Twelve-month health status response after peripheral vascular intervention for femoropopliteal lesions using Zilver PTX databases focusing on the role of preprocedural health status, comorbid risks, and global setting

Abstract

Objective: Tailoring resources of peripheral vascular interventions (PVIs) to those who stand to gain the most would allow for more equitable and value-based care. One way of evaluating the benefit of PVIs in patients with symptomatic peripheral artery disease is evaluating their health status and identifying predictors of health status response 12 months after the intervention.

Methods: Patients who underwent femoropopliteal PVI between March 2005 and August 2008 from the Zilver PTX randomized trial and single-arm study were combined into a single cohort for secondary data analysis. The preprocedural and 12-month health status was assessed by the EuroQol-5D-3 L (EQ-5D). First, we evaluated the 12-month EQ-5D Index (per 1-unit increase), adjusted for treatment condition and patient characteristics using a linear regression. Second, using the minimally clinically important difference threshold for the EQ-5D Index, we identified 12-month nonresponders (worsened or no change) vs responders (improved) and conducted an adjusted logistic regression model.

Results: A total of 513 patients were included (mean age: 67.8 ± 9.2 years; 25.1% female), with 17.8% U.S. and 82.2% non-U.S. global enrollment sites. The minimally clinically important difference for the EQ-5D was 0.058. For 12-month health status after PVI, a total of 57.9% improved, 31.4% experienced no change, and 10.7% worsened, relative to their preprocedural health status. Patients who were more likely to be nonresponders were more likely to have a history of carotid artery disease or were located at a U.S. enrolling center.

Conclusions: The majority of patients reported improved or stable health status after femoral-popliteal PVI. Approximately 4 in 10 patients were nonresponders, with the highest risk for nonresponse including individuals with existing carotid disease or those undergoing PVIs in the U.S. vs non-U.S.

Keywords: Health status; Peripheral artery disease; Peripheral vascular interventions; Responder analysis.