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Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft.

ABSTRACT: BACKGROUND:In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term patency rates have been suboptimal. Drug-coated balloon (DCB) has been used to treat stenosed arteriovenous access in recent years with encouraging results but data on its effect in clotted AVG is unavailable. METHODS:This is an investigator-initiated, single-center, single-arm prospective pilot study to determine the safety and outcome of the sirolimus-coated balloon (SCB) in the salvage of thrombosed AVG. Twenty patients who undergo successful percutaneous thrombectomy will receive treatment with SCB at the graft vein junction. The patients will be followed-up for 6-months. The primary endpoint is the patency rates at 3-month while the secondary endpoints are the patency rates and the number of interventions needed to maintain patency at 6-month. DISCUSSION:Unremitting efforts have been made to prolong the patency of AV accesses over the years. DCB angioplasty combines mechanical and biological treatment for vascular stenosis. Sirolimus, being a cystostatic anti-proliferative agent, has been successfully used in coronary artery interventions. As the primary pathology of vascular stenosis in the dialysis circuit is neointimal hyperplasia, the use of sirolimus in balloon angioplasty may be effective. With this prospective study, we evaluate the efficacy and safety of SCB in patients with clotted AVG. TRIAL REGISTRATION:ClinicalTrials.gov Identifier: NCT03666208 on 11 September 2018.

SUBMITTER: Tan RY

PROVIDER: S-EPMC7335758 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft.

Tan Ru Yu RY Tan Chee Wooi CW Pang Suh Chien SC Foo Marjorie Wai Yin MWY Tang Tjun Yip TY Gogna Apoorva A Chong Tze Tec TT Tan Chieh Suai CS

CVIR endovascular 20200705 1

<h4>Background</h4>In arteriovenous graft (AVG) for haemodialysis, the primary cause of failure is venous stenosis of the graft-vein junction from neointimal hyperplasia (NIH), resulting in thrombosis. While interventions to salvage clotted AVG are known to have high clinical success rates, long-term patency rates have been suboptimal. Drug-coated balloon (DCB) has been used to treat stenosed arteriovenous access in recent years with encouraging results but data on its effect in clotted AVG is u ...[more]

PMID: 32627114

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Project description:BackgroundPercutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied.Methods/designThis is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical.DiscussionThis study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients.Trial registrationClinicalTrials.gov NCT04409912 . Registered on 1 June 2020.

Project description:BackgroundEndovascular revascularization has established as the first-line therapy of femoropopliteal artery disease. Paclitaxel-coated balloon angioplasty proved to be superior to plain old balloon angioplasty (POBA) regarding prevention of restenosis and need for recurrent revascularization. Over the past years, paclitaxel was the only active drug to inhibit neointimal proliferation which could be processed to an appropriate balloon coating. The purpose of this study is to assess whether efficacy and safety of sirolimus-coated balloon angioplasty is noninferior to paclitaxel-coated balloon angioplasty.MethodsThis randomized controlled, single-blinded, multicentre, investigator-initiated noninferiority trial aims to enrol a total of 478 participants with symptomatic femoropopliteal artery disease of Rutherford category 2 to 4 due to de novo stenosis or restenosis. After pre-dilation, participants will be allocated in a 1:1 ratio to either sirolimus- or paclitaxel-coated balloon angioplasty. Post-dilation with the drug-coated balloon (DCB) used or standard balloon is mandatory in case ≥ 50%, and optional in case of ≥ 30% residual diameter stenosis. Bailout stenting with bare-metal nitinol stents should be conducted in case of flow-limiting dissection. Primary noninferiority endpoints are primary patency and the composite of all-cause mortality, major target limb amputation, and clinically driven target lesion revascularization at 12 months. Secondary outcomes are clinical and hemodynamic improvement, change in health-related quality of life, and safety throughout 60 months.DiscussionAlthough concerns about long-term safety of paclitaxel-coated devices were not confirmed by recent patient-level data analyses, conflicting evidence contributed to a loss of confidence among patients and physicians. Therefore, sirolimus, known for a broader therapeutic range than paclitaxel, may serve as a welcome alternative. This will be justified if noninferiority of sirolimus-coated balloon angioplasty against the current standard of paclitaxel-coated balloon angioplasty can be demonstrated.Trial registrationClinicalTrials.gov NCT04475783 . Registered on 17 July 2020 EUDAMED No. CIV-20-11-035172, DRKS00022452.

Project description:IntroductionScoring balloon angioplasty (SBA) for lumen gain prior to stent implantations or drug-coated balloon angioplasty (DCB) is considered an essential interventional tool for lesion preparation. Recent evidence indicates that SBA may play a pivotal role in enhancing the angiographic and clinical outcomes of DCB angioplasty.MethodsWe studied the systematic use of SBA with a low profile, non-slip element device prior to DCB angioplasty in an unselected, non-randomized patient population. This prospective, all-comers study enrolled patients with de novo lesions as well as in-stent restenotic lesions in bare metal stents (BMS-ISR) and drug-eluting stents (DES-ISR). The primary endpoint was the target lesion failure (TLF) rate at 9 months (ClinicalTrials.gov Identifier NCT02554292).ResultsA total of 481 patients (496 lesions) were recruited to treat de novo lesions (78.4%, 377), BMS-ISR (4.0%, 19), and DES-ISR (17.6%, 85). Overall risk factors were acute coronary syndrome (ACS, 20.6%, 99), diabetes mellitus (46.8%, 225), and atrial fibrillation (8.5%, 41). Average lesion lengths were 16.7 ± 10.4 mm in the de novo group, and 20.1 ± 8.9 mm (BMS-ISR) and 16.2 ± 9.8 mm (DES-ISR) in the ISR groups. Scoring balloon diameters were 2.43 ± 0.41 mm (de novo), 2.71 ± 0.31 mm (BMS-ISR), and 2.92 ± 0.42 mm (DES-ISR) whereas DCB diameters were 2.60 ± 0.39 mm (de novo), 3.00 ± 0.35 mm (BMS-ISR), and 3.10 ± 0.43 mm (DES-ISR), respectively. The overall accumulated TLF rate of 3.0% (14/463) was driven by significantly higher target lesion revascularization rates in the BMS-ISR (5.3%, 1/19) and the DES-ISR group (6.0%, 5/84). In de novo lesions, the TLF rate was 1.1% (4/360) without differences between calcified and non-calcified lesions (p = 0.158) and small vs. large reference vessel diameters with a cutoff value of 3.0 mm (p = 0.901).ConclusionsThe routine use of a non-slip element scoring balloon catheter to prepare lesions suitable for drug-coated balloon angioplasty is associated with high procedural success rates and low TLF rates in de novo lesions.

Project description:BACKGROUND:Restenosis remains a problem in hemodialysis access interventions. Paclitaxel-coated balloons have shown promise in reducing access-related restenosis in small trials. The primary hypotheses for our multicenter trial were superior effectiveness at 180 days and noninferior safety at 30 days of a drug-coated balloon compared with conventional angioplasty for treatment of dysfunctional arteriovenous fistulas. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:This randomized trial enrolled 285 patients with dysfunctional arteriovenous fistulas at 23 centers. Grafts, central venous stenoses, thrombosed fistulas, and immature fistulas were excluded. All patients received angioplasty of the lesion responsible for access dysfunction. After successful angioplasty (?30% residual stenosis), lesions were treated with either a paclitaxel-coated balloon or an uncoated control balloon of similar design to the drug-coated balloon. Access function during follow-up was determined per centers' usual protocols; reintervention was clinically driven. The primary efficacy outcome assessment was done at 6 months, and the safety assessment was done within 30 days of the procedure. Prespecified secondary end points included assessment of postintervention target lesion primary patency and access circuit primary patency at 6 months. RESULTS:The 180-day end point was not met with target lesion primary patency (71%±4% for the drug-coated balloon and 63%±4% for control; P=0.06), representing a difference of 8%±6% (95% confidence interval, -3% to 20%). Access circuit primary patency did not differ between groups. Interventions to maintain target lesion patency were fewer for the drug-coated balloon at 6 months (0.31 versus 0.44 per patient; P=0.03). The primary safety noninferiority end point was met and did not differ between groups (P=0.002). CONCLUSIONS:Paclitaxel-coated balloon-assisted angioplasty did not meet the primary effectiveness end point at 180 days compared with conventional angioplasty. Both arms showed equivalent safety (ClinicalTrials.gov number NCT02440022).

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Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft.

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Study protocol of a pilot study on sirolimus-coated balloon angioplasty in salvaging clotted arteriovenous graft.

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