Abstract Body (Do not enter title and authors here): Background
Symptomatic peripheral artery disease (PAD) is prevalent and targeted therapies include optimal medical care (OMC), supervised exercise therapy (SET) and revascularization (ST). Although most PAD trials focus on objective outcomes, improvement in quality of life is important to the patient. The Supervised Exercise, Stent Revascularization, or Medical Therapy for Claudication (CLEVER) Trial examined longitudinal patient-reported outcomes to assess response to OMC, SET and ST. The predictors of symptomatic improvement have not been fully assessed.

Research Question
What are the predictors of symptomatic response to therapy for patients with PAD?

Aims
To assess how demographics, comorbidities, and treatment modality predict improvement in patient-reported outcomes as measured by the Peripheral Artery Questionnaire (PAQ).

Methods
This is a secondary analysis of the CLEVER trial, which randomized patients with claudication to OMC alone, SET or ST. The primary outcome measure was PAQ at 18 months. Response was defined as a change in the PAQ Summary Score by the minimal clinically important difference (MCID) of ≥10 points compared with baseline. Multivariable logistic regression was used to identify predictors of response.

Results
Of the 103 participants (66 male, median age 63 years) included in this analysis, 22 were randomized to OMC, 40 to SET, and 41 to ST. Sixty-five (63%) participants had a decrease in PAQ Summary score of 10 or more points at 6 months. Of 98 participants who completed the 18-month PAQ, 52 (55%) had a response to therapy. Compared to those randomized to OMC, on univariate analyses, participants randomized to SET had a 4.5 (95%CI:1.5-13.6) increased odds of response at 6 months and a 4.2 (95%CI:1.2-15.1) increased odds at 18 months. Those randomized ST had a 6.6 (95% CI:2.1-20.9) and 10.9 (95% CI:2.9-40.6) increased odds of response at 6 and 18 months respectively. When controlling for demographics, comorbidities, and ABI, SET (18-month OR 3.9; 95%CI:1.1-14.7) and ST (18-month OR11.5 95%CI 2.9-45.7) remained associated with symptomatic response at 6 and 18 months. Treatment group was the only independent predictor of clinically meaningful symptomatic improvement.

Conclusion
Among randomized patients in the CLEVER trial, treatment with either SET or ST was most predictive of quality life improvement at 6 and 18 months. These interventions, with a prioritization of SET, should be more widely available and offered to symptomatic PAD patients.