Abstract Body (Do not enter title and authors here): Introduction: Peripheral vascular intervention (PVI) is increasingly used for the treatment of peripheral arterial disease (PAD) with intermittent claudication (IC). Large, real-world studies of PVI are needed.

Research Question: What is the comparative effectiveness and costs of elective PVI compared to no PVI among patients with PAD and IC?

Methods: We conducted a 1:1 propensity-matched retrospective cohort analysis of insured individuals ≥18 years with incident PAD diagnosis and IC without acute or chronic limb ischemia from 1/1/16-9/30/23 in OptumLabs^® Data Warehouse. Patients receiving elective PVI were matched to those who did not receive PVI based on 17 variables, including demographics, prior amputations, comorbidities, medications, and year. Patients with rest pain, ulcer, gangrene, and acute limb ischemia (ALI) were excluded. The primary outcome was major adverse limb events (MALE), a composite of new major amputations, conversion to chronic limb threatening ischemia (CLTI), and new ALI at 12 months. Secondary outcomes were probability of subsequent PVI after a 30-day delay and total costs of care.

Results: Among 26,726 propensity-matched patients, mean age was 70.4 years, 41% were women. PVI was associated with a higher risk of MALE (hazard ratio [HR] 2.10, 95% CI 1.95-2.27), including major amputations, conversion to CLTI, and new ALI (Table). Among the 13,363 patients who received PVI, 3,479 (26.0%) received a repeat procedure within the next 12 months, compared to 61 (0.46%) who did not (HR 66.1, 95% CI 51.3-85.1). PVI was associated with higher mean costs of care over 12 months compared to no PVI ($44,951 [SD $44,342] vs $26,626 [SD $43,811]).

Conclusion: In this large real-world study, elective PVI for PAD with IC was associated with increased major adverse limb events and subsequent PVIs along with an average $18,000 higher total cost of care at 12 months. These findings suggest that the role of PVI in treatment of IC should be re-assessed.