Real-world outcomes of 600 drug-coated balloon angioplasties

Abstract

Introduction: The principal challenge in maintaining functional vascular access for hemodialysis is managing outflow stenoses, which are primarily caused by intimal hyperplasia. These stenoses are the leading cause of access dysfunction, leading to inadequate dialysis, increased morbidity, and frequent reinterventions. While drug-coated balloons (DCBs) have emerged as a promising solution by delivering antiproliferative agents to reduce restenosis rates, further clinical insights are needed to establish their role in vascular access management.

Materials and methods: We conducted a single-center, retrospective cohort study analyzing 600 DCB angioplasties performed on 234 patients with stenoses or thromboses in arteriovenous fistulas (AVFs) or vascular access grafts (AVGs). Central vein stenoses accounted for 17.5% of cases. Inclusion criteria comprised symptomatic or asymptomatic stenoses >50% detected through Doppler ultrasound. DCBs (Aperto OTW, Cardionovum GmbH, Bonn, Germany) were used following pre-dilatation. Patients were followed for a minimum of 6 months, with functional patency and complications as the primary outcomes.

Results: The technical success rate was 95%, with functional patency rates of 82%, 63%, and 42%, at 12, 24, and 36 months, respectively. Freedom from restenosis was 71% in AVFs, 64% in AVGs, and 57% in central vein stenoses at 12 months. The annual reintervention rate was 1.3 (IQR: 0.9-3.1). No major adverse events were reported, and vascular injuries occurred in 1.3% of cases. Univariate analysis revealed no significant impact of comorbidities on outcomes. Our clinical approach prioritizes DCB angioplasty as the first-line treatment, reserving stent grafts for select cases with recurrent or complex stenoses to preserve vascular anatomy and surgical options.

Conclusion: Drug-coated balloon angioplasty is a safe and effective treatment for vascular access stenoses, demonstrating robust functional patency and low restenosis rates. Our findings support the use of paclitaxel-eluting DCBs as a cornerstone in vascular access management, emphasizing their role in reducing complications and maintaining long-term access functionality.

Keywords: AV fistula; dialysis; dialysis access; prosthetic grafts; techniques and procedures; ultrasonography - Doppler evaluation.