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2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines

Originally publishedhttps://doi.org/10.1161/CIR.0000000000000471Circulation. 2017;135:e726–e779

Table of Contents

Preamblee 727

  1. Introduction e728

    1.1. Methodology and Evidence Review e728

    1.2. Organization of the Writing Committee e730

    1.3. Document Review and Approval e730

    1.4. Scope of Guideline e731

  2. Clinical Assessment for PAD e733

    2.1. History and Physical Examination: Recommendations e733

  3. Diagnostic Testing for the Patient With Suspected Lower Extremity PAD (Claudication or CLI) e735

    3.1. Resting ABI for Diagnosing PAD: Recommendations e735

    3.2. Physiological Testing: Recommendations e735

    3.3. Imaging for Anatomic Assessment: Recommendations e739

  4. Screening for Atherosclerotic Disease in Other Vascular Beds for the Patient With PAD e740

    4.1. Abdominal Aortic Aneurysm: Recommendation e740

    4.2. Screening for Asymptomatic Atherosclerosis in Other Arterial Beds (Coronary, Carotid, and Renal Arteries) e740

  5. Medical Therapy for the Patient With PAD e740

    5.1. Antiplatelet Agents: Recommendations e741

    5.2. Statin Agents: Recommendation e742

    5.3. Antihypertensive Agents: Recommendations e742

    5.4. Smoking Cessation: Recommendations e743

    5.5. Glycemic Control: Recommendations e743

    5.6. Oral Anticoagulation: Recommendations e744

    5.7. Cilostazol: Recommendation e744

    5.8. Pentoxifylline: Recommendation e745

    5.9. Chelation Therapy: Recommendation e745

    5.10. Homocysteine Lowering: Recommendation e745

    5.11. Influenza Vaccination: Recommendation e745

  6. Structured Exercise Therapy: Recommendations e745

  7. Minimizing Tissue Loss in Patients With PAD: Recommendations e747

  8. Revascularization for Claudication e748

    8.1. Revascularization for Claudication: Recommendation e748

    8.1.1. Endovascular Revascularization for Claudication: Recommendations e749

    8.1.2. Surgical Revascularization for Claudication: Recommendations e750

  9. Management of CLI e750

    9.1. Revascularization for CLI: Recommendations e751

    9.1.1. Endovascular Revascularization for CLI: Recommendations e751

    9.1.2. Surgical Revascularization for CLI: Recommendations e752

    9.2. Wound Healing Therapies for CLI: Recommendations e753

  10. Management of ALI e754

    10.1. Clinical Presentation of ALI: Recommendations e754

    10.2. Medical Therapy for ALI: Recommendations e755

    10.3. Revascularization for ALI: Recommendations e755

    10.4. Diagnostic Evaluation of the Cause of ALI: Recommendations e756

  11. Longitudinal Follow-Up: Recommendations e757

  12. Evidence Gaps and Future Research Directions e758

  13. Advocacy Priorities e758

Referencese 759

Appendix 1. Author Relationships With Industry and Other Entities (Relevant) e771

Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive) e774

Appendix 3. Abbreviationse 779

Preamble

Since 1980, the American College of Cardiology (ACC) and American Heart Association (AHA) have translated scientific evidence into clinical practice guidelines with recommendations to improve cardiovascular health. These guidelines, based on systematic methods to evaluate and classify evidence, provide a cornerstone of quality cardiovascular care.

In response to reports from the Institute of Medicine1,2 and a mandate to evaluate new knowledge and maintain relevance at the point of care, the ACC/AHA Task Force on Clinical Practice Guidelines (Task Force) modified its methodology.35 The relationships among guidelines, data standards, appropriate use criteria, and performance measures are addressed elsewhere.5

Intended Use

Practice guidelines provide recommendations applicable to patients with or at risk of developing cardiovascular disease. The focus is on medical practice in the United States, but guidelines developed in collaboration with other organizations may have a broader target. Although guidelines may be used to inform regulatory or payer decisions, the intent is to improve quality of care and align with patients’ interests. Guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances, and should not replace clinical judgment. Guidelines are reviewed annually by the Task Force and are official policy of the ACC and AHA. Each guideline is considered current until it is updated, revised, or superseded by published addenda, statements of clarification, focused updates, or revised full-text guidelines. To ensure that guidelines remain current, new data are reviewed biannually to determine whether recommendations should be modified. In general, full revisions are posted in 5-year cycles.36

Modernization

Processes have evolved to support the evolution of guidelines as “living documents” that can be dynamically updated. This process delineates a recommendation to address a specific clinical question, followed by concise text (ideally <250 words) and hyperlinked to supportive evidence. This approach accommodates time constraints on busy clinicians and facilitates easier access to recommendations via electronic search engines and other evolving technology.

Evidence Review

Writing committee members review the literature; weigh the quality of evidence for or against particular tests, treatments, or procedures; and estimate expected health outcomes. In developing recommendations, the writing committee uses evidence-based methodologies that are based on all available data.37 Literature searches focus on randomized controlled trials (RCTs) but also include registries, nonrandomized comparative and descriptive studies, case series, cohort studies, systematic reviews, and expert opinion. Only selected references are cited.

The Task Force recognizes the need for objective, independent Evidence Review Committees (ERCs) that include methodologists, epidemiologists, clinicians, and biostatisticians who systematically survey, abstract, and assess the evidence to address systematic review questions posed in the PICOTS format (P=population, I=intervention, C=comparator, O=outcome, T=timing, S=setting).2,46 Practical considerations, including time and resource constraints, limit the ERCs to evidence that is relevant to key clinical questions and lends itself to systematic review and analysis that could affect the strength of corresponding recommendations.

Guideline-Directed Management and Treatment

The term “guideline-directed management and therapy” (GDMT) refers to care defined mainly by ACC/AHA Class I recommendations. For these and all recommended drug treatment regimens, the reader should confirm dosage with product insert material and carefully evaluate for contraindications and interactions. Recommendations are limited to treatments, drugs, and devices approved for clinical use in the United States.

Class of Recommendation and Level of Evidence

The Class of Recommendation (COR; ie, the strength of the recommendation) encompasses the anticipated magnitude and certainty of benefit in proportion to risk. The Level of Evidence (LOE) rates evidence supporting the effect of the intervention on the basis of the type, quality, quantity, and consistency of data from clinical trials and other reports (Table 1).35 Unless otherwise stated, recommendations are sequenced by COR and then by LOE. Where comparative data exist, preferred strategies take precedence. When >1 drug, strategy, or therapy exists within the same COR and LOE and no comparative data are available, options are listed alphabetically.

Table 1. ACC/AHA Recommendation System: Applying Class of Recommendation and Level of Evidence to Clinical Strategies, Interventions, Treatments, or Diagnostic Testing in Patient Care* (Updated August 2015)

Table 1.

Relationships With Industry and Other Entities

The ACC and AHA sponsor the guidelines without commercial support, and members volunteer their time. The Task Force zealously avoids actual, potential, or perceived conflicts of interest that might arise through relationships with industry or other entities (RWI). All writing committee members and reviewers are required to disclose current industry relationships or personal interests, from 12 months before initiation of the writing effort. Management of RWI involves selecting a balanced writing committee and assuring that the chair and a majority of committee members have no relevant RWI (Appendix 1). Members are restricted with regard to writing or voting on sections to which their RWI apply. For transparency, members’ comprehensive disclosure information is available online. Comprehensive disclosure information for the Task Force is also available online.

The Task Force strives to avoid bias by selecting experts from a broad array of backgrounds representing different geographic regions, sexes, ethnicities, intellectual perspectives/biases, and scopes of clinical practice, and by inviting organizations and professional societies with related interests and expertise to participate as partners or collaborators.

Individualizing Care in Patients With Associated Conditions and Comorbidities

Managing patients with multiple conditions can be complex, especially when recommendations applicable to coexisting illnesses are discordant or interacting.8 The guidelines are intended to define practices meeting the needs of patients in most, but not all, circumstances. The recommendations should not replace clinical judgment.

Clinical Implementation

Management in accordance with guideline recommendations is effective only when followed. Adherence to recommendations can be enhanced by shared decision making between clinicians and patients, with patient engagement in selecting interventions on the basis of individual values, preferences, and associated conditions and comorbidities. Consequently, circumstances may arise in which deviations from these guidelines are appropriate.

Jonathan L. Halperin, MD, FACC, FAHA

Chair, ACC/AHA Task Force on Clinical Practice Guidelines

1. Introduction

1.1. Methodology and Evidence Review

The recommendations listed in this guideline are, whenever possible, evidence based. An initial extensive evidence review, which included literature derived from research involving human subjects, published in English, and indexed in MEDLINE (through PubMed), EMBASE, the Cochrane Library, the Agency for Healthcare Research and Quality, and other selected databases relevant to this guideline, was conducted from January through September 2015. Key search words included but were not limited to the following: acute limb ischemia, angioplasty, ankle-brachial index, anticoagulation, antiplatelet therapy, atypical leg symptoms, blood pressure lowering/hypertension, bypass graft/bypass grafting/surgical bypass, cilostazol, claudication/intermittent claudication, critical limb ischemia/severe limb ischemia, diabetes, diagnostic testing, endovascular therapy, exercise rehabilitation/exercise therapy/exercise training/supervised exercise, lower extremity/foot wound/ulcer, peripheral artery disease/peripheral arterial disease/peripheral vascular disease/lower extremity arterial disease, smoking/smoking cessation, statin, stenting, and vascular surgery. Additional relevant studies published through September 2016, during the guideline writing process, were also considered by the writing committee, and added to the evidence tables when appropriate. The final evidence tables included in the Online Data Supplement summarize the evidence utilized by the writing committee to formulate recommendations. Additionally, the writing committee reviewed documents related to lower extremity peripheral artery disease (PAD) previously published by the ACC and AHA.9,10 References selected and published in this document are representative and not all-inclusive.

As stated in the Preamble, the ACC/AHA guideline methodology provides for commissioning an independent ERC to address systematic review questions (PICOTS format) to inform recommendations developed by the writing committee. All other guideline recommendations (not based on the systematic review questions) were also subjected to an extensive evidence review process. For this guideline, the writing committee in conjunction with the Task Force and ERC Chair identified the following systematic review questions: 1) Is antiplatelet therapy beneficial for prevention of cardiovascular events in the patient with symptomatic or asymptomatic lower extremity PAD? 2) What is the effect of revascularization, compared with optimal medical therapy and exercise training, on functional outcome and quality of life (QoL) among patients with claudication? Each question has been the subject of recently published, systematic evidence reviews.1113 The quality of these evidence reviews was appraised by the ACC/AHA methodologist and a vendor contracted to support this process (Doctor Evidence [Santa Monica, CA]). Few substantive randomized or nonrandomized studies had been published after the end date of the literature searches used for the existing evidence reviews, so the ERC concluded that no additional systematic review was necessary to address either of these critical questions.

A third systematic review question was then identified: 3) Is one revascularization strategy (endovascular or surgical) associated with improved cardiovascular and limb-related outcomes in patients with critical limb ischemia (CLI)? This question had also been the subject of a high-quality systematic review that synthesized evidence from observational data and an RCT14; additional RCTs addressing this question are ongoing.1517 The writing committee and the Task Force decided to expand the survey to include more relevant randomized and observational studies. Based on evaluation of this additional evidence the ERC decided that further systematic review was not needed to inform the writing committee on this question. Hence, the ERC and writing committee concluded that available systematic reviews could be used to inform the development of recommendations addressing each of the 3 systematic review questions specified above. The members of the Task Force and writing committee thank the members of the ERC that began this process and their willingness to participate in this volunteer effort. They include Aruna Pradhan, MD, MPH (ERC Chair); Natalie Evans, MD; Peter Henke, MD; Dharam J. Kumbhani, MD, SM, FACC; and Tamar Polonsky, MD.

1.2. Organization of the Writing Committee

The writing committee consisted of clinicians, including noninvasive and interventional cardiologists, exercise physiologists, internists, interventional radiologists, vascular nurses, vascular medicine specialists, and vascular surgeons, as well as clinical researchers in the field of vascular disease, a nurse (in the role of patient representative), and members with experience in epidemiology and/or health services research. The writing committee included representatives from the ACC and AHA, American Association of Cardiovascular and Pulmonary Rehabilitation, Inter-Society Consensus for the Management of Peripheral Arterial Disease, Society for Cardiovascular Angiography and Interventions, Society for Clinical Vascular Surgery, Society of Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, and Vascular and Endovascular Surgery Society.

1.3. Document Review and Approval

This document was reviewed by 2 official reviewers nominated by the ACC and AHA; 1 to 2 reviewers each from the American Association of Cardiovascular and Pulmonary Rehabilitation, Inter-Society Consensus for the Management of Peripheral Arterial Disease, Society for Cardiovascular Angiography and Interventions, Society for Clinical Vascular Surgery, Society of Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, and Vascular and Endovascular Surgery Society; and 16 additional individual content reviewers. Reviewers’ RWI information was distributed to the writing committee and is published in this document (Appendix 2).

This document was approved for publication by the governing bodies of the ACC and the AHA and endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation, Inter-Society Consensus for the Management of Peripheral Arterial Disease, Society for Cardiovascular Angiography and Interventions, Society for Clinical Vascular Surgery, Society of Interventional Radiology, Society for Vascular Medicine, Society for Vascular Nursing, Society for Vascular Surgery, and Vascular and Endovascular Surgery Society.

1.4. Scope of Guideline

Lower extremity PAD is a common cardiovascular disease that is estimated to affect approximately 8.5 million Americans above the age of 40 years and is associated with significant morbidity, mortality, and QoL impairment.18 It has been estimated that 202 million people worldwide have PAD.19 The purpose of this document is to provide a contemporary guideline for diagnosis and management of patients with lower extremity PAD. This document supersedes recommendations related to lower extremity PAD in the “ACC/AHA 2005 Guidelines for the Management of Patients With Peripheral Arterial Disease”9 and the “2011 ACCF/AHA Focused Update of the Guideline for the Management of Patients With Peripheral Artery Disease.”10 The scope of this guideline is limited to atherosclerotic disease of the lower extremity arteries (PAD) and includes disease of the aortoiliac, femoropopliteal, and infrapopliteal arterial segments. It does not address nonatherosclerotic causes of lower extremity arterial disease, such as vasculitis, fibromuscular dysplasia, physiological entrapment syndromes, cystic adventitial disease, and other entities. Future guidelines will address aneurysmal disease of the abdominal aorta and lower extremity arteries and diseases of the renal and mesenteric arteries.

In developing the “2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease,” the writing committee reviewed the evidence to support recommendations in the relevant ACC/AHA guidelines noted in Table 2 and affirms the ongoing validity of the related recommendations, thus obviating the need to repeat existing guideline recommendations in the current guideline. Table 2 also contains a list of other statements that may be of interest to the reader. Table 3 includes definitions for PAD key terms used throughout the guideline.

Table 2. Important Guideline Policy

TitleOrganizationPublication Year (Reference)
ACC/AHA Guideline policy relevant to the management of lower extremity PAD
 Duration of dual antiplatelet therapy in patients with coronary artery diseaseACC/AHA201620
 Perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgeryACC/AHA201421
 Lifestyle management to reduce cardiovascular riskAHA/ACC201322
 Assessment of cardiovascular riskACC/AHA201323
 Blood cholesterol to reduce atherosclerotic cardiovascular risk in adultsACC/AHA201324
 PAD (lower extremity, renal, mesenteric, and abdominal aortic)ACC/AHA20059 and 201110
 Secondary prevention and risk-reduction therapy for patients with coronary and other atherosclerotic vascular diseaseAHA/ACC201125
Other related publications
 Atherosclerotic occlusive disease of the lower extremities guidelineSVS201526
 Measurement and interpretation of the ankle-brachial indexAHA201227
 Cardiac disease evaluation and management among kidney and liver transplantation candidatesAHA/ACC201228
 Intensive glycemic control and the prevention of cardiovascular eventsADA/ACC/AHA200929
 Influenza vaccination as secondary prevention for cardiovascular diseaseAHA/ACC200630
 Indications for renal arteriography at the time of coronary arteriographyAHA/CLCD/CVRI/KCVD200631
 Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7)*NHLBI200332

*A revision to the current document is being prepared, with publication expected in 2017. The new title is expected to be “ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Detection, Evaluation, Prevention and Management of High Blood Pressure.”

AAPA indicates American Academy of Physician Assistants; ABC, Association of Black Cardiologists; ACC, American College of Cardiology; ACPM, American College of Preventive Medicine; ADA, American Diabetes Association; AGS, American Geriatrics Society; AHA, American Heart Association; APhA, American Pharmacists Association; ASH, American Society of Hypertension; ASPC, American Society for Preventive Cardiology; CLCD, Council on Clinical Cardiology; CVRI, Council on Cardiovascular Radiology and Intervention; KCVD, Council on the Kidney in Cardiovascular Disease; NHLBI, National Heart, Lung, and Blood Institute; NMA, National Medical Association; PAD, peripheral artery disease; PCNA, Preventive Cardiovascular Nurses Association; and SVS, Society for Vascular Surgery.

Table 3. Definition of PAD Key Terms

TermDefinition
ClaudicationFatigue, discomfort, cramping, or pain of vascular origin in the muscles of the lower extremities that is consistently induced by exercise and consistently relieved by rest (within 10 min).
Acute limb ischemia (ALI)Acute (<2 wk), severe hypoperfusion of the limb characterized by these features: pain, pallor, pulselessness, poikilothermia (cold), paresthesias, and paralysis. One of these categories of ALI is assigned (Section 10):
  1. Viable—Limb is not immediately threatened; no sensory loss; no muscle weakness; audible arterial and venous Doppler.

  2. Threatened—Mild-to-moderate sensory or motor loss; inaudible arterial Doppler; audible venous Doppler; may be further divided into IIa (marginally threatened) or IIb (immediately threatened).

  3. Irreversible—Major tissue loss or permanent nerve damage inevitable; profound sensory loss, anesthetic; profound muscle weakness or paralysis (rigor); inaudible arterial and venous Doppler.33,34

Tissue lossType of tissue loss:

Minor—nonhealing ulcer, focal gangrene with diffuse pedal ischemia.

Major—extending above transmetatarsal level; functional foot no longer salvageable.33

Critical limb ischemia (CLI)A condition characterized by chronic (≥2 wk) ischemic rest pain, nonhealing wound/ulcers, or gangrene in 1 or both legs attributable to objectively proven arterial occlusive disease. The diagnosis of CLI is a constellation of both symptoms and signs. Arterial disease can be proved objectively with ABI, TBI, TcPO2, or skin perfusion pressure. Supplementary parameters, such as absolute ankle and toe pressures and pulse volume recordings, may also be used to assess for significant arterial occlusive disease. However, a very low ABI or TBI does not necessarily mean the patient has CLI. The term CLI implies chronicity and is to be distinguished from ALI.35
In-line blood flowDirect arterial flow to the foot, excluding collaterals.
Functional statusPatient’s ability to perform normal daily activities required to meet basic needs, fulfill usual roles, and maintain health and well-being. Walking ability is a component of functional status.
Nonviable limbCondition of extremity (or portion of extremity) in which loss of motor function, neurological function, and tissue integrity cannot be restored with treatment.
Salvageable limbCondition of extremity with potential to secure viability and preserve motor function to the weight-bearing portion of the foot if treated.
Structured exercise programPlanned program that provides individualized recommendations for type, frequency, intensity, and duration of exercise. Program provides recommendations for exercise progression to assure that the body is consistently challenged to increase exercise intensity and levels as functional status improves over time. There are 2 types of structured exercise program for patients with PAD:
  1. Supervised exercise program

  2. Structured community- or home-based exercise program

Supervised exercise programStructured exercise program that takes place in a hospital or outpatient facility in which intermittent walking exercise is used as the treatment modality. Program can be standalone or can be made available within a cardiac rehabilitation program. Program is directly supervised by qualified healthcare provider(s). Training is performed for a minimum of 30 to 45 min per session, in sessions performed at least 3 times/wk for a minimum of 12 wk.3646 Patients may not initially achieve these targets, and a treatment goal is to progress to these levels over time. Training involves intermittent bouts of walking to moderate-to-maximum claudication, alternating with periods of rest. Warm-up and cool-down periods precede and follow each session of walking.
Structured community- or home-based exercise programStructured exercise program that takes place in the personal setting of the patient rather than in a clinical setting.41,4751 Program is self-directed with the guidance of healthcare providers who prescribe an exercise regimen similar to that of a supervised program. Patient counseling ensures that patients understand how to begin the program, how to maintain the program, and how to progress the difficulty of the walking (by increasing distance or speed). Program may incorporate behavioral change techniques, such as health coaching and/or use of activity monitors.
Emergency versus urgent An emergency procedure is one in which life or limb is threatened if the patient is not in the operating room or interventional suite and/or where there is time for no or very limited clinical evaluation, typically within <6 h. An urgent procedure is one in which there may be time for a limited clinical evaluation, usually when life or limb is threatened if the patient is not in the operating room or interventional suite, typically between 6 and 24 h.
Interdisciplinary care teamA team of professionals representing different disciplines to assist in the evaluation and management of the patient with PAD. For the care of patients with CLI, the interdisciplinary care team should include individuals who are skilled in endovascular revascularization, surgical revascularization, wound healing therapies and foot surgery, and medical evaluation and care. Interdisciplinary care team members may include:

Vascular medical and surgical specialists (ie, vascular medicine, vascular surgery, interventional radiology, interventional cardiology)

Nurses

Orthopedic surgeons and podiatrists

Endocrinologists

Internal medicine specialists

Infectious disease specialists

Radiology and vascular imaging specialists

Physical medicine and rehabilitation clinicians

Orthotics and prosthetics specialists

Social workers

Exercise physiologists

Physical and occupational therapists

Nutritionists/dieticians

Cardiovascular ischemic eventsAcute coronary syndrome (acute MI, unstable angina), stroke, or cardiovascular death.
Limb-related eventsWorsening claudication, new CLI, new lower extremity revascularization, or new ischemic amputation.

ABI indicates ankle-brachial index; ALI, acute limb ischemia; CLI, critical limb ischemia; MI, myocardial infarction; PAD, peripheral artery disease; TBI, toe-brachial index; and TcPO2, transcutaneous oxygen pressure.

Table 4. Patients at Increased Risk of PAD

Age ≥65 y
Age 50–64 y, with risk factors for atherosclerosis (eg, diabetes mellitus, history of smoking, hyperlipidemia, hypertension) or family history of PAD63
Age <50 y, with diabetes mellitus and 1 additional risk factor for atherosclerosis
Individuals with known atherosclerotic disease in another vascular bed (eg, coronary, carotid, subclavian, renal, mesenteric artery stenosis, or AAA)

AAA indicates abdominal aortic aneurysm; PAD, peripheral artery disease.

2. Clinical Assessment for PAD

Evaluating the patient for PAD begins with the clinical history, review of symptoms, and physical examination.

2.1. History and Physical Examination: Recommendations

3. Diagnostic Testing for the Patient With Suspected Lower Extremity PAD (Claudication or CLI)

3.1. Resting ABI for Diagnosing PAD: Recommendations

3.2. Physiological Testing: Recommendations

Figure 1.

Figure 1. Diagnostic Testing for Suspected PAD. Colors correspond to Class of Recommendation in Table 1. ABI indicates ankle-brachial index; CLI, critical limb ischemia; CTA, computed tomography angiography; GDMT, guideline-directed management and therapy; MRA, magnetic resonance angiography; PAD, peripheral artery disease; and TBI, toe-brachial index.

3.3. Imaging for Anatomic Assessment: Recommendations

Figure 2.

Figure 2. Diagnostic Testing for Suspected CLI. Colors correspond to Class of Recommendation in Table 1. *Order based on expert consensus. †TBI with waveforms, if not already performed. ABI indicates ankle-brachial index; CLI, critical limb ischemia; CTA, computed tomography angiography; MRA, magnetic resonance angiography; TcPO2, transcutaneous oxygen pressure; and TBI, toe-brachial index.

4. Screening for Atherosclerotic Disease in Other Vascular Beds for the Patient With PAD

4.1. Abdominal Aortic Aneurysm: Recommendation

4.2. Screening for Asymptomatic Atherosclerosis in Other Arterial Beds (Coronary, Carotid, and Renal Arteries)

The prevalence of atherosclerosis in the coronary, carotid, and renal arteries is higher in patients with PAD than in those without PAD.128,130135 However, intensive atherosclerosis risk factor modification in patients with PAD is justified regardless of the presence of disease in other arterial beds. Thus, the only justification for screening for disease in other arterial beds is if revascularization results in a reduced risk of myocardial infarction (MI), stroke, or death, and this has never been shown. Currently, there is no evidence to demonstrate that screening all patients with PAD for asymptomatic atherosclerosis in other arterial beds improves clinical outcome. Intensive treatment of risk factors through GDMT is the principle method for preventing adverse cardiovascular ischemic events from asymptomatic disease in other arterial beds.

5. Medical Therapy for the Patient With PAD

Patients with PAD should receive a comprehensive program of GDMT, including structured exercise and lifestyle modification, to reduce cardiovascular ischemic events and improve functional status. Smoking cessation is a vital component of care for patients with PAD who continue to smoke. A guideline-based program of pharmacotherapy to reduce cardiovascular ischemic events and limb-related events should be prescribed for each patient with PAD and is customized to individual risk factors, such as whether the patient also has diabetes mellitus. Previous studies have demonstrated that patients with PAD are less likely to receive GDMT than are patients with other forms of cardiovascular disease, including coronary artery disease (CAD).136138

5.1. Antiplatelet Agents: Recommendations

5.2. Statin Agents: Recommendation

5.3. Antihypertensive Agents: Recommendations

5.4. Smoking Cessation: Recommendations

5.5. Glycemic Control: Recommendations

5.6. Oral Anticoagulation: Recommendations

5.7. Cilostazol: Recommendation

5.8. Pentoxifylline: Recommendation

5.9. Chelation Therapy: Recommendation

5.10. Homocysteine Lowering: Recommendation

5.11. Influenza Vaccination: Recommendation

6. Structured Exercise Therapy: Recommendations

Structured exercise therapy is an important element of care for the patient with PAD. Components of structured exercise programs for PAD are outlined in Table 8.

7. Minimizing Tissue Loss in Patients With PAD: Recommendations

8. Revascularization for Claudication

An individualized approach to revascularization for claudication is recommended for each patient to optimize outcome. Revascularization is but one component of care for the patient with claudication, as each patient should have a customized care plan that also includes medical therapy (Section 5), structured exercise therapy (Section 6), and care to minimize tissue loss (Section 7). If a strategy of revascularization for claudication is undertaken, the revascularization strategy should be evidence based and can include endovascular revascularization, surgery, or both.

Because of the variability of ischemic limb symptoms and impact of these symptoms on functional status and QoL, patients should be selected for revascularization on the basis of severity of their symptoms. Factors to consider include a significant disability as assessed by the patient, adequacy of response to medical and structured exercise therapy, status of comorbid conditions, and a favorable risk–benefit ratio. Patient preferences and goals of care are important considerations in the evaluation for revascularization. The revascularization strategy should have a reasonable likelihood of providing durable relief of symptoms. A general recommendation for revascularization as a treatment option for claudication is provided below followed by specific recommendations for endovascular (Section 8.1.1) and surgical (Section 8.1.2) procedures if a revascularization strategy is undertaken.

8.1. Revascularization for Claudication: Recommendation

8.1.1. Endovascular Revascularization for Claudication: Recommendations

Endovascular techniques to treat claudication include balloon dilation (angioplasty), stents, and atherectomy. These techniques continue to involve and now include covered stents, drug-eluting stents (DES), cutting balloons, and drug-coated balloons. The technique chosen for endovascular treatment is related to lesion characteristics (eg, anatomic location, lesion length, degree of calcification) and operator experience. Assessment of the appropriateness of specific endovascular techniques for specific lesions for the treatment of claudication is beyond the scope of this document.

Revascularization is performed on lesions that are deemed to be hemodynamically significant, and stenoses selected for endovascular treatment should have a reasonable likelihood of limiting perfusion to the distal limb. Stenoses of 50% to 75% diameter by angiography may not be hemodynamically significant, and resting or provoked intravascular pressure measurements may be used to determine whether lesions are significant.238,239 Multiple RCTs have compared endovascular procedures to various combinations of medical treatment with or without supervised or unsupervised exercise programs.12,37,38,217,232,233,240251 These trials have used different endpoints and enrolled patients with anatomic disease distribution at different levels.

8.1.2. Surgical Revascularization for Claudication: Recommendations

9. Management of CLI

Patients with CLI are at increased risk of amputation and major cardiovascular ischemic events. Care of the patient with CLI includes evaluation for revascularization and wound healing therapies, with the objective to minimize tissue loss, completely heal wounds, and preserve a functional foot. Medical therapy to prevent cardiovascular ischemic events is also an important component of care for the patient with CLI (Section 5).

9.1. Revascularization for CLI: Recommendations

9.1.1. Endovascular Revascularization for CLI: Recommendations
9.1.2. Surgical Revascularization for CLI: Recommendations

9.2. Wound Healing Therapies for CLI: Recommendations

10. Management of ALI

ALI is one of the most treatable and potentially devastating presentations of PAD. Timely recognition of arterial occlusion as the cause of an ischemic, cold, painful leg is crucial to successful treatment. The writing committee has used a standard definition of ALI in which symptom duration is <2 weeks (Table 3).33,34 Category I refers to viable limbs that are not immediately threatened. Category II refers to threatened limbs. Category IIa limbs are marginally threatened and salvageable, if promptly treated. Category IIb are immediately threatened limbs that require immediate revascularization if salvage is to be accomplished. Category III are irreversibly damaged limbs, in which case resultant major tissue loss or permanent nerve damage is inevitable.34

10.1. Clinical Presentation of ALI: Recommendations

10.2. Medical Therapy for ALI: Recommendations

Figure 3.

Figure 3. Diagnosis and Management of ALI.33,34 Colors correspond to Class of Recommendation in Table 1. ALI indicates acute limb ischemia.

10.3. Revascularization for ALI: Recommendations

10.4. Diagnostic Evaluation of the Cause of ALI: Recommendations

11. Longitudinal Follow-Up: Recommendations

PAD is a lifelong chronic medical condition. Ongoing care focuses on cardiovascular risk reduction with medical therapy, optimizing functional status with structured exercise and, when indicated, revascularization.

12. Evidence Gaps and Future Research Directions

In performing the evidence review and in developing the present guidelines, the writing committee identified the following critical evidence gaps and future directions for PAD-related research:

  • Basic science and translational studies to better understand the vascular biology of endovascular therapies and bypass grafting and to develop new methods for preventing restenosis after revascularization.

  • Determination of risk factors for progression from asymptomatic PAD to symptomatic disease, including CLI.

  • RCTs needed to determine the value of using the ABI to identify asymptomatic patients with PAD for therapies to reduce cardiovascular risk (eg, antiplatelet agents, statins, and other therapies).

  • Advancement in PAD diagnostics, such as technologies for simplified yet highly accurate measurement of the ABI and tools for more reliable noninvasive perfusion assessment in CLI.

  • Comparative-effectiveness studies to determine the optimal antiplatelet therapy (drug or drugs and dosage) for prevention of cardiovascular and limb-related events in patients with PAD.

  • Development of additional medical therapies for claudication–an area of unmet medical need with a currently limited research pipeline.404

  • Studies to investigate the role of dietary intervention, in addition to statin therapy, to improve outcome and modify the natural history of PAD.

  • Additional research to identify the best community- or home-based exercise programs for patients with PAD to maximize functional status and improve QoL, as well as the role of such exercise programs before or in addition to revascularization.

  • Development and validation of improved clinical classification systems for PAD that incorporate symptoms, anatomic factors, and patient-specific risk factors and can be used to predict clinical outcome and optimize treatment approach. An example of a recently developed classification system is the Society for Vascular Surgery limb classification system, based on wound, ischemia, and foot infection (WIfI), which has been validated in different populations and may permit more meaningful prognosis in patients with CLI.405409

  • Comparative- and cost-effectiveness studies of the different endovascular technologies for treatment of claudication and CLI, including drug-coated balloons and DES. Studies should include patient-centered endpoints, such as functional parameters, time to wound healing, and QoL, in addition to standard patency-focused outcomes. These studies could then be incorporated into value-based clinical algorithms for approach to revascularization for claudication and CLI.

  • Additional studies to demonstrate the impact of multisocietal registries on clinical outcomes and appropriate use. At present, these include the Vascular Quality Initiative (VQI), the National Cardiovascular Data Registry Peripheral Vascular Intervention Registry™ (PVI Registry™), and the National Radiology Data Registry for Interventional Radiology (NRDR). These registries provide an opportunity to obtain “real-world” data on surgical and endovascular procedures for PAD and to improve quality by providing feedback to participating centers. Future efforts should incorporate these registries into interventional RCTs and postmarketing studies of PAD-related devices.

13. Advocacy Priorities

The writing committee identified 3 priorities for multisocietal advocacy initiatives to improve health care for patients with PAD. First, the writing committee supports the availability of the ABI as the initial diagnostic test to establish the diagnosis of PAD in patients with history or physical examination findings suggestive of PAD (Table 5). Although the ABI test is generally reimbursed by third-party payers for patients with classic claudication or lower extremity wounds, payers may not provide reimbursement for the ABI with other findings suggestive of PAD, such as lower extremity pulse abnormalities or femoral bruits. The writing committee affirms the importance of confirming the diagnosis of PAD in such patients to allow for GDMT as delineated in this document. Second, the writing committee supports the vital importance of insuring access to supervised exercise programs for patients with PAD. Although extensive high-quality evidence supports supervised exercise programs to improve functional status and QoL, only a minority of patients with PAD participate in such programs because of lack of reimbursement by third-party payers. Third, the writing committee recognizes the need for incorporation of patient-centered outcomes into the process of regulatory approval of new medical therapies and revascularization technologies. For revascularization technologies, regulatory approval is driven primarily by data on angiographic efficacy (ie, target lesion patency) and safety endpoints. The nature of the functional limitation associated with PAD warrants the incorporation of patient-centered outcomes, such as functional parameters and QoL, into the efficacy outcomes for the approval process.

Table 5. History and/or Physical Examination Findings Suggestive of PAD

History
 Claudication
 Other non–joint-related exertional lower extremity symptoms (not typical of claudication)
 Impaired walking function
 Ischemic rest pain
Physical Examination
 Abnormal lower extremity pulse examination
 Vascular bruit
 Nonhealing lower extremity wound
 Lower extremity gangrene
 Other suggestive lower extremity physical findings (eg, elevation pallor/dependent rubor)

PAD indicates peripheral artery disease.

Table 6. Alternative Diagnoses for Leg Pain or Claudication With Normal Physiological Testing (Not PAD-Related)

ConditionLocationCharacteristicEffect of ExerciseEffect of RestEffect of PositionOther Characteristics
Symptomatic Baker’s cystBehind knee, down calfSwelling, tendernessWith exerciseAlso present at restNoneNot intermittent
Venous claudicationEntire leg, worse in calfTight, bursting painAfter walkingSubsides slowlyRelief speeded by elevationHistory of iliofemoral deep vein thrombosis; edema; signs of venous stasis
Chronic compartment syndromeCalf musclesTight, bursting painAfter much exercise (jogging)Subsides very slowlyRelief with restTypically heavy muscled athletes
Spinal stenosisOften bilateral buttocks, posterior legPain and weaknessMay mimic claudicationVariable relief but can take a long time to recoverRelief by lumbar spine flexionWorse with standing and extending spine
Nerve root compressionRadiates down legSharp lancinating painInduced by sitting, standing, or walkingOften present at restImproved by change in positionHistory of back problems; worse with sitting; relief when supine or sitting
Hip arthritisLateral hip, thighAching discomfortAfter variable degree of exerciseNot quickly relievedImproved when not weight bearingSymptoms variable; history of degenerative arthritis
Foot/ankle arthritisAnkle, foot, archAching painAfter variable degree of exerciseNot quickly relievedMay be relieved by not bearing weightSymptoms variable; may be related to activity level or present at rest

Modified from Norgren L et al.35

PAD indicates peripheral artery disease.

Table 7. Alternative Diagnoses for Nonhealing Wounds With Normal Physiological Testing (Not PAD-Related)

ConditionLocationCharacteristics and Causes
Venous ulcerDistal leg, especially above medial mellolusDevelops in regions of skin changes due to chronic venous disease and local venous hypertensionTypically wet (ie, wound drainage) rather than dry lesion
Distal small arterial occlusion (microangiopathy)Toes, foot, legDiabetic microangiopathyEnd-stage renal diseaseThromboangiitis obliterans (Buerger’s)Sickle cell anemiaVasculitis (eg, Churg-Strauss, Henoch-Schonlein purpura, leukocytoclastic vasculitis, microscopic polyangiitis, polyarteritis nodosa)SclerodermaCryoagglutinationEmbolic (eg, cholesterol emboli, thromboemboli, endocarditis)Thrombotic (eg, antiphospholipid antibody syndrome, Sneddon’s syndrome, warfarin skin necrosis, disseminated intravascular coagulation, livedoid vasculitis, protein C or S deficiency, prolonged vasospasm)
Local injuryToes, foot, legTraumaInsect or animal biteBurn
Medication relatedToes, foot, legDrug reactions (eg, erythema multiforme)Medication direct toxicity (eg, doxorubicin, hydroxyurea, some tyrosine kinase inhibitors)
NeuropathicPressure zones of footHyperkeratosis surrounds the ulcerDiabetes mellitus with peripheral neuropathyPeripheral neuropathy without diabetes mellitusLeprosy
Autoimmune injuryToes, foot, legWith blisters (eg, pemphigoid, pemphigus, epidermolysis bullosa)Without blisters (eg, dermatomyositis, lupus, scleroderma)
InfectionToes, foot, legBacterial (eg, pseudomonas, necrotizing streptococcus)Fungal (eg, blastomycosis, Madura foot, chromomycosis)MycobacterialParasitic (eg, Chagas, leishmaniasis)Viral (eg, herpes)
MalignancyToes, foot, legPrimary skin malignancyMetastatic malignancyMalignant transformation of ulcer
InflammatoryToes, foot, legNecrobiosis lipoidicaPyoderma gangrenosumGranuloma annulare

PAD indicates peripheral artery disease.

Table 8. Structured Exercise Programs for PAD: Definitions

Supervised exercise program (COR I, LOE A)
 Program takes place in a hospital or outpatient facility.
 Program uses intermittent walking exercise as the treatment modality.
 Program can be standalone or within a cardiac rehabilitation program.
 Program is directly supervised by qualified healthcare provider(s).
 Training is performed for a minimum of 30–45 min/session; sessions are performed at least 3 times/wk for a minimum of 12 wk.3646
 Training involves intermittent bouts of walking to moderate-to-maximum claudication, alternating with periods of rest.
 Warm-up and cool-down periods precede and follow each session of walking.
Structured community- or home-based exercise program (COR IIa, LOE A)
 Program takes place in the personal setting of the patient rather than in a clinical setting.41,4751
 Program is self-directed with guidance of healthcare providers.
 Healthcare providers prescribe an exercise regimen similar to that of a supervised program.
 Patient counseling ensures understanding of how to begin and maintain the program and how to progress the difficulty of the walking (by increasing distance or speed).
 Program may incorporate behavioral change techniques, such as health coaching or use of activity monitors.

COR indicates Class of Recommendation; LOE, Level of Evidence; and PAD, peripheral artery disease.

Table 9. Interdisciplinary Care Team for PAD

A team of professionals representing different disciplines to assist in the evaluation and management of the patient with PAD. For the care of patients with CLI, the interdisciplinary care team should include individuals who are skilled in endovascular revascularization, surgical revascularization, wound healing therapies and foot surgery, and medical evaluation and care.
 Interdisciplinary care team members may include:
  Vascular medical and surgical specialists (ie, vascular medicine, vascular surgery, interventional radiology, interventional cardiology)
  Nurses
  Orthopedic surgeons and podiatrists
  Endocrinologists
  Internal medicine specialists
  Infectious disease specialists
  Radiology and vascular imaging specialists
  Physical medicine and rehabilitation clinicians
  Orthotics and prosthetics specialists
  Social workers
  Exercise physiologists
  Physical and occupational therapists
  Nutritionists/dieticians

CLI indicates critical limb ischemia; and PAD, peripheral artery disease.

Table 10. Therapy for CLI: Findings That Prompt Consideration of Surgical or Endovascular Revascularization

Findings That Favor Consideration of Surgical RevascularizationExamples
 Factors associated with technical failure or poor durability with endovascular treatment Lesion involving common femoral artery, including origin of deep femoral artery
 Long segment lesion involving the below-knee popliteal and/or infrapopliteal arteries in a patient with suitable single-segment autogenous vein conduit
 Diffuse multilevel disease that would require endovascular revascularization at multiple anatomic levels
 Small-diameter target artery proximal to site of stenosis or densely calcified lesion at location of endovascular treatment
 Endovascular treatment likely to preclude or complicate subsequent achievement of in-line blood flow through surgical revascularization Single-vessel runoff distal to ankle
Findings That Favor Consideration of Endovascular RevascularizationExamples
 The presence of patient comorbidities may place patients at increased risk of perioperative complications from surgical revascularization. In these patients, an endovascular-first approach should be used regardless of anatomy Patient comorbidities, including coronary ischemia, cardiomyopathy, congestive heart failure, severe lung disease, and chronic kidney disease
 Patients with rest pain and disease at multiple levels may undergo a staged approach as part of endovascular-first approach In-flow disease can be addressed first, and out-flow disease can be addressed in a staged manner, when required, if clinical factors or patient safety prevent addressing all diseased segments at one setting
 Patients without suitable autologous vein for bypass grafts Some patients have had veins harvested for previous coronary artery bypass surgery and do not have adequate remaining veins for use as conduits. Similarly, patients may not have undergone prior saphenous vein harvest, but available vein is of inadequate diameter

CLI indicates critical limb ischemia.

ACC/AHA Task Force Members

Jonathan L. Halperin, MD, FACC, FAHA, Chair; Glenn N. Levine, MD, FACC, FAHA, Chair-Elect; Sana M. Al-Khatib, MD, MHS, FACC, FAHA; Kim K. Birtcher, PharmD, MS, AACC; Biykem Bozkurt, MD, PhD, FACC, FAHA; Ralph G. Brindis, MD, MPH, MACC; Joaquin E. Cigarroa, MD, FACC; Lesley H. Curtis, PhD, FAHA; Lee A. Fleisher, MD, FACC, FAHA; Federico Gentile, MD, FACC; Samuel Gidding, MD, FAHA; Mark A. Hlatky, MD, FACC; John Ikonomidis, MD, PhD, FAHA; José Joglar, MD, FACC, FAHA; Susan J. Pressler, PhD, RN, FAHA; Duminda N. Wijeysundera, MD, PhD

Presidents and Staff

American College of Cardiology

Richard A. Chazal, MD, FACC, President

Shalom Jacobovitz, Chief Executive Officer

William J. Oetgen, MD, MBA, FACC, Executive Vice President, Science, Education, Quality, and Publishing

Amelia Scholtz, PhD, Publications Manager, Science, Education, Quality, and Publishing

American College of Cardiology/American Heart Association

Katherine Sheehan, PhD, Director, Guideline Strategy and Operations

Lisa Bradfield, CAE, Director, Guideline Methodology and Policy

Abdul R. Abdullah, MD, Associate Science and Medicine Advisor

Allison Rabinowitz, MPH, Project Manager, Clinical Practice Guidelines

American Heart Association

Steven R. Houser, PhD, FAHA, President

Nancy Brown, Chief Executive Officer

Rose Marie Robertson, MD, FAHA, Chief Science and Medicine Officer

Gayle R. Whitman, PhD, RN, FAHA, FAAN, Senior Vice President, Office of Science Operations

Comilla Sasson, MD, PhD, FACEP, Vice President, Science and Medicine

Jody Hundley, Production Manager, Scientific Publications, Office of Science Operations

Footnotes

The American Heart Association requests that this document be cited as follows: Gerhard-Herman MD, Gornik HL, Barrett C, Barshes NR, Corriere MA, Drachman DE, Fleisher LA, Fowkes FGR, Hamburg NM, Kinlay S, Lookstein R, Misra S, Mureebe L, Olin JW, Patel RAG, Regensteiner JG, Schanzer A, Shishehbor MH, Stewart KJ, Treat-Jacobson D, Walsh ME. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2017;135:e726–e779. DOI: 10.1161/CIR.0000000000000471.

This document was approved by the American College of Cardiology Board of Trustees in October 2016, the American Heart Association Science Advisory and Coordinating Committee in September 2016, and the American Heart Association Executive Committee in October 2016.

The Comprehensive RWI Data Supplement table is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000471/-/DC1.

The Data Supplement is available with this article at http://circ.ahajournals.org/lookup/suppl/doi:10.1161/CIR.0000000000000471/-/DC2.

This article has been copublished in the Journal of the American College of Cardiology and reprinted in Vascular Medicine.

Copies: This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association (professional.heart.org). A copy of the document is available at http://professional.heart.org/statements by selecting either the “By Topic” link or the “By Publication Date” link. To purchase additional reprints, call 843-216-2533 or e-mail .

Expert peer review of AHA Scientific Statements is conducted by the AHA Office of Science Operations. For more on AHA statements and guidelines development, visit http://professional.heart.org/statements and select the “Policies and Development” link.

Permissions: Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American Heart Association. Instructions for obtaining permission are located at http://www.heart.org/HEARTORG/General/Copyright-Permission-Guidelines_UCM_300404_Article.jsp. A link to the “Copyright Permissions Request Form” appears on the right side of the page.

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Appendix 1. Author Relationships With Industry and Other Entities (Relevant)—2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease (March 2014)

Committee MemberEmploymentConsultantSpeakers BureauOwnership/Partnership/PrincipalPersonal ResearchInstitutional, Organizational, or Other Financial BenefitExpert WitnessVoting Recusals by Section*
Marie D. Gerhard-Herman, ChairHarvard Medical School—Associate ProfessorNoneNoneNoneNoneNoneNoneNone
Heather L. Gornik, Vice ChairCleveland Clinic Foundation, Cardiovascular Medicine—Medical Director, Noninvasive Vascular LaboratoryNoneNone• Summit Doppler Systems• Zin Medical• AstraZeneca• TheravascNoneNone3.1, 3.2, 5.1–5.3, and 5.6.
Coletta BarrettOur Lady of the Lake Regional Medical Center—Vice PresidentNoneNoneNoneNoneNoneNoneNone
Neal R. BarshesBaylor College of Medicine, Division of Vascular Surgery and Endovascular Therapy Michael E. DeBakey Department of Surgery—Assistant ProfessorNoneNoneNoneNoneNoneNoneNone
Matthew A. CorriereUniversity of Michigan—Frankel Professor of Cardiovascular Surgery, Associate Professor of SurgeryNoneNoneNoneNoneNoneNoneNone
Douglas E. DrachmanMassachusetts General Hospital—Training Director• Abbott Vascular• St. Jude MedicalNoneNone• Atrium Medical• Bard• LutonixNoneNone4, 8.1.1–9.1.2, and 10.2.2.
Lee A. FleisherUniversity of Pennsylvania Health System Department of Anesthesiology and Critical Care—ChairNoneNoneNoneNoneNoneNoneNone
Francis Gerry R. FowkesUniversity of Edinburgh—Emeritus Professor of Epidemiology• AstraZeneca• Bayer• MerckNoneNoneNoneNoneNone5.1–5.3, 5.6, 5.10, 7, and 9.2.
Naomi M. HamburgBoston University School of Medicine, Cardiovascular Medicine Section—Associate Professor of MedicineNoneNoneNoneNoneNoneNoneNone
Scott KinlayVA Boston Healthcare System—Associate Chief, Cardiology Director, Cardiac Catheterization Laboratory & Vascular MedicineNoneNoneNone• Medtronic• The Medicines CompanyNoneNone4, 5.6, 8.1.1, 9.1.1, 10.2.1, and 10.2.2.
Robert LooksteinMount Sinai Medical Center—Chief, Interventional Radiology; Professor of Radiology and Surgery; Vice Chair, Department of Radiology• Boston Scientific• Medrad Interventional• Possis• The Medicines Company• CordisNone• Shockwave (DSMB)NoneNone4, 5.6, 8.1.1, 9.1.1, 10.2.1, and 10.2.2.
Sanjay MisraMayo Clinic, Division of Vascular and Interventional Radiology—Professor; Department of Radiology—Interventional RadiologistNoneNoneNone• Johnson & Johnson (DSMB)NoneNone4, 7, 8, and 10.2.2.
Leila MureebeDuke University Medical Center—Associate Professor of Surgery, Division of Vascular SurgeryNoneNoneNoneNoneNoneNoneNone
Jeffrey W. OlinIchan School of Medicine at Mount Sinai, Zena and Michael A. Wiener Cardiovascular Institute and Marie-Josée and Henry R. Kravis Center for Cardiovascular Health—Professor of Medicine, Cardiology; Director, Vascular Medicine• AstraZeneca• Merck• Novartis• PlurestemNone• Northwind• AstraZenecaNoneNone5.1–5.3, 5.6, 5.10, and 12.
Rajan A.G. PatelJohn Ochsner Heart & Vascular Center, Ochsner Clinical School, University of Queensland School of Medicine—Senior LecturerNoneNoneNoneNoneNoneNoneNone
Judith G. RegensteinerUniversity of Colorado, Health Sciences Center, Division of Cardiology—Associate Professor of MedicineNoneNoneNoneNoneNoneNoneNone
Andres SchanzerUniversity of Massachusetts Medical School—Professor of Surgery and Quantitative Health Sciences; Program Director, Vascular Surgery Residency• Cook MedicalNoneNoneNoneNoneNone4, 8.1.1, 9.1.1, and 10.2.2.
Mehdi H. ShishehborCleveland Clinic, Interventional Cardiology and Vascular Medicine—Director, Endovascular Services• Boston Scientific• MedtronicNoneNoneNone• Atrium Medical• AstraZenecaNone4, 8.1.1–9.1.2, and 10.2.2.
Kerry J. StewartJohns Hopkins University, School of Medicine; Johns Hopkins Bayview Medical Center—Professor of Medicine; Director, Clinical and Research Exercise PhysiologyNoneNoneNoneNoneNoneNoneNone
Diane Treat-JacobsonUniversity of Minnesota, School of Nursing—ProfessorNoneNoneNoneNoneNoneNoneNone
M. Eileen WalshUniversity of Toledo, College of Nursing—ProfessorNoneNoneNoneNoneNoneNoneNone

This table represents the relationships of committee members with industry and other entities that were determined to be relevant to this document. These relationships were reviewed and updated in conjunction with all meetings and/or conference calls of the writing committee during the document development process. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. According to the ACC/AHA, a person has a relevant relationship IF: a) the relationship or interest relates to the same or similar subject matter, intellectual property or asset, topic, or issue addressed in the document; or b) the company/entity (with whom the relationship exists) makes a drug, drug class, or device addressed in the document, or makes a competing drug or device addressed in the document; or c) the person or a member of the person’s household, has a reasonable potential for financial, professional, or other personal gain or loss as a result of the issues/content addressed in the document.

*Writing committee members are required to recuse themselves from voting on sections to which their specific relationships with industry and other entities may apply.

Significant relationship.

No financial benefit.

ACC indicates American College of Cardiology; AHA, American Heart Association; DSMB, data safety monitoring board; and VA, Veterans Affairs.

Appendix 2. Reviewer Relationships With Industry and Other Entities (Comprehensive)—2016 AHA/ACC Guideline on the Management of Patients With Lower Extremity Peripheral Artery Disease (March 2016)

ReviewerRepresentationEmploymentConsultantSpeakers BureauOwnership/Partnership/PrincipalPersonal ResearchInstitutional, Organizational, or Other Financial BenefitExpert Witness
Deepak L. BhattOfficial Reviewer—ACC Board of TrusteesBrigham and Women’s Hospital—Executive Director of Interventional Cardiovascular Programs; Harvard Medical School—Professor of Medicine• ElsevierNoneNone• Amarin*• Amgen*• AstraZeneca*• Bristol-Myers Squibb*• Cardax• Eisai*• Ethicon*• FlowCo• Forest Laboratories*• Ischemix*• Mayo Clinic• Medtronic*• Merck• Pfizer*• PLx Pharma• Regado Biosciences• Roche*• Sanofi-aventis*• St. Jude Medical• Takeda• The Medicines Company*• WebMD*• Belvoir Publications (Editor)*• Biotronik• Boston Scientific• Clinical Cardiology (Deputy Editor)• Harvard Clinical Research Institute• HMP Communications (Editor)*• Duke Clinical Research Institute*• Journal of Invasive Cardiology (Editor)*• Medscape Cardiology• Slack Publications (Editor)*• St. Jude Medical• VA Healthcare SystemNone
Mark A. CreagerOfficial Reviewer—AHADartmouth-Hitchcock Medical Center—DirectorNoneNoneNoneNone• AHA (Past President)None
Philip GoodneyOfficial Reviewer—AHADartmouth-Hitchcock—Associate Professor of Surgery and The Dartmouth Institute DirectorNoneNoneNone• NIH*• NIHNone
John S. IkonomidisOfficial Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesMedical University of South Carolina—ChiefNoneNoneNoneNoneNoneNone
Amy W. PollakOfficial Reviewer—AHAMayo Clinic—Cardiovascular Medicine PhysicianNoneNoneNoneNoneNoneNone
Michael D. WhiteOfficial Reviewer—ACC Board of GovernorsCatholic Health Initiatives—Chief Academic Officer• Anthera PharmaceuticalsNoneNone• AstraZenecaNoneNone
Ehrin J. ArmstrongOrganizational Reviewer—SVMUniversity of Colorado—Director, Interventional Cardiology• Abbott• Medtronic• Merck• SpectraneticsNoneNoneNoneNoneNone
Bernadette AulivolaOrganizational Reviewer—VESSLoyola University medical Center, Stritch School of Medicine—Director, Division of Vascular Surgery and Endovascular Therapy; Associate Professor, Department of Surgery; Program Director, Vascular Surgery Fellowship; Medical Director, Vascular Noninvasive labNoneNoneNoneNoneNoneNone
Alison BaileyOrganizational Reviewer—AACVPRUniversity of Tennessee Chattanooga—CardiologistNoneNoneNone• CSL Behring• AACVPR• ZOLL MedicalNone
Todd BrownOrganizational Reviewer—AACVPRUniversity of Alabama at Birmingham—Associate ProfessorNoneNoneNone• Amgen*• Omthera• NIH*NoneNone
Kristen ColumbiaOrganizational Reviewer—SVNUniversity of Maryland Baltimore Washington Medical Center, Maryland Vascular Center—Nurse practitionerNoneNoneNoneNoneNoneNone
Michael S. ConteOrganizational Reviewer—SVSUniversity of California San Francisco—Professor and Chief• Cook Medical• MedtronicNoneNone• Bard• University of California Department of SurgeryNone
Alik FarberOrganizational Reviewer—SCVSBoston Medical Center—Chief, Division of Vascular Surgery• BardNoneNoneNoneNoneNone
Robert FeezorOrganizational Reviewer—VESSUniversity of Florida—Associate Professor of Surgery, Division of Vascular Surgery and Endovascular Therapy• Cook Medical*• Medtronic• TerumoNoneNone• Cook Medical• Cook Medical• Novate• Defendant, peripheral angioplasty, 2015
Dmitriy N. FeldmanOrganizational Reviewer—SCAIWeill Cornell Medical College, New York Presbyterian Hospital—Associate Professor of Medicine• AstraZeneca• Abbott• Bristol-Myers Squibb• Daiichi-Sankyo• Eli Lilly• Medtronic• Pfizer• The Medicines CompanyNoneNone• Biotronic• The Medicines CompanyNone
Jonathan GolledgeOrganizational Reviewer—TASCJames Cook University—Professor, Department of Surgery, Head of Vascular Biology UnitNoneNoneNone• James Cook University*NoneNone
Bruce H. GrayOrganizational Reviewer—SCAIGreenville Health System—Director of Clinical Trials, Department of SurgeryNone• MedtronicNone• Abbott• W.L. Gore• NCDR• ACCNone
William R. HiattOrganizational Reviewer—TASCColorado Prevention Center—Professor of MedicineNoneNoneNone• AstraZeneca*• Bayer*• CSI• Kowa• Kyushu University• Merck• Pluristem*• ReNeuron• CPC Clinical Research*• NIH*None
Joseph MillsOrganizational Reviewer—SVSBaylor College of Medicine—Professor and Chief, Division of Vascular surgery and Endovascular TherapyNoneNoneNoneNone• AnGes• Bayer• CescaNone
Mohammad Reza RajebiOrganizational Reviewer—SIRUniversity of Colorado Denver—Assistant ProfessorNoneNoneNoneNoneNoneNone
Mitchell J. SilverOrganizational Reviewer—SVMMcConnell Heart Hospital for Critical Limb Care—Director of Vascular Imaging• Boston Scientific• W.L. Gore• Medtronic• Bristol-Myers Squibb*• Pfizer*• Contego Medical*None• W.L. Gore• Medtronic• NIHNone
Lily ThomsonOrganizational Reviewer—SVNHôpital St-Boniface Hospital—Clinical Research Coordinator, Vascular Surgery Nurse, Section of Vascular Surgery, Health Sciences CentreNoneNoneNoneNoneNoneNone
Sana M. Al-KhatibContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesDuke Clinical Research Institute—Associate Professor of MedicineNoneNoneNone• FDA*• NHLBI*• PCORI*• VA (DSMB)• HRS (Board of Trustees)• Elsevier*None
Herbert AronowContent Reviewer—ACC Peripheral Vascular Disease Member SectionRhode Island Hospital—Director of Cardiac Catheterization LaboratoriesNoneNoneNone• Silk Road Medical• Saint Luke’s Health System• The Medicines Company• Bard• NIH• PCORI• SVM• W.L. Gore
Joshua A. BeckmanContent ReviewerVanderbilt University Medical Center—Director• AstraZeneca*• Merck*• Sanofi*None• EMX• JanaCare• Bristol-Myers Squibb*• Merck*• NIH• Vascular Interventional Advances• Defendant, venous thrombo-embolism, 2015*
James C. BlankenshipContent ReviewerGeisinger Medical Center—Staff Physician; Director, Cardiac Catheterization LaboratoryNoneNoneNone• Abbott• AstraZeneca• Boston Scientific• GlaxoSmithKline• Hamilton Health Sciences• Medinal LTD• Orexigen Therapeutics• St. Jude Medical• Stentys• Takeda Pharmaceuticals• SCAI (Past President)• AMANone
Biykem BozkurtContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesMichael E. DeBakey VA Medical Center—The Mary and Gordon Cain Chair and Professor of MedicineNoneNoneNone• NovartisNoneNone
Joaquin E. CigarroaContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesOregon Health and Science University—Clinical Professor of MedicineNoneNoneNoneNone• ACC/AHA• AHA• ASA• Catheterization and Cardiovascular Intervention• Portland Metro Area AHA (President)• SCAI Quality Interventional Council• NIHNone
Federico GentileContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesCentro Medico Diagnostico—Director, Cardiovascular DiseaseNoneNoneNoneNoneNoneNone
Anuj GuptaContent Reviewer—ACC Peripheral Vascular Disease Member SectionUniversity of Maryland—Assistant Professor of MedicineNoneNoneNone• Seimens*• Medtronic• Direct Flow Medical• EdwardsNone
John Jeb HallettContent ReviewerMedical University of South Carolina—Clinical Professor of SurgeryNoneNoneNoneNoneNoneNone
Alan HirschContent ReviewerUniversity of Minnesota Medical School—Professor of Medicine, Epidemiology and Community Health, and Director Vascular Medicine Program• Merck*• NovartisNoneNone• Bayer*• Pluristem (PLX-PAD trial–PI)• AstraZeneca (EUCLID trial–PI)• Pluristem*• AHA• Tactile Medical*None
Mark A. HlatkyContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesStanford University School of Medicine—Professor of Health Research and Policy, Professor of Medicine• Acumen*• GenentechNoneNone• Blue Cross/Blue Shield Center for Effectiveness Evaluation*• George Institute• HeartFlow*• NHLBI• Sanofi-aventis• ACC (Associate Editor)*None
Michael R. JaffContent ReviewerNewton-Wellesley Hospital; Harvard Medical School—Professor of Medicine• AOPA• Cardinal Health• Covidien• Micell• Vascular TherapiesNone• MC10• Janacare• Northwind• PQ Bypass• Primacea• SanoV• Valiant Medical• Abbott• Boston Scientific• Cordis• IC Sciences• Medtronic• Novello• CBSET• Intersocietal Accreditation Commission• SCAI• VIVA Physicians Group*None
José A. JoglarContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesUT Southwestern Medical Center—Professor of Internal Medicine; Clinical Cardiac Electrophysiology—Fellowship Program DirectorNoneNoneNoneNoneNoneNone
Glenn N. LevineContent Reviewer—ACC/AHA Task Force on Clinical Practice GuidelinesBaylor College of Medicine—Professor of Medicine; Director, Cardiac Care UnitNoneNoneNoneNoneNoneNone
Khusrow NiaziContent Reviewer—ACC Peripheral Vascular Disease Member SectionEmory University Department of Medicine—Associate Professor of MedicineNone• Medtronic*None• Bard• Impeto• TerumoNone• Plaintiff, MI resulting in death, 2015*
Paul D. VarosyContent Reviewer—Task Force on Performance MeasuresVA Eastern Colorado Health Care System—Associate ProfessorNoneNoneNone• VA Health Services Research and Development (PI)*• AHA (Guest Editor)None
Christopher J. WhiteContent ReviewerOchsner Clinical School, University of Queensland—Chairman, Department of Cardiology• NeovascNoneNone• AstraZeneca Pharmaceuticals• NIH• Neovasc• Surmodics• ACE (Board of Directors)None

This table represents all relationships of reviewers with industry and other entities that were reported by authors, including those not deemed to be relevant to this document, at the time this document was under development. The table does not necessarily reflect relationships with industry at the time of publication. A person is deemed to have a significant interest in a business if the interest represents ownership of ≥5% of the voting stock or share of the business entity, or ownership of ≥$5000 of the fair market value of the business entity; or if funds received by the person from the business entity exceed 5% of the person’s gross income for the previous year. Relationships that exist with no financial benefit are also included for the purpose of transparency. Relationships in this table are modest unless otherwise noted. Please refer to http://www.acc.org/guidelines/about-guidelines-and-clinical-documents/relationships-with-industry-policy for definitions of disclosure categories or additional information about the ACC/AHA Disclosure Policy for Writing Committees.

*Significant relationship.

No financial benefit.

AACVPR indicates American Association of Cardiovascular and Pulmonary Rehabilitation; ACC, American College of Cardiology; ACE, Accreditation for Cardiovascular Excellence; AHA, American Heart Association; AMA, American Medical Association; DSMB, data and safety monitoring board; EUCLID, Effects of Ticagrelor and Clopidogrel in Patients with Peripheral Artery Disease; FDA, US Food and Drug Administration; HRS, Heart Rhythm Society; MI, myocardial infarction; NCDR, National Cardiovascular Data Registry; NIH, National Institutes of Health; NHLBI, National Heart, Lung, and Blood Institute; PCORI, Patient-Centered Outcomes Research Institute; PI, primary investigator; PLX-PAD, placental-derived adherent stromal cell; SCAI, Society for Cardiovascular Angiography and Interventions; SCVS, Society for Clinical Vascular Surgery; SIR, Society of Interventional Radiology; SVM, Society for Vascular Medicine; SVN, Society for Vascular Nursing; SVS, Society for Vascular Surgery; TASC, Trans-Atlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease; VA, Veterans Affairs; VESS, Vascular and Endovascular Surgery Society; and VIVA, Vascular Intervention Advances.

Appendix 3. Abbreviations

AAA = abdominal aortic aneurysm
ABI = ankle-brachial index
ALI = acute limb ischemia
CAD = coronary artery disease
CLI = critical limb ischemia
CTA = computed tomography angiography
DAPT = dual antiplatelet therapy
DES = drug-eluting stent(s)
GDMT = guideline-directed management and therapy
MI = myocardial infarction
MRA = magnetic resonance angiography
PAD = peripheral artery disease
PTA = percutaneous transluminal angioplasty
RCT = randomized controlled trial
SPP = skin perfusion pressure
TBI = toe-brachial index
TcPO2 = transcutaneous oxygen pressure
QoL = quality of life

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