AHA/ACC and Others Issue PAD Guideline Update With Focus on Collaborative Care

New guidance on the treatment of peripheral artery disease (PAD) encourages collaborative vascular care to address health disparities, gaps in medical therapy, the need for structured exercise, and good foot care in addition to appropriate revascularization to prevent limb loss.

The document, from the American College of Cardiology (ACC) and the American Heart Association (AHA) in collaboration with nine other organizations, is an update to the 2016 guidelines. It also issues a call for advocacy, including broad implementation of the PAD National Action Plan along with the updated guideline recommendations, to improve outcomes.

“One of the cornerstones of this guideline is that all patients with PAD, no matter what clinical subset they're in, need rigorous medical therapy,” writing committee chair Heather Gornik, MD (University Hospitals Harrington Heart & Vascular Institute and Case Western Reserve University School of Medicine, Cleveland, OH), told TCTMD. “We have a lot of opportunities there, but it's not as sexy as the interventions. People are debating endovascular or surgical, yet these patients are not getting on basic medical therapy or smoking cessation.”

Among the medical therapies entering the guidelines for the first time is low-dose rivaroxaban (Xarelto; Bayer/Janssen) combined with low-dose aspirin, with a class 1, level of evidence A recommendation in symptomatic PAD patients and in those who have had an endovascular or surgical revascularization to reduce the risk of MACE and major adverse limb events (MALE).

Other medical therapies making their first appearance in these guidelines include sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP-1) receptor agonists—both with class 1, level of evidence A recommendations—for prevention of MACE in patients with PAD who have diabetes.

In patients with PAD who are on maximally tolerated statin therapy and have an LDL-cholesterol level of ≥70 mg/dL, the guidelines give a class 2a recommendation to PCSK9 inhibitors and ezetimibe.

Spotlight on Disparities

The guideline, published this week in Circulation, addresses four clinical subsets of PAD: asymptomatic PAD (may have functional impairment), chronic symptomatic PAD (including claudication), chronic limb-threatening ischemia (CLTI), and acute limb ischemia. It also addresses PAD-related risk amplifiers, which can escalate the likelihood of MACE and MALE. Among these is polyvascular disease, defined as the presence of atherosclerotic disease involving two or more vascular beds.

Additionally, the document recognizes the importance of depression as a prevalent comorbidity in PAD, having been linked to increased risk of MACE and MALE as well as other adverse outcomes such as length of stay and readmission after revascularization. Gornik and colleagues advise use of the Geriatric Depression Score (GDS) and the Patient Heath Questionnaire (PHQ)-9 to assess for depression.

People are debating endovascular or surgical, yet these patients are not getting on basic medical therapy or smoking cessation. Heather Gornik

Health disparities is another area where the guideline has expanded its focus, recognizing the intersectionality between social determinants of health and PAD disparities across race, ethnicity, and income level. It advises patient-centric efforts to address some of these disparities, including “identifying patients from disenfranchised at-risk populations for symptoms and signs of PAD, such as exertional leg symptoms and impairment in walking abilities, and conducting regular thorough physical examinations, including assessment of the legs and feet and assessment of pulses for those at risk.”

The guideline also reinforces the importance of longitudinal follow-up, particularly for disadvantaged at-risk populations, and voices support for the broad adoption of quality measures for PAD care as well as education and funding support as proposed in a recent AHA policy statement aimed at driving amputation rates down 20% by the year 2030.

Exercise and Team-Based Care

Since the previous PAD guidelines were released in 2016, the Centers for Medicare & Medicaid Services (CMS) agreed to cover supervised exercise therapy (SET) for patients with PAD. An expanded exercise section has been added. The class 1, level of evidence A recommendations for SET apply to those with chronic symptomatic PAD, with or without revascularization, to improve walking performance, functional status, and quality of life. They also include a recommendation for structured community-based exercise programs with behavioral change techniques in those with chronic symptomatic PAD. Additionally, in those with functionally limiting claudication, the guideline gives a class 1, level of evidence A recommendation for either SET or a structured community-based exercise program as an initial treatment option.

The guideline committee notes that while the evidence base is strongest for SET, structured exercise programs encompass a range of options that can be considered, including those in nonclinical settings such as home-, community-, and neighborhood-based programs.

Gornik said the expanded emphasis on these programs is important given that traditional advice given to PAD patients such as walking more has not been effective. The guideline notes that this type of advice should “only have a limited role in care when structured exercise programs are unavailable.”

“The other piece that I think is new and really exciting is the importance of foot care across the whole spectrum of PAD,” Gornik said. “So, not just preventive foot care, but also the importance of foot care and foot care professionals in managing patients with CLTI.”

The American Podiatric Medical Association collaborated on the guideline, which features sections on risk factors for foot ulcers and components and questions that should be included in comprehensive foot assessments.

A consistent theme that runs through the new guideline is collaborative vascular care, particularly team-based care for CLTI. According to Gornik, the recommendations reflect the multispecialty nature of the writing committee and the realization that there are many different ways to provide care for patients with PAD.

“The medical therapy, the revascularization experts, endovascular, surgical, maybe both; the foot care experts, the wound-healing experts, the people who have input on what will be a shoe-able foot and a functional limb and a prosthesis in the future. You want all those people to work together to try to save as much of the patient's limb as possible, so they have good functional outcomes,” she added.

While asymptomatic patients with PAD may not need a whole team, Gornik and the guideline committee say collaborative care is a must for those in the most severe subset of disease.

“That being said, some permutations of the team could be involved in the patient's care depending on the complexity of their individual situation,” Gornik added. “In order for us to move the needle on the outcomes in PAD, which historically have not been great, we really all need to work together.”