Association of elective peripheral vascular intervention with outcomes among patients with peripheral arterial disease and intermittent claudication.

Abstract

Peripheral vascular intervention (PVI) is increasingly used for the treatment of peripheral arterial disease (PAD) with intermittent claudication (IC). However, large, real-world comparative studies of the safety and effectiveness of PVI compared with no PVI are limited. We sought to compare the effectiveness and costs of elective PVI compared with no PVI among patients with PAD and IC. We conducted a 1:1 propensity-matched retrospective cohort analysis of commercially insured and Medicare Advantage patients in OptumLabs Data Warehouse from January 1, 2016, to September 30, 2023. Patients aged 18 years and older with incident diagnosis codes for PAD with IC were included. Patients undergoing elective PVI were matched to those who did not receive PVI based on demographics, calendar year, comorbidities, PAD-related medications, office visits, and baseline costs. The primary outcome was major adverse limb events (MALE), defined as a composite of new major amputation, new acute limb ischemia, and progression to chronic limb-threatening ischemia among patients with 12-months continuous enrollment. Secondary outcomes included subsequent PVI after a 30-day delay and costs of care. Among 26,716 propensity-matched patients, mean age was 70.5 years, and 41% of patients were women. Elective PVI was associated with a higher risk of MALE [incidence rate ratio (IRR), 2.20; 95% confidence interval (CI), 2.04-2.38], including new major amputations (IRR, 4.01; 95% CI, 2.45-6.55), new acute limb ischemia (IRR, 1.94; 95% CI, 1.73-2.18), and progression to chronic limb-threatening ischemia (IRR, 2.43; 95% CI, 2.22-2.67). Among the 13,358 patients who received elective PVI, 3477 patients (26.0%) received a repeat procedure during months 2 to 12 following the initial PVI. Elective PVI treatment was also associated with higher mean total cost of care, $44,934 compared with $26,452 among patients who did not receive PVI (cost ratio, 1.70; 95% CI, 1.65-1.75). In this large real-world study of patients with PAD and IC, elective PVI was associated with increased MALE compared with no PVI. These findings should inform a re-evaluation of the increasing use of PVI in this population.