Open versus Endovascular Revascularisation for Femoropopliteal Disease in Patients with Chronic Limb Threatening Ischaemia.

Abstract

Multiple options exist for the treatment of femoropopliteal (FP) disease, including endovascular interventions (ENDOs) and bypass surgery (OPEN). There are limited data directly comparing ENDO and OPEN strategies for FP disease in chronic limb threatening ischaemia (CLTI). Outcomes of patients in the Best Endovascular vs. Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial who underwent revascularisation for FP disease were examined. ENDO and OPEN were compared using single segment great saphenous vein (SSGSV) or alternative conduits (ACs). The primary outcome was major adverse limb event (MALE) or death; secondary outcomes included major amputation (MA); major re-intervention; amputation free survival; any re-intervention, MA, or death (RAD); and any re-intervention. Seven hundred and sixty-four patients underwent ENDO (378), OPEN with SSGSV (265), or OPEN with AC (121) procedures for FP disease. Patients had a mean age of 67 years; 66.6% were men, and 75.9% were White. Comorbidities included hypertension (85.5%), hyperlipidaemia (75.4%), diabetes mellitus (59.5%), smoking (47.2%), coronary artery disease (40.4%), and end-stage renal disease (7.6%); 68.4% of patients had tissue loss. Wound, Ischemia, and foot Infection (WIfI) stages were stage 1 (7.3%), stage 2 (35.2%), stage 3 (28.4%), and stage 4 (29.1%). TASC II classification of the FP disease was A and B (24.0%), C (25.4%), D (34.8%), or not scored (15.8%). Associated (untreated) infrapopliteal disease was present in 42.5%. ENDO treatments included plain balloon angioplasty (9.3%), drug coated balloons (32%), drug eluting stents (24.9%), bare metal stents (55.6%), stent grafts (17.5%), and atherectomy (11.1%). Cox models demonstrated superior MALE and death, MA, RAD, major re-intervention, and any re-intervention for OPEN SSGSV vs. ENDO. OPEN SSGSV also demonstrated superior freedom from MALE and death, and greater amputation free survival vs. OPEN AC. Presence of infrapopliteal disease, tissue loss, TASC classification, and diabetes mellitus were significant covariables. Open FP bypass with an SSGSV conduit provides the most effective revascularisation for patients with CLTI due to advanced FP disease.