IFT06 - Real World Comparison of Popliteal-Distal Bypass Versus Tibial Endovascular Therapy for Chronic Limb-Threatening Ischemia Secondary to Infra-Popliteal Occlusive Disease

Objectives: Chronic limb-threatening ischemia (CLTI) secondary to infra-popliteal occlusive disease can be treated with surgical bypass or endovascular therapy (ET). The Bypass versus Angioplasty in Severe Ischemia of the Leg-2 (BASIL-2) trial demonstrated improved amputation-free survival (AFS) when ET was used as the initial treatment. However, most patients screened for the trial were deemed not eligible for randomization in BASIL-2. We aim to analyze real-world data to compare the outcomes of popliteal-distal bypass (PDB) versus tibial artery ET for isolated infra-popliteal occlusive disease.

Methods: Patients undergoing PDB and tibial artery ET for CLTI were identified in the Vascular Quality Initiative (VQI) between 2010-2023. Only bypasses using single-segment great saphenous vein (GSV) from a popliteal inflow were included. Tibial artery ET included transluminal balloon angioplasty, atherectomy, and/or stenting of the tibial vessels; patients with a more proximal peripheral vascular intervention were excluded. Patients who underwent PDB were one-to-three propensity score matched to patients who underwent isolated tibial artery ET. Kaplan Meier and Cox-regression analysis were used to evaluate the long-term outcomes of primary patency, major amputation, re-intervention, mortality, major adverse limb evens (MALE), and amputation-free survival (AFS).

Results: 3,478 patients undergoing PDB were matched to 10,434 patients undergoing tibial artery ET. After matching, the two groups were similar in all demographics and pre-operative characteristics (Table I). PDB was associated with higher peri-operative morbidity, including higher rates of myocardial infarction (2.7% vs 0.4%, p< 0.001), acute kidney injury (7.1% vs 1.4%, p< 0.001), surgical site infection (3.1% vs 1.0%, p< 0.001), and perioperative mortality (1.5% vs 0.9%, p=0.002). At 1-year follow-up, PDB was associated with higher primary patency (73% vs 69%, p< 0.001) and lower major amputation (13% vs 16%, p=0.003), lower re-intervention (14% vs 17%, p=0.026), lower MALE (26% vs 30%, p< 0.001), and lower mortality (14% vs 17%, p< 0.001) compared to tibial artery ET. PDB was also associated with significantly improved AFS (70% vs 64%, p< 0.001), reflecting a 17% reduction in the relative risk of amputation/death for PDB compared to tibial artery ET (Figure 1).

Conclusions: Using real-world data, this study suggests that PDB has superior 1-year primary patency and AFS compared to isolated tibial artery ET. PDB is a more durable and effective revascularization strategy despite having higher perioperative morbidity and mortality. Consideration for both revascularization options, inclusive of GSV assessment, remains crucial in optimizing and improving the long-term outcomes of CLTI patients secondary to infra-popliteal occlusive disease.