Elective PVI for Claudication Linked to Higher Limb Loss, Costs

Elective peripheral vascular intervention (PVI) for patients with peripheral arterial disease (PAD) and intermittent claudication (IC) was associated with more than double the rate of major adverse limb events (MALE) compared with no PVI, according to a large real-world study published in the Journal of Vascular Surgery.¹

"I think it comes down to several factors,” said Ken Cohen, MD, FACP, chief medical officer, Optum Health, chief scientific officer for the Healthcare Transformation Hub, and study co-author, in an interview with The American Journal of Managed Care^® (AJMC^®). “First, physicians tend to overestimate the benefits of the services we provide and underestimate the harms, and that allows us, on occasion, to do procedures in individuals who may best be managed with conservative therapy. I think that is the chief underlying finding in this study."

Researchers conducted a 1:1 propensity-matched retrospective cohort analysis using the OptumLabs Data Warehouse, drawing on commercially insured and Medicare Advantage claims from January 2016 through September 2023. Among 26,716 matched patients (mean age, 70.5 years; 41% women), 13,358 underwent elective outpatient PVI and were matched to 13,358 who did not, based on demographics, comorbidities, PAD-related medications, office visits, and baseline costs across 17 variables.

Higher Rates of Amputation and Limb Ischemia

Over 12 months, the MALE composite—new major amputation, new acute limb ischemia, and progression to chronic limb-threatening ischemia—occurred in 15.6% of the PVI group versus 7.5% of the no-PVI group (incidence rate ratio [IRR], 2.20; 95% CI, 2.04-2.38). New major amputations were more than 4 times as likely after PVI (IRR, 4.01; 95% CI, 2.45-6.55).

Roughly 1 in 4 patients who received an initial elective PVI underwent a repeat procedure between 2 and 12 months later, after procedures within the first 30 days were excluded to avoid counting planned staged interventions.

Subgroup analyses found that patients who received atherectomy had higher rates of MALE (IRR, 1.17; 95% CI, 1.07-1.28) and subsequent PVI (IRR, 1.73; 95% CI, 1.62-1.85) than those who did not. Patients who received infrapopliteal (tibial-level) intervention likewise had higher MALE and reintervention rates than those treated at the femoropopliteal level alone.

Additionally, the total cost of care over 12 months was substantially higher among patients who underwent PVI ($44,934) than among those who did not ($26,452; cost ratio, 1.70; 95% CI, 1.65-1.75), driven largely by medical costs; out-of-pocket costs were also significantly higher in the PVI group.

SET Remains Underused Despite Guideline Support

Supervised exercise therapy (SET)—the guideline-recommended first-line treatment for claudication—was used by only 0.2% of patients at baseline and by just 0.5% to 0.6% of either group during follow-up, despite a Class 1A society endorsement and Medicare coverage.

The findings echo a 2025 focused-update guideline from the Society for Vascular Surgery, which suggests against infrapopliteal revascularization in patients with IC, absent signs of chronic limb-threatening ischemia, citing a lack of demonstrated benefit and potential for harm.²

However, the authors noted that unmeasured confounding by disease severity could not be entirely ruled out, though matching achieved standardized mean differences below 10% across all 17 variables, and negative control outcomes (mortality, myocardial infarction, and stroke) showed no significant differences between groups—arguing against substantial residual confounding.¹

The study's authors conclude that improving care for patients with PAD and claudication should prioritize greater use of SET and optimal medical therapy while avoiding the risks associated with elective PVI. At minimum, they write, patients should be fully informed of the potential downstream risks of revascularization as part of shared decision-making before pursuing intervention.

"This study, I think, is highly useful in shining a bright light on this—not only allowing us to look more closely at those that are overusing interventions, but also using comparative research within our markets to identify who we think are the most evidence-based vascular interventionalists to whom we should be referring our patients,” said Cohen. “I think that's the take-home message from the study."

References

1. Dhruva SS, Murillo J, Ameli O, Conte MS, Redberg RF, Cohen K. Association of elective peripheral vascular intervention with outcomes among patients with peripheral arterial disease and intermittent claudication. J Vasc Surg. Published online June 12, 2026. doi:10.1016/j.jvs.2026.05.052
2. Conte MS, Aulivola B, Barshes NR, et al. Society for Vascular Surgery Clinical Practice Guideline on the management of intermittent claudication: Focused update. J Vasc Surg. 2025;82(2):303-326.e11. doi:10.1016/j.jvs.2025.04.041