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CLINICAL STATEMENTS AND GUIDELINES

June 11, 2024 Circulation. 2024;149:e1313–e1410. DOI: 10.1161/CIR.0000000000001251 e1350

Synopsis Strong, high-quality, and consistent data support the use of SET to improve functional status, walking performance, and QOL in patients with chronic symptomatic PAD. This includes those who are being considered for revascularization as exercise improvements are at least as effective as revascularization.17,18,40 Medicare and most commercial insurance companies now cover SET for patients with claudication. SET can be delivered in a clinic office space or hospital, although cardiac rehabilitation programs are considered an ideal setting. Some third-party payers may require SET to be performed in a hospital outpatient setting. When revascularization is performed, referral to SET can result in optimization of benefits.39 Although most randomized clinical trials have compared SET to control or usual care conditions, the evidence supporting a structured community-based exercise program (including home-based programs) continues to grow. A 2019 meta-analysis including 11 trials and 807 patients showed that, overall, these programs improve walking performance and physical activity compared with usual care.11 Two additional RCTs support the efficacy of structured community-based exercise programs to improve functional status among patients with chronic symptomatic PAD.5,15 Similarly, increasing evidence exists that alternative forms of exercise that do not involve treadmill walking to moderate to severe claudication also improve walking performance and QOL, similar to improvements seen with traditional treadmill walking programs.19,20 Unstructured exercise programs, such as education from the vascular specialist for patients with chronic symptomatic PAD to “go out and walk,” have not been shown to be effective and only have a limited role in care when structured exercise programs are unavailable. Recommendation-Specific Supportive Text

1 Data supporting the efficacy of SET as an initial

treatment for claudication are high quality and consistently show functional improvements, although specific functional measures used as outcomes across RCTs have varied.7,16–28 Trials with long-term follow-up using treadmill walking parameters as the performance measure have shown persistent benefits of SET among patients with claudication ranging from 18 months17,18 up to 7 years.25 However, a trial of SET using the 6-minute walk test (6MWT) as the performance measure did not show durable changes at 6 months after training ceased, highlighting an opportunity for future research on the durability of SET and the measures used to assess its efficacy (ie, traditional standard of treadmill walking versus 6MWT).48 Data also support a benefit of SET for patients with symptomatic PAD and diabetes.49 The risk–benefit ratio for SET in PAD is favorable, with an excellent safety profile in patients screened for contraindications to exercise, such as exercise-limiting CVD, amputation, or wheelchair confinement, and other major comorbidities that would preclude exercise.6,10,25,42,43,50,51 However, amputation and wheelchair use should not be an absolute contraindication because in specific settings, alternative exercise modalities may be available and useful in these individuals.52 Despite the health benefits associated with SET, its rating as a COR 1 recommendation statement, and a covered Medicare benefit,53 referral rates remain very low and are approximately 2% in the United States.54 In patients with PAD, initiating and maintaining a high level of adherence to SET is challenging. Frequent contact with patients both when performing exercise in the supervised setting and at home, as well as multimodal exercise, has been somewhat effective in promoting retention in SET programs in the research setting.55 Although patients with asymptomatic PAD may have functional impairment and benefit from increased physical activity, the benefit of SET for patients with asymptomatic PAD has not been adequately studied.9,56 Some patients with PAD who do not self-report claudication may experience limiting leg symptoms during objective assessment, such as an exercise treadmill ABI test or 6MWT, and may thus qualify for SET. 2.	 Structured community-based exercise programs

have emerged as an effective alternative to SET for patients with chronic symptomatic PAD. Studies supporting structured community-based programs for patients with claudication or leg symptoms atypical for claudication are more recent than studies supporting supervised exercise programs and have provided strong evidence in support of the community-based approach.6,8–11,57,58 The GOALS (Group Oriented Arterial Leg Study)8 included patients with confirmed PAD with and without claudication (atypical lower extremity symptoms or no symptoms) and showed increases in several parameters of functional status for both of these patient cohort subgroups versus nonexercising control groups after 6 months,8 with improvement maintained at 12 months.9 As with SET, despite proven benefit, initiating and maintaining a high level of adherence to structured community-based exercise programs also remains challenging. Studies that have incorporated behavioral change techniques, such as health coaching and activity tracking used in supervised settings, appear to reduce attrition and promote higher levels of adherence, thereby improving functional and QOL outcomes, both short- and long-term.6,8,9,12 The LITE (Low Intensity Exercise Intervention in PAD) trial5 used virtual coaching and activity tracking in a population of patients with chronic symptomatic

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