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

H Hu; Q Tan; J Wang; Y Liu; Y Yang; J Zhao

doi:10.1093/bjs/znab301

. 2021 Oct 1;108(11):1293–1303. doi: 10.1093/bjs/znab301

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

H Hu ¹, Q Tan ², J Wang ¹, Y Liu ¹, Y Yang ¹, J Zhao ^1,^✉

PMCID: PMC10364885 PMID: 34595522

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.

This study showed that drug-coated balloon angioplasty was safe within 12 months and had better performance than plain balloon angioplasty in treating failing haemodialysis access, especially when predilatation with a high-pressure balloon was used. However, it is not recommended when the haemodialysis access has been in place for 6 months or less.

Introduction

Haemodialysis is the main treatment for patients with end-stage kidney disease requiring renal replacement therapy. Haemodialysis is preferentially delivered through arteriovenous fistulas (AVFs) or arteriovenous grafts (AVGs) because of the complications associated with central venous catheters. Unfortunately, both AVFs and AVGs are associated with high rates of stenosis that impairs delivery of successful dialysis. These stenoses are usually managed by balloon angioplasty.

Paclitaxel, a cytotoxic agent used to treat various types of cancer, has been applied to angioplasty balloons in an attempt to reduce restenosis rates following angioplasty¹. Paclitaxel has been used in the treatment of de novo or restenotic lesions of the femoropopliteal arteries². Preliminary data from small studies in patients with failing haemodialysis access are also encouraging^3–5. These analyses did not include some more recent studies^6–12, including three large, well designed multicentre RCTs⁷^,¹¹^,¹². The aim of this work was to conduct an up-to-date systematic review of the safety and efficacy of use of drug-coated angioplasty balloons (DCBs) in patients with failing haemodialysis access.

Methods

Study design

A study-level pooled analysis of RCTs was performed. It was conducted in accordance with PRISMA guidelines¹³. The protocol was registered with the International Prospective Register of Systematic Reviews (CRD42021239271).

Relevant studies were searched using MEDLINE, Embase, and Cochrane Library databases. The terms used in the search are shown in Appendix S1. All of the search terms were connected with the operators AND/OR in different combinations. The literature search was last updated in May 2021.

Eligibility criteria

Types of study

All RCTs evaluating the outcomes of DCBs used in failing haemodialysis access in comparison with plain balloon angioplasty (PBA) were included. Studies comparing use of a DCB and PBA for treating central venous stenosis were excluded.

Types of participant

Patients of any age who had failure of haemodialysis access and who underwent PBA or DCB angioplasty were eligible. Studies had to report at least one of the endpoints detailed below. Studies with insufficient data or duplicate study populations were excluded from the meta-analysis.

Endpoints

The primary efficacy endpoints were target-lesion primary patency (TLPP) and access-circuit primary patency (ACPP), which were defined as freedom from the requirement for clinically driven target-lesion revascularization (TLR) and entire access-circuit thrombosis during follow-up after the index procedure respectively. The primary safety endpoint was all-cause death. The secondary endpoint was TLR, which was defined as any reintervention for the same lesion.

Extraction and management of data

Two authors independently extracted the relevant data from selected studies, including: name of first author, year, age of participants, sex of participants, study design, study population, duration of follow-up, target lesion, outcome of interest, balloons used for predilatation, type of DCB employed, paclitaxel dose, inflation time of balloon, and AVF age. Retrieved data were recorded in Excel™ (Microsoft, Redmond, WA, USA).

Quality assessment

The risk of bias of each included RCT was evaluated by two review authors using a specific assessment tool derived from Cochrane Handbook for Systematic Reviews of Interventions¹⁴. If disagreement arose, a corresponding author acted as adjudicator. The quality of evidence was graded using the system developed by the Grading of Recommendations Assessment, Development and Evaluation working group using an online platform (https://gdt.gradepro.org/app/) according to its guidelines¹⁵. Funnel plots and Egger’s tests were used to determine publication bias in the meta-analysis, with data from more than nine trials.

Analysis and synthesis of data

Dichotomous outcome data were pooled using odds ratios (ORs) and 95 per cent confidence intervals according to the Mantel–Haenszel method¹⁶. Time-to-event data were evaluated using the inverse-variance method and the result was reported as a summary hazard ratio (HR) with 95 per cent confidence interval. The HRs and 95 per cent confidence intervals for individual studies were extracted from Kaplan–Meier survival curves using Plot Digitizer (http://plotdigitizer.sourceforge.net/) according to a specific method described by Tierney and colleagues¹⁷ if they could not be exacted from original studies directly.

Potential heterogeneity among studies was assessed by means of the I² test; I² values of less than 30, 30–60, 61–75, and over 75 per cent suggested a low, moderate, substantial, and considerable degree of heterogeneity respectively. If the I² value exceeded 50 per cent, a random-effects meta-analysis was conducted. Otherwise, fixed-effect models were used to pool the data.

Sensitivity analysis combined with subgroup analyses were undertaken to investigate the source of heterogeneity and influence of each trial on pooled data. Subgroup analysis was done according to the type of DCB if the I² value exceeded 50 per cent, and a leave-one-out meta-analysis was carried out for each endpoint to ensure that these results were robust. Analyses were conducted using R 4.0.2 with statistical packages in RStudio 1.3.1093 (RStudio, Boston, MA, USA).

Results

Some 504 records were identified through searching of electronic databases. After removing duplicate records and discarding irrelevant studies, the literature search identified 19 articles involving 18 RCTs that fulfilled the inclusion criteria. One study¹⁸ updated the long-term mortality data from a previous RCT¹⁹ (Fig. S1).

Characteristics of studies

The population comprised 1898 patients from 19 studies^6–12^,^18–29, of whom 952 used a DCB, and the remaining 946 underwent PBA. Ten of these RCTs were multicentre studies, and the remainder were from single centres. The duration of follow-up ranged from 6 to 48 months. Eight studies⁶^,⁸^,¹⁰^,¹²^,²⁰^,²²^,²⁷^,²⁸ recruited patients with both AVFs and AVGs, nine⁷^,⁹^,¹¹^,¹⁹^,²¹^,²³^,²⁴^,²⁶^,²⁹ focused only on AVFs, and one study²⁵ focused only on AVGs. Five types of DCB were used in these studies, and the dose of paclitaxel ranged from 2.0 to 3.5 µg/mm². Predilatation with a high-pressure balloon or PBA was undertaken before use of a DCB or PBA in 14 studies^6–12^,^19–21^,²⁴^,²⁶^,²⁷^,²⁹. Postdilatation was used widely in the studies⁶^,⁸^,¹⁹^,²¹^,^23–26^,²⁸ with PBA predilatation or no predilatation, except in the study by Björkman and colleagues¹⁹ (Tables S1 and S2). Notably, one study¹⁰ mentioned that the randomized list was modified owing to a shortage of DCBs at the early stage of the trial.

Risk of bias

The quality of evidence was generally high, and it was downgraded mainly because of the imprecision of findings (Table 1). The optimal information size criterion was not met, and the estimate of the effect size for each outcome had wide confidence intervals, which extended from the DCB treatment regimen being appreciably better to the regimen being appreciably worse than the PBA regimen.

Table 1.

Summary of findings of RCTs comparing drug-coated balloon angioplasty versus plain balloon angioplasty in treating dysfunctional haemodialysis access

Certainty assessment		No. of patients*		Effect^†		Certainty	Importance
No. of studies	Risk of bias, inconsistency, indirectness, imprecision, and other considerations^‡	DCB	PBA	Relative	Absolute	Certainty	Importance
Target-lesion primary patency
16	0	903 participants	897 participants	HR 0.60 (0.45, 0.79)	n.a.	⊕⊕⊕⊕ High	Critical
6-month target-lesion primary patency
15	0	220 of 858 (25.6)	352 of 851 (41.4)	OR 0.43 (0.28, 0.64 )	181 (from 103 fewer to 249 fewer) fewer per 1000	⊕⊕⊕⊕ High	Critical
12-month target-lesion primary patency
14	0	294 of 666 (44.1)	346 of 664 (52.1)	OR 0.68 (0.46, 1.03)	96 (from 188 fewer to 7 more) fewer per 1000	⊕⊕⊕⊕ High	Critical
24-month target-lesion primary patency
2	4^§	94 of 161 (58.4)	108 of 163 (66.3)	OR 0.72 (0.45, 1.13)	77 fewer (from 193 fewer to 27 more) per 1000	⊕⊕⊕◯ Moderate	Critical
36-month target-lesion primary patency
1	4^§	17 of 20 (85)	13 of 19 (68)	OR 2.62 (0.55, 12.48)	166 more (from 140 fewer to 280 more) per 1000	⊕⊕⊕◯ Moderate	Critical
6-month target-lesion revascularization
6	0	62 of 359 (17.3)	131 of 355 (36.9)	OR 0.33 (0.23, 0.47)	207 (from 153 to 250) fewer per 1000	⊕⊕⊕⊕ High	Important
12-month target-lesion revascularization
8	0	111 of 382 (29.1)	151 of 380 (39.7)	OR 0.62 (0.28, 1.37)	107 fewer (from 242 fewer to 77 more) per 1000	⊕⊕⊕⊕ High	Important
Access-circuit primary patency
9	0	572 participants	568 participants	HR 0.67 (0.56, 0.80)	n.a.	⊕⊕⊕⊕ High	Critical
6-month access-circuit primary patency
6	0	136 of 442 (30.8)	215 of 436 (49.3)	OR 0.44 (0.33, 0.59)	193 (from 128 to 250) fewer per 1000	⊕⊕⊕⊕ High	Critical
12-month access-circuit primary patency
6	0	168 of 332 (50.6)	206 of 336 (61.3)	OR 0.60 (0.43, 0.84)	126 (from 42 fewer to 208) fewer per 1000	⊕⊕⊕⊕ High	Critical
24-month access-circuit primary patency
1	4^§	95 of 141 (67.4)	111 of 144 (77.1)	OR 0.61 (0.36, 1.04)	99 fewer (from 223 fewer to 7 more) per 1000	⊕⊕⊕◯ Moderate	Critical
6-month mortality
7	4^§	23 of 521 (4.4)	19 of 518 (3.7)	OR 1.20 (0.65 to 2.21)	7 more (from 13 fewer to 41 more) per 1000	⊕⊕⊕◯ Moderate	Important
12-month mortality
9	4^§	51 of 603 (8.5)	51 of 602 (8.5)	OR 0.99 (0.66, 1.49)	1 fewer (from 27 fewer to 36 more) per 1000	⊕⊕⊕◯ Moderate	Important
24-month mortality
4	4^§	45 of 195 (23.1)	33 of 199 (16.6)	OR 1.53 (0.92, 2.53)	67 more (from 11 fewer to 169 more) per 1000	⊕⊕⊕◯ Moderate	Important

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Values in parentheses are *percentages and ^†95 per cent confidence intervals. ^‡1, risk of bias; 2, inconsistency; 3, indirectness; 4, imprecision; 5, other considerations; 0, not serious or none. ^§The optimal information size criterion was not met, and the estimate of the effect size for each outcome had wide confidence intervals. DCB, drug-coated angioplasty balloon; PBA, plain balloon angioplasty; HR, hazard ratio; n.a., not applicable; OR, odds ratio.

Neither patients nor investigators in studies reported by Kitrou et al.²³ and Maleux and colleagues²⁶ were blinded, and only patients (not those delivering the intervention nor assessors) were blinded to the study protocol in the remaining studies. Thus, all trials were judged to be at a high risk of bias in the domain of blinding of participants and personnel. In the study by Therasse and colleagues¹⁰, the number of losses to follow-up exceeded 50 per cent after 3 months. In the work by Yin and co-workers⁹, additional angiography or ultrasonography data for the target lesion at the very first reinterventions in the control group were not available to the authors (9 in DCB group, 14 in PBA group), which may have had a negative impact on analyses of the degree of recurrent stenosis in the target lesion. These two trials were judged to be at a high risk of bias in the domain of incomplete outcome data. In the study by Roosen et al.²⁸, TLPP and ACPP were not reported, and TLR was reported incompletely; the study was therefore judged to be at a high risk of bias in the domain of selective reporting, and could be entered only into a meta-analysis of mortality. Studies that did not mention explicitly the details required in the relevant domain were judged to be unclear in terms of bias (Fig. 1).

Fig. 1 — Risk of bias of included studies

a Overall risk-of-bias summary and b risk of bias in each study.

Target-lesion primary patency

Eighteen studies^6–12^,^19–29 reported TLPP in 1898 patients during follow-up, and HR could be extracted from 16 studies^6–12^,^19–25^,²⁷^,²⁹ . DCB use was associated with higher TLPP than PBA (HR 0.60, 95 per cent c.i. 0.45 to 0.79; P<0.001; I² = 68 per cent) (Fig. 2a).

Fig. 2 — Forest plot showing effect of drug-coated balloon angioplasty *versus* plain balloon angioplasty on target-lesion primary patency

a Hazard ratios for target-lesion primary patency (TLPP), and odds ratios for b 6-month, c 12-month, d 24-month, and e 36-month TLPP. *Values in parentheses are standard errors. Hazard and odds ratios are shown with 95 per cent confidence intervals. DCB, drug-coated angioplasty balloon; PBA, plain balloon angioplasty.

Six-month TLPP, presented in 15 studies^6–9^,¹²^,^20–27^,²⁹, was 74.4 per cent (638 of 858) in the DCB group and 58.6 per cent (499 of 851 ) in the PBA group. The DCB group had higher 6-month TLPP than the PBA group (OR 0.43, 0.28 to 0.64; P<0.01; I² = 62 per cent) (Fig. 2b).

Fourteen studies⁶^,⁸^,^10–12^,^19–24^,²⁶^,²⁷^,²⁹ reported 12-month TLPP. A total of 666 patients were randomized to the DCB group and 664 to the PBA group. The DCB group had higher 12-month TLPP than the PBA group (55.9 and 47.9 per cent respectively) (OR 0.68, 0.46 to 1.03; P = 0.07; I² = 59 per cent) (Fig. 2c).

Two studies⁶^,¹² reported 24-month TLPP and only one⁶ described 36-month TLPP. The differences between the DCB and PBA groups were not significant. The pooled OR for 24-month TLPP was 0.72 (0.45 to 1.13; P = 0.280; I² = 15 per cent), and that for 36-month TLPP was 2.62 (0.55 to 12.48; P = 0.230) (Fig. 2d,e).

Target-lesion revascularization

The 6-month TLR rate was reported in six studies⁷^,⁹^,²⁰^,²²^,²⁴^,²⁵ with moderate heterogeneity (I² = 38 per cent, P = 0.15). Some 17.3 per cent of patients (62 of 359) in the DCB group and 36.9 per cent (131 of 355) in the PBA group underwent TLR. A lower prevalence of TLR was observed in the DCB group (OR 0.33, 95 per cent c.i. 0.23 to 0.47; P<0.001) (Fig. 3a).

Fig. 3 — Forest plot showing showing effect of drug-coated balloon angioplasty *versus* plain balloon angioplasty on target-lesion revascularization

Odds ratios for a 6-month and b 12-month target-lesion revascularization (TLR). Odds ratios are shown with 95 per cent confidence intervals. DCB, drug-coated angioplasty balloon; PBA, plain balloon angioplasty.

Eight studies^9–11^,¹⁹^,²²^,²⁴^,²⁵^,²⁹ presented 12-month TLR, comprising 382 patients in the DCB group and 380 in the PBA group. A total of 111 patients (29.1 per cent) in the DCB group and 151 in the PBA group (39.7 per cent) underwent TLR. The increase in TLR between 6 and 12 months in the DCB group was greater than that in the PBA group. Although the PBA group received more TLR than the DCB group, the pooled analysis showed no significant difference between the two groups, with significant heterogeneity (OR 0.62, 0.28 to 1.37; P = 0.24; I² = 74 per cent) (Fig. 3b).

Access-circuit primary patency

The pooled HR for ACPP was derived from nine studies⁷^,¹⁰^,¹¹^,¹²^,²⁰^,²¹^,²³^,²⁴^,²⁵. DCB use was associated with higher ACPP than PBA (HR 0.67, 95 per cent c.i. 0.56 to 0.80; P<0.001; I² = 46 per cent)²³. Six-month ACPP was reported in six studies⁷^,¹²^,²⁰^,²¹^,²³^,²⁵, 12-month ACPP in six studies¹⁰^,¹²^,²⁰^,²¹^,²³^,²⁵, and one study¹² described 24-month ACPP²³.

The DCB group had higher 6-month ACPP (OR 0.44, 0.33 to 0.59; P < 0.001; I² = 34 per cent)²³ and 12-month ACPP (OR 0.60, 0.43 to 0.84; P = 0.003; I² = 0 per cent) (Fig. 4c). However, there was no significant difference in 24-month ACPP between the two groups (OR 0.61, 0.36 to 1.04; P = 0.070) (Fig. 4d). The meta-analysis of 6-month ACPP had moderate heterogeneity.

Mortality

Six-month mortality was documented in seven studies⁷^,⁹^,¹²^,¹⁹^,²⁰^,²⁵^,²⁶. Twenty-three of 521 patients (4.4 per cent) died in the DCB group and 19 of 518 (3.7 per cent) in the PBA group. There was no significant difference between the two groups (OR 1.20, 95 per cent c.i. 0.65 to 2.21; P = 0.550; I² = 0 per cent) (Fig. 5a).

Fig. 5 — Forest plot showing the showing the effect of drug-coated balloon angioplasty *versus* plain balloon angioplasty on mortality

Odds ratios for a 6-month, b 12-month, and c 24-month mortality. Odds ratios are shown with 95 per cent confidence intervals. DCB, drug-coated angioplasty balloon; PBA, plain balloon angioplasty.

Nine studies⁶^,⁷^,⁹^,¹⁰^,¹²^,¹⁹^,^25–27 reported 12-month mortality. A total of 603 and 602 patients were randomized to the DCB and PBA groups respectively. Of these, 51 patients (8.5 per cent) in the DCB group and 51 (8.5 per cent) in the PBA group died. There was no significant difference between the two groups (OR 0.99, 0.66 to 1.49; P = 0.980; I² = 0 per cent) (Fig. 5b).

Four studies⁶^,¹²^,¹⁸^,²⁸ presented 24-month mortality. The overall mortality rate continued to increase in the DCB group (23.1 per cent) and PBA group (16.6 per cent). The DCB group had a higher mortality rate, but there was no significant difference between the two groups (OR 1.53, 0.92 to 2.53; P = 0.10; I² = 0 per cent) (Fig. 5c). The statistical heterogeneity of the pooled 6-, 12-, and 24-month mortality was negligible.

One study¹⁸ reported 3-, 4-, and 5-year mortality. The mortality rate in the DCB group was unchanged during the 3 years (10 of 18), whereas it was 9 of 18, 10 of 18, and 11 of 18 in the control group at 3, 4, and 5 years respectively. There was no significant difference between these two groups.

Karunanithy and colleagues¹¹ identified a higher overall mortality rate in the DCB group (45 of 195) than in the PBA group (33 of 199). The duration of follow-up of recruited patients ranged from 1 to 3 years, but the authors reported the total mortality only when the trial had been completed, and did not report mortality at any time point.

Sensitivity analysis

Only one study¹⁹ reported DCB use to be associated with worse outcomes in terms of reintervention in comparison with PBA. In this study, patients were younger at the time of haemodialysis access than those in other studies. After removing this study¹⁹, the heterogeneity of the meta-analysis for overall TLPP decreased from 68 to 47 per cent, and the pooled HR for TLPP was 0.57 (95 per cent c.i. 0.49 to 0.67) (Fig. S2a). DCB use became associated with higher 12-month TLPP (OR 0.65, 0.52 to 0.82; I² = 24 per cent) (Fig. S2b) and lower 12-month TLR (OR 0.44, 0.28 to 0.70; I² =27 per cent) than PBA.

Trerotola and colleagues¹² reported that they treated only one lesion with a DCB in a given circuit according to their experimental design. The heterogeneity of the pooled 6-month ACPP became negligible (I² = 0) by removing that study. The pooled OR for 6-month ACPP became 0.33 (0.23 to 0.47) (Fig. S2d).

In the leave-one-out meta-analysis, the overall effect measures, except for 12-month TLPP and 12-month TLR (Fig. S3), were unchanged if the included studies were removed one by one. The pooled 12-month TLPP and pooled 12-month TLR were not robust if the study of Björkman and colleagues¹⁹ was omitted, and DCB use was associated with higher 12-month TLPP and 12-month TLR than use of PBA.

Subgroup analysis

Five types of DCB were used in the selected trials (Table S3). All of these had their own special excipient and contained different doses of paclitaxel. A subgroup analysis according to the type of DCB was performed to investigate the source of heterogeneity. Heterogeneity did not diminish if subgroup analysis was conducted (Fig. S4). However, the IN.PACT™ (Medtronic, Minneapolis, MN, USA), SeQuent Please^® (B.Braun, Melsungen, Hessen, Germany), and APERTO^® (Cardionovum, Bonn, Germany) balloons were superior to PBA in terms of the overall TLPP and 6-month TLPP, whereas the Lutonix™ 035 (Bard, Franklin Lakes, NJ, USA) and passeo^®-18 Lux (Biotronik SE & Co. KG, Lake Oswego, OR, USA) balloons did not improve the therapeutic effect compared with using PBA.

Publication bias

Publication bias was not identified using Egger’s test. The values for Egger’s test for TLPP were t = −0.42 with P = 0.680. After removing the study by Bjorkman and colleagues¹⁹, the values for Egger’s test became t = −1.55 with P = 0.144. The values were t = −1.40 with P = 0.184 for 6-month TLPP, and t = 0.34 with P = 0.739 for 12-month TLPP. After removing the study by Trerotola and colleagues¹², values for 12-month TLPP became t = −0.57 with P = 0.581.

Discussion

Meta-analysis of HRs of RCTs suggested that DCB use was associated with a significantly higher rate of TLPP and ACPP than PBA. Pooled ORs showed that the DCB group had higher TLPP (within 12 months), ACPP (within 12 months), and lower TLR (within 6 months) than the PBA group.

Meta-analysis of follow-up data showed no significant difference in all-cause mortality between the DCB and PBA groups. However, the mortality rate (especially at 24 months) was higher in the DCB group, although not statistically significantly different.

Interestingly, the age at which haemodialysis access was achieved could affect the performance of DCB use. The result reported by Björkman et al.¹⁹ was contrary to that in other studies. The baseline values for participants in the study by Björkman and colleagues were comparable to those in other studies, except for the age at which haemodialysis access was obtained. The authors hypothesized that DCB use was harmful to young native AVFs because venous walls may be more susceptible to the local potential toxic effects of paclitaxel. Yildiz³¹ identified AVF age less than 6 months as an independent risk factor for AVF restenosis, and another article²⁰ also described the positive relationship between the age of achieving haemodialysis access and TLPP. Further trials are warranted to ensure a suitable age of haemodialysis access for DCB use.

Interestingly, the outcomes of endovascular intervention using DCBs for failing haemodialysis access were associated with the type of DCB. This might be attributed to the different doses of drug delivered to vessels. However, most of included studies in this meta-analysis used IN.PACT balloons, so this conclusion might not be reliable.

The present study did not find a significant difference between the DCB and PBA groups in terms of overall mortality, but more patients died in the DCB group. Likewise, Karunanithy and colleagues¹¹ reported a higher overall mortality rate in the DCB group than in the PBA group. One meta-analysis³² documented increased mortality in individuals with peripheral disease and at least 2 years’ follow-up after angioplasty using a DCB; the reasons for this are unknown, but the finding led to safety concerns about paclitaxel-coated devices. However, the most recent meta-analyses^33–36 did not confirm this finding, so DCB use in peripheral vessels and coronary arteries is considered safe. In the present meta-analysis, the duration of follow-up in most of the included RCTs ranged from 6 to 24 months, which was not sufficient to judge whether paclitaxel could affect long-term mortality. Moreover, patients met the endpoint if restenosis occurred in the target lesion; several studies reported the TLR, but no study described which type of balloon was used for revascularization if restenosis occurred, or the outcomes of reintervention. Whether repeated use of a DCB would reduce its efficacy or result in accumulation of toxicity to a life-threatening level merits further investigation.

A conventional angioplasty balloon is frequently inadequate for treatment of failure of haemodialysis access. According Trerotola and colleagues³⁷, 55 per cent of lesions required pressures exceeding 15 atm (1.6195*10^6 Pa) (high-pressure angioplasty balloon), and some parts of a lesion required pressures above 20 atm to achieve revascularization. Likewise, the pressure of a DCB is commonly insufficient for treating dysfunctional haemodialysis access alone. All studies⁶^,^8–10^,¹²^,²¹^,^23–26 in which predilatation was not undertaken or was ATM done using a conventional angioplasty balloon (except that by Björkman and colleagues¹⁹) reported that postdilatation was used in the procedure. This is not surprising because haemodialysis was achieved in patients treated at a much younger mean age by Björkman et al.¹⁹, so probably less neointimal hyperplasia and calcification had developed in the lesions. It is not known whether repeated or incomplete dilatation resulted from use of a conventional angioplasty balloon or DCB would affect the efficacy of a DCB . Therefore, predilatation should be done using a high-pressure balloon before use of a DCB.

Several meta-analyses³^,⁵^,^38–40 have compared the outcomes of DCB versus PBA in treating failing haemodialysis access. Most of them included cohort studies and RCTs. However, mixing RCTs and retrospective studies in meta-analysis models is not recommended⁴¹. Liao and collaborators³⁸, pooling data from RCTs alone, showed that DCB was not superior to PBA, a finding that was different from observations in other meta-analyses. However, that result did not seem robust owing to the inclusion of a relatively small number of patients and studies with a high level of heterogeneity. With inclusion of the most recent articles, the present pooled data analysis indicated that DCB use had better performance in the treatment of dysfunctional haemodialysis access.

The present study has a number of limitations. It was a study-level meta-analysis rather than an individual patient-level study. Study-level meta-analysis can lead to biased assessments, and explaining the heterogeneity has some limitations⁴².

RCTs were not blinded or single-blinded for patients. Because of the different appearance of a DCB from a plain balloon, lack of blinding is likely for operators, which could elicit performance bias, especially in the decision to reintervene or not. Many of the RCTs included in this study had a small sample size and ended within 24 months. Evaluating the influence of DCB use on long-term mortality is difficult. A large, pragmatic clinical-effectiveness study would ideally be required to best inform routine clinical practice. In the study by Karunanithy and colleagues¹¹, actual mortality at each time point (6, 12, and 24 months) was not reported, which would affect the pooled mortality significantly. Every effort was made to contact the authors, but it was not possible to obtain the relevant data. Postdilatation with a conventional balloon, high-pressure balloon or cutting balloon was done if the desired treatment outcome of a DCB or PBA was not achieved⁶^,⁸^,^21–26^,²⁸. Pang et al.⁸ and Maleux and colleagues²⁶ even placed stents if stenosis of the target lesion was not eliminated. Assessment of the efficacy of a DCB would not be accurate in that circumstance. Although a systematic search of the literature was conducted to identify all relevant articles, only manuscripts written in English were included in the meta-analysis. Although all trials were randomized, there were differences in study design. For instance, a high-pressure angioplasty balloon was used as the control by Liao and co-workers²⁵ whereas a conventional angioplasty balloon was used in the other studies.

Funding

This study was supported by the West China Hospital postdoctoral fund (2018HXBH045) and the West China Hospital 1.3.5 project for disciplines of excellence (ZYJC21065).

Supplementary Material

znab301_Supplementary_Data

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Acknowledgements

H.H. and Q.T. contributed equally to this article and are joint first authors.

Disclosure. The authors declare no conflict of interest.

Supplementary material

Supplementary material is available at BJS online.

References

1. Stage TB, Bergmann TK, Kroetz DL.. Clinical pharmacokinetics of paclitaxel monotherapy: an updated literature review. Clin Pharmacokinet 2018;57:7–19. [DOI] [PMC free article] [PubMed] [Google Scholar]
2. Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK.. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev 2016;(8)CD011319. [DOI] [PMC free article] [PubMed] [Google Scholar]
3. Yan Wee IJ, Yap HY, Hsien Ts’ung LT, Lee Qingwei S, Tan CS, Tang TY. et al. A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis. J Vasc Surg 2019;70:970.e973–979.e973. [DOI] [PubMed] [Google Scholar]
4. Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK.. Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis. J Vasc Interv Radiol 2019;30:483.e481–494.e481. [DOI] [PubMed] [Google Scholar]
5. Cao Z, Li J, Zhang T, Zhao K, Zhao J, Yang Y. et al. Comparative effectiveness of drug-coated balloon vs balloon angioplasty for the treatment of arteriovenous fistula stenosis: a meta-analysis. J Endovasc Ther 2020;27:266–275. [DOI] [PubMed] [Google Scholar]
6. Kim JW, Kim JH, Byun SS, Kang JM, Shin JH.. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: a prospective randomized controlled trial. Korean J Radiol 2020;21:1239–1247. [DOI] [PMC free article] [PubMed] [Google Scholar]
7. Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S. et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med 2020;383:733–742. [DOI] [PubMed] [Google Scholar]
8. Pang SYC, Au-Yeung KCL, Liu GYL, Tse ROH, Lai D, Leung WKW. et al. Randomized controlled trial for paclitaxel-coated balloon versus plain balloon angioplasty in dysfunctional hemodialysis vascular access: 12-month outcome from a nonsponsored trial. Ann Vasc Surg 2021;72:299–306. [DOI] [PubMed] [Google Scholar]
9. Yin Y, Shi Y, Cui T, Li H, Chen J, Zhang L. et al. Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial. Am J Kidney Dis 2021;78:19–27.e1. [DOI] [PubMed] [Google Scholar]
10. Therasse E, Caty V, Gilbert P, Giroux MF, Perreault P, Bouchard L. et al. Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone. J Vasc Interv Radiol 2021;32:350.e2–359.e2. [DOI] [PubMed] [Google Scholar]
11. Karunanithy N, Robinson EJ, Ahmad F, Burton JO, Calder F, Coles S. et al. A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas. Kidney Int 2021;100:447–456. [DOI] [PubMed] [Google Scholar]
12. Trerotola SO, Saad TF, Roy-Chaudhury P.. The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis. J Vasc Interv Radiol 2020;31:1.e15–14.e15. [DOI] [PubMed] [Google Scholar]
13. Stewart LA, Clarke M, Rovers M, Riley RD, Simmonds M, Stewart G. et al. ; PRISMA-IPD Development Group. Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD statement. JAMA 2015;313:1657–1665. [DOI] [PubMed] [Google Scholar]
14. Cumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP. et al. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev 2019;(10)ED000142. [DOI] [PMC free article] [PubMed] [Google Scholar]
15. Hao C, Yan W, Xuan-Ming HU, Fang Z, Xian-Tao Z, Gu Y-H.. How to use GRADEpro GDT to rate the quality of evidence in systematic reviews of intervention studies: an introduction. Chin J Evid-Based Med 2015;15:600–606. [Google Scholar]
16. Mantel N, Haenszel W.. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719–748. [PubMed] [Google Scholar]
17. Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR.. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 2007;8:16. [DOI] [PMC free article] [PubMed] [Google Scholar]
18. Björkman P, Weselius EM, Venermo M.. No difference in mid-term and long-term mortality after vascular paclitaxel exposure. Ann Vasc Surg 2021;72:253–260. [DOI] [PubMed] [Google Scholar]
19. Björkman P, Weselius EM, Kokkonen T, Rauta V, Albäck A, Venermo M.. Drug-coated versus plain balloon angioplasty in arteriovenous fistulas: a randomized, controlled study with 1-year follow-up (the Drecorest Ii-Study). Scand J Surg 2019;108:61–66. [DOI] [PubMed] [Google Scholar]
20. Irani FG, Teo TKB, Tay KH, Yin WH, Win HH, Gogna A. et al. Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty. Radiology 2018;289:238–247. [DOI] [PubMed] [Google Scholar]
21. Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access. Ann R Coll Surg Engl 2020;102:601–605. [DOI] [PMC free article] [PubMed] [Google Scholar]
22. Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D.. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol 2015;84:418–423. [DOI] [PubMed] [Google Scholar]
23. Kitrou PM, Spiliopoulos S, Katsanos K, Papachristou E, Siablis D, Karnabatidis D.. Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial. J Vasc Interv Radiol 2015;26:348–354. [DOI] [PubMed] [Google Scholar]
24. Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY.. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol 2014;25:535–541 [DOI] [PubMed] [Google Scholar]
25. Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L. et al. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg 2020;71:1994–2003. [DOI] [PubMed] [Google Scholar]
26. Maleux G, Vander Mijnsbrugge W, Henroteaux D, Laenen A, Cornelissen S, Claes K. et al. Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae. J Vasc Interv Radiol 2018;29:470.e473–475.e473 [DOI] [PubMed] [Google Scholar]
27. Moreno-Sánchez T, Moreno-Ramírez M, Machancoses FH, Pardo-Moreno P, Navarro-Vergara PF, García-Revillo J.. Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial. Cardiovasc Intervent Radiol 2020;43:382–390 [DOI] [PubMed] [Google Scholar]
28. Roosen LJ, Karamermer Y, Vos JA, de Jong GM, Bos WJ, Elgersma OE.. Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: results of a randomized clinical trial. Ital J Vasc Endovasc Surg 2017;24:35–40. [Google Scholar]
29. Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D. et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon versus sham in recurrent native dialysis fistula stenoses. J Vasc Access 2019;20:260–269. [DOI] [PubMed] [Google Scholar]
30. Karunanithy N, Mesa IR, Dorling A, Calder F, Katsanos K, Semik V. et al. Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial. Trials 2016;17:241. [DOI] [PMC free article] [PubMed] [Google Scholar]
31. Yildiz I. The efficacy of paclitaxel drug-eluting balloon angioplasty versus standard balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas: an analysis of clinical success, primary patency and risk factors for recurrent dysfunction. Cardiovasc Intervent Radiol 2019;42:685–692. [DOI] [PubMed] [Google Scholar]
32. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D.. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018;7:e011245. [DOI] [PMC free article] [PubMed] [Google Scholar]
33. Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R. et al. Survival after coronary revascularization with paclitaxel-coated balloons. J Am Coll Cardiol 2020;75:1017–1028. [DOI] [PubMed] [Google Scholar]
34. Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK. et al. Mortality assessment of paclitaxel-coated balloons: patient-level meta-analysis of the ILLUMENATE clinical program at 3 years. Circulation 2019;140:1145–1155. [DOI] [PMC free article] [PubMed] [Google Scholar]
35. Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA. et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol 2019;4:332–340. [DOI] [PMC free article] [PubMed] [Google Scholar]
36. Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M. et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol 2019;73:2550–2563. [DOI] [PubMed] [Google Scholar]
37. Trerotola SO, Kwak A, Clark T, Mondschein JI, Patel AA, Soulen MC. et al. Prospective study of balloon inflation pressures and other technical aspects of hemodialysis access angioplasty. J Vasc Interv Radiol 2005;16:1613–1618. [DOI] [PubMed] [Google Scholar]
38. Liao MT, Chen MK, Hsieh MY, Yeh NL, Chien KL, Lin CC. et al. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: a systematic review and meta-analysis of randomized controlled trials. PLoS One 2020;15:e0231463. [DOI] [PMC free article] [PubMed] [Google Scholar]
39. Dinh K, Limmer AM, Paravastu SCV, Thomas SD, Bennett MH, Holden A. et al. Mortality after paclitaxel-coated device use in dialysis access: a systematic review and meta-analysis. J Endovasc Ther 2019;26:600–612. [DOI] [PubMed] [Google Scholar]
40. Chen X, Liu Y, Wang J, Zhao J, Singh N, Zhang WW.. A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access. J Vasc Surg 2020;72:2186.e3–2196. e3. [DOI] [PubMed] [Google Scholar]
41.Deeks JJ, Higgins JP, Altman DG: Analysing Data and Undertaking Meta-Analyses. Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series. 2008. [Google Scholar]
42. Teramukai S, Matsuyama Y, Mizuno S, Sakamoto J.. Individual patient-level and study-level meta-analysis for investigating modifiers of treatment effect. Jpn J Clin Oncol 2004;34:717–721. [DOI] [PubMed] [Google Scholar]

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

znab301_Supplementary_Data

Click here for additional data file.^{(53.2KB, zip)}

[znab301-B1] 1. Stage TB, Bergmann TK, Kroetz DL.. Clinical pharmacokinetics of paclitaxel monotherapy: an updated literature review. Clin Pharmacokinet 2018;57:7–19. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B2] 2. Kayssi A, Al-Atassi T, Oreopoulos G, Roche-Nagle G, Tan KT, Rajan DK.. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev 2016;(8)CD011319. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B3] 3. Yan Wee IJ, Yap HY, Hsien Ts’ung LT, Lee Qingwei S, Tan CS, Tang TY. et al. A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis. J Vasc Surg 2019;70:970.e973–979.e973. [DOI] [PubMed] [Google Scholar]

[znab301-B4] 4. Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK.. Drug-coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis. J Vasc Interv Radiol 2019;30:483.e481–494.e481. [DOI] [PubMed] [Google Scholar]

[znab301-B5] 5. Cao Z, Li J, Zhang T, Zhao K, Zhao J, Yang Y. et al. Comparative effectiveness of drug-coated balloon vs balloon angioplasty for the treatment of arteriovenous fistula stenosis: a meta-analysis. J Endovasc Ther 2020;27:266–275. [DOI] [PubMed] [Google Scholar]

[znab301-B6] 6. Kim JW, Kim JH, Byun SS, Kang JM, Shin JH.. Paclitaxel-coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: a prospective randomized controlled trial. Korean J Radiol 2020;21:1239–1247. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B7] 7. Lookstein RA, Haruguchi H, Ouriel K, Weinberg I, Lei L, Cihlar S. et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. N Engl J Med 2020;383:733–742. [DOI] [PubMed] [Google Scholar]

[znab301-B8] 8. Pang SYC, Au-Yeung KCL, Liu GYL, Tse ROH, Lai D, Leung WKW. et al. Randomized controlled trial for paclitaxel-coated balloon versus plain balloon angioplasty in dysfunctional hemodialysis vascular access: 12-month outcome from a nonsponsored trial. Ann Vasc Surg 2021;72:299–306. [DOI] [PubMed] [Google Scholar]

[znab301-B9] 9. Yin Y, Shi Y, Cui T, Li H, Chen J, Zhang L. et al. Efficacy and safety of paclitaxel-coated balloon angioplasty for dysfunctional arteriovenous fistulas: a multicenter randomized controlled trial. Am J Kidney Dis 2021;78:19–27.e1. [DOI] [PubMed] [Google Scholar]

[znab301-B10] 10. Therasse E, Caty V, Gilbert P, Giroux MF, Perreault P, Bouchard L. et al. Safety and efficacy of paclitaxel-eluting balloon angioplasty for dysfunctional hemodialysis access: a randomized trial comparing with angioplasty alone. J Vasc Interv Radiol 2021;32:350.e2–359.e2. [DOI] [PubMed] [Google Scholar]

[znab301-B11] 11. Karunanithy N, Robinson EJ, Ahmad F, Burton JO, Calder F, Coles S. et al. A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas. Kidney Int 2021;100:447–456. [DOI] [PubMed] [Google Scholar]

[znab301-B12] 12. Trerotola SO, Saad TF, Roy-Chaudhury P.. The Lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis. J Vasc Interv Radiol 2020;31:1.e15–14.e15. [DOI] [PubMed] [Google Scholar]

[znab301-B13] 13. Stewart LA, Clarke M, Rovers M, Riley RD, Simmonds M, Stewart G. et al. ; PRISMA-IPD Development Group. Preferred reporting items for systematic review and meta-analyses of individual participant data: the PRISMA-IPD statement. JAMA 2015;313:1657–1665. [DOI] [PubMed] [Google Scholar]

[znab301-B14] 14. Cumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP. et al. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev 2019;(10)ED000142. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B15] 15. Hao C, Yan W, Xuan-Ming HU, Fang Z, Xian-Tao Z, Gu Y-H.. How to use GRADEpro GDT to rate the quality of evidence in systematic reviews of intervention studies: an introduction. Chin J Evid-Based Med 2015;15:600–606. [Google Scholar]

[znab301-B16] 16. Mantel N, Haenszel W.. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719–748. [PubMed] [Google Scholar]

[znab301-B17] 17. Tierney JF, Stewart LA, Ghersi D, Burdett S, Sydes MR.. Practical methods for incorporating summary time-to-event data into meta-analysis. Trials 2007;8:16. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B18] 18. Björkman P, Weselius EM, Venermo M.. No difference in mid-term and long-term mortality after vascular paclitaxel exposure. Ann Vasc Surg 2021;72:253–260. [DOI] [PubMed] [Google Scholar]

[znab301-B19] 19. Björkman P, Weselius EM, Kokkonen T, Rauta V, Albäck A, Venermo M.. Drug-coated versus plain balloon angioplasty in arteriovenous fistulas: a randomized, controlled study with 1-year follow-up (the Drecorest Ii-Study). Scand J Surg 2019;108:61–66. [DOI] [PubMed] [Google Scholar]

[znab301-B20] 20. Irani FG, Teo TKB, Tay KH, Yin WH, Win HH, Gogna A. et al. Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty. Radiology 2018;289:238–247. [DOI] [PubMed] [Google Scholar]

[znab301-B21] 21. Karmota AG. Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access. Ann R Coll Surg Engl 2020;102:601–605. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B22] 22. Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D.. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472). Eur J Radiol 2015;84:418–423. [DOI] [PubMed] [Google Scholar]

[znab301-B23] 23. Kitrou PM, Spiliopoulos S, Katsanos K, Papachristou E, Siablis D, Karnabatidis D.. Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial. J Vasc Interv Radiol 2015;26:348–354. [DOI] [PubMed] [Google Scholar]

[znab301-B24] 24. Lai CC, Fang HC, Tseng CJ, Liu CP, Mar GY.. Percutaneous angioplasty using a paclitaxel-coated balloon improves target lesion restenosis on inflow lesions of autogenous radiocephalic fistulas: a pilot study. J Vasc Interv Radiol 2014;25:535–541 [DOI] [PubMed] [Google Scholar]

[znab301-B25] 25. Liao MT, Lee CP, Lin TT, Jong CB, Chen TY, Lin L. et al. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg 2020;71:1994–2003. [DOI] [PubMed] [Google Scholar]

[znab301-B26] 26. Maleux G, Vander Mijnsbrugge W, Henroteaux D, Laenen A, Cornelissen S, Claes K. et al. Multicenter, randomized trial of conventional balloon angioplasty versus paclitaxel-coated balloon angioplasty for the treatment of dysfunctioning autologous dialysis fistulae. J Vasc Interv Radiol 2018;29:470.e473–475.e473 [DOI] [PubMed] [Google Scholar]

[znab301-B27] 27. Moreno-Sánchez T, Moreno-Ramírez M, Machancoses FH, Pardo-Moreno P, Navarro-Vergara PF, García-Revillo J.. Efficacy of paclitaxel balloon for hemodialysis stenosis fistulae after one year compared to high-pressure balloons: a controlled, multicenter, randomized trial. Cardiovasc Intervent Radiol 2020;43:382–390 [DOI] [PubMed] [Google Scholar]

[znab301-B28] 28. Roosen LJ, Karamermer Y, Vos JA, de Jong GM, Bos WJ, Elgersma OE.. Paclitaxel-coated balloons do not prevent recurrent stenosis in hemodialysis access fistulae: results of a randomized clinical trial. Ital J Vasc Endovasc Surg 2017;24:35–40. [Google Scholar]

[znab301-B29] 29. Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D. et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon versus sham in recurrent native dialysis fistula stenoses. J Vasc Access 2019;20:260–269. [DOI] [PubMed] [Google Scholar]

[znab301-B30] 30. Karunanithy N, Mesa IR, Dorling A, Calder F, Katsanos K, Semik V. et al. Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial. Trials 2016;17:241. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B31] 31. Yildiz I. The efficacy of paclitaxel drug-eluting balloon angioplasty versus standard balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas: an analysis of clinical success, primary patency and risk factors for recurrent dysfunction. Cardiovasc Intervent Radiol 2019;42:685–692. [DOI] [PubMed] [Google Scholar]

[znab301-B32] 32. Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D.. Risk of death following application of paclitaxel-coated balloons and stents in the femoropopliteal artery of the leg: a systematic review and meta-analysis of randomized controlled trials. J Am Heart Assoc 2018;7:e011245. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B33] 33. Scheller B, Vukadinovic D, Jeger R, Rissanen TT, Scholz SS, Byrne R. et al. Survival after coronary revascularization with paclitaxel-coated balloons. J Am Coll Cardiol 2020;75:1017–1028. [DOI] [PubMed] [Google Scholar]

[znab301-B34] 34. Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK. et al. Mortality assessment of paclitaxel-coated balloons: patient-level meta-analysis of the ILLUMENATE clinical program at 3 years. Circulation 2019;140:1145–1155. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B35] 35. Secemsky EA, Kundi H, Weinberg I, Jaff MR, Krawisz A, Parikh SA. et al. Association of survival with femoropopliteal artery revascularization with drug-coated devices. JAMA Cardiol 2019;4:332–340. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B36] 36. Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M. et al. Mortality not correlated with paclitaxel exposure: an independent patient-level meta-analysis of a drug-coated balloon. J Am Coll Cardiol 2019;73:2550–2563. [DOI] [PubMed] [Google Scholar]

[znab301-B37] 37. Trerotola SO, Kwak A, Clark T, Mondschein JI, Patel AA, Soulen MC. et al. Prospective study of balloon inflation pressures and other technical aspects of hemodialysis access angioplasty. J Vasc Interv Radiol 2005;16:1613–1618. [DOI] [PubMed] [Google Scholar]

[znab301-B38] 38. Liao MT, Chen MK, Hsieh MY, Yeh NL, Chien KL, Lin CC. et al. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: a systematic review and meta-analysis of randomized controlled trials. PLoS One 2020;15:e0231463. [DOI] [PMC free article] [PubMed] [Google Scholar]

[znab301-B39] 39. Dinh K, Limmer AM, Paravastu SCV, Thomas SD, Bennett MH, Holden A. et al. Mortality after paclitaxel-coated device use in dialysis access: a systematic review and meta-analysis. J Endovasc Ther 2019;26:600–612. [DOI] [PubMed] [Google Scholar]

[znab301-B40] 40. Chen X, Liu Y, Wang J, Zhao J, Singh N, Zhang WW.. A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access. J Vasc Surg 2020;72:2186.e3–2196. e3. [DOI] [PubMed] [Google Scholar]

[znab301-B41] 41.Deeks JJ, Higgins JP, Altman DG: Analysing Data and Undertaking Meta-Analyses. Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series. 2008. [Google Scholar]

[znab301-B42] 42. Teramukai S, Matsuyama Y, Mizuno S, Sakamoto J.. Individual patient-level and study-level meta-analysis for investigating modifiers of treatment effect. Jpn J Clin Oncol 2004;34:717–721. [DOI] [PubMed] [Google Scholar]

PERMALINK

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

H Hu

Q Tan

J Wang

Y Liu

Y Yang

J Zhao

Abstract

Background

Methods

Results

Conclusion

Introduction

Methods

Study design

Eligibility criteria

Types of study

Types of participant

Endpoints

Extraction and management of data

Quality assessment

Analysis and synthesis of data

Results

Characteristics of studies

Risk of bias

Table 1.

Fig. 1.

Target-lesion primary patency

Fig. 2.

Target-lesion revascularization

Fig. 3.

Access-circuit primary patency

Fig. 4.

Mortality

Fig. 5.

Sensitivity analysis

Subgroup analysis

Publication bias

Discussion

Funding

Supplementary Material

Acknowledgements

Supplementary material

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

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