Dialysis Access Malfunction, Stenosis
Conditions
Brief summary
Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and accelerate intimal hyperplasia, resulting in rapid restenosis and need for repeated procedure to maintain vessel patency. The anti-proliferative drug that is coated on the surface of balloon is released to the vessel wall during balloon angioplasty and blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty. Additionally, unlike stents, DCB does not leave a permanent structure that may impede future surgical revision. Recent randomized control trials (RCT) have shown the superiority of paclitaxel durg-coated balloon (PDCB) over POBA in the treatment of stenosis in AVFs. In a large multicenter RCT, PDCB was demonstrated to result in a 6-month target lesion primary patency of 82.2% compared to 59.5% for POBA. However, concerns had also arisen recently in the use of PDCB. In large lower limb studies involving the use of paclitaxel devices, meta-analysis by Katsanos et al had revealed increased late risk mortality in patient that are treated with PDCB or paclitaxel-coated stent. Sirolimus drug-coated balloon (SDCB) is the new generation of drug eluting balloons that are available in the market. Compared to paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. The effectiveness of SDCB in patients with dialysis access dysfunction has been shown in a small pilot study in AVF stenosis and AVG thrombosis. SAVE AVF registry ams to assess the efficacy and safety of SDCB vs PDCB angioplasty.
Interventions
AVFs treated with SDCB
AVFs treated with PDCB
Sponsors
Singapore General Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Inclusion criteria
* Age 21-85 years * Patient who required balloon angioplasty for dysfunctional or thrombosed AVF * Successful thrombolysis and angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA) based on visual assessment of the operator and restoration of thrill in the AVF on clinical examination. For concurrent asymptomatic or angiographically not significant central vein stenosis, patients can be included in no treatment is required. * received either PDCB or SDCB for the treatment of stenosis.
Exclusion criteria
* Patient unable to provide informed consent * Presence of symptomatic or angiographically significant central vein stenosis who require treatment, with more than 30% residual stenosis post angioplasty * Patients who had underwent stent placement within the AVF circuit * Sepsis or active infection * Recent intracranial bleed or gastrointestinal bleed within the past 12 months. * Allergy to iodinated contrast media, heparin, paclitaxel or sirolimus * Pregnancy * Inadequate treatment of underlying stenosis, defined as \>= 30% residual stenosis of the underlying lesions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Circuit Primary Patency Rate at 6 months | 6 months post-op | Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Restenosis | 6 and 12 months post-op | Incidence of stenosis \>50% diameter of adjacent reference vessel segment from angiography images |
| Number of repeat interventions to treated lesion | 6 and 12 months post-op | — |
| Number of repeat interventions to maintain access circuit | 6 and 12 months post-op | This will include interventions to treated lesion |
| Circuit Primary Patency at 12 months | 12 months post-op | Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm. |
| Complication rates of the procedure | Time of procedure | Categorised according to SIR definitions (Aruny et al) |
| Mortality rates of patients | 6 and 12 months post-op | — |
| Target lesion revascularization free interval | 12 months post-op | Interval from intervention to repeat clinically driven target lesion reintervention |
Countries
Singapore
Contacts
Primary ContactCharyl Yap
Outcome results
None listed