(PC074) Early Peripheral Vascular Intervention for Treating Patients with Claudication: A Decision Analysis using National Administrative Claims Data

Objectives: Previous studies have shown that early peripheral vascular interventions (PVI) performed within 6 months of an initial claudication diagnosis does not confer benefits and carries potential harm to patients. Traditional cohort studies, however, may not accurately reflect the patient experience, particularly the duration and burden of lifestyle-limiting claudication symptoms. A decision analysis is needed to integrate data, information, and knowledge about the stages of a patient’s journey in claudication to understand the trade-offs between benefits and burdens of early PVI versus conservative management and subsequent clinical outcomes.

Methods: We designed a decision model considering patients’ perspective and published outcomes of claudication after early PVI vs. conservative management. Probabilities came from 100% Medicare fee-for-service claims data between 01/2017 and 12/2021 using a Markov model. Using Monte Carlo Simulation, 1,000,000 patients were run through the model for the 2-year time horizon to calculate differences in estimated number of PVIs, number of open bypass procedures, and total time in claudication for patients managed with early PVI vs. conservative management. Sensitivity analysis using propensity score matching was conducted to control for baseline differences between groups, matching patients on age, sex, race, and comorbidities.

Results: A cohort comprised of 444,555 patients with newly diagnosed with claudication was identified (mean age 76.2 years, 52.0% male, 8.5% Black). Among these patients, 12,102 (2.7%) underwent early PVI, while 433,203 (97.3%) had no early PVI. Figure shows the Markov state–transition diagram. Monte Carlo simulation demonstrated that patients undergoing early PVI experienced higher mean number of PVIs over 2 years compared to patients managed conservatively (3.7 vs. 0.3, P< 0.001), more frequently required open bypass (1.6 vs. 0.8, P< 0.001), but spent less time in a state of claudication (190 vs. 355 days, P< 0.001) (Table). Sensitivity analysis using propensity score-matched cohorts (N=12,102 in each group) yielded similar results, confirming the robustness of the findings.

Conclusions: The decision model approach integrates research evidence, patient perspective, and expert opinions, which provides a coherent environment for assessing trade-offs and accounting for comprehensive research knowledge. Our findings reinforce those from prior studies suggesting that early PVI may not confer beneficial outcomes to patients, potentially leading to adverse effects and necessitating further interventions.