PRELIMINARY RESULTS OF A REAL-WORLD REGISTRY INVESTIGATING SIROLIMUS-COATED BALLOON VERSUS PACLITAXEL-COATED BALLOON ANGIOPLASTY FOR THE TREATMENT OF DYSFUNCTIONAL ARTERIOVENOUS FISTULA (SAVE AVF REGISTRY)

 

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PRELIMINARY RESULTS OF A REAL-WORLD REGISTRY INVESTIGATING SIROLIMUS-COATED BALLOON VERSUS PACLITAXEL-COATED BALLOON ANGIOPLASTY FOR THE TREATMENT OF DYSFUNCTIONAL ARTERIOVENOUS FISTULA (SAVE AVF REGISTRY)

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Ru Yu
Tan
Ru Yu Tan tan.ru.yu@singhealth.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore *
Suh Chien Pang pang.suh.chien@singhealth.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore -
Chee Wooi Tan tan.chee.wooi@singhealth.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore -
Alvin Ren Kwang Tng alvin.tng.r.k@singhealth.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore -
Si Ming Chew siming.chew@mohh.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore -
Charyl Jia Qi Yap charyl.tap,j,q@sgh.com.sg Singapore General Hospital Department of Vascular Surgery Singapore Singapore -
Apoorva Gogna apoorva.gogna@singhealth.com.sg Singapore General Hospital Department of Vascular and Interventional Radiology Singapore Singapore -
Kiang Hong Tay tay.kiang.hong@singhealth.com.sg Singapore General Hospital Department of Vascular and Interventional Radiology Singapore Singapore -
Hsien Ts'ung Tay tay.hsien.tsung@singhealth.com.sg Singapore General Hospital Department of Vascular Surgery Singapore Singapore -
Tze Tec Chong chong.tze.tec@singhealth.com.sg Singapore General Hospital Department of Vascular Surgery Singapore Singapore -
Chieh Suai Tan tan.chieh.suai@singhealth.com.sg Singapore General Hospital Department of Renal Medicine Singapore Singapore -
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Paclitaxel-coated balloon (PCB) and sirolimus-coated balloon have both been shown to be superior to plain old balloon angioplasty (POBA) in maintaining the patency of arteriovenous fistula (AVF). However, they work through different mechanisms to combat neointimal hyperplasia within the AVF circuit, and there have been no head-to-head comparisons of PCB and SCB in AVF. This real-world registry aims to compare the efficacy and safety of PCB vs SCB in the treatment of AVF stenosis. 

A total of 116 patients who received PCB or SCB treatment during percutaneous angioplasty (PTA) for all the stenosis within their AVF circuits were enrolled. Propensity score matching was performed using the following baseline characteristics: age, gender, presence of diabetes, duration of end-stage kidney failure (ESKF), type of AVF, age of AVF, number of previous interventions, and use of antiplatelet and anticoagulants. The matched sample consists of 78 well-matched groups of patients (39 in the PCB and 39 in the SCB groups) that have completed at least 6 months follow-up as of 25 September 2025. The primary outcome was access circuit primary patency (ACPP) at 6 months, while the secondary outcomes were target lesion primary patency (TLPP), access circuit primary assisted patency, access circuit secondary patency at 6 and 12 months. The safety endpoint was patient survival at 6 and 12 months.

Kaplan Meier survival analysis demonstrated that the 6-month ACPP of PCB vs. SCB was 66.0% (95% CI: 52.0 – 83.8%) vs. 51.8% (95% CI: 37.1 – 72.2%), p = 0.983.  The TLPP at 6 months was 77.1% (95% CI: 65.5 – 90.7%) vs. 63.2% (50.7 – 78.8%), p = 0.34. The access circuit primary-assisted patency and secondary patency at 6 months were 88.7% (95% CI: 78.8 – 99.8%) vs. 93.8% (95% CI: 85.7 – 100%), p = 0.22, and 100% vs.100%, p = 0.68, respectively. Patient survival was 89.5% (80.3 – 99.8%) vs. 94.6% (87.5 – 200%), p = 073.

The preliminary results of this study demonstrated that SCB angioplasty is a safe alternative to PCB in maintaining post-angioplasty patency. However, more patients should be enrolled and matched to reduce the possibility of type 1 error. Further large-scale randomized controlled trials are also needed to confirm the observations.

Kewords