Abstract 075: Heterogeneity in Treatment Effect in Patients With Peripheral Artery Disease Insights From the CLEVER Trial

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Background: The CLEVER trial (Claudication: Exercise versus Endoluminal Revascularization) showed significant improvement in peripheral artery disease (PAD)-specific health status (Peripheral Artery Questionnaire, PAQ) at 6 and 18 months for both supervised exercise (SE) and stent therapy (ST) compared with optimal medical care (OMC) in PAD patients. However, it is unknown whether there is variation in treatment by age, gender or race, or if recovery is similar across these groups over time.Methods: A total of 111 patients from 22 sites with hemodynamically significant aortoiliac arterial stenosis were randomized to SE, ST, or OMC. Using maximum likelihood methods for longitudinal analyses, we analyzed change from baseline in PAQ summary scores at 6 and 18 months and tested interactions between demographic factors (≥65 vs. <65 years; women vs. men; non-Caucasians vs. Caucasians) and treatment, time, and treatment by time. When significant, we further examined effects by different treatment modalities (OMC, SE and ST).Results: The mean age of the study population was 64.4 years (53.1% <65 years), 37.8% were women and 32.4% were non-Caucasians (26.1% African Americans and 6.3% other race). There was a significant interaction by race and treatment (p=0.006, overall difference in PAQ summary scores in non-Caucasians minus Caucasians -4.0 [-11.6, 3.6], p=0.30), but there was no significant interaction between other demographic factors and treatment, time, or treatment and time. In Caucasians, PAQ summary scores improved only with ST; in non-Caucasians, improvement was similar with ST or SE (Figure). Estimates of difference in PAQ scores between SE or ST and OMC showed similar results (Table).Conclusion: There was a significant interaction between treatment and race, with only ST showing significant improvement in PAQ scores in Caucasians, whereas both ST and SE showed significant improvements in PAQ among non-Caucasians. Further studies should validate and explore the mechanisms of different racial responses to PAD treatment.

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