Related Experiment Video
Updated: Jul 2, 2026
Technical Aspects of the Mouse Aortocaval Fistula
Published on: July 11, 2013
Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard
Geert Maleux1, Edwin van der Linden2, Roeland J J Heijboer3
1University Hospitals Leuven, Leuven, Belgium.
Insights
The APERTO-paclitaxel-coated balloon is safe for dysfunctional dialysis access but did not show longer circuit functioning than standard angioplasty. A non-significant benefit was observed in de novo lesions of autologous fistulas.
Area of Science:
- Vascular Surgery
- Interventional Nephrology
- Medical Device Technology
Background:
- Dysfunctional hemodialysis access, including native arteriovenous fistulae, is a common complication.
- Maintaining adequate dialysis circuit functioning is crucial for patient outcomes.
- Percutaneous transluminal angioplasty is a standard treatment for efferent vein stenosis.
Purpose of the Study:
- To compare the safety and efficacy of APERTO-paclitaxel-coated balloon angioplasty versus standard angioplasty.
- To evaluate the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae.
Main Methods:
- A randomized controlled trial comparing APERTO-paclitaxel drug-coated balloon with standard percutaneous transluminal angioplasty.
- 103 patients with dysfunctional dialysis access were randomized 1:1.
- Primary endpoint: time to dialysis access dysfunction; assessed by Kaplan-Meier curves and log-rank analysis.
Main Results:
- No device-related complications occurred in either group.
- At 1 year, functional hemodialysis access without re-intervention was observed in 19.6% (paclitaxel) vs. 9.6% (standard angioplasty), p=0.612.
- A non-significant benefit of paclitaxel was noted in de novo lesions of autologous fistulas (25% vs. 11%, p=0.953).
Conclusions:
- APERTO-paclitaxel drug-coated balloon is a safe device for managing dysfunctional hemodialysis access.
- It did not demonstrate a longer period of adequate hemodialysis circuit functioning compared to standard angioplasty.
- Further research may be needed to explore its role in specific lesion types, such as de novo lesions in autologous fistulas.
Purpose:
to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae.
Methods:
consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure.
Results:
The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas.
Conclusion:
APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated.Clinical ImpactAPERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.
Related Concept Videos
01:27Peripheral Artery Disease III: Interprofessional Care
01:25Hemodialysis I: Introduction