Abstract 14433: Rates of Serious Adverse Events During Home-Based Exercise in Lower Extremity Peripheral Artery Disease: Results From Three Randomized Clinical Trials

Background: Home-based exercise is recommended by guidelines for people with lower extremity peripheral artery disease (PAD) to improve walking performance. This post-hoc analysis of three randomized clinical trials studied the association of home-based exercise, compared to control, on rates of serious adverse events in people with PAD. Methods Data were combined from three randomized clinical trials that compared home-based walking exercise to a control group that did not exercise. In all three trials, people with an abnormal baseline exercise stress test were excluded. Participants randomized to home-based exercise worked with a coach, who used behavioral methods to help them adhere to home-based walking exercise, consisting of walking for exercise five times per week for up to 50 minutes/session. The control groups received educational sessions instead of exercise. Participants were questioned each month about occurrence of serious adverse events, defined as hospitalizations, deaths, or events causing persistent disability. Results 651 people with PAD from three randomized trials were included (mean age 70, 49% women, 53% Black). People randomized to exercise had higher rates of cardiovascular events than control (Table). Among those randomized to exercise, people with history of myocardial infarction (p=0.0002), angina (p=0.0004), stroke (p=0.03), pulmonary disease (p=0.02), and poorer baseline six-minute walk distance (280.29 vs 338.15 meters, p=0.0002) had higher rates of cardiovascular events. Conclusion In these post-hoc analyses, people with PAD randomized to a home-based walking exercise intervention had higher rates of cardiovascular events, compared to a control group during the trial. Further study is needed to determine whether this association represents a causal effect. People with PAD who have lower six-minute walk distance or a history of cardiovascular disease may require closer monitoring during a home-based exercise program.