Peripheral Artery Disease (PAD) Guidelines 

Updated: Dec 31, 2015
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Screening

Because early detection of peripheral artery disease (PAD) in asymptomatic patients and subsequent treatment may reduce cardiovascular disease (CVD) in a potentially large group of individuals, screening guidelines have been addressed by a number of organizations, including the following:

  • U.S. Preventive Services Task Force (USPSTF)
  • American College of Preventive Medicine (ACPM)
  • American College of Cardiology/American Heart Association (ACC/AHA)
  • Society for Vascular Surgery (SVS)
  • European Society of Cardiology (ESC)
  • American Diabetes Association (ADA)

Currently, no organization recommends routine screening for PAD in asymptomatic patients. In 2013, the USPSTF changed its recommendation against screening to an indeterminate recommendation, due to insufficient evidence to assess the balance of benefits and harms. However, for individuals with known CVD or diabetes, the USPSTF recommends risk reduction interventions (eg, antiplatelet or lipid-lowering therapies). [1]

Recommendations for PAD screening are listed in Table 1, below.

Table 1. Recommendations for peripheral artery disease screening in adults. (Open Table in a new window)

Issuing organization Year Recommendation
U.S. Preventive Services Task Force [1] 2013 Insufficient evidence that screening for PAD in asymptomatic adults leads to clinically important benefits. Risk reduction interventions (such as antiplatelet or lipid-lowering therapies) are recommended for high- risk individuals with known CVD or diabetes.
American College of Preventive Medicine [2] 2011 No routine screening is recommended but clinicians should be alert to symptoms of PAD in patients with risk factors (eg, age ≥50 years, history of smoking, diabetes mellitus)
American College of Cardiology/American Heart Association [3, 4] 2005/2011 Screen with ankle-brachial index (ABI) in patients at increased risk, including adults ≥65 years old, adults ≥50 years old with a history of smoking or diabetes, and adults of any age with exertional leg symptoms or nonhealing wounds
Society for Vascular Surgery [5] 2015 Screening is reasonable if used to improve risk stratification, preventive care, and medical management in asymptomatic patients at increased risk, (eg, adults >70 years old, smokers, individuals with diabetes, those with an abnormal pulse examination, or other established CVD)
European Society of Cardiology [6] 2011 Consider screening with ABI in patients with coronary artery disease (CAD)
American Diabetes Association [7] 2015 Screen with ABI in patients with diabetes who are symptomatic or are asymptomatic and >50 years old or have at least one other risk factor (eg, smoking, hypertension, hyperlipidemia, or duration of diabetes >10 years)
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Lower Extremity PAD

The following organizations have released guidelines for the management of peripheral artery disease (PAD) in the lower extremities:

  • American College of Cardiology/American Heart Association (ACC/AHA)
  • Society for Vascular Surgery (SVS)
  • European Society of Cardiology (ESC)

Risk factors

The ACC/AHA identifies the following as the most common risk factors for lower-extremity PAD [3] :

  • Age ≥70 years
  • Age 50-69 years and history of smoking or diabetes
  • Age <50 years with diabetes and at least one of these additional atherosclerosis risk factor: smoking, hypertension, dyslipidemia, hyperhomocysteinemia
  • Known coronary, carotid, or renal atherosclerotic disease

The SVS and ESC guidelines concur that older age, smoking, and diabetes are associated with the highest relative risk of developing lower-extremity PAD. [5, 6]

Diagnosis

All three guidelines recommend ankle-brachial index (ABI) determination as the first-line noninvasive test to establish a diagnosis of PAD, because of its high sensitivity and specificity. [3, 5, 6] The ACC/AHA recommends using the resting ABI in patients with any of the following:

  • Exertional leg symptoms
  • Nonhealing wounds
  • Age ≥70 years
  • Age ≥50 years and older with a history of smoking or diabetes

ABI diagnostic values are as follows: [4]

  • ≤0.90: Abnormal (PAD)
  • 0.91-0.99: Borderline
  • 1.00-1.40: Normal
  • >1.40: Noncompressible (often due to diabetes or advanced age)

ACC/AHA and SVS recommend exercise ABI testing in patients with claudication or other risk factors whose ABI is borderline or normal. [3, 5] For patients with ABI >140, the ACC/AHA and ESC recommended toe-brachial index or pulse volume recording as alternative tests. [3, 6]

For symptomatic patients who may undergo revascularization, all three guidelines recommend imaging studies such as duplex ultrasound, computed tomography angiography, magnetic resonance angiography, and contrast arteriography. The use of segmental pressures and pulse volume recordings to assess localization and severity is also recommended. [3, 5, 6]

Cardiovascular disease risk reduction

Treatment of asymptomatic disease is directed at risk factor reduction. The following measures are recommended by the ACC/AHA and ESC [3, 4, 6] :

  • Smoking cessation
  • Beta-blocker (class I recommendation) or angiotensin-converting enzyme (ACE) inhibitor therapy to achieve a blood pressure of <140/90 mm Hg, or <130/80 mm Hg for adults with diabetes or chronic kidney disease
  • Statin therapy to achieve a low density lipoprotein (LDL) cholesterol level <100 mg/dL, or <70 mg/dL for those at very high risk for ischemic events
  • In patients with diabetes, proper foot care and glycemic control to reduce hemoglobin A1C to <7%
  • Antiplatelet therapy with daily low-dose aspirin (75-325 mg)

Intermittent claudication—first-line intervention

Intermittent claudication (IC) is managed with exercise and medication to improve symptoms and impede progression of the disease. Endovascular and surgical revascularization are generally recommended when exercise and medication have failed. [3, 5, 6]

In addition to lifestyle modification for risk reduction, similar to those outlined above, the 2015 SVS guidelines for treatment of IC recommend the following first-line interventions [5] :

  • A supervised exercise program consisting of walking a minimum of three times per week (30-60 min/session) for at least 12 weeks
  • Home-based exercise, with a goal of at least 30 minutes of walking three to five times per week when a supervised exercise program is unavailable or for long-term benefit after a supervised exercise program is completed
  • Clopidogrel, 75 mg daily, as an effective alternative to aspirin for antiplatelet therapy (warfarin should not be used for the sole indication of reducing the risk of adverse cardiovascular events or vascular occlusions)
  • In patients who do not have chronic heart failure, consider a 3-month trial of cilostazol (100 mg twice daily) to improve pain-free walking; in patients who cannot tolerate cilostazol, pentoxifylline (400 mg thrice daily) may be considered
  • Ramipril (10 mg/d) may also be considered to improve pain-free and maximal walking times, but is contraindicated in individuals with known renal artery stenosis
  • Annual follow-up to assess compliance with lifestyle measures (eg, smoking cessation, exercise) and medical therapies as well as to assess for evidence of progression in symptoms or signs of PAD; ABI testing may be of value to provide objective evidence of disease progression

In general, the ACC/AHA and ESC recommendations are in agreement but include the following variations:

  • ACC/AHA finds the usefulness of unsupervised exercise programs to be not well established [3]
  • ESC recommends considering revascularization for patients who have poor improvement after 3-6 months of conservative therapy (risk factor reduction, exercise therapy, and pharmacotherapy) [5]
  • ESC recommends revascularization as a first-line therapy, along with risk factor management, for patients with severe intermittent claudication that impacts their activities of daily life [5]

Revascularization

ACC/AHA guidelines recommend endovascular revascularization as second-line therapy for patients with lifestyle- or vocation-limiting disability when there is a reasonable likelihood of symptomatic improvement with treatment, and pharmacologic or exercise therapy, or both, have failed.

Aortobifemoral bypass is appropriate for patients who are unsuitable for endovascular repair; iliac endarterectomy and aortoiliac or iliofemoral bypass for surgical treatment of unilateral disease may be considered if aortobifemoral bypass is not possible. Axillofemoral-femoral bypass should not be considered except in very limited settings. [3]

SVS guidelines recommend an individualized approach to selection of invasive treatment. The SVS advises, however, that endovascular procedures are generally preferred over open surgery. [5]

ESC guidelines recommend an endovascular approach. An experienced team is required in patients with multi-vessel disease and severe comorbidities. Stent implementation should be considered for femoropopliteal lesions classified as type B according to the Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC B lesions). [6]

In its 2014 consensus statement on femoral-popliteal arterial intervention, the Society for Cardiac Angiography and Interventions (SCAI) advised that endovascular treatment is appropriate care for patients who have any of the following [8] :

  • Chronic total occlusion (CTO) with lifestyle- or vocation-limiting claudication despite pharmacological therapy and/or walking therapy
  • CTO with critical limb ischemia (CLI)
  • CTO and the clinical need for vascular access (eg, access needed for transaortic valvular repair)

The SCAI advises that endovascular treatment may be appropriate care for CTO with severe claudication or CLI, but is rarely appropriate care for most mildly symptomatic or asymptomatic blockages.

Critical limb ischemia

The ACC/AHA guideline includes the following recommendations for management of CLI [3, 4] :

  • In patients with combined inflow and outflow disease, inflow lesions should be treated first; if symptoms of CLI or infection persist after inflow revascularization, an outflow revascularization procedure is required
  • Balloon angioplasty is reasonable when an autogenous vein conduit is not available for patients with limb-threatening CLI and life expectancy ≤2 years
  • Bypass surgery, when possible and an autogenous vein conduit is available, is reasonable as initial treatment for patients with limb-threatening CLI and life expectancy >2 years

The ACC/AHA guideline recommends evaluation for primary amputation of the leg in patients with any of the following:

  • Significant necrosis of weight-bearing portions of the foot
  • Uncorrectable flexion contracture
  • Paresis of the extremity
  • Refractory ischemic rest pain
  • Sepsis
  • Limited life expectancy

The ESC recommends revascularization whenever feasible for limb salvage. Endovascular therapy is preferred, if technically possible. [6]

In 2014, the Society for Cardiac Angiography and Interventions (SCAI) issued a consensus statement on the treatment of infrapopliteal arterial disease. The statement provided the following recommendations [9] :

  • Invasive intervention for infrapopliteal disease is appropriate in patients with two- or three-vessel disease and (1) moderate-to-severe claudication with a focal arterial lesion; (2) ischemic foot pain during rest (Rutherford classification 4); or (3) minor and major (skin necrosis, gangrene) tissue loss
  • Primary amputation should be the preferred intervention in nonambulatory patients with a limited life expectancy and extensive necrosis or gangrene
  • Consider surgical bypass and evaluate its associated risks for ambulatory patients with a patent infrapopliteal artery that has direct flow to the foot and an adequate autologous venous conduit
  • Use balloon angioplasty for clinically significant infrapopliteal arterial disease; consider bailout bare-metal and drug-eluting stents for tibial arterial disease that is refractory to treatment with balloon angioplasty
  • Endovascular intervention is not appropriate for most single-vessel, mildly symptomatic, or asymptomatic blockages of infrapopliteal vessels
  • It is not appropriate to treat most cases of moderate-to-severe claudication or major tissue loss in one-vessel disease and mild claudication in one-, two-, or three-vessel disease
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Renal Arterial Stenosis

The following organizations have released guidelines for the management of renal artery stenosis (RAS):

  • American College of Cardiology (ACC)/American Heart Association(AHA)
  • European Society of Cardiology (ESC)
  • Society for Cardiovascular Angiography and Interventions (SCAI)

Diagnosis

The 2003 ACC/AHA and 2014 ESC guidelines recommend performing diagnostic studies to identify RAS in patients with any of the following [3, 6] :

  • Onset of hypertension before the age of 30
  • Onset of severe hypertension after the age of 55
  • Accelerated hypertension (sudden and persistent worsening of previously controlled hypertension)
  • Resistant hypertension (failure of blood-pressure control despite full doses of an appropriate three-drug regimen including a diuretic
  • Malignant hypertension (hypertension with coexistent end-organ damage;  ie, acute kidney injury, flash pulmonary edema, hypertensive left ventricular failure, aortic dissection, new visual or neurological disturbance, and/or advanced retinopathy)
  • New azotemia or worsening renal function after the administration of an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB)
  • Unexplained atrophic kidney or size discrepancy of greater than 1.5 cm between the kidneys
  • Unexplained renal failure

The ACC/AHA guidelines also include patients with sudden, unexplained pulmonary edema in its class I recommendations. [3] In its 2014 SCAI Expert Consensus Statement for Renal Artery Stenting Appropriate Use, the SCAI utilized the ACC/AHA recommendations. [10]

The ESC has additional recommendation for patients with hypertension and abdominal bruit as well as those with hypertension and hypokalemia in particular when receiving thiazide diuretics. [6]

Class I recommendations for establishing a diagnosis of RAS generally concur and include the following [3, 6] :

  • Duplex ultrasonography (DUS) is the first-line test
  • Computed tomography angiography in patients with creatinine clearance >60 mL/min
  • Magnetic resonance angiography in patients with creatinine clearance >30 mL/min

When the clinical index of suspicion is high and the results of noninvasive tests are inconclusive, ACC/AHA recommends catheter angiography, [3] while ESC recommends digital subtraction angiography. [6]

Both guidelines are in agreement that captopril renal scintigraphy, selective renal vein renin measurements, plasma renin activity, and the captopril test are not recommended as useful screening tests for RAS (class III). [3, 6]

SCAI recommends renal angiography as the gold standard for invasive assessment of hemodynamically significant RAS and categorizes stenosis severity as follows [10] :

  • Mild: <50%
  • Moderate: 50–70%
  • Severe: >70%

Severe angiographic stenosis is considered hemodynamically significant. Moderate angiographic stenosis is considered hemodynamically significant only when the patient also has a resting mean pressure gradient >10 mm Hg or systolic hyperemic pressure gradient >20 mm Hg or renal fractional flow reserve (FFR) ≤0.8. Mild and moderate stenosis that is not hemodynamically significant should only rarely be considered for revascularization. [10]

Medical Therapy

ACC/AHA, ESC and SCAI all prefer medical therapy as the first-line treatment for RAS. [3, 6, 10] ACC/AHA and ESC recommend ACE inhibitors, ARBs, and calcium channel blockers for unilateral RAS, [3, 6] but ESC considers ACE inhibitors and ARBs contraindicated for the treatment of bilateral severe RAS and in the case of a single functional kidney. [6] ACC/AHA also recommends beta-blockers for treatment of hypertension associated with RAS.

Revascularization

The ACC/AHA guidelines recommend percutaneous revascularization in patients with hemodynamically significant RAS and any of the following [3] :

  • Recurrent congestive heart failure or sudden unexplained pulmonary edema (class I)
  • Unstable angina (class IIa)
  • Accelerated, resistant, or malignant hypertension or hypertension with unexplained unilateral small kidney and intolerance to medication (class IIa)
  • Asymptomatic bilateral or single functioning kidney; however, this treatment is clinically unproven in asymptomatic unilateral hemodynamically significant RAS in a viable kidney (class IIb)

In addition, percutaneous revascularization is reasonable for patients with progressive chronic kidney disease (CKD) and bilateral RAS or a RAS to a single functioning kidney and can be considered for unilateral RAS with chronic renal insufficiency. [3]

ACC/AHA and ESC recommend renal stent placement for ostial atherosclerotic RAS (class I). [3]

ACC/AHA  gives a class I recommendation for balloon angioplasty with bailout stent placement if necessary for fibromuscular dysplasia lesions, [3] whereas ESC recommends considering balloon angioplasty with or without stenting for patients with RAS and recurrent congestive heart failure or sudden pulmonary edema and preserved left ventricular systolic function (class IIb). [6]

Based on an expert panel review of scientific data, the SCAI concluded that patients with the following are most likely to benefit from renal artery stenting [10] :

  • Cardiac disturbance syndromes (flash pulmonary edema or acute coronary syndrome)
  • Hypertension that has not been controlled by three or more medications at maximal tolerated doses
  • Blockages in both kidneys or severe blockages in a single functioning kidney when blood pressure or renal dysfunction cannot be managed medically

The SCAI concluded that patients with any of the following are typically not good candidates for renal artery stenting [10] :

  • Mild or moderate blockages (less than 70%)
  • Long-standing loss of blood flow
  • Complete blockage of the renal artery

ACC/AHA gives class I recommendations to surgical revascularization for the following indications [3] :

  • Fibromuscular dysplasia, especially in those exhibiting complex disease or macroaneurysms
  • Atherosclerotic RAS and multiple small renal arteries or early primary branching of the main renal artery
  • Atherosclerotic RAS in combination with pararenal aortic reconstruction

ESC gives a class IIb recommendation to consider surgical revascularization in patients undergoing repair of the aorta or with complex anatomy of renal arteries or after failure of endovascular treatment. [6]

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Abdominal Aortic Aneurysms (AAA)

Screening

Screening guidelines for abdominal aortic aneurysms (AAA) have been released by the following organizations:

  • U.S Preventive Services Task Force (USPSTF)
  • American College of Preventive Medicine(ACPM)
  • American College of Cardiology (ACC)/American Heart Association(AHA)
  • Society for Vascular Surgery (SVS)
  • European Society of Cardiology (ESC)
  • European Society of Vascular Surgery (ESVS)

Because most AAA are asymptomatic until they rupture but the risk for death with AAA rupture is as high as 75-90%, all the organizations recommend a one-time screening with ultrasound for high-risk men >65 years old. Because of the relatively low risk in women, including those who have smoked, the guidelines vary from recommending against screening to recommending it for in specific higher-risk populations. A comparison of all screening recommendations for AAA is outlined in Table 2, below.

Table 2. Abdominal aortic aneurysm screening recommendations (Open Table in a new window)

One-time abdominal screening with ultrasound USPSTF (2014)   [11] ACPM (2011)   [2] ACC/AHA (2003/2011)   [3, 4] SVS (2009)   [12] ESC (2014)   [13] ESVS (2011)   [14]
All men 65-74 years old (offer selectively)     ≥65 years old >65 years old ≥65 years old
Men who have smoked 65-74 years old 65-74 years old 65-74 years old     Consider <65 years old
Men with family history of AAA     ≥60 years old ≥55 years old   Consider <65 years old
All women Recommend against in women who have never smoked Recommend against     Recommend against in absence of family history or smoking Not beneficial
Women who have smoked Insufficient evidence     ≥65 years old >65 years old (consider) Requires further investigation
Women with a family history of AAA       ≥65 years old    

SVS guidelines do not recommend rescreening patients for AAA if an initial ultrasound scan performed on patients 65 years of age or older demonstrates an aortic diameter of <2.6 cm. [12] ESVS guidelines recommend considering rescreening in those initially screened at a younger age or at higher risk for AAA. [14]

Asymptomatic AAA

ACC/AHA, SVS, ESC and ESVS  guidelines agree that in asymptomatic patients with AAA <5.5 cm, surveillance and smoking cessation are recommended; surgical repair is indicated for AAA ≥5.5 cm or if growth exceeds 1.0 cm/year. [3, 12, 13, 14] In addition, for patients with AAA <5.5 cm, ACC/AHA and ESC recommend monitoring and controlling blood pressure and serum lipids. [3, 13] However, the SVS guidelines find doxycycline, roxithromycin, ACE inhibitors, and ARBs of uncertain benefit in reducing the risk of AAA expansion and rupture, and that use of beta- blockers is not recommended. [12]

All the guidelines recommend that the interval for monitoring by ultrasound for expansion of AAAs should shorten as the AAA enlarges. ACC/AHA guidelines recommend that with AAA <4.0 cm, monitoring should take place every 2 to 3 years and with AAA 4.0-5.4cm, every 6 to 12 months. [3] A comparison of the intervals recommended by the other three guidelines is shown in Table 3, below.

Table 3. Recommendations for monitoring of abdominal aortic aneurysms (Open Table in a new window)

Monitoring Interval  Aneurysm size (cm)
SVS (2009)  [12] ESC (2014)  [13] ESVS (2011)  [14]
5 years 2.6 to <3.0    
4 years   2.5 to <3.0  
3 years 3.0 to <3.5 3.0 to <4.0  
2 years   4.0 to ≤4.5 3.0 to <4.0
12 months 3.5 to <4.5 >4.5 4.0 to <4.5
6 months ≥4.5   4.5 to ≤5.0

According to the ESVS guidelines, surgery may be indicated for AAA ≥5.0 cm in women or in men at higher risk of rupture due to smoking, hypertension, or chronic airway disease. Patients should be referred to a vascular surgeon for risk assessment when the AAA reaches 5.0 cm. [14]

Rupture Prevention/Repair

The ACC/AHA and ESC guidelines recommend endovascular or open aortic repair for patients with large aneurysms who are good surgical candidates. [4, 13] ACC/AHA further recommends that for patients who have undergone endovascular repair, long-term imaging surveillance should be performed to monitor for endoleak, document shrinkage or stability of excluded aneurysm sac, and to determine if further intervention is needed. Open repair is a reasonable option for those patients who cannot comply with long-term surveillance. [4]

Symptomatic AAA

ACC/AHA guidelines recommend immediate surgical evaluation of patients presenting with abdominal and/or back pain, pulsatile abdominal mass and hypotension. Surgical repair is indicated for all symptomatic AAAs regardless of size. [3]

ESC and ESVS guidelines recommend emergency repair for ruptured AAA and urgent repair for non-ruptured  symptomatic AAA. [13, 14] In addition, ESVS finds no evidence to support endovascular repair of ruptured AAA. However, SVS guidelines recommend considering emergent endovascular repair if anatomically feasible. [12]

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