A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

Karunanithy, Narayan; Robinson, Emily; Ahmad, Farhan; Burton, James O.; Calder, Francis; Coles, Simon; Das, Neelanjan; Dorling, Anthony; Forman, Colin; Jaffer, Ounali; Lawman, Sarah; Lakshminarayan, Raghuram; Lewlellyn, Rhys; Peacock, Janet L.; Ramnarine, Raymond; Mesa, I. Rebollo; Shaikh, Shoaib Ahmed; Simpson, James Young; Steiner, Kate; Suckling, Rebecca; Szabó, L.; Turner, Douglas; Wadoodi, Ashar; Wang, Yanzhong; Weir, Graeme; Wilkins, C. Jason; Gardner, Leanne Margaret; Robson, Michael G.

doi:10.1016/j.kint.2021.02.040

Cited by 40 publications

(41 citation statements)

References 27 publications

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“…However, a recent trial revealed a contrasting outcome. In 2021, the paclitaxel-coated balloons and angioplasty of AV fistulas (PAVE) trial was conducted with 212 randomized patients [14]. Time to loss of TLPP with DCB was not significantly different from that with the standard balloon (hazard ratio (HR), 1.18; 95% confidence interval (CI), 0.78-1.79; p = 0.440) [14].…”

Section: Effectiveness Of Dcbs In Preventing Restenosis Of Arteriovenous Access According To Randomized Controlled Trialsmentioning

confidence: 99%

“…In 2021, the paclitaxel-coated balloons and angioplasty of AV fistulas (PAVE) trial was conducted with 212 randomized patients [14]. Time to loss of TLPP with DCB was not significantly different from that with the standard balloon (hazard ratio (HR), 1.18; 95% confidence interval (CI), 0.78-1.79; p = 0.440) [14]. One possible explanation for the contrasting result between the PAVE and IN.PACT trials is that the trials used different treatment balloons with different drug doses, although this does not refer to the actual doses that reached the target.…”

Section: Effectiveness Of Dcbs In Preventing Restenosis Of Arteriovenous Access According To Randomized Controlled Trialsmentioning

confidence: 99%

“…However, the higher density of the IN.PACT balloon does not seem to result in a significant difference in action between the two balloons. Compared to the Lutonix balloon, the IN.PACT balloon has demonstrated greater drug loss with dry handling or inflation and greater downstream embolization, which did not result in a higher dose delivered to the target lesion[14].Another drug used to prevent restenosis is sirolimus. A sirolimus-based DCB is a second-generation DCB that has been successfully used to prevent restenosis in the coronary vessels.…”

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confidence: 99%

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Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

Kim

2021

Kidney and Dialysis

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Hemodialysis access stenosis is a pervasive problem that occurs due to the physiology of the high-flow circuit. Stenosis occurs due to endothelial and smooth muscle injuries that result in neointimal hyperplasia. Percutaneous transluminal angioplasty is the standard treatment for dialysis access-induced stenosis. Unfortunately, it is also associated with vessel wall trauma, which causes further intimal hyperplasia and restenosis. Data from randomized controlled trials (RCTs) and systematic reviews of the use of drug-coated balloons (DCBs) for dialysis access stenosis have been controversial. While several single-center trials or RCTs have reported safe and effective use of DCBs, conflicting results still exist. Furthermore, paclitaxel is known to be associated with an increased mortality risk. Herein, we review the current evidence on the role of DCBs in the treatment of dialysis access stenosis.

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Section: Effectiveness Of Dcbs In Preventing Restenosis Of Arteriovenous Access According To Randomized Controlled Trialsmentioning

confidence: 99%

Section: Effectiveness Of Dcbs In Preventing Restenosis Of Arteriovenous Access According To Randomized Controlled Trialsmentioning

confidence: 99%

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confidence: 99%

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Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

Kim

2021

Kidney and Dialysis

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“…A total of 4 RCTs were identi ed and included in the meta-analyses, with 956 participants (11)(12)(13)(14). An overview of the study ow of the selection process is presented in Fig.…”

Section: Included Studiesmentioning

confidence: 99%

“…Several randomized controlled trials (RCTs) that compared DCB angioplasty with conventional balloon angioplasty for the treatment of dysfunctional hemodialysis vascular access with a larger sample size have been published (11)(12)(13)(14). Results of these trials were less consistent and led to an ongoing debate on whether DCB angioplasty could indeed improve outcomes.…”

Section: Introductionmentioning

confidence: 99%

Angioplasty for dysfunctional arteriovenous fistulas: a meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty

Yang

Zhang²,

Cai³

et al. 2021

Preprint

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Background Stenosis in arteriovenous fistulas (AVF) due to neointimal hyperplasia is one of the most common causes of hemodialysis vascular access dysfunction. Treating patients with dysfunctional AVF with drug-coated balloon (DCB) angioplasty may potentially improve outcomes. This systematic review aimed to compare the effectiveness and safety of DCB angioplasty versus conventional balloon angioplasty by pooling evidence from the most recent randomized controlled trials. Methods We conducted a comprehensive literature search in the Medline, Embase, and Cochrane central databases. Two independent researchers screened the article, extracted interest and evaluated included studies for risk of bias. Pooled estimation was conducted in terms of 6-month target-lesion primary patency (TLPP) and target-lesion reintervention (TLR), as well as other outcomes. Results were expressed with odds ratio (OR) and 95% confidence interval (CI). Results A total of 4 RCTs were identified and included in the meta-analyses, with 911 participants. There was no significant increase in rates of 6-month TLPP (OR 1.63, 95%CI 0.39–6.79, p = 0.35), or decrease in 6-month TLR (OR 0.45, 95%CI 0.17–1.19 p = 0.07) in patients who received DCB as compared to those who received conventional balloon angioplasty. Similarly, we found no difference in the 6-month access circuit primary patency and reinvention between the two groups. Conclusion There was no evidence supporting that DCB has a statistically significant higher rate of TLPP and lower rates of TLR in the treatment of dysfunctional AVF than conventional balloon angioplasty. However, DCB was non-inferior to conventional balloon angioplasty in terms of safety. Therefore, further study is needed to clarify whether DCB angioplasty can benefit hemodialysis patients with dysfunction AVF.

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Arteriovenous Access for Hemodialysis

Lok,

Huber,

Orchanian-Cheff

et al. 2024

JAMA

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ImportanceHemodialysis requires reliable vascular access to the patient’s blood circulation, such as an arteriovenous access in the form of an autogenous arteriovenous fistula or nonautogenous arteriovenous graft. This Review addresses key issues associated with the construction and maintenance of hemodialysis arteriovenous access.ObservationsAll patients with kidney failure should have an individualized strategy (known as Patient Life-Plan, Access Needs, or PLAN) for kidney replacement therapy and dialysis access, including contingency plans for access failure. Patients should be referred for hemodialysis access when their estimated glomerular filtration rate progressively decreases to 15 to 20 mL/min, or when their peritoneal dialysis, kidney transplant, or current vascular access is failing. Patients with chronic kidney disease should limit or avoid vascular procedures that may complicate future arteriovenous access, such as antecubital venipuncture or peripheral insertion of central catheters. Autogenous arteriovenous fistulas require 3 to 6 months to mature, whereas standard arteriovenous grafts can be used 2 to 4 weeks after being established, and “early-cannulation” grafts can be used within 24 to 72 hours of creation. The prime pathologic lesion of flow-related complications of arteriovenous access is intimal hyperplasia within the arteriovenous access that can lead to stenosis, maturation failure (33%-62% at 6 months), or poor patency (60%-63% at 2 years) and suboptimal dialysis. Nonflow complications such as access-related hand ischemia (“steal syndrome”; 1%-8% of patients) and arteriovenous access infection require timely identification and treatment. An arteriovenous access at high risk of hemorrhaging is a surgical emergency.Conclusions and RelevanceThe selection, creation, and maintenance of arteriovenous access for hemodialysis vascular access is critical for patients with kidney failure. Generalist clinicians play an important role in protecting current and future arteriovenous access; identifying arteriovenous access complications such as infection, steal syndrome, and high-output cardiac failure; and making timely referrals to facilitate arteriovenous access creation and treatment of arteriovenous access complications.

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A multicenter randomized controlled trial indicates that paclitaxel-coated balloons provide no benefit for arteriovenous fistulas

Cited by 40 publications

References 27 publications

Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

Angioplasty for dysfunctional arteriovenous fistulas: a meta-analysis of recent randomized controlled trials compared paclitaxel-coated balloon versus conventional balloon angioplasty

Arteriovenous Access for Hemodialysis

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