Vascular surgeons have long debated whether and when to intervene on claudication. A new study suggests the field may be intervening too often, too early and with consequences that compound over time.
The findings, recently published in the Journal of Vascular Surgery, come from a propensity-matched analysis of more than 26,000 patients with peripheral arterial disease (PAD) and intermittent claudication (IC). Researchers found that elective peripheral vascular intervention (PVI) was associated with significantly higher rates of major adverse limb events (MALE), a markedly higher rate of repeat procedures and substantially greater costs of care compared with medical management alone.
“We know that an increasing number of patients with PAD and IC are receiving elective PVI,” said lead study author Sanket Dhruva, MD, a cardiologist and assistant professor of medicine at the University of California in San Francisco. “However, medical management, including supervised exercise therapy (SET), is the standard of care,” said Dhruva. “Our study objective was to evaluate the association of elective PVI versus medical management with clinical and cost outcomes in a large, contemporary real-world cohort.”
The investigators conducted a retrospective cohort analysis of commercially insured and Medicare Advantage patients in the OptumLabs Data Warehouse with incident PAD and IC diagnoses, yielding a matched sample of 26,716 patients with 13,358 in each group.
Elective PVI was associated with more than double the incidence of MALE compared with no PVI, with all three component endpoints — new major amputations, new acute limb ischemia and progression to CLTI — significantly higher in the intervention group. One in four patients who underwent PVI received a repeat procedure within the following year, after excluding staged procedures in the first 30 days.
“Elective PVI for patients with PAD and IC was associated with worse clinical outcomes and frequent reintervention compared to no intervention,” said Dhruva. “Rather than reducing downstream events, elective PVI was associated with increased rates of MALE.”
The cost burden was substantial as well. Mean total cost of care over 12 months reached $44,934 among patients who underwent elective PVI, compared with $26,452 among those who did not — a cost ratio of 1.70. Both health plan-paid costs and out-of-pocket costs were significantly higher in the PVI group, as were rates of emergency department visits and acute inpatient hospitalizations.
Additionally, patients who received atherectomy had higher MALE rates and were significantly more likely to undergo repeat procedures compared with those who received PVI without atherectomy. Patients who received infrapopliteal PVI fared worse still, with higher composite MALE and repeat PVI rates than those who underwent only femoropopliteal intervention, which is consistent with Society for Vascular Surgery guidelines that recommend against infrapopliteal revascularization for claudication.
Equally significant was what the data revealed about the underuse of conservative care. SET — which carries a Class 1A guideline endorsement and has been shown to meaningfully improve walking distance — was used by only 0.2% of patients in either group at baseline and barely improved within the 12 months that followed. The authors note that while SET is covered by Medicare, utilization remains extremely low in practice.
“These findings raise important questions about the effectiveness of elective PVI in this population and highlight that patients should be receiving guideline-directed medical management and SET before invasive treatment is considered,” said Dhruva.
Beyond the utilization gap, Dhruva stressed the importance of how conversations about intervention happen at the individual patient level. If elective PVI is ultimately recommended, the downstream risks need to be part of the discussion.
“If elective PVI is recommended to a patient in clinical practice, it’s very important that informed, shared decision-making occurs so that patients understand the potential risks later, including repeat procedures and adverse limb events,” said Dhruva.
Dhruva and colleagues acknowledged the inherent constraints of a retrospective, claims-based design. Patients selected for elective PVI may have had more advanced or refractory disease than their matched counterparts and diagnosis codes alone cannot fully capture disease severity. However, matching on 17 variables substantially reduced baseline imbalances and negative control outcomes — including 12-month mortality and incident myocardial infarction or stroke — did not differ significantly between groups, lending support to the primary findings.
Dhruva pointed to several questions the study leaves open, including whether particular patient subgroups might benefit from revascularization while avoiding the subsequent harms seen in the broader population. But the more pressing near-term priority is structural, he said.
“Future research should evaluate whether there are any subgroups of patients who derive meaningful clinical outcome benefit from revascularization while minimizing downstream harm,” said Dhruva. “More broadly, we need to evaluate how we can ensure patients with PAD and IC receive optimal guideline-directed medical management and we clearly need to double down on improving the extremely low rates of SET, given that it carries the strongest clinical practice guideline recommendation and many additional benefits beyond improving outcomes in PAD,” he said.
“Elective PVI for patients with PAD and IC was associated with worse limb outcomes, frequent repeat procedures and substantially higher costs compared with no PVI,” said Dhruva. “These findings reinforce the need to ensure that patients are actually receiving important conservative therapies before surgical intervention is pursued.”
