Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC)

Abstract

The lack of consistent definitions and nomenclature across clinical trials of novel devices, drugs, or biologics poses a significant barrier to accrual of knowledge in and across peripheral artery disease therapies and technologies. Recognizing this problem, the Peripheral Academic Research Consortium, together with the U.S. Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, has developed a series of pragmatic consensus definitions for patients being treated for peripheral artery disease affecting the lower extremities. These consensus definitions include the clinical presentation, anatomic depiction, interventional outcomes, surrogate imaging and physiological follow-up, and clinical outcomes of patients with lower-extremity peripheral artery disease. Consistent application of these definitions in clinical trials evaluating novel revascularization technologies should result in more efficient regulatory evaluation and best practice guidelines to inform clinical decisions in patients with lower extremity peripheral artery disease.

Keywords: amputation; foot; intermittent claudication; leg; myocardial infarction; stroke.

Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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CENTRAL ILLUSTRATION. PARC-PAD Definitions: Consensus Definitions for Evaluation of Patients With Lower Extremity Peripheral Artery Disease: The PARC

The Peripheral Academic Research Consortium (PARC) included input from both the Food and Drug Administration and the Pharmaceuticals and Medical Devices Agency to develop consensus definitions. Patient features and clinical care data will be entered into patients’ electronic health records (EHRs) used in peripheral artery disease (PAD) registries for clinical trials, and were on the basis of the data elements for PAD in the 2012 American Heart Association/American College of Cardiology (AHA/ACC) data standards document (9). Patient features and clinical care data, data elements, and PAD registries all are used in clinical trials.