EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS

NEW ORLEANS (FRONTLINE MEDICAL NEWS) – The latest revision of U.S. guidelines for diagnosing and managing lower-extremity peripheral artery disease is seen by several experts as primarily a renewed call to action by American physicians to more diligently identify at-risk people in their practices, diagnose the disease with ankle-brachial index measurement, and appropriately treat patients who have the disease.

The new lower-extremity peripheral artery disease (PAD) guidelines “give us a platform to get something done,” said Heather L. Gornik, MD , vice chair of the guidelines panel and medical director of the noninvasive vascular lab at the Cleveland Clinic. Improved PAD identification and care “starts with the fundamentals of recognizing who is at risk for PAD and then doing some clinical investigation to find it, because it’s there. You just need to ask patients if they have leg symptoms, have them take off their socks and examine their feet,” Dr. Gornik said in an interview following a program devoted to the revised guidelines at the American Heart Association scientific sessions.

Although the recent guidelines revision (Circulation. 2016 Nov 13. doi: 10.1161/CIR.0000000000000470 ) includes a lot of new evidence beyond what had been in the first PAD guidelines released by the AHA and American College of Cardiology in 2005 ( Circulation. 2006 March 23;113[11]:e463-654 ) and in a “focused update” in 2011 ( J Am Coll Cardio. 2011 Nov;58[19]:2020-45 ), “a lot is the same” in the latest version, compared with the two prior documents, Dr. Gornik noted. “What we need now is buy in and dissemination, and have people beyond the vascular experts actually use these guidelines,” she said. “The time is prime now to really have an impact, with greater recognition that PAD is a problem.”

The new guidelines are “a clarion call to action,” commented Alan T. Hirsch, MD , professor of medicine, epidemiology, and community health and director of the vascular medicine program at the University of Minnesota in Minneapolis. PAD “is the single most morbid and fatal of all cardiovascular diseases, so why in 2016 are we challenged to have every cardiologist trained in basic PAD competency?” asked Dr. Hirsch, who chaired the 2005 guidelines panel.

“The AHA has created a new public and health professional initiative on behalf of PAD so we can do better in the future” diagnosing and managing lower-extremity PAD, Dr. Hirsch said in an interview. “This is incredibly important and likely can assure that we achieve a paradigm shift in focusing on highly prevalent and dangerous diseases, like PAD. The AHA has assigned staff and resources to assure that we can accomplish this goal in the immediate future by more promptly diagnosing and managing lower-extremity PAD.”

The AHA wants to “elevate awareness of PAD among the public and health professionals, and we want to better understand how we can be a catalyst for change,” said Terri Wiggins , the organization’s vice president for vascular health programs. AHA publications now stress that clinicians need to have patients “take off their socks and look at the patient’s feet,” she said.

The problem with the way many U.S. physicians handle PAD goes beyond a failure to properly screen and diagnose the disease. Analysis of data collected by the National Ambulatory Medical Care Survey and the National Hospital Ambulatory Medical Care Survey during 2006-2013 showed that, among an average of 3.9 million patients seen each year with PAD, just 38% received treatment with an antiplatelet drug, 35% received a statin, and among those patients who smoked, 36% received counseling for smoking cessation, Jeffrey S. Berger, MD , reported in a separate talk at the meeting. These rates were roughly constant throughout the 8-year period he examined.

His analysis also showed that just under a quarter of the PAD patients were also diagnosed with coronary artery disease (CAD), and in patients with disease in both arterial beds, prescription of an antiplatelet drug – aspirin or clopidogrel – jumped by more than twofold, compared with patients diagnosed with PAD only, prescription of a statin was 60% higher for patients diagnosed with both PAD and CAD, and smoking cessation treatment occurred greater than threefold more often among patients with both diseases diagnosed, reported Dr. Berger, a preventive cardiologist at New York University.

“These data are eye-opening. They highlight a clear opportunity to improve the care of patients with PAD with guideline-directed therapy. PAD is problematic because only 10%-15% of patients have typical symptoms, so many physicians have a false perception that these patients are not at high risk,” Dr. Berger said in an interview. “What the AHA is doing is great” for raising awareness, he added.

The revised 2016 PAD guidelines made several changes, compared with what had been on the books from the 2005 guidelines and 2011 update, including classifying vorapaxar (Zontivity) treatment a class IIb recommendation with “uncertain” incremental benefit when used as an add-on agent on top of standard antiplatelet therapy, endorsement of annual influenza vaccination as something every PAD patient should receive and a class I recommendation, and acknowledgment that selected patients with critical limb ischemia are candidates for an “endovascular first” approach to revascularization,

Perhaps just as important was inclusion for the first time in the new guidelines of three advocacy priorities for initiatives by various professional societies with an interest in PAD: easy availability of ankle-brachial index measurement as the initial test to establish a diagnosis of PAD in patients with physical examination findings suggestive of the disease; access to supervised exercise programs for patients diagnosed with PAD; and incorporation of patient-centered outcomes into the regulatory approval process of new medical therapies and revascularization technologies for treating PAD.

The new guidelines “ form the basis for the AHA establishing a Get With The Guidelines program for PAD so that clinicians can be held accountable for delivering these treatments,” said Naomi M. Hamburg, MD, chief of vascular biology at Boston University and a member of the guidelines panel.

After release of both the first guidelines in 2005 and the update in 2011, U.S. physicians, public health agencies, and insurers failed to widely apply the recommendations to routine practice, Dr. Hirsch noted. He was hopeful that response to the 2016 revision will be different, triggering a more diligent and concerted approach to a major public health problem.

Dr. Gornik has an ownership interest in Summit Doppler Systems and Zin Medical and has received research support from AstraZeneca and Theravasc. Dr. Hamburg has been a consultant to Acceleron and has received research support from Everest Genomics, Hershey’s, Unex, and Welch’s. Dr. Hirsch, Ms. Wiggins, and Dr. Berger had no disclosures.

mzoler@frontlinemedcom.com

On Twitter @mitchelzoler

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