons with enough eligible studies by using the leave-one-out method. The results revealed that the pooled estimates of the target comparisons were robust and credible, as presented in Table S2.

Subgroup analysis of AVF

We performed a separate network meta-analysis to determine the comparative effectiveness and safety of the four common balloon angioplasty techniques in patients with AVF. Pooled results did not reveal significant differences in all comparisons regarding all outcomes (Figure S3).

Publication bias examination

The comparison-adjusted funnel plots of TLPP at 6 (Figure S4A) and 12 (Figure S4B) months of follow-up indicated asymmetric outline, suggesting a possibility of publication bias. A symmetric comparison-adjusted funnel plot of complications suggested an absence of publication bias (Figure S4C).

Discussion

Although balloon angioplasty has been regarded as the preferred option for treating venous outflow stenosis by clinical guidelines (1,2,54), it remains unclear which type of balloon angioplasty technique should be selected in routine daily practice. This network meta-analysis aimed to solve this issue. Our results revealed that all available balloon angioplasty techniques were not statistically significant in terms of TLPP at 6 and 12 months; however, CtBA was found to have a higher risk of complications than DcBA, HBA, and CBA. Moreover, the network meta-analysis did not detect significant differences among patients with AVFs.

Three direct meta-analyses (16-18) investigated the comparative effectiveness and safety of DcBA versus CBA in patients with AFVs, AVGs, and CVFs. Among three meta-analyses (16,18), two found that DcBA was superior to CBA in primary patency. However, another meta-analysis of RCTs (17) suggested that DcBA did not have a significant patency benefit for treating hemodialysis vascular access dysfunction compared with CBA, which is consistent with our findings. Interestingly, two meta-analyses that combined RCTs and cohort studies detected statistically significant differences, which might be the major reason for the conflicting results.

Two meta-analyses (13,15) investigated the comparative effectiveness and safety of DcBA versus CBA in patients with AVFs. Abdul Salim et al. found that DcBA did not significantly improve over CBA in decreasing fistula stenosis in the RCT (13), which is consistent with our findings. However, Cao et al. reported DcBA as an effective procedure associated with lower 6- and 12-month TLPP than CBA in de novo or recurrent AVF stenosis (15). DcBA has been found to have greater treatment benefits for restenotic lesions than de novo lesions (39,40), which may somewhat explain these inconsistencies. Moreover, the inclusion of cohort studies might contribute to the conflict because statistical significance was identified in cohort studies by Abdul Salim et al. (13).

In 2015, Agarwal et al. performed the first meta-analysis to compare CtBA with CBA, reporting CtBA as more effective in treating hemodialysis access stenosis, with significantly higher six-month patency than balloon angioplasty (14), which is not in line with our findings. Unfortunately, the authors combined conventional and high-pressure in this meta-analysis as an individual regimen (21,38,50). Meanwhile, another eligible study that compared CtBA with HBA and detected a conflicting result was excluded (48). These two reasons are of critical importance for explaining these conflicting findings.

In 2021, a network meta-analysis was conducted to investigate the comparative effectiveness of different endovascular treatments for patients with failing autogenous AVFs with outflow vein stenosis (19). In this network meta-analysis, the authors found that DcBA was substantially superior to CBA, with improved 6-month failure rates, which is inconsistent with our findings. It must be noted that this network meta-analysis incorrectly included a study with an ineligible design in the final analysis (20). Meanwhile, CBA and HBA were simultaneously combined as an individual regime. However, in the present network meta-analysis, CBA and HBA were separately defined as individual regimens, and eight additional eligible studies were included. More importantly, we also evaluated the safety of four available balloon angioplasty techniques, finding that CtBA was associated with an increased risk of complications. Published evidence suggested that AVFs were associated with the lowest risk of complications, lowest need for intervention, and best long-term patency compared to other access routes (55). It was also found that AVF patency post-angioplasty was usually superior to AVG patency (43,56). Therefore, a separate network meta-analysis in patients with AVFs was performed in the present study; yet, the subgroup analysis with 4 additional studies still did not detect any significant differences in available comparisons.

The present network meta-analysis has several limitations. First, most eligible studies included in our network meta-analysis only enrolled a limited sample size, which might introduce a small sample bias. Second, doses of paclitaxel were different from one to another, and most eligible studies did not provide information on the dose. Therefore, performing subgroup analyses to explore the impact of dose on pooled results was not possible. Third, eligible studies included in this network meta-analysis comprised combinations of various AVF configurations and de novo lesions with recurrent ones. However, subgroup analysis could not be designed due to limited data, which may impair the reliability of our pooled results. Forth, the majority of eligible studies were judged with a high risk of bias, which may inevitably impair the robustness and reliability of our findings.

Conclusions

For patients with failing autogenous AVFs and AVGs stenosis, although it might be a preferred option for improving primary patency, CtBA should not be selected as a preferential approach considering it may significantly increase the risk of complications. In contrast, HBA might be a preferred treatment option as it is associated with a lower risk of complications and has numerically higher primary patency than DcBA and CBA. However, our findings should be further verified owing to the several limitations detailed above.

Acknowledgments

We would like to deeply appreciate all the authors who performed all eligible studies which have been included in the present network meta-analysis. Thanks to Medsci for improving the language text of my manuscript.

Funding: None.

Footnote

Reporting Checklist: The authors have completed the PRISMA NMA reporting checklist. Available at https://atm.amegroups.com/article/view/10.21037/atm-22-381/rc

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://atm.amegroups.com/article/view/10.21037/atm-22-381/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. No institutional ethical approval and patients’ informed consent was required as this is a network meta-analysis of published data.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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