Trial reportAnnals of the Royal College of Surgeons of England2020
Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.
Trial report in Annals of the Royal College of Surgeons of England, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06480331 (A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction), which is not on this map. Cited by 9 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized Controlled Study on the Efficacy of Ultrasound-guided Fistuloplasty in Comparison to Fluoroscopy-guided Fistuloplasty in Patients With Arteriovenous Access Flow Dysfunction
Who cites it
9 citing papers in PubMed, 5 syntheses or guidelines pooled it.
- 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.Cardiovascular and interventional radiology · 2026Pooled it
- Efficacy of drug-coated balloon versus uncoated balloon for dysfunctional dialysis access: a systematic review and meta-analysis.Clinical and experimental nephrology · 2025Pooled it
- Pooled it
- Drug-Coated Balloon Versus Plain Balloon Angioplasty for Hemodialysis Dysfunction: A Meta-Analysis of Randomized Controlled Trials.Journal of the American Heart Association · 2021Pooled it
- Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials.The British journal of surgery · 2021Pooled it
- Six-Month Outcomes from the Prospective, Multi-Center, Non-Randomized Clinical Study of the COVERACardiovascular and interventional radiology · 2025Trial
- Dialysis Access Maintenance: Plain Balloon Angioplasty.Cardiovascular and interventional radiology · 2023Review
- 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.Cardiovascular diagnosis and therapy · 2023Review
- Canalotymapnoplasty: Nomenclature of the Surgical Procedure for Correcting Congenital Aural Atresia.The journal of international advanced otology · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis study aimed to evaluate the safety and efficacy of paclitaxel-coated balloon compared with conventional plain balloon for the treatment of failing native dialysis access. MATERIALS AND
methodsThis prospective study included 60 patients presenting to the Kasr Alainy Hospitals and Aseer Central Hospital in the period from September 2015 to December 2017 with failing native vascular access. Dilatation with a plain balloon was done in 30 patients (group I) and with a paclitaxel-coated balloon in 30 patients (group II) with either stenosis or occlusion. The majority were outflow lesions, with 20 (66.7 %) patients in group I and 21 (70%) patients in group II. Mean balloon diameter was 7.1mm (± 1.5mm) compared with 6.5mm (± 1.2mm) and length 66mm (± 19.1mm) compared with 54.6mm (± 15.7mm), respectively. Safety endpoint was reported as 30 day's freedom from procedure-related major complications and mortality. Procedural technical success was defined as a residual diameter 30% or less for treated lesions. Target lesion primary patency, circuit primary patency and secondary patency were reported at 3, 6 and 12 months.
resultsThere were no 30-day procedure-related major complications or mortality in either group. Procedural technical success of 100% was achieved in both groups. Target lesion primary patency, circuit primary patency and secondary patency in group II were better than in group I, especially at 12 months (90% vs 66.7%, 83.3% vs 60% and 96.7% vs 93.3%, respectively). There was a statistically significant difference in target lesion primary patency (
conclusionThe paclitaxel-coated balloon proved to be safe and effective, and improved the patency of failing vascular access. Results are comparable with previous studies.
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