A Multicenter Global Registry of Paclitaxel Drug-Coated Balloon in Dysfunctional Arteriovenous Fistulae and Grafts: 6-Month Results

Abstract

To assess the safety and clinical benefit of the Lutonix drug-coated balloon (DCB) catheter for the treatment of dysfunctional arteriovenous fistulae (AVF) and grafts (AVG) in a heterogenous real-world population.Materials and Methods: This multicenter, prospective study enrolled 320 subjects from 12 countries in 25 sites across Europe and Asia. A total of 392 lesions were treated with the Lutonix 035 DCB catheter. Lesions were de novo and restenotic, located in every part of the circuit from the cannulation zone to central venous outflow. In-stent restenotic lesions also were treated. The primary safety endpoint was freedom from serious adverse events involving the access circuit through 30 days. The primary effectiveness endpoint was target lesion primary patency (TLPP) through 6 months. Secondary endpoints included access circuit primary patency (ACPP) at 6 months and the investigation of factors that would independently influence the primary endpoints.Results: The primary safety endpoint was 95.5%, while TLPP was 73.9% at 6 months, per Kaplan-Meier survival analysis. ACPP was 71% at 6 months. TLPP for stenosis of AVFs was 78.1%. Subgroup analysis showed significantly improved TLPP when DCB was dilated for 120 seconds (P ¼ .007). TLPP was significantly better when predilation occurred compared with cases where only DCB angioplasty was performed (77% vs 48.6%, P ¼ .0005). Conclusions:The Lutonix AV Global Registry confirms that the Lutonix DCB is a safe and effective treatment option in real-world patients with dysfunctional AVF or AVG. Procedural details had a significant role in TLPP. No significant difference in TLPP was observed among different treatment areas. ABBREVIATIONSAVG ¼ arteriovenous graft, AVF ¼ arteriovenous fistula, DCB ¼ drug-coated balloon, TLPP ¼ target lesion primary patency Vascular access (VA) stenosis in arteriovenous fistulae (AVFs) and arteriovenous grafts (AVGs) constitutes one of the main reasons for their dysfunction (1). According to the latest Kidney Disease Outcomes Quality Initiative clinical practice guidelines for VA, it is considered reasonable to use high-pressure balloon angioplasty as From the Interventional Radiology Department (D.

Drug-Coated Balloon for Arteriovenous Access Stenosis in Hemodialysis Patients

“…The primary role of the balloon platform is satisfactory drug delivery; therefore, vessel preparation before the application of a DCB and prolonged inflation time of DCB are important events for a successful outcome [9]. A recently published report confirmed that the procedural details had a significant role in target lesion primary patency (TLPP); pre-dilation before DCB angioplasty (77% with pre-dilation vs. 48.6% without pre-dilation, p = 0.0005) or DCB dilation for ≥120 s (p = 0.007) significantly improved TLPP in a subgroup analysis [10]. The use of a lipophilic excipient results in homogenous transfer of the drugs onto the vessel wall.…”

“…Recently published results of a DCB trial of 392 treatment areas in 320 participants from Europe and Asia who underwent DCB angioplasty included data from the Lutonix AV Global Registry, which is a multicenter, single-arm real-world registry, and suggested that a DCB is a safe and effective treatment option [10]. The access circuit primary patency was 71% at 6 months, and TLPP for stenosis of AVFs was 78.1%.…”

Choosing the right treatment for the right lesion, Part II: a narrative review of drug-coated balloon angioplasty and its evolving role in dialysis access maintenance

“…The majority of evidence for the above has come from literature regarding DCB use in atherosclerotic arterial disease, however, the same principles likely hold true in the treatment of AV access stenosis (68)(69)(70). Results of a multi-center global registry of DCBs in AVFs and AVGs, published by Karnabatidis et al, demonstrated improved outcomes in target primary lesion patency at 6 months in those who underwent pre-dilation (77%) compared to those who did not (49%), with P=0.0005 (71).…”

“…Additionally, there was improved patency when lesions were pre-dilated with "focal force" balloons or cutting balloons as compared to normal HPBs (90). The previously mentioned global registry reported by Karnabatidis et al enrolled 320 patients with either AVFs or AVGs treated with the Lutonix DCB, with overall TLPP of 74% at 6 months, and significantly improved patency in those in whom the DCB was dilated for >120 seconds and in those in whom pre-dilation was performed (71).…”

Intimal Hyperplasia and Arteriovenous Fistula Failure: Looking Beyond Size Differences

“…Multiple individual studies have shown patency and/or re-intervention benefits of DEB vs. conventional angioplasty (12)(13)(14)(92)(93)(94)(95). However, meta-analysis studies have yielded variable conclusions, and patency rates over six months still have much room for improvement (96)(97)(98)(99).…”