Drug-Coated Balloons in Autologous Vein Peripheral-Distal Bypass Graft Maintenance: Advancements and Potential Impact

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.

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.

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.

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 ImpactThis 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.