SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial.

BACKGROUND: Percutaneous 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/DESIGN: This 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. DISCUSSION: This study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04409912 . Registered on 1 June 2020.

Management of arterial dissections in 12 patients during transarterial chemoembolization and yttrium-90 selective internal radiotherapy for primary and secondary liver tumours.

OBJECTIVE: To describe rates and management strategies of arterial dissections in transarterial chemoembolization (TACE) and Yttrium-90 selective internal radiotherapy (90Y SIRT) for primary and secondary liver tumours. MATERIALS AND METHODS: This retrospective review included 1377 hepatic angiographies between May 2010 and June 2015 in a single centre for TACE and 90Y SIRT of liver tumours. The angiogram results, management, treatment outcomes and follow-up angiography/imaging findings were recorded. RESULTS AND DISCUSSION: Twelve cases of arterial dissections (12/1377, 0.87%) were documented. Three dissections (3/633, 0.47%) occurred during TACE, seven (7/449, 1.56%) during pre-treatment planning angiographies (PTPA) for 90Y SIRT, and two (2/249, 0.80%) during the treatment procedure of 90Y SIRT. The preferred management strategy was to manoeuvre past the dissection and complete the procedure, which was achieved in six patients (50%). Angioplasty with stenting was performed in one patient. In three patients, the procedure was held off for up to 3 months to allow the dissection to heal before repeating the procedure. A dissection that occurred during PTPA was detected only when the patient returned for 90Y SIRT. PTPA was immediately repeated for this patient. The last patient opted for sorafenib. Residual 50% stenosis was seen in one patient on follow-up hepatic angiography, but he was otherwise asymptomatic. In the remaining patients, no residual dissection or clinical sequelae was observed on follow-up. CONCLUSION: Arterial dissection is a rare but important complication of transarterial locoregional therapy. Where possible, attempts should be made at completing the therapy. Deferring treatment can be considered as dissections usually heal within 3 months. LEVEL OF EVIDENCE: Level 4, case series.