Abstract
Hemodialysis vascular access dysfunction remains a major cause of morbidity and repeated interventions. Stenosis related to neointimal hyperplasia and altered hemodynamics leads to access flow limitation and thrombosis, particularly in AVFs. While percutaneous transluminal angioplasty is the standard first-line treatment, durability is often limited, resulting in frequent reinterventions. Drug-coated balloons, most commonly paclitaxel-based, have been introduced to inhibit restenosis and have demonstrated improved target lesion patency compared with conventional balloon angioplasty in several randomized trials, though outcomes vary by lesion location and study design. This narrative review summarizes the current evidence for drug-coated balloon angioplasty in dysfunctional arteriovenous access, discusses key trial endpoints, reviews safety and practical considerations, and highlights ongoing controversies and future directions.
-
Keywords: Angioplasty; Arteriovenous fistula; Hemodialysis
Introduction
Maintaining long-term patency of hemodialysis vascular access remains a persistent challenge in patients with end-stage renal disease. AVFs, although preferred for durability and lower infection risk, frequently develop stenosis that compromises access flow and necessitates repeated interventions. Percutaneous transluminal angioplasty (PTA) has long been the cornerstone of treatment and provides excellent immediate technical success [
1,
2]. However, contemporary outcomes after plain balloon angioplasty remain suboptimal: post-PTA primary patency at 1 year is typically only 40% to 65% for AVFs and 20 to 50% for AVGs [
3-
6]. Consequently, restenosis is common, and many patients require multiple repeat procedures to maintain access function.
Over the past decade, drug-coated balloon (DCB) angioplasty has emerged as a strategy to improve the durability of endovascular treatment by combining mechanical dilation with local delivery of antiproliferative therapy. Overall, available evidence suggests that DCBs tend to provide favorable outcomes compared with plain balloon angioplasty in dysfunctional arteriovenous (AV) access; however, several randomized controlled trials (RCTs) and registry studies have also reported no statistically significant benefit in certain settings [
7-
9]. These mixed findings likely reflect differences in lesion location, access type, device characteristics, and procedural technique.
In this review, we first outline the pathophysiology of AV access stenosis from an interventional radiology perspective, then summarize the scientific rationale and clinical evidence for DCB angioplasty, discuss key technical and safety considerations, and highlight current knowledge gaps and future directions in the management of failed AVFs.
An AV Access Stenosis: An Interventional Radiology Perspective on Pathophysiology
From an interventional radiology perspective, AV access stenosis can be understood as a cycle of repeated vascular injury followed by an exaggerated healing response. The initiating or upstream events include surgical manipulation during fistula creation, exposure of the vein to high-pressure arterial flow and abnormal shear stress, uremia-related endothelial dysfunction, and repeated needle cannulation during dialysis. These injuries activate endothelial inflammation and thrombotic signaling, which lead to the downstream biologic response including migration and proliferation of vascular smooth muscle cells and fibroblasts, extracellular matrix deposition, and progressive intimal thickening known as neointimal hyperplasia (NIH) [
10-
12]. As the lumen narrows, disturbed flow further amplifies endothelial injury, creating a self-perpetuating cycle of stenosis. Importantly for interventionalists, balloon angioplasty relieves the obstruction mechanically but also causes additional barotrauma, which represents another upstream injury that can trigger the same downstream proliferative cascade and explains the high rate of restenosis [
13-
15]. Thus, AV access stenosis is not purely a mechanical problem but a biologic response to repeated injury, providing the rationale for antiproliferative strategies such as DCBs to interrupt this upstream–downstream cycle and potentially improve long-term patency.
Biological Rationale and Device Characteristics of DCBs
Recurrent stenosis in dysfunctional AV access is driven by NIH resulting from repeated vascular injury, as described above. DCBs were developed to interrupt this proliferative cascade at the time of angioplasty [
16]. Unlike plain balloon angioplasty, which mechanically fractures the lesion but leaves the biological response unchecked, DCBs deliver an antiproliferative drug directly to the vessel wall during balloon inflation. Paclitaxel, the most widely used agent, stabilizes microtubules and arrests smooth muscle cell division, suppressing neointimal growth while allowing endothelial recovery [
17,
18]. Because of its lipophilicity, brief balloon contact can achieve sustained tissue retention and prolonged biologic effect [
19].
The concept of local antiproliferative drug delivery has been validated in other vascular territories. DCBs were first widely adopted in femoropopliteal peripheral artery disease, where randomized trials showed improved patency compared with plain balloon angioplasty in selected lesions, and they later became an established treatment for coronary in-stent restenosis and small-vessel coronary disease [
20,
21]. Experience has also extended to venous stenoses, including AV access stenoses and central venous lesions, although outcomes have been more variable due to differences in vessel biology and hemodynamics [
22]. These cross-territory experiences support the biologic rationale for DCB use while highlighting that AVFs represent a unique environment characterized by extreme flow, repetitive puncture injury, and complex upstream–downstream dynamics that may modify treatment response.
Commercial DCB platforms differ in several design features that may influence clinical performance (
Table 1). Each device combines a balloon catheter, an antiproliferative drug, and an excipient that facilitates drug transfer. Balloon compliance and surface properties affect vessel wall contact, while drug dose density, coating stability, and excipient chemistry determine how much drug is retained during delivery and transferred into the vessel wall [
23]. In practice, these differences contribute to variable patency outcomes among devices, particularly in lesions with elastic recoil, calcification, or inadequate predilation [
24-
27]. Accordingly, careful lesion preparation, appropriate balloon sizing, sufficient inflation time, and avoidance of geographic miss remain essential to maximize drug delivery and clinical benefit.
Evolution of Randomized Evidence for DCB Angioplasty in Dialysis Access
To date, most RCTs evaluating DCB angioplasty in dialysis access have focused predominantly on AVFs rather than grafts. Since the initial clinical reports in 2012, multiple RCTs have examined whether DCB angioplasty improves patency compared with plain balloon angioplasty [
28,
29]. Overall, a substantial portion of the literature suggests meaningful benefit, but results remain heterogeneous across trials.
The most influential evidence comes from the IN.PACT AV Access, a multicenter RCT enrolling 330 patients with dysfunctional native AVFs [
24]. The target lesion primary patency (TLPP) was significantly higher with DCB than conventional balloon (CB) (82.2% vs. 59.5% at 6 months, p < 0.001). The advantage persisted at 12 months (63.8% vs. 43.6%, p < 0.001) with a 35.4% reduction in reinterventions required to maintain TLPP (total 93 vs. 144) [
30]. Extended follow-up through 36 months further supported durability: event-free TLPP remained higher (43.1% vs. 28.6%, p < 0.001), and access-circuit primary patency was improved (33.2% vs. 21.1%, p < 0.001) in the DCB group [
31].
By contrast, the Lutonix AV trial showed a smaller and time-dependent signal. At the prespecified primary analysis, TLPP at 6 months was 71% (DCB) vs. 63% (CB) (p = 0.06), narrowly missing statistical significance. An analysis allowing a 30-day window (9 months) showed TLPP 64% vs. 53% (p = 0.02). In the 2-year follow-up, TLPP differences were modest and time-dependent (12 months: 44% vs. 36%, p = 0.04; 24 months: 27% vs. 24%, p = 0.09), with no mortality difference through 2 years [
25,
32]. Importantly, even recent RCTs continue to report opposing signals, underscoring persistent controversy. In a contemporary RCT by Zhao et al. [
33], 12-month TLPP remained significantly higher with DCB than CB (66.1% [74/112] vs. 46.4% [52/112], p = 0.0037), with higher freedom from reintervention at 12 months (67.5% vs. 48.6%, p = 0.0006) and fewer reinterventions to maintain target lesion patency (48 vs. 94 total; mean, 0.4 vs 0.8 per patient; p = 0.001) [
33]. In contrast, the multicenter APERTO trial did not demonstrate a significant improvement in its primary clinical outcome at 1 year: functional hemodialysis access without reintervention at 12 months was achieved in 19.6% (10/51) of DCB group versus 9.6% (5/52) in the CB group (p = 0.612), and the authors concluded that longer adequate circuit function with DCB could not be shown [
34].
Within the native AV access circuit, lesion location appears to influence treatment response. In particular, cephalic arch stenosis is a lesion in which restenosis after CB angioplasty is frequent, largely because elastic recoil, marked vessel angulation with turbulent hemodynamics, and potential extrinsic compression often limit durable luminal gain. In this setting, a systematic review and meta-analysis focused on cephalic arch stenosis found no significant difference between DCB and CB angioplasty in primary patency at 6 and 12 months, suggesting that biologic inhibition of NIH alone may not fully overcome the predominant mechanical failure mechanisms [
35]. For central venous stenosis, clinical evidence specifically evaluating DCB angioplasty remains sparse. By analogy to cephalic arch stenosis, central venous lesions are frequently driven by elastic recoil, extrinsic compression, and long-segment fibrotic remodeling, mechanisms that can limit durable luminal gain after angioplasty. Therefore, it is plausible that the clinical effect of DCB angioplasty may likewise be attenuated in central venous stenosis.
Key aspects of trial design and major outcomes are presented in
Tables 2 and
3 [
24-
28,
31-
34,
36-
47]. As shown in these tables, there is substantial heterogeneity across studies with respect to the DCB platform, procedural technique, and the definitions of clinical and patency endpoints. In particular, differences between TLPP and access-circuit primary patency (ACPP) may contribute to variability in reported outcomes, as improvements in lesion-level patency do not necessarily translate into overall access durability. Taken together, the randomized evidence base in native AVFs more often suggests improved patency with DCB angioplasty; however, recent trials continue to report both positive and neutral findings. This pattern supports the concept that the clinical benefit of DCBs is context-dependent and underscores the need for additional standardized, lesion-specific randomized trials.
Evidence supporting DCB angioplasty in AVGs has historically been limited, as most randomized trials enrolled predominantly AVF patients and included only small numbers of graft lesions. One early single-center randomized trial by Liao et al. [
41] evaluated 44 dysfunctional AVGs with venous anastomotic stenosis and reported significantly higher 6-month TLPP in the DCB group compared with CB angioplasty (41% vs. 9%, p = 0.001), as well as higher 6-month ACPP (36% vs. 9%, p = 0.002) [
42]. However, this benefit was not sustained at 1 year, with 1-year ACPP of 14% vs. 9% (p = 0.273), suggesting that short-term improvement may not translate into durable long-term outcomes in AVGs.
More recently, a prospective multicenter RCT by Goo et al. [
46] specifically enrolled patients with dysfunctional AVGs caused by venous anastomotic stenosis and randomized 94 patients to DCB and 92 to CB angioplasty after successful lesion preparation. DCB angioplasty demonstrated significantly higher TLPP at 3 months (91.1% vs. 74.4%, p < 0.001) and 6 months (64.6% vs. 43.2%, p = 0.002), as well as improved ACPP at 6 months (63.4% vs. 42.0%, p = 0.002) and 12 months (29.1% vs. 14.6%, p = 0.022). Mortality at 12 months was similar between groups, although early thrombotic events within 3 months were more frequent in the DCB arm. This finding suggests a potential trade-off between short-term patency benefit and early thrombotic risk. Clinically, close early surveillance may help mitigate its impact, and further studies are needed to clarify the role of peri-procedural management in influencing these events.
Together, these studies suggest that DCB angioplasty may improve short- to mid-term patency in AVG stenosis but the evidence base remains smaller than that for AVFs, and long-term durability and lesion-specific benefit require further investigation.
Technical Considerations for DCB Angioplasty
Vessel Preparation
DCBs should be viewed primarily as drug delivery platforms rather than definitive angioplasty tools. Therefore, outcomes often depend on how well the lesion is prepared before DCB use. In AV access, DCBs are compliant or semi-compliant and are not designed for high-pressure dilation. Their nominal inflation pressures are typically around 5 to 8 atmospheres, with burst pressures around 12 to 14 atmospheres for commonly used platforms [
23,
48]. As a result, resistant venous stenoses that require higher pressures to fully eliminate balloon waist may not respond well to a DCB alone. For this reason, operators should first perform predilation with a high-pressure plain balloon to achieve an acceptable mechanical result. Trials commonly define this as 30% or less residual stenosis and no flow-limiting dissection [
24,
25]. Adequate predilation is also a simple angiographic test of whether the lesion is treatable with a DCB. For long or tandem lesions, careful measurement and segment-by-segment preparation help ensure full coverage and reduce the risk of geographic miss.
Because part of the drug coating can be lost before balloon inflation, keeping balloon transit time short is an important step. Drug loss may occur during device preparation, advancement through the sheath, or navigation across tight or tortuous segments [
49,
50]. To reduce avoidable coating loss, it is practical to complete all preparatory steps before opening the DCB package and to prepare the DCB only when the operator is ready for immediate deployment. Once introduced, the DCB should be advanced efficiently to the target lesion to minimize transit time, avoiding repeated push and pull maneuvers, unnecessary repositioning, or prolonged dwell time within the sheath [
51]. When feasible, selecting an access route that shortens the distance to the lesion and using an adequately sized sheath to reduce friction may further help preserve the coating during delivery. These workflow details are rarely captured in clinical trial endpoints, but they can influence the effective drug dose delivered in real-world practice.
Because DCB angioplasty is intended to achieve local pharmacologic effect, inflation time should be selected to ensure sustained and uniform balloon-wall contact that supports drug deposition and tissue uptake. In contemporary AV access practice, inflation durations commonly fall within 60- to 180-second range per treated segment, with some protocols favoring longer inflations when balloon position is stable and the patient can tolerate prolonged occlusion [
52].
Notably, real-world registry data have suggested a time-dependent signal. In the prospective registry, 6-month TLPP was higher with longer inflation, with TLPP increasing across longer inflation time (68% for 50–120 seconds vs. 80% for 120–180 seconds; p = 0.007), implying that longer contact may improve clinical durability [
53]. Similar themes have been raised in meta-analyses, although it remains difficult to isolate the independent contribution of inflation time from other tightly linked determinants of success, such as lesion preparation quality, balloon sizing, device platform, and avoidance of geographic miss [
22].
Accordingly, when satisfactory vessel preparation has already been achieved and the balloon can be maintained in a stable position, a minimum DCB inflation time of ≥3 minutes (≥180 seconds) seems to be reasonable to maximize the likelihood of effective drug transfer, while acknowledging that the optimal duration is not definitively established and should be refined by future protocolized studies.
Safety Profile of DCBs in Dialysis Access Interventions
The safety of DCB angioplasty in AV access has been evaluated with attention to systemic paclitaxel exposure, downstream embolization, and long-term outcomes. Although DCBs are designed for local drug delivery, a small amount of drug may be lost during device handling, transit, or inflation, resulting in only limited systemic exposure. The total paclitaxel dose used in AV access procedures is far lower than that used in systemic cancer therapy, and current clinical trials in dialysis access have not shown a consistent increase in morbidity and mortality [
54].
Concerns about possible late mortality from paclitaxel-coated devices were first raised in peripheral arterial disease studies [
55]. However, this signal has not been clearly reproduced in AV access trials, and subsequent individual patient data analyses in femoropopliteal peripheral arterial disease have also not demonstrated a significant increase in mortality associated with paclitaxel-coated devices [
56,
57]. These findings are generally reassuring; however, they should be interpreted with caution in the dialysis population. Patients with hemodialysis access frequently undergo repeated endovascular interventions, which may result in higher cumulative paclitaxel exposure over time compared with patients treated for peripheral arterial disease. In addition, their distinct comorbidity profile and competing risks may modify both short- and long-term outcomes, underscoring the need for continued surveillance and long-term safety evaluation in this population.
Additional procedural safety considerations include non-target particulate embolization from balloon coatings, especially with excessive device handling or prolonged transit time, and the possibility of vessel injury if DCBs are used without adequate lesion preparation [
49,
50]. Overall, available evidence suggests that DCB angioplasty has an acceptable safety profile in AV access interventions [
9,
58,
59]. Nevertheless, careful patient selection, standardized technique, and long-term follow-up remain essential to fully define its risk-benefit balance.
Korean Reimbursement Landscape and Real-World Practice Considerations
In Korea, reimbursement for DCB angioplasty in hemodialysis access was introduced in May 2025, but its application remains restricted to narrowly defined clinical scenarios. Under the current national insurance criteria, DCB use is reimbursed for stenotic lesions in native AVFs or AVG when recurrent stenosis is documented within 3 months after prior plain balloon angioplasty at the same lesion. Accordingly, primary DCB use without evidence of early restenosis after conventional angioplasty is not reimbursed, which has an important impact on real-world case selection and treatment strategy. From a practice standpoint, these criteria concentrate DCB use in patients with biologically aggressive restenosis or early failure after PTA, thereby enriching Korean DCB-treated cohorts for higher-risk lesions compared with many Western settings where DCB use may be more readily implemented in routine practice. This reimbursement-driven selection effect should be considered when interpreting domestic outcomes, comparing Korean real-world data with international studies, and designing future studies, as observed effectiveness may be attenuated or appear more variable when the treated population is skewed toward early recurrent stenosis. As Korean experience expands under the current reimbursement system, prospective registries and lesion-specific studies that explicitly account for these policy constraints will be valuable to define the most cost-effective and clinically impactful indications for DCB use in dialysis access maintenance.
Knowledge Gaps and Future Directions
DCBs show promise for maintaining AV access, but evidence remains heterogeneous. A major gap is that outcomes are highly lesion- and technique-dependent; differences in lesion preparation, balloon sizing, inflation strategy, and technical endpoints likely contribute to inconsistent RCT results. Accordingly, future multicenter trials should standardize procedural protocols and stratify by lesion location and access characteristics to clarify where DCBs provide the most benefit.
Another key gap is the unique biology and hemodynamics of AV access such as high flow, repeated cannulation injury, and complex upstream–downstream stresses, which may alter drug transfer and durability compared with arterial applications. Mechanistic studies linking hemodynamics, tissue drug retention, and imaging/pathology are needed. Finally, device variability lacks robust head-to-head data and comparative effectiveness and safety studies including repeated exposure in patients needing frequent reinterventions remain priorities. Overall, progress will depend on combining better lesion selection with standardized technique and evaluating emerging platforms such as sirolimus-based coatings or combination strategies with lesion preparation devices.
Conclusion
DCB angioplasty offers a biologically targeted adjunct to conventional angioplasty for dysfunctional AV access by suppressing the NIH that drives recurrent stenosis. While randomized trials suggest improved patency in selected settings, results remain heterogeneous and appear dependent on lesion characteristics, device design, and procedural technique. Overall, DCBs have an acceptable safety profile and may provide meaningful benefit when used after high-quality vessel preparation with careful attention to delivery factors. Future studies should standardize technique and refine lesion-specific selection to better define where DCBs add the greatest value in AV access maintenance.
Conflict of interest
No potential conflict of interest relevant to this article was reported.
Funding
None.
Acknowledgments
None.
Author contributions
The author conducted all aspects of the study.
Data availability statement
The datasets generated or analyzed during the study are available from the corresponding author on reasonable request.
Table 1.Drug-coated balloon used in hemodialysis access trials
Table 1.
|
Brand name (manufacturer) |
Paclitaxel dose (μg/mm2) |
Excipient material |
Balloon diameter (mm) |
|
In.Pact (Medtronic) |
3.5 |
Urea |
4–12 |
|
Lutonix (Becton Dickison) |
2.0 |
Polysorbate and sorbitol |
4–12 |
|
APERTO (Cardionovum) |
3.0 |
Ammonium salt |
5–10 |
|
Passeo-18 Lux (Biotronik) |
3.0 |
Hydrophobic butyryl-tri-hexyl citrate |
2–7 |
|
AcoArt Orchid (Acotec) |
3.3 |
Magnesium stearate |
4–12 |
Table 2.Design characteristics and procedural techniques in randomized trials
Table 2.
|
Study |
Publication year |
No. of patients |
Access type (AVF or AVG) |
Lesion type (de novo or recurrent) |
Vessel preparation |
DCB type |
Inflation time (s) |
|
Katsanos et al. [28] |
2012 |
40 |
Both |
NR |
No |
In.Pact |
>60 |
|
Kitrou et al. [36] |
2015 |
40 |
AVF |
Both |
No |
In.Pact |
90 |
|
Irani et al. [37] |
2018 |
119 |
Both |
Both |
Yes |
In.Pact |
60 |
|
Trerotola et al. [25,32] |
2018 |
285 |
AVF |
Both |
Yes |
Lutonix |
>30 |
|
Maleux et al. [38] |
2018 |
64 |
AVF |
Both |
Yes |
In.Pact |
NA |
|
Bjorkman et al. [39] |
2019 |
36 |
AVF |
Both |
Yes |
In.Pact |
90 |
|
Kim et al. [26] |
2020 |
39 |
AVF |
Both |
Yes |
In.Pact |
120 |
|
Karmota [40] |
2020 |
60 |
AVF |
NR |
Yes |
Lutonix |
180 |
|
Liao et al. [41] |
2020 |
44 |
AVG |
Recurrent |
No |
In.Pact |
60 |
|
Lookstein et al. [24] |
2020 |
330 |
AVF |
Both |
Yes |
In.Pact |
>180 |
|
Moreno-Sanchez et al. [42] |
2020 |
148 |
Both |
Both |
Yes |
Passeo-Lux |
45 |
|
Pang et al. [43] |
2021 |
40 |
Both |
Both |
Yes |
In.Pact |
180 |
|
Karunanithy et al. [27] |
2021 |
212 |
AVF |
Both |
Yes |
Lutonix |
>60 |
|
Yin et al. [44] |
2021 |
161 |
AVF |
Both |
Yes |
APERTO |
120–180 |
|
Therasse et al. [45] |
2021 |
120 |
Both |
Both |
Yes |
Passeo-Lux |
60 |
|
Goo et al. [46] |
2024 |
190 |
AVG |
Both |
Yes |
In.Pact |
180 |
|
Zhao et al. [33] |
2024 |
244 |
AVF |
Both |
Yes |
AcoArt |
120 |
|
Maleux et al. [34] |
2025 |
103 |
Both |
Both |
No |
APERTO |
60–120 |
Table 3.Clinical outcomes of randomized trials comparing DCB and CB angioplasty
Table 3.
|
Study |
Publication year |
Primary endpoint |
Outcomes |
Significant effect |
Significant AE difference |
|
Katsanos et al. [28] |
2012 |
TLPP at 6 mo |
70% (DCB) vs. 25% (CB), p < 0.001 |
Yes |
No |
|
Kitrou et al. [36] |
2015 |
TLPP at 12 mo |
35% (DCB) vs. 5% (CB), p < 0.001 |
Yes |
No |
|
Irani et al. [37] |
2018 |
TLPP at 6 mo |
81% (DCB) vs. 61% (CB), p = 0.03 |
Yes |
No |
|
Trerotola et al. [25,32] |
2018 |
TLPP at 6, 9, 12, 24 mo |
71% (DCB) vs. 63% (CB) at 6 mo, p = 0.06 |
Noa
|
No |
|
58% (DCB) vs. 46% (CB) at 9 mo, p = 0.02 |
|
44% (DCB) vs. 36% (CB) at 12 mo, p = 0.04 |
|
27% (DCB) vs. 24% (CB) at 24 mo, p = 0.09 |
|
Maleux et al. [38] |
2018 |
ACPP at 6, 12 mo |
68% (DCB) vs. 65% (CB) at 6 mo, p = 0.8 |
No |
No |
|
42% (DCB) vs. 39% (CB) at 12 mo, p = 0.95 |
|
Bjorkman et al. [39] |
2019 |
TLR at 12 mo |
89% (DCB) vs. 22% (CB), p = 0.001 |
No |
No |
|
Kim et al. [26] |
2020 |
TLPP at 12 mo |
65% (DCB) vs. 58% (CB) at 12 mo, p = 0.9 |
No |
No |
|
Karmota [40] |
2020 |
TLPP at 6, 12 mo |
97% (DCB) vs. 90% (CB) at 6 mo, p = 0.3 |
Noa
|
No |
|
90% (DCB) vs. 67% (CB) at 12 mo, p = 0.03 |
|
Liao et al. [41] |
2020 |
TLPP at 6 mo |
41% (DCB) vs. 9% (CB), p = 0.006 |
Yes |
No |
|
Lookstein et al. [24,31,47] |
2020 |
TLPP at 6, 12, 24, 36 mo |
82% (DCB) vs. 60% (CB) at 6 mo, p < 0.001 |
Yes |
No |
|
63.8% (DCB) vs. 43.6% (CB) at 12 mo, p < 0.001 |
|
52.1% (DCB) vs. 36.7% (CB) at 24 mo, p < 0.001 |
|
43.1% (DCB) vs. 28.6% (CB) at 36 mo, p < 0.001 |
|
Moreno-Sanchez et al. [42] |
2020 |
TLPP at 6 and 12 mo |
153 days (DCB) vs. 142 days (CB) at 6 mo, p = 0.07 |
No |
No |
|
266 days (DCB) vs. 238 days (CB) at 12 mo, p = 0.37 |
|
Pang et al. [43] |
2021 |
TLPP at 12 mo |
65% (DCB) vs. 30% (CB), p = 0.007 |
Yes |
No |
|
Karunanithy et al. [27] |
2021 |
Time to lose TLPP at 6 mo |
159 days (DCB) vs. 215 days (CB), p = 0.44 |
No |
No |
|
Yin et al. [44] |
2021 |
TLR-free survival at 6 mo |
86% (DCB) vs. 78% (CB), p = 0.3 |
No |
No |
|
Therasse et al. [45] |
2021 |
LLL at 6 mo |
0.64 mm (DCB) vs. 1.13 mm (CB), p = 0.08 |
No |
No |
|
Goo et al. [46] |
2024 |
TLPP at 3, 6 mo |
91.1% (DCB) vs. 64.6% (CB) at 3 mo, p = 0.001 |
Yes |
Yes (thrombosis) |
|
74.4% (DCB) vs. 43.2% (CB) at 6 mo, p = 0.001 |
|
Zhao et al. [33] |
2024 |
TLPP at 6 mo |
91% (DCB) vs. 67% (CB), p < 0.001 |
Yes |
No |
|
Maleux et al. [34] |
2025 |
TLPP at 12 mo |
19.6% (DCB) vs. 9.6% (CB), p = 0.612 |
No |
No |
References
- 1. Lok CE, Moist L. KDOQI 2019 Vascular access guidelines: what is new? Adv Chronic Kidney Dis. 2020;27:171-176. https://doi.org/10.1053/j.ackd.2020.02.003
- 2. Beathard GA. Percutaneous transvenous angioplasty in the treatment of vascular access stenosis. Kidney Int. 1992;42:1390-1397. https://doi.org/10.1038/ki.1992.431
- 3. Lawson JH, Niklason LE, Roy-Chaudhury P. Challenges and novel therapies for vascular access in haemodialysis. Nat Rev Nephrol. 2020;16:586-602. https://doi.org/10.1038/s41581-020-0333-2
- 4. Rajan DK, Bunston S, Misra S, Pinto R, Lok CE. Dysfunctional autogenous hemodialysis fistulas: outcomes after angioplasty: are there clinical predictors of patency? Radiology. 2004;232:508-515. https://doi.org/10.1148/radiol.2322030714
- 5. Heye S, Maleux G, Vaninbroukx J, Claes K, Kuypers D, Oyen R. Factors influencing technical success and outcome of percutaneous balloon angioplasty in de novo native hemodialysis arteriovenous fistulas. Eur J Radiol. 2012;81:2298-2303. https://doi.org/10.1016/j.ejrad.2011.09.004
- 6. 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;70:970-979. https://doi.org/10.1016/j.jvs.2019.01.082
- 7. Xu ZW, Li HB, Yang XS, Qin HS, Hao QZ. Comparison of drug-coated balloon versus plain balloon angioplasty for the treatment of arteriovenous fistula stenosis: a systematic review and meta-analysis of randomized controlled trials. Cardiovasc Intervent Radiol. 2026;49:17-31. https://doi.org/10.1007/s00270-025-04279-1
- 8. Elahi A, Qamar M, Khan FM, Babar R, Zahid MJ, Ahmad MO, et al. Efficacy of drug-coated balloon versus uncoated balloon for dysfunctional dialysis access: a systematic review and meta-analysis. Clin Exp Nephrol. 2025;29:974-986. https://doi.org/10.1007/s10157-025-02642-7
- 9. Lee H, Choi H, Han E, Kim YJ. Comparison of clinical effectiveness and safety of drug-coated balloons versus percutaneous transluminal angioplasty in arteriovenous fistulae: a review of systematic reviews and updated meta-analysis. J Vasc Interv Radiol. 2024;35:949-962. https://doi.org/10.1016/j.jvir.2024.03.027
- 10. Lee T, Ul Haq N. New developments in our understanding of neointimal hyperplasia. Adv Chronic Kidney Dis. 2015;22:431-437. https://doi.org/10.1053/j.ackd.2015.06.010
- 11. Remuzzi A, Ene-Iordache B. Novel paradigms for dialysis vascular access: upstream hemodynamics and vascular remodeling in dialysis access stenosis. Clin J Am Soc Nephrol. 2013;8:2186-2193. https://doi.org/10.2215/CJN.03450413
- 12. Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol. 2006;17:1112-1127. https://doi.org/10.1681/ASN.2005050615
- 13. Portugaller RH, Kalmar PI, Deutschmann H. The eternal tale of dialysis access vessels and restenosis: are drug-eluting balloons the solution? J Vasc Access. 2014;15:439-447. https://doi.org/10.5301/jva.5000271
- 14. Davidson CJ, Newman GE, Sheikh KH, Kisslo K, Stack RS, Schwab SJ. Mechanisms of angioplasty in hemodialysis fistula stenoses evaluated by intravascular ultrasound. Kidney Int. 1991;40:91-95. https://doi.org/10.1038/ki.1991.185
- 15. Lee T. Novel paradigms for dialysis vascular access: downstream vascular biology: is there a final common pathway? Clin J Am Soc Nephrol. 2013;8:2194-2201. https://doi.org/10.2215/CJN.03490413
- 16. Gray WA, Granada JF. Drug-coated balloons for the prevention of vascular restenosis. Circulation. 2010;121:2672-2680. https://doi.org/10.1161/CIRCULATIONAHA.110.936922
- 17. Weaver BA. How taxol/paclitaxel kills cancer cells. Mol Biol Cell. 2014;25:2677-2681. https://doi.org/10.1091/mbc.E14-04-0916
- 18. Scheller B, Speck U, Abramjuk C, Bernhardt U, Bohm M, Nickenig G. Paclitaxel balloon coating, a novel method for prevention and therapy of restenosis. Circulation. 2004;110:810-814. https://doi.org/10.1161/01.CIR.0000138929.71660.E0
- 19. Granada JF, Stenoien M, Buszman PP, Tellez A, Langanki D, Kaluza GL, et al. Mechanisms of tissue uptake and retention of paclitaxel-coated balloons: impact on neointimal proliferation and healing. Open Heart. 2014;1:e000117. https://doi.org/10.1136/openhrt-2014-000117
- 20. Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, et al. Trial of a paclitaxel-coated balloon for femoropopliteal artery disease. N Engl J Med. 2015;373:145-153. https://doi.org/10.1056/NEJMoa1406235
- 21. Unverdorben M, Vallbracht C, Cremers B, Heuer H, Hengstenberg C, Maikowski C, et al. Paclitaxel-coated balloon catheter versus paclitaxel-coated stent for the treatment of coronary in-stent restenosis. Circulation. 2009;119:2986-2994. https://doi.org/10.1161/CIRCULATIONAHA.108.839282
- 22. Kitrou PM, Katsanos K, Spyridonidis I, Theofanis M, Papachristou E, Papadoulas S, et al. Use of drug-coated balloons in dysfunctional arteriovenous dialysis access treatment: the effect of consecutive treatments on lesion patency. J Vasc Interv Radiol. 2019;30:212-216. https://doi.org/10.1016/j.jvir.2018.11.013
- 23. Shazly T, Torres WM, Secemsky EA, Chitalia VC, Jaffer FA, Kolachalama VB. Understudied factors in drug-coated balloon design and evaluation: a biophysical perspective. Bioeng Transl Med. 2023;8:e10370. https://doi.org/10.1002/btm2.10370
- 24. 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. https://doi.org/10.1056/NEJMoa1914617
- 25. Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug coated balloon angioplasty in failing AV fistulas: a randomized controlled trial. Clin J Am Soc Nephrol. 2018;13:1215-1224. https://doi.org/10.2215/CJN.14231217
- 26. 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. https://doi.org/10.3348/kjr.2020.0067
- 27. 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. https://doi.org/10.1016/j.kint.2021.02.040
- 28. Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D. 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;19:263-272. https://doi.org/10.1583/11-3690.1
- 29. Manaki V, Bontinis V, Giannopoulos A, Kontes I, Rafailidis V, Ktenidis K. Drug-eluting stents for the treatment of arteriovenous access stenosis: a systematic review and individual patient data (IPD) meta-analysis. Ann Vasc Surg. 2026;123:514-523. https://doi.org/10.1016/j.avsg.2025.10.028
- 30. Holden A, Haruguchi H, Suemitsu K, Isogai N, Ross J, Hull J, et al. IN.PACT AV access randomized trial: 12-month clinical results demonstrating the sustained treatment effect of drug-coated balloons. J Vasc Interv Radiol. 2022;33:884-894. https://doi.org/10.1016/j.jvir.2022.03.606
- 31. Lookstein R, Haruguchi H, Suemitsu K, Isogai N, Gallo V, Madassery S, et al. IN.PACT AV access randomized trial of drug-coated balloons for dysfunctional arteriovenous fistulae: clinical outcomes through 36 months. J Vasc Interv Radiol. 2023;34:2093-2102. https://doi.org/10.1016/j.jvir.2023.07.007
- 32. Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The lutonix AV randomized trial of paclitaxel-coated balloons in arteriovenous fistula stenosis: 2-year results and subgroup analysis. J Vasc Interv Radiol. 2020;31:1-14. https://doi.org/10.1016/j.jvir.2019.08.035
- 33. Zhao Y, Wang P, Wang Y, Zhang L, Zhao Y, Li H, et al. Drug-coated balloon angioplasty for dysfunctional arteriovenous hemodialysis fistulae: a randomized controlled trial. Clin J Am Soc Nephrol. 2024;19:336-344. https://doi.org/10.2215/CJN.0000000000000359
- 34. Maleux G, van der Linden E, Heijboer RJJ, Serafino GP, Wust AFJ, Dol JA, et al. Multicenter randomized controlled trial of APERTO-paclitaxel drug-eluting balloon angioplasty versus standard percutaneous transluminal angioplasty in dysfunctional hemodialysis grafts and native fistulae. J Endovasc Ther. 2025;32:1580-1588. https://doi.org/10.1177/15266028231215212
- 35. Kim H, Kim YS, Labropoulos N. Management of cephalic arch stenosis in hemodialysis access: updated systematic review and meta-analysis. J Vasc Access. 2025;26:1229-1240. https://doi.org/10.1177/11297298241264583
- 36. 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. https://doi.org/10.1016/j.ejrad.2014.11.037
- 37. Irani FG, Teo TK, 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. https://doi.org/10.1148/radiol.2018170806
- 38. 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;29:470-475. https://doi.org/10.1016/j.jvir.2017.10.023
- 39. Bjorkman P, Weselius EM, Kokkonen T, Rauta V, Alback 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. https://doi.org/10.1177/1457496918798206
- 40. 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. https://doi.org/10.1308/rcsann.2020.0121
- 41. 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. https://doi.org/10.1016/j.jvs.2019.07.090
- 42. Moreno-Sanchez T, Moreno-Ramirez M, Machancoses FH, Pardo-Moreno P, Navarro-Vergara PF, Garcia-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. https://doi.org/10.1007/s00270-019-02372-w
- 43. Pang SY, Au-Yeung KC, Liu GY, Tse RO, Lai D, Leung WK, 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. https://doi.org/10.1016/j.avsg.2020.10.005
- 44. 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. https://doi.org/10.1053/j.ajkd.2020.11.022
- 45. 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;32:350-359. https://doi.org/10.1016/j.jvir.2020.10.030
- 46. Goo DE, Kim YJ, Park SW, Cheon HJ, Won YD, Yang SB. A prospective multicenter randomized controlled trial for comparing drug-coated and conventional balloon angioplasty in venous anastomotic stenosis of hemodialysis arteriovenous grafts. Cardiovasc Intervent Radiol. 2024;47:36-44. https://doi.org/10.1007/s00270-023-03536-5
- 47. Pietzsch JB, Geisler BP, Manda B, Misra S, Lyden SP, Pflederer TA, et al. IN.PACT AV access trial: economic evaluation of drug-coated balloon treatment for dysfunctional arteriovenous fistulae based on 12-month clinical outcomes. J Vasc Interv Radiol. 2022;33:895-902. https://doi.org/10.1016/j.jvir.2022.04.014
- 48. Boitet A, Massy ZA, Goeau-Brissonniere O, Javerliat I, Coggia M, Coscas R. Drug-coated balloon angioplasty for dialysis access fistula stenosis. Semin Vasc Surg. 2016;29:178-185. https://doi.org/10.1053/j.semvascsurg.2016.08.002
- 49. Faenger B, Heinrich A, Hilger I, Teichgraber U. Drug loss from paclitaxel-coated balloons during preparation, insertion and inflation for angioplasty: a laboratory investigation. Cardiovasc Intervent Radiol. 2022;45:1186-1197. https://doi.org/10.1007/s00270-022-03164-5
- 50. Heinrich A, Engler MS, Guttler FV, Matthaus C, Popp J, Teichgraber UK. Systematic evaluation of particle loss during handling in the percutaneous transluminal angioplasty for eight different drug-coated balloons. Sci Rep. 2020;10:17220. https://doi.org/10.1038/s41598-020-74227-1
- 51. Villar-Matamoros E, Stokes L, Lloret A, Todd M, Tillman BW, Yazdani SK. Understanding the mechanism of drug transfer and retention of drug-coated balloons. J Cardiovasc Pharmacol Ther. 2022;27:10742484221119559. https://doi.org/10.1177/10742484221119559
- 52. DePietro DM, Trerotola SO. Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance. Cardiovasc Diagn Ther. 2023;13:233-259. https://doi.org/10.21037/cdt-22-497
- 53. Karnabatidis D, Kitrou PM, Ponce P, Chong TT, Pietura R, Pegis JD, et al. A multicenter global registry of paclitaxel drug-coated balloon in dysfunctional arteriovenous fistulae and grafts: 6-month results. J Vasc Interv Radiol. 2021;32:360-368. https://doi.org/10.1016/j.jvir.2020.11.018
- 54. 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. https://doi.org/10.1177/1526602819872154
- 55. 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. https://doi.org/10.1161/JAHA.118.011245
- 56. Rocha-Singh KJ, Duval S, Jaff MR, Schneider PA, Ansel GM, Lyden SP, et al. Mortality and paclitaxel-coated devices: an individual patient data meta-analysis. Circulation. 2020;141:1859-1869. https://doi.org/10.1161/CIRCULATIONAHA.119.044697
- 57. Parikh SA, Schneider PA, Mullin CM, Rogers T, Gray WA. Mortality in randomised controlled trials using paclitaxel-coated devices for femoropopliteal interventional procedures: an updated patient-level meta-analysis. Lancet. 2023;402:1848-1856. https://doi.org/10.1016/S0140-6736(23)02189-X
- 58. Yang Q, Xia C. Angioplasty for dysfunctional arteriovenous fistulas: A meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty. J Vasc Access. 2025;26:81-88. https://doi.org/10.1177/11297298231213724
- 59. Zhang Y, Yuan FL, Hu XY, Wang QB, Zou ZW, Li ZG. Comparison of drug-coated balloon angioplasty versus common balloon angioplasty for arteriovenous fistula stenosis: a systematic review and meta-analysis. Clin Cardiol. 2023;46:877-885. https://doi.org/10.1002/clc.24078
