Drug-Coated Balloons in Autologous Vein Peripheral-Distal Bypass Graft Maintenance: Advancements and Potential Impact
Authors: Barillà David , Roscitano Giuseppe , Derone Graziana , Virga Vittorio , Montelione Nunzio , Cutrupi Andrea , Costa Francesco , Pascucci Maria Giulia , Versace Antonio , Vizzari Giampiero , Spinelli Francesco , Civilini Efrem , Stilo Francesco , Micari Antonio 
Published: December 2024

Introduction:

Initial surgical revascularization has a recognized primary role in patients with critical limb-threatening ischemia with a high-quality great saphenous vein for conduit. However, approximately one-third of lower extremity vein grafts develop lesions threatening graft patency. Traditional treatments have limitations, highlighting the need for innovative solutions. The advantage of drug-coated balloons (DCBs) in treating native femoropopliteal occlusive disease is well established for its anti-restenotic features. This study evaluates the use of DCBs in maintaining the patency of autologous vein infrainguinal bypass grafts.

Methods:

This retrospective multicenter cohort study included consecutive patients who underwent DCB angioplasty of infrainguinal bypass vein graft stenoses from January 2010 to December 2022 in 4 tertiary Vascular Surgery referral Centers. The primary endpoints were assisted primary patency rate, amputation, and death. All endpoints were assessed at baseline, at 1, 3, and 6 months, and every 6 months after the procedure. Follow-up was mainly performed via duplex ultrasound, by hand of an experienced independent operator.

Results:

In total, 296 patients received an endovascular procedure for primary patency loss of a pre-existing infrainguinal saphenous vein bypass graft. Of these, 86 cases (29%) were treated with a paclitaxel-coated balloon. The mean age of patients was 72 (67–75) years, most being males (62%, n=53). The median time from the primary revascularization to reintervention with DCB was 2.58 (95% confidence interval [CI]: 2.31–3.10) years. The DCB angioplasty involved the proximal anastomosis in 20%, the graft in 51%, the distal anastomosis in 33%, and the outflow region in 28% of cases. During a median follow-up of 5 years (3.93–7.01), a 69% assisted primary patency rate was recorded. Limb salvage was achieved in 100% of cases at 1 year and in 90% of cases at 3 years. Only 6 cases of major amputation were recorded in a median follow-up time of 10 years. Overall survival reached 84% at 5 years, calculated on a median follow-up of 9.4 (95% CI: 8.7–10.1) years.

Conclusion:

Results suggest that DCBs may have a transformative impact on vascular care, reducing the need for repeated reinterventions, and thus improving the quality of life for patients with peripheral bypass grafts.

Clinical Impact

This study proposes a groundbreaking shift in the management of lower extremity vein graft lesions. By demonstrating the efficacy of drug-coated balloons (DCBs) in maintaining patency of infrainguinal vein bypass grafts, it offers clinicians a novel strategy to address a significant clinical challenge. Unlike traditional treatments with their limitations, DCBs present a promising alternative, potentially reducing the burden of repeated reinterventions. This innovation signifies a tangible improvement in patient outcomes, promising enhanced limb salvage rates and overall survival, thereby revolutionizing vascular care and enhancing the quality of life for individuals with peripheral bypass grafts.