Peripheral Arterial Disease Revascularization

Infrainguinal bypass surgery using autologous saphenous vein was the gold standard for critical limb-threatening ischemia (CLTI) for decades, with 5-year patency rates of 60-80% for vein grafts. However, bypass surgery carried significant perioperative morbidity and mortality, particularly in the elderly, diabetic, and renally impaired patients who constituted the majority of CLTI sufferers. The development of percutaneous transluminal angioplasty by Gruntzig and its application to the lower extremity arteries offered a less invasive alternative, initially for short, focal lesions in the iliac and superficial femoral arteries. Early results were encouraging for claudication but less clear for the critical limb ischemia population that most needed revascularization.

The BASIL trial (Bypass versus Angioplasty in Severe Ischaemia of the Leg) was the first major RCT comparing bypass surgery to angioplasty in 452 patients with severe limb ischemia due to infrainguinal disease. At 2 years, amputation-free survival was equivalent between groups. However, in patients who survived beyond 2 years, bypass surgery with autologous vein provided superior amputation-free survival and overall survival. The trial suggested a strategy of angioplasty-first for patients with limited life expectancy (<2 years) and bypass-first for those expected to live longer, provided adequate vein conduit was available. BASIL fundamentally challenged the growing trend toward endovascular-first treatment and established that bypass surgery still had an important role in CLTI.

Drug-coated balloons (DCBs) and drug-eluting stents transformed endovascular treatment by reducing restenosis rates, particularly in the femoropopliteal segment. However, a 2018 meta-analysis by Katsanos raised safety concerns about increased mortality with paclitaxel-coated devices, triggering a major investigation. Subsequent analyses and the SWEDEPAD trial largely resolved these concerns, showing no excess mortality. The BEST-CLI trial (2022, 1830 patients) provided the most definitive modern evidence, showing that surgical bypass with adequate single-segment great saphenous vein was superior to endovascular therapy for CLTI in terms of major adverse limb events and death. However, when only alternative vein conduits were available, bypass and endovascular outcomes were equivalent. This reinforced the primacy of vein quality in determining the optimal revascularization strategy.

The GVG (Global Vascular Guidelines) for CLTI published in 2019 introduced the PLAN (Patient risk, Limb staging, ANatomic pattern) framework and the GLASS (Global Limb Anatomic Staging System) classification to guide revascularization strategy. These guidelines recommend that revascularization strategy should be individualized based on the GLASS anatomic classification, availability of adequate vein conduit, patient life expectancy, and functional status. Bypass with great saphenous vein is recommended for GLASS stage III-IV infrainguinal disease when conduit is available. The SVS and ESVS guidelines align with this approach, emphasizing the importance of multidisciplinary limb preservation teams.

The BEST-CLI trial has reinvigorated bypass surgery for CLTI, confirming that vein bypass remains superior to endovascular therapy when good-quality single-segment saphenous vein is available. The modern approach is truly individualized: endovascular-first for short lesions, limited life expectancy, or absent vein conduit; bypass for complex disease with adequate vein in patients fit for surgery. Drug-coated technologies continue to improve endovascular durability. Emerging approaches include endovascular deep venous arterialization for no-option CLTI patients and percutaneous deep vein harvest techniques. The greatest unmet need remains patients with no revascularization option—approximately 20% of CLTI patients—where cell therapy, gene therapy, and novel angiogenic approaches are under investigation. Limb preservation programs integrating vascular surgery, interventional radiology, podiatry, wound care, and prosthetics represent the current best practice model.