Paclitaxel-Coated Balloons Compared to Plain Balloon Angioplasty in the Management of Dysfunctional Arteriovenous Fistulae: A Single-Center Randomized Clinical Trial

Arabi, Mohammad; Salman, Refaat; Alharbi, Ahoud; Alzahrani, Yahya A.; Bashir, Omar; Qazi, Shahbaz; Abdallah, Mubarak; Farooqui, Mahfooz; Hejaili, Fayez; Almoaiqel, Mohammad

doi:10.4103/1319-2442.318513

Cited by 5 publications

(2 citation statements)

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“…For the sake of completeness, a small 40-patient RCT by Pang et al , published in 2021, was not available for review, but available data was included in Tables 3,4 , and an additional RCT not previously mentioned due to its small size (n=23) was terminated prematurely due to safety concerns regarding DCBs in 2018, with no significant difference in outcomes between those treated with DCBs and those in the control arm in this inherently underpowered study ( 79 , 89 ).…”

Section: Additional Smaller Rcts Non-randomized Prospective Studies A...mentioning

confidence: 99%

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

DePietro¹,

Trerotola²

2023

Cardiovasc Diagn Ther

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Background and Objective: Drug-coated balloons (DCBs) seek to inhibit restenosis in treated hemodialysis access lesions by delivering an anti-proliferative agent (paclitaxel) into the vessel wall. While DCBs have proven effective in the coronary and peripheral arterial vasculature, the evidence for their use in arteriovenous (AV) access has been less robust. In part two of this review, a comprehensive overview of DCB mechanisms, implementation, and design is provided, followed by an examination of the evidence basis for their use in AV access stenosis.Methods: An electronic search was performed on PubMed and EMBASE to identify relevant randomized controlled trials (RCTs) comparing DCBs and plain balloon angioplasty from January 1, 2010 to June 30, 2022 published in English. As part of this narrative review, a review of DCB mechanisms of action, implementation, and design is provided, followed by a review of available RCTs and other studies.Key Content and Findings: Numerous DCBs have been developed, each with unique properties, although the degree to which these differences impact clinical outcomes is unclear. Target lesion preparation, achieved by pre-dilation, and balloon inflation time have proven important factors in achieving optimal DCB treatment. Numerous RCTs have been performed, but have suffered from significant heterogeneity, and have often reported contrasting clinical results, making it difficult to draw conclusions on how to implement DCBs in daily practice. On the whole, it is likely there is a population of patients who benefit from DCB use, but it is unclear which patients benefit most and what device, technical, and procedural factors lead to optimal outcomes. Importantly, DCBs use appears safe in the end-stage renal disease (ESRD) population.Conclusions: DCB implementation has been tempered by the lack of clear signal regarding the benefits of DCB use. As further evidence is obtained, it is possible that a precision-based approach to DCBs may shed light onto which patients will truly benefit from DCBs. Until that time, the evidence reviewed herein may serve to guide interventionalists in their decision making, knowing that DCBs appear safe when used in AV access and may provide some benefit in certain patients.

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Section: Additional Smaller Rcts Non-randomized Prospective Studies A...mentioning

confidence: 99%

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

DePietro¹,

Trerotola²

2023

Cardiovasc Diagn Ther

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“… 6 , 7 , 9 However, other trials and a meta-analysis found no statistically significant difference in target lesion primary patency at 3, 6, 9, and 12 months. 2 - 5 , 10 , 11 This 10-year single center study aims to retrospectively evaluate the use of DCBs as a primary treatment for treatment naïve dysfunctional AVFs compared to standard percutaneous transluminal angioplasty (PTA), and tries to determine the predictors that may influence the patency rates.…”

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confidence: 99%

Drug-coated balloons versus conventional percutaneous transluminal angioplasty for treatment-naïve dysfunctional arteriovenous fistulas.

AlQubaisi,

Arabi,

AlZahrani

et al. 2024

SMJ

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Objectives: To compare the primary patency and restenosis rates in treatment naieve dialysis arteriovenous fistulas (AVFs) after drug-coated balloons (DCB) versus plain balloon angioplasty (PTA). Methods: This retrospective study included 157 patients who underwent AVF angioplasty for treatment-native AVF stenosis between January 2012 to 2022. The fistulas were Brachiocephalic (75%), Brachiobasilic (17%), and radiocephalic (8%). The index intervention was with either DCB or percutaneous transluminal angioplasty (PTA) with subsequent follow up. Patients with central venous stenosis, thrombosed fistula, fistula stents, AV graft or surgical intervention after the index procedure were excluded. Results: Arteriovenous fistula angioplasty was done in 28 patients using DCB and in 129 patients using PTA. A total of 108 patients presented with a single stenosis, 42 with 2 stenoses, and 7 with 3 stenoses. The location of these stenoses was in the venous outflow (57%), the juxta anastomotic segment (31%), and cephalic arch (12%). The median time to re-intervention for the PTA was 216 days compared to 304 days for the DCB ( p =0.079). Primary patency at 6 months was 60.4% for PTA and 75% for DCB ( p =0.141) Conclusion: Although DCB angioplasty of treatmentnaïve dysfunctional AVF tends to improve the time to intervention and 6-month primary patency compared to PTA, this difference did not reach statistical significance.

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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

Lee,

Choi,

Han

et al. 2024

Journal of Vascular and Interventional Radiology

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Paclitaxel-Coated Balloons Compared to Plain Balloon Angioplasty in the Management of Dysfunctional Arteriovenous Fistulae: A Single-Center Randomized Clinical Trial

Cited by 5 publications

References 0 publications

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

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

Drug-coated balloons versus conventional percutaneous transluminal angioplasty for treatment-naïve dysfunctional arteriovenous fistulas.

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

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