Abstract P626: Associations of Supervised and Home-Based Exercise With Serious Adverse Event Rates During Exercise Interventions for Peripheral Artery Disease: A Meta-Analysis of Five Randomized Clinical Trials

Abstract

Background: Supervised or home-based walking exercise therapy (ET) are guideline recommended to improve walking performance in people with peripheral artery disease (PAD). This study compared serious adverse event (SAE) rates associated with home-based compared to supervised exercise in people randomized into clinical trials of ET for PAD. Methods: Data from five randomized clinical trials of ET for PAD were combined. In three trials (GOALS, HONOR, and LITE), participants were randomized to home-based ET or control. In two trials (PROPEL and TELEX), participants were randomized to supervised ET or control. The primary outcome in all trials was change in six-minute walk. SAEs consisted of hospitalization or death and were identified from participants, family members, and medical records. In post-hoc analyses, a meta-analysis compared associations of supervised ET and home-based ET on odds of a SAE or death. Control groups from the trials of supervised and home-based ET were not combined. Results: 867 unique participants were included (mean age + SD: 69 ±10 years, 47% female, 57 % Black, mean + SD ABI 0.66 ±0.15). Results are shown in the Table. Conclusion: In clinical trials of home-based ET, rates of coronary revascularizations and cardiovascular events were significantly higher in participants randomized to exercise, compared to control. However, there were no significant differences in rates of coronary revascularizations or cardiovascular events between participants randomized to home-based, compared to supervised ET. Improved walking performance from home-based exercise may precipitate symptoms from underlying coronary artery disease in people with PAD.