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      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

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          Abstract

          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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          Most cited references104

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          KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update

          The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for hemodialysis vascular access since 1996. Since the last update in 2006, there has been a great accumulation of new evidence and sophistication in the guidelines process. The 2019 update to the KDOQI Clinical Practice Guideline for Vascular Access is a comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access. New topics include the end-stage kidney disease "Life-Plan" and related concepts, guidance on vascular access choice, new targets for arteriovenous access (fistulas and grafts) and central venous catheters, management of specific complications, and renewed approaches to some older topics. Appraisal of the quality of the evidence was independently conducted by using a Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, and interpretation and application followed the GRADE Evidence to Decision frameworks. As applicable, each guideline statement is accompanied by rationale/background information, a detailed justification, monitoring and evaluation guidance, implementation considerations, special discussions, and recommendations for future research.
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            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

            Background Several randomized controlled trials (RCTs) have already shown that paclitaxel‐coated balloons and stents significantly reduce the rates of vessel restenosis and target lesion revascularization after lower extremity interventions. Methods and Results A systematic review and meta‐analysis of RCTs investigating paclitaxel‐coated devices in the femoral and/or popliteal arteries was performed. The primary safety measure was all‐cause patient death. Risk ratios and risk differences were pooled with a random effects model. In all, 28 RCTs with 4663 patients (89% intermittent claudication) were analyzed. All‐cause patient death at 1 year (28 RCTs with 4432 cases) was similar between paclitaxel‐coated devices and control arms (2.3% versus 2.3% crude risk of death; risk ratio, 1.08; 95% CI, 0.72–1.61). All‐cause death at 2 years (12 RCTs with 2316 cases) was significantly increased in the case of paclitaxel versus control (7.2% versus 3.8% crude risk of death; risk ratio, 1.68; 95% CI, 1.15–2.47; —number‐needed‐to‐harm, 29 patients [95% CI, 19–59]). All‐cause death up to 5 years (3 RCTs with 863 cases) increased further in the case of paclitaxel (14.7% versus 8.1% crude risk of death; risk ratio, 1.93; 95% CI, 1.27–2.93; —number‐needed‐to‐harm, 14 patients [95% CI, 9–32]). Meta‐regression showed a significant relationship between exposure to paclitaxel (dose‐time product) and absolute risk of death (0.4±0.1% excess risk of death per paclitaxel mg‐year; P<0.001). Trial sequential analysis excluded false‐positive findings with 99% certainty (2‐sided α, 1.0%). Conclusions There is increased risk of death following application of paclitaxel‐coated balloons and stents in the femoropopliteal artery of the lower limbs. Further investigations are urgently warranted. Clinical Trial Registration URL: www.crd.york.ac.uk/PROSPERO. Unique identifier: CRD42018099447.
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              Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease.

              The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.
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                Author and article information

                Journal
                Cardiovasc Diagn Ther
                Cardiovasc Diagn Ther
                CDT
                Cardiovascular Diagnosis and Therapy
                AME Publishing Company
                2223-3652
                2223-3660
                09 January 2023
                28 February 2023
                : 13
                : 1
                : 233-259
                Affiliations
                [1]deptDivision of Interventional Radiology, Department of Radiology , Perelman School of Medicine at the University of Pennsylvania , Philadelphia, PA, USA
                Author notes

                Contributions: (I) Conception and design: Both authors; (II) Administrative support: Both authors; (III) Provision of study materials or patients: Both authors; (IV) Collection and assembly of data: Both authors; (V) Data analysis and interpretation: Both authors; (VI) Manuscript writing: Both authors; (VII) Final approval of manuscript: Both authors.

                Correspondence to: Daniel M. DePietro, MD. Division of Interventional Radiology, Department of Radiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA 19104, USA. Email: Daniel.depietro@ 123456pennmedicine.upenn.edu .
                Article
                cdt-13-01-233
                10.21037/cdt-22-497
                9971313
                36864970
                8d3d2856-01d2-4068-9f4d-971c6835db64
                2023 Cardiovascular Diagnosis and Therapy. All rights reserved.

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

                History
                : 25 September 2022
                : 13 December 2022
                : 09 January 2023
                Categories
                Review Article on Endovascular and Surgical Interventions in the End Stage Renal Disease Population

                hemodialysis (hd),stenosis,drug-coated balloon (dcb),angioplasty,paclitaxel

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