Bypass Versus Endovascular Therapy for Elective Infrapopliteal Interventions in Chronic Limb-threatening Ischemia: Propensity Score-matched Analyses of Vascular Quality Initiative Registry

Abstract

Objective: We used multi-institutional data from the Vascular Quality Initiative (VQI) to compare outcomes following revascularization in infrapopliteal chronic limb-threatening ischemia (CLTI).

Background: The choice between bypass and endovascular therapy (ET) in patients with CLTI is controversial, particularly when the distal target is within the infrapopliteal region.

Methods: We used VQI data (2018-2023) to compare bypass with single-segment great saphenous vein (SSGSV) versus ET and bypass with an alternative conduit (AC) versus ET in patients presenting with CLTI who underwent first-time elective infrapopliteal-only or femorotibial revascularizations. We performed 2 one-to-one propensity score matchings (PSM) in patients who had at least one follow-up. Two pairs of matched cohorts were created: SSGSV versus ET and AC versus ET. PSMs were conducted based on demographics, insurance status, smoking status, comorbidities, prior procedures, type of CLTI, and preoperative and discharge medications. The primary outcome was amputation-free survival (AFS). The secondary outcomes included overall survival, limb salvage, freedom from reintervention, freedom from major adverse limb event (MALE), and MALE-free survival. MALE was defined as any reintervention and/or major amputation following index revascularization. All outcomes were analyzed up to 1 year. Kaplan-Meier survival estimates and Cox regression were used for analyses.

Results: There were 25,138 limbs and 21,339 patients. The interventions included: ET, N=21,506 (85.5%); SSGSV, N=2299 (9.2%); and AC, N=1333 (5.3%). After PSM, the SSGSV versus ET (1884 pairs) and AC versus ET cohorts (1038 pairs) were well balanced. In the matched cohorts, the SSGSV cohort was associated with decreased hazards of death [hazard ratio (HR)=0.73 (95% CI, 0.60-0.88); P =0.001] and major amputation/death [HR=0.84 (95% CI, 0.72-0.97); P =0.020] compared with the ET cohort. Moreover, the AC cohort was associated with increased hazards of major amputation [HR=1.82 (95% CI, 1.36-2.44); P <.001], major amputation/death [HR=1.22 (95% CI, 1.01-1.46); P =0.035], and MALE [HR=1.24 (95% CI, 1.02-1.51); P =0.031] compared with the ET cohort. MALE/death was not associated with the type of revascularization in matched cohorts.

Conclusions: Our multi-institutional analyses revealed superior one-year outcomes with bypass using SSGSV compared with ET in terms of overall survival and AFS. However, ET was superior to bypass with AC in terms of limb salvage, AFS, and freedom from MALE. We conclude that bypass with SSGSV should be considered first-line therapy for CLTI when there is infrapopliteal involvement. However, when a good quality SSGSV is not available, ET can offer lower amputation and MALE risk and higher AFS compared with AC. These decisions should be individualized based on each patient's physiological and anatomic factors.

Keywords: bypass; chronic limb-threatening ischemia; endovascular therapy; peripheral artery disease; revascularization.