Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

Abstract

Purpose:

To compare all-cause mortality and primary patency with drug-coated balloon angioplasty (DCBA) compared with plain balloon angioplasty (PBA) in people with hemodialysis-related stenosis.

Materials and methods:

PubMed, Embase, and Cochrane Library databases were searched from November 1966 to February 2021 to identify randomized controlled trials (RCTs) that assessed the use of DCBA versus PBA for stenosis in hemodialysis circuits. Data extracted from the articles were integrated to determine all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), 30-day adverse events, and technical success for the two approaches. We performed meta-analysis on these results using a fixed-effects model to evaluate odds ratios (ORs) and 95% confidence intervals (CIs) where I² < 50% in a test for heterogeneity, or a random-effect model if otherwise. Sensitivity and subgroup analyses were also performed.

Results:

Sixteen RCTs of 1672 individuals were included in our meta-analysis, of which 839 individuals received DCBA and 833 received PBA. The pooled outcome showed no statistical difference between DCBA and PBA in all-cause mortality at 6 months (OR = 1.29, 95% CI = 0.72–2.32, p = 0.39, I² = 4%), 12 months (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, I² = 0%), and 24 months (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, I² = 0%), 30-day adverse events (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, I² = 66%), and technical success (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, I² = 65%). The DCBA had significantly better outcomes versus PBA in TLPP at 6 months (OR = 2.37, 95% CI = 1.84–3.04, p < 0.001, I² = 44%) and 12 months (OR = 1.77, 95% CI = 1.22–2.56, p = 0.002, I² = 56%), and CAPP at 6 months (OR = 2.07, 95% CI = 1.21–3.54, p = 0.008, I² = 67%) and 12 months (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, I² = 0%).

Conclusion:

In hemodialysis circuit stenosis, DCBA appears to have similar safety but greater efficacy than PBA.

Keywords

Hemodialysis circuit balloon angioplasty drug-coated balloon mortality primary patency stenosis

Introduction

Hemodialysis (HD) is the most well-adopted method of renal replacement therapy globally since the 1960s.^1,2 Longevity on dialysis is directly proportional to dialysis quality, and that quality in turn depends on the reliability and integrity of access to the individual’s vascular system. The ideal HD access provides reliable, complication-free access for the delivery of prescribed dialysis and is suited to the individual’s needs. However, it is not possible to avoid stenosis with either arteriovenous fistular (AVF), as recommended by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative guidelines,³ or arteriovenous graft (AVG) and central venous catheter (CVS). Stenosis is the most common complication of HD, which seriously affects the quality of HD and can be life-threatening, owing to neointimal hyperplasia.^4–6

Balloon angioplasty is typically used for the primary treatment of clinically and angiographically significant AVF and AVG stenotic lesions.³ Unfortunately, the percentage of older individuals who undergo repeat intervention within 6 months is relatively high, at approximately 50%.^7–11 Drug-coated balloon angioplasty (DCBA), such as paclitaxel-coated balloon angioplasty, is already widely used in the therapy of peripheral arterial disease (PAD), and has been shown to improve the restenosis rate and freedom of reintervention.^12,13 DCBA may decrease the risk of de novo stenosis or restenosis by inhibiting neointimal hyperplasia and decreasing inflammatory responses in the vessel wall.

However, previous studies on the application of DCBA in HD access are controversial compared with plain balloon angioplasty (PBA): some studies show that the DCBA is superior compared with PBA in de novo stenosis or restenosis with AVF, AVG, and CVS,^14–17 while some studies do not.¹⁸ One meta-analysis showed that the application of DCBA increases all-cause mortality compared with PBA among people with PAD.¹⁹ This study therefore aimed to investigate long-term mortality and patency with DCBA versus PBA for individuals with HD circuit de novo stenosis or restenosis.

Materials and methods

Literature search and inclusion/exclusion criteria

Based on the standards outlined in the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) statement, we searched PubMed, Embase, and Cochrane Library databases for randomized controlled trials (RCTs) that evaluated DCBA versus PBA in de novo stenosis or restenosis with AVF/AVG/CVS from November 1966 to February 2021. The last literature search was updated on February 3, 2021. The following search terms were used in combinations with AND/OR: “fistula,” “arteriovenous fistula,” “arteriovenous fistulae,” “arteriovenous fistulas,” “arteriovenous access,” “AV fistulas,” “hemodialysis fistulas,” “dialysis fistulas,” “hemodialysis access,” “dialysis access,” “dialysis fistulae,” “dialysis fistula,” “drug-coated balloon,” “drug-eluting,” “drug-coated,” “plain balloon angioplasty,” “paclitaxel-coated,” “paclitaxel-eluting,” “conventional balloon,” “angioplasty,” “standard balloon,” “de novo stenosis,” “restenosis.”

Study Selection

Two authors independently assessed the eligibility of all retrieved articles, with a third author resolving any conflicts. Conflicts were settled by agreement among the authors. References from the retrieved articles were also searched. Eligibility for inclusion in our meta-analysis was based on the following criteria: (1) RCTs; (2) focused on DCBA application in de novo or recurrent AVF/AVG/CVS stenosis with PBA as the control; (3) contained data on all-cause mortality, target lesion primary patency (TLPP), circuit access primary patency (CAPP), technical/anatomic success, and 30-day adverse events for both DCBA and PBA; and (4) included a clinical follow-up of at least 6 months.

Data extraction and quality assessment

The following data were extracted from the enrolled studies: first author, year of publication, 6, 12, and 24-month all-cause mortality, 6, 12, 18, and 24-month TLPP, 6, 12, 18, and 24-month CAPP, 30-day adverse events, and technical/anatomic success. The Cochrane Risk of Bias tool was used to evaluate the quality of RCTs, and contained seven main sections: random sequence generation (selection bias), allocation concealment (selection bias), blinding of participants and personnel (performance bias), blinding of outcome assessment (detection bias), incomplete outcome data (attrition bias), selective reporting (reporting bias), and other bias. Heterogeneity was evaluated using the I² statistic; I² < 25% was taken to indicate a low risk of heterogeneity, 25%–50% a moderate risk of heterogeneity, and >50% a high risk of heterogeneity. Heterogeneity with an I² > 50% and p < 0.05 was considered significant across the enrolled studies. Potential publication bias was determined using the Egger test.

Outcome measures and statistical methods

All-cause mortality, TLPP, CAPP, 30-day adverse events, and technical/anatomic success were evaluated to determine the safety and effectiveness of DCBA compared with PBA. TLPP was defined as freedom from clinically-driven target lesion revascularization or access circuit thrombosis during the follow-up period after the index procedure. CAPP was defined as the interval from the index procedure to the next access intervention anywhere in the hemodialysis circuit. Thirty-day adverse events were categorized according to the Society of Interventional Radiology (SIR) criteria for adverse events.²⁰ Technical/anatomic success was defined as successful completion of the angioplasty procedure with less than 30% residual stenosis on the final angioplasty.

According to the Mantel–Haenszel method, the meta-analysis of these results was conducted using a fixed-effects model to evaluate the odds ratios (ORs) and 95% confidence intervals (Cls) when the risk of heterogeneity was low or moderate; otherwise, a random effects model was used. Subgroup analyses were conducted according to the study design. Sensitivity analyses for all-cause mortality, TLPP, CAPP, 30-day adverse events, and technical success rates were also conducted to estimate the sensitivity of the results by omitting one article at a time. A two-sided p < 0.05 indicated statistical significance. Analyses were performed using Stata software (version 14.0; StataCorp, College Station, TX, USA) and Review Manager (version 5.4.1; Cochrane Information Management System; http://ims.cochrane.org/revman).

Results

Characteristics of included studies

In total, 3748 potentially relevant records were identified, of which 3687 articles were removed by abstract and title screening. The remaining 61 articles were submitted for full-text review. Of these, 17 reports^{14–18,21–32} (16 RCTs) involving 1672 individuals met the selection criteria (Figure 1). Most studies focused on the target lesion of AVF and AVG, and others also included CVS. More than 81% of studies focused on both de novo and restenosis lesion types, and more than 68% of studies used IN.PCT Admiral (Medtronic) as the type of DCBA invention, with a drug dose of 2–3.5 μg/mm². The DCBA maintenance time ranged from 45 s to 3 min. More than 62% of studies used pre-dilation with a high-pressure balloon (HBP) before DCBA. Characteristics of all enrolled articles are summarized in Table 1. Among the 16 RCTs included in our study, eight were multicenter studies.^{14–16,25–28,31}

Table 1.

Characteristics of included RCTs.

Author	Study Des	No. of patients		Mean age (y)^a		Target lesion	Lesion type	DCBA intervention type	DCBA diameter	DCB Main.	Pre-dilation	Drug dose	Follow-up
Author	Study Des	DCBA	PBA	DCBA	PBA	Target lesion	Lesion type	DCBA intervention type	DCBA diameter	DCB Main.	Pre-dilation	Drug dose	Follow-up
Katsanos et al.²¹	RCT	20	20	65.7 ± 13.2	62.5 ± 15.4	AVF/AVG	De novo/restenosis	IN.PCT admiral	4–7/40–120	1	NA	3	6
Kitrou et al.²²	RCT	20	20	65.7 ± 13.2	62.5 ± 15.4	AVF/AVG	De novo/restenosis	IN.PCT admiral	4–7/40–80	NA	NA	3	12
Kitrou et al.²³	RCT	20	20	64.3 ± 14.5	57 ± 14.2	AVF	NA	IN.PCT admiral	4–7/40–120	1.5	No	3	12
Kitrou et al.²⁴	RCT	20	18	56.7 (25–81)	57 (33–81)	AVF/AVG/CV	De novo/restenosis	Lutonix	8–12/40–120	2	Yes	2	16
Irani et al.²⁵	RCT MC	59	60	59.0 ± 11.5	59.4 ± 8.8	AVF/AVG/CV	De novo/restenosis	IN.PCT admiral	4–7/40–80	1	Yes	3	12
Maleux et al.²⁶	RCT MC	33	31	69.3 ± 14.8	66.9 ± 17.0	AVF	De novo/restenosis	IN.PCT admiral	NA	2	Yes	NA	12
Swinnen et al.²⁷	RCT MC	68	60	64.5 ± 13.9	65.2 ± 13.6	AVF	Restenosis	IN.PCT admiral	NA	2	NA	3	12
Bjorkman et al.¹⁸	RCT	18	18	67.4 (46–87)	67.0 (28–82)	AVF	De novo/restenosis	IN.PCT admiral	NA	1.5	Yes	3.5	12
Liao et al.¹⁷	RCT	22	22	70.4 ± 10.6	65.9 ± 15.9	AVG	NA	IN.PCT admiral	4–7/40–80	1	No	NA	12
Moreno-Sánchez et al.²⁸	RCT MC	70	78	69 ± 12.99	71 ± 11.31	AVF/AVG/CV	De novo/restenosis	Lutonix	NA	0.75	Yes	NA	12
Kim et al.²⁹	RCT	20	19	60.7 ± 12.2	63.7 ± 11.8	AVF/AVG	De novo/restenosis	IN.PCT admiral	4–5	2	Yes	NA	42
Lookstein et al.¹⁴	RCT MC	170	160	65.8 ± 13.1	65.5 ± 13.4	AVF	De novo/restenosis	IN.PCT admiral	4–12/40–150	NA	Yes	3.5	12
Pang et al.³⁰	RCT	20	20	58.1 ± 8.93	57.4 ± 6.9	AVF/AVG	De novo/restenosis	IN.PCT admiral	NA	3	Yes	NA	12
Therasse et al.³¹	RCT MC	60	60	63.5 ± 12.6	66.6 ± 12.6	AVF/AVG	De novo/restenosis	Lutonix	NA	1	Yes	NA	12
Trerotola et al.³²	RCT MC	141	144	64 ± 15	61 ± 13	AVF	De novo/restenosis	Lutonix	4–12/20–100	2	NA	2	24
Yin et al.¹⁶	RCT MC	78	83	56 ± 13	54 ± 13	AVF	De novo/restenosis	APERTO	NA	2–3	Yes	3.0	12

RCT: randomized controlled trial; DCBA: drug-coated balloon angioplasty; PBA: plain balloon angioplasty; AVF: arteriovenous fistula; AVG: arteriovenous graft; CVS: central venous stenosis; NA: not available.

Data are expressed as mean or mean ± standard deviation.

Figure 1.

Flowchart of paper screening and selection process.

The Cochrane Risk of Bias Tool showed that most RCTs included in this meta-analysis had insufficient blinding strategies (Supplemental Table 1).

All-cause mortality

Eight studies^{14–18,25,26,31,32} reported all-cause mortality at 6 months. The pooled 6-month all-cause mortality rate in the DCBA group was 4.48% (26/581) compared with 3.46% (20/578) in the PBA group. There was no significant difference in 6-month all-cause mortality between the two groups (OR = 1.29, 95% CI = 0.72–2.32, Z = 0.86, p = 0.39, Figure 2(a)). The heterogeneity in the pooled results for this variable was low (I² = 4%). The results of the Egger test showed no significant publication bias (p = 0.103).

Figure 2.

Forest plots of all-cause mortality at (a) 6 months, (b) 12 months, and (c) 24 months between drug-coated balloon angioplasty (DCBA) and plain balloon angioplasty (PBA).

Nine studies^{14–18,25,26,28,31,32} reported all-cause mortality at 12 months. The pooled 12-month all-cause mortality rate in the DCBA group was 7.9% (52/651), compared with 7.8% (51/656) in the PBA group. There was no significant difference in 12-month all-cause mortality between the two groups (OR = 1.02, 95% CI = 0.68–1.53, p = 0.91, Z = 0.11, Figure 2(b)). The heterogeneity in the pooled results for this variable was low (I² = 0%). The results of the Egger test showed no publication bias (p = 0.163).

Only two studies^25,32 reported all-cause mortality at 24-months. The pooled 24-month all-cause mortality rate in the DCBA group was 19% (38/200) compared with 13.7% (28/204) in the PBA group. There was no significant difference in 24-month all-cause mortality between the two groups (OR = 1.50, 95% CI = 0.87–2.57, p = 0.15, Z = 1.46, Figure 2(c)). The heterogeneity in the pooled results for this variable was low (I² = 0%).

Target lesion primary patency

Eleven studies reported TLPP at 6 months.^{14–17,21,23–25,28,30,32,33} The TLPP at 6 months in the DCBA group was 75.2% (468/622), compared with 57.8% (365/632) in the PBA group. The pooled results showed a significant statistical difference between the two groups, with a moderate risk of heterogeneity (OR: 2.37, 95% CI: 1.84–3.04, p < 0.00001, Z = 6.73, I² = 44%, Figure 3(a)). A significant publication bias was observed in the Egger test (p = 0.049). However, the p value of the Egger test was 0.250 if one study³² was omitted.

Figure 3.

Forest plots of target lesion primary patency (TLPP) at (a) 6 months and (b) 12 months between drug-coated balloon angioplasty (DCBA) and plain balloon angioplasty (PBA).

Fourteen studies reported TLPP at 12 months.^{14–18,22–25,27–31} The pooled TLPP at 12 months in DCBA group was 47.8% (376/786), compared with 36.2% (283/782) in the PBA group. The pooled results showed a significant statistical difference between the two groups, with a high risk of heterogeneity (OR = 1.77, 95% CI = 1.22–2.56, Z = 3.04, p = 0.002, I² = 56%, Figure 3(b)). Heterogeneity was reduced to low (I² = 0%) if one study was omitted.¹⁸ As the sensitivity analysis showed no change in the pooled results after omitting each study, these results were considered relatively reliable. No significant publication bias was observed in the Egger test (p = 0.954).

Three studies reported TLPP at 18-months and 24-months.^22,23,29,32 The pooled results showed no significant difference between the DCBA and PBA groups at 18 months (OR = 1.46, 95% CI = 0.89–2.39, p = 0.13, Z = 1.51, I² = 33%), or 24 months (OR = 2.06, 95% CI = 0.14–29.62, p = 0.60, Z = 0.53, I² = 65%).

Circuit access primary patency

Eight studies reported CAPP at 6 months.^{14,15,17,21,22,24–26} The pooled CAPP at 6 months in the DCBA group was 64.1% (300/468), compared with 49.2% (228/463) in the PBA group. The pooled results showed a significant increase in this variable with DCBA versus PBA, with a high risk of heterogeneity (OR = 2.07, 95% CI = 1.21–3.54, Z = 2.66, p = 0.008, I² = 67%), Figure 4(a)). The sensitivity analysis showed no change in the pooled results after omitting each study, indicating reliability. The results of the Egger test showed no significant publication bias (p = 0.453).

Figure 4.

Forest plots of circuit access primary patency (CAPP) at (a) 6 months and (b) 12 months between drug-coated balloon angioplasty (DCBA) and plain balloon angioplasty (PBA). CI, confidence interval; M-H, Mantel-Haenszel.

Nine studies reported CAPP 12 months.^{14,15,17,23–27,31} The pooled CAPP at 12 months in the DCBA group was 36.4% (216/593) compared with 25.9% (149/575) in the PBA group. The pooled results showed a significant increase in this variable with DCBA versus PBA, with a low risk of heterogeneity (OR = 1.66, 95% CI = 1.29–2.15, p < 0.001, Z = 3.92, I² = 0%, Figure 4(b)). The results of the Egger test showed no significant publication bias (p = 0.660).

Only one paper reported CAPP at 18- and 24-months.³² The CAPP at 18-months in the DCBA group was 21.2% (24/113) compared with 18.4% (24/130) in the PBA group. The CAPP at 24-months was 0 in both DCBA and PBA groups.

Subgroup analysis based on study design

The pooled CAPP at 6 months (OR = 2.55, 95% CI = 1.77–3.68, p < 0.001, Z = 5.03, I² = 1%) and 12 months (OR: 1.89, 95% CI = 1.37–2.62, p = 0.0001, Z = 3.87, I² = 0%) indicated that DCBA was more effective compared with PBA in the prevention of stenosis where pre-dilation was used (Supplemental Figure 1A and 1B). However, the pooled CAPP with no pre-dilation at 6 months (OR = 3.17, 95% CI = 0.93–10.82, p = 0.06, Z = 1.85, I² = 78%) and CAPP at 12 months (OR = 1.34, 95% CI = 0.89–2.03, p = 0.16, Z = 1.40, I² = 0%) indicated no significant differences between DCBA and PBA (Supplemental Figure 2A and 2B).

The pooled TLPP at 6 months showed significant differences between DCBA and PBA group with both pre-dilation (OR = 2.86, 95% CI = 2.07–3.95, p < 0.001, Z = 6.34, I² = 0%) and no pre-dilation (OR = 3.39, 95% CI = 1.12–10.24, p = 0.03, Z = 2.17, I² = 73%) (Supplemental Figures 1C and 2C). The pooled TLPP at 12 months with no pre-dilation also demonstrated a significant difference between the groups (OR = 1.61, 95% CI = 1.10–2.34, p = 0.01, Z = 2.46, I² = 37%, Supplemental Figure 2D). However, the 12 months TLPP with pre-dilation showed no significant difference between the two groups (OR: 1.64, 95% CI = 1.00–2.67, p = 0.05, Z = 1.98, I² = 65%), owing to the influence of the study by Bjorkman et al.¹⁸ (Supplemental Figure 1D).

30-day adverse events

Seven studies^{14,15,26–29,31} reported 30-day adverse events. Overall, 3.9% (22/558) individuals had adverse events in the 30 days after the index procedure in the DBCA group, compared with 3.5% (19/550) in the PBA group. Four studies^26,27,29,31 reported 0 adverse events in this time period. The pooled 30-day adverse events indicated no significant difference between the DCBA and PBA groups, with a high risk of heterogeneity (OR = 1.09, 95% CI = 0.30–3.98, p = 0.90, Z = 0.12, I² = 66%, Supplemental Figure 3). One study¹⁴ accounted for most of the heterogeneity, with I² = 0% following its omission. The results of the Egger test showed no significant publication bias (p = 0.051).

Technical Success

Thirteen studies^{14,16–18,21–26,28–30} reported technical success rates (Supplemental Figure 4). Only three studies reported technical success rates of less than 100%. Overall, technical success was observed for 96.7% (551/570) in the DCBA group, compared with 99.1% (564/569) in the PBA group. There was no significant difference in technical success between the two groups, with high heterogeneity (OR = 0.18, 95% CI = 0.02–1.92, p = 0.16, Z = 1.41, I² = 66%, Supplemental Figure 4). There was no significant difference in the results when each of the included studies were omitted. The results of the Egger test showed no significant publication bias (p = 0.325).

Discussion

Maintaining the effectiveness of HD access is a challenge that frequently requires remedial treatment owing to complications associated with arteriovenous (AV) access. Stenosis is the most common complication, which may be life-threatening and seriously affects the quality of HD.⁵ Venous stenosis is often the result of neointimal hyperplasia,⁶ which leads to AV access non-maturation or dysfunction.³⁴

PTA is the first-line treatment recommended by the KDOQI guidelines for stenosis in HD access.³ Previous research has suggested that DCBA could reduce the times of intervention and prolong the access lifespan compared with PBA,^35–38 despite no significant difference in the primary patency at 200 days compared with PBA.²³ However, an RCT conducted by Bjorkman and colleagues¹⁸ with a one year follow-up period suggested that target lesion revascularization-free survival was worse after DCBA. This study contributed to a high risk of heterogeneity in past meta-analyses. Compared with previous systematic and meta-analyses, we included 16 RCTs, 8 of which were multicenter, which included 1672 individuals, most of whom received AVF. We evaluated the effectiveness of paclitaxel drug-coated balloon angioplasty, and found the TLPP and CAPP at 6 and 12 months was superior with DCBA compared with PBA. The TLPP in the DCBA group was 75.2% and 64.1% and the CAPP was 47.8%, and 36.4% at 6 and 12 months, respectively; this is similar to the values reported in previous studies.^8,10 However, the TLPP and CAPP at 18 or 24 months were not significantly different between the groups. These findings are clinically useful, describing the short and long-term benefits of DCBA.

A meta-analysis in 2018 found that paclitaxel-coated stents and balloons used in individuals with PAD for claudication were associated with an increase in 5-year all-cause mortality.¹⁹ As the relevance of this in people who receive hemodialysis was unclear, the 2019 KDOQI guidelines did not make a recommendation regarding the use of drug-coated balloons.³ Our analyses showed no significant difference in all-cause mortality between DCBA and PBA at 6, 12, and 24 months; these values were 4.48%, 7.9%, and 19%, respectively (Figure 2). This result corresponds with the annual mortality of the population of people receiving HD in general.³⁹ Factors affecting mortality in this group include cardiovascular events, infection, nutrition, age at dialysis, and others.^39–42 Paclitaxel had been used for almost 30 years as a chemotherapeutic agent in cancer, and can prolong lifespan.⁴³ Although the dosage used in chemotherapy is greater than in DCBA, no studies demonstrating increased mortality with paclitaxel in a proper application. Thirty-day adverse events also need to be considered, as an indicator of safety; our analysis found no significant difference in 30-day adverse events between DCBA and PBA. Based on the results, paclitaxel-coated balloons do not appear to increase all-cause mortality among people who receive HD.

The pooled technical success results also showed no significant difference between the DCBA and PBA groups. Interestingly, in the subgroup analysis, DCBA with pre-dilation was associated with a longer CAPP with significant differences at both 6 and 12 months compared with the group with no pre-dilation. The technical success rate with pre-dilation was also slightly higher than with no pre-dilation (99.6% vs 96.7%). This indicates that pre-dilation before DCBA should be used.

Limitations

There were several limitations to this study. First, Although the number of RCTs and patients enrolled in our meta-analysis was greater than in previous comparable studies, some articles did not distinguish between types of HD access, or list outcomes based on the type of HD access, and some did not distinguish between types of stenosis. Secondly, the follow-up time in most studies was 12 months, and the longest follow-up among the studies was 24 months. Compared with other diseases such as PAD, individuals with end-stage renal disease receiving HD are vulnerable to complications that were not easy for longer follow-up periods. Only a few articles reported on 24-month data, so our analysis has limited value in assessing this outcome. Thirdly, this meta-analysis was not registered in PROSPERO. Finally, sample sizes of enrolled articles were different, and the presence of heterogeneity and bias also affected outcomes.

Conclusions

In hemodialysis circuit stenosis, DCBA appears to result in similar all-cause mortality but better TLPP and CAPP compared with PBA. However, heterogeneity and risk of bias in the enrolled studies mean that these results should be interpreted with caution. Further studies that extend the follow-up period to 2–5 years are needed to provide more extensive safety and efficacy data for the use of DCBA.

Supplemental Material

sj-pdf-1-jva-10.1177_11297298211070125 – Supplemental material for Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials

Supplemental material, sj-pdf-1-jva-10.1177_11297298211070125 for Long-term mortality and patency after drug-coated balloon angioplasty in the hemodialysis circuit: A systematic review and meta-analysis of randomized controlled trials by Yunfeng Li, Zhenwei Shi, Yunyun Zhao, Zhanjiang Cao and Zhengli Tan in The Journal of Vascular Access

Footnotes

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical statement

All analyses were based on previous published studies, thus no ethical approval and patient consent were required.

ORCID iDs

Yunfeng Li

Zhanjiang Cao

Supplemental material

Supplemental material for this article is available online.

References

Saran

Robinson

Abbott

. United States Renal data System: 2016 USRDS annual data report: epidemiology of kidney disease in the United States. Am J Kidney Dis 2017; 69(3): A4.

Chatzimanouil

MKT

Wilkens

Anders

. Quantity and reporting quality of kidney research. J Am Soc Nephrol 2019; 30(1): 13–22.

Lok

Huber

Lee

, et al. KDOQI clinical practice guideline for vascular access: 2019 update. Am J Kidney Dis 2020; 75(4): S1–S164.

Viecelli

Mori

Roy-Chaudhury

, et al. The pathogenesis of hemodialysis vascular access failure and systemic therapies for its prevention: optimism unfulfilled. Semin Dial 2018; 31(3): 244–257.

Riella

Roy-Chaudhury

. Vascular access in haemodialysis: strengthening the Achilles’ heel. Nat Rev Nephrol 2013; 9(6): 348–357.

Roy-Chaudhury

Wang

Krishnamoorthy

, et al. Cellular phenotypes in human stenotic lesions from haemodialysis vascular access. Nephrol Dial Transplant 2009; 24(9): 2786–2791.

Kennedy

Mafeld

Baerlocher

, et al. Drug-Coated balloon angioplasty in hemodialysis circuits: a systematic review and meta-analysis. J Vasc Interv Radiol 2019; 30(4): 483–494.e1.

Cao

Zhang

, 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(2): 266–275.

Tripsianis

Christaina

Argyriou

, et al. Network meta-analysis of trials comparing first line endovascular treatments for arteriovenous fistula stenosis. J Vasc Surg 2021; 73: 2198–2203.e3.

10.

Chen

Liu

Wang

, et al. 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(6): 2186–2196.e3.

11.

Rokoszak

Syed

Salata

, et al. A systematic review and meta-analysis of plain versus drug-eluting balloon angioplasty in the treatment of juxta-anastomotic hemodialysis arteriovenous fistula stenosis. J Vasc Surg 2020; 71(3): 1046–1054.e1.

12.

Schmidt

Piorkowski

Görner

, et al. Drug-coated balloons for complex femoropopliteal lesions: 2-year results of a real-world registry. JACC Cardiovasc Interv 2016; 9(7): 715–724.

13.

Tepe

Zeller

Albrecht

, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. New Engl J Med 2008; 358(7): 689–699.

14.

Lookstein

Haruguchi

Ouriel

, et al. Drug-coated balloons for dysfunctional dialysis arteriovenous fistulas. New Engl J Med 2020; 383(8): 733–742.

15.

Trerotola

Lawson

Roy-Chaudhury

, et al. Drug coated balloon angioplasty in failing AV fistulas: a randomized controlled trial. Clin J Am Soc Nephrol 2018; 13(8): 1215–1224.

16.

Yin

Shi

Cui

, 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.

17.

Liao

Lee

Lin

, et al. A randomized controlled trial of drug-coated balloon angioplasty in venous anastomotic stenosis of dialysis arteriovenous grafts. J Vasc Surg 2020; 71(6): 1994–2003.

18.

Björkman

Weselius

Kokkonen

, et al. 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(1): 61–66.

19.

Katsanos

Spiliopoulos

Kitrou

, et al. 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(24): e011245.

20.

Gray

Sacks

Martin

, et al. Reporting standards for percutaneous interventions in dialysis access. J Vasc Interv Radiol 2003; 14(9): S433–S442.

21.

Katsanos

Karnabatidis

Kitrou

, et al. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther 2012; 19(2): 263–272.

22.

Kitrou

Katsanos

Spiliopoulos

, et al. 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(3): 418–423.

23.

Kitrou

Spiliopoulos

Katsanos

, et al. 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(3): 348–354.

24.

Kitrou

Papadimatos

Spiliopoulos

, et al. Paclitaxel-Coated balloons for the treatment of symptomatic central venous stenosis in dialysis access: results from a randomized controlled trial. J Vasc Interv Radiol 2017; 28(6): 811–817.

25.

Irani

Teo

TKB

Tay

, et al. Hemodialysis arteriovenous fistula and graft stenoses: randomized trial comparing drug-eluting balloon angioplasty with conventional angioplasty. Radiology 2018; 289(1): 238–247.

26.

Maleux

Vander Mijnsbrugge

Henroteaux

, 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(4): 470–475.e3.

27.

Swinnen

J“

Hitos

Kairaitis

, et al. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs sham in recurrent native dialysis fistula stenoses. J Vasc Access 2019; 20(3): 260–269.

28.

Moreno-Sánchez

Moreno-Ramírez

Machancoses

, et al. 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(3): 382–390.

29.

Kim

Byun

, et al. Paclitaxel-Coated balloon versus plain balloon angioplasty for dysfunctional autogenous radiocephalic arteriovenous fistulas: a prospective randomized controlled trial. Korean J Radiol 2020; 21(11): 1239–1247.

30.

Pang

SYC

Au-Yeung

KCL

Liu

GYL

, 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.

31.

Therasse

Caty

Gilbert

, 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: 350–359.e2.

32.

Trerotola

Saad

Roy-Chaudhury

. 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): 1–14.e5.

33.

Albalas

Almehmi

. Arterial emboli in the setting of prolonged dialysis access thrombosis. J Am Soc Nephrol 2020; 31: 445–446.

34.

Cheung

Imrey

Alpers

, et al. Intimal hyperplasia, stenosis, and arteriovenous fistula maturation failure in the hemodialysis fistula maturation study. J Am Soc Nephrol 2017; 28(10): 3005–3013.

35.

Khawaja

Cassidy

Shakarchi

, et al. Drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis: a systematic review and meta-analysis. J Vasc Access 2016; 17(2): 103–110.

36.

Yazar

Provoost

Broughton

, et al. Paclitaxel drug-coated balloon angioplasty for the treatment of failing arteriovenous fistulas: a single-center experience. Acta Chir Belg 2020; 120(2): 85–91.

37.

Somma

Ferro

Paudice

, et al. Drug coated balloons reduce the risk of restenosis in hemodialysis patients with recurrent stenosis of arteriovenous fistula. Nephrol Dial Transplant 2017; 32: 668–669.

38.

Troisi

Frosini

Somma

, et al. Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis. Int Angiol 2018; 37(1): 59–63.

39.

Collins

Foley

Herzog

, et al. Excerpts from the US renal data system 2009 annual data report. Am J Kidney Dis 2010; 55(1): A6–A7.

40.

Bloembergen

Port

Mauger

, et al. Causes of death in dialysis patients: racial and gender differences. J Am Soc Nephrol 1994; 5(5): 1231–1242.

41.

Cohen

McCue

Germain

, et al. Dialysis discontinuation: a ‘good’ death? Arch Intern Med 1995; 155(1): 42–47.

42.

Wallen

Radhakrishnan

Appel

, et al. An analysis of cardiac mortality in patients with new-onset end-stage renal disease in New York state. Clin Nephrol 2001; 55(2): 101–108.

43.

Wall

. Camptothecin and taxl. In: Chronicles of drug discovery. 1993, pp.327–348.

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