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Peripheral-Artery-Disease-Treatment Comparative Effectiveness Review Number 118 Effective Health Care Program Treatment Strategies for Patients With Peripheral Artery Disease Executive Summary Background Effective Health Care Program Peripheral artery disease (PAD) refers to chronic narrowing or atherosclerosis The Effective Health Care Program of the lower extremities1 and represents was initiated in 2005 to provide valid a spectrum of disease severity from evidence about the comparative asymptomatic disease to intermittent effectiveness of different medical claudication (IC), to critical limb ischemia interventions. The object is to help (CLI). PAD has a similar atherosclerotic consumers, health care providers, and process to coronary artery disease and others in making informed choices shares similar risk factors: male gender, among treatment alternatives. Through age, diabetes, smoking, hypertension, high its Comparative Effectiveness Reviews, cholesterol, and renal insufficiency.2 PAD the program supports systematic is known to be associated with a reduction appraisals of existing scientific in functional capacity and quality of life evidence regarding treatments for as well as an increased risk for myocardial high-priority health conditions. It infarction (MaI), stroke, and death; it is also promotes and generates new also a major cause of limb amputation.3-7 scientific evidence by identifying gaps Therefore, the general goals of treatment in existing scientific evidence and for PAD are cardiovascular protection, supporting new research. The program relief of symptoms, preservation of puts special emphasis on translating walking and functional status, and findings into a variety of useful prevention of amputation. The optimal formats for different stakeholders, treatment for PAD—with specific emphasis including consumers. on the comparative effectiveness of The full report and this summary are treatment options—is not known.8 available at www.effectivehealthcare. The backbone of treatment for PAD ahrq.gov/reports/final.cfm. is smoking cessation, risk factor modification, dietary modification, and increased physical activity. There (1) medical therapy, (2) exercise training, are three main treatment options for and (3) revascularization. The treatment improving functional status and other options offered to PAD patients depend clinical outcomes in patients with PAD: on whether the patient is asymptomatic or symptomatic (with either IC or CLI). Effective Health Care 1 Medical Therapy regarding the absolute indications for and the appropriate use of revascularization strategies in patients with PAD.11 The goal of medical therapy in patients with PAD is Ultimately, clinicians must weigh risks and benefits in to reduce the risk of future cardiovascular morbidity determining which patients have the greatest chance for and mortality in patients with high ischemic risk, and/ success with revascularization. Multiple strategies for or to improve walking distance and functional status in revascularization include surgery, angioplasty (cryoplasty, patients with IC. Secondary prevention includes the use drug-coated, cutting, and standard angioplasty balloons of antiplatelet agents and angiotensin-converting enzyme are available for use in peripheral arteries), stenting (self- (ACE) inhibitors and the management of other risk expanding and balloon-expandable stents are available, but factors such as tobacco use, diabetes, LDL levels, and drug-eluting stents are not currently approved for treating hypertension. With respect to antiplatelet therapy, there peripheral arteries in the United States), and atherectomy is clinical uncertainty. It is not clear which antiplatelet (laser, directional, orbital, and rotational atherectomy strategy—aspirin versus clopidogrel, monotherapy devices are approved for use in the United States). With versus dual antiplatelet therapy (DAPT)—is of most improvements in endovascular techniques and equipment, benefit. Further, the role of these agents in patients with the use of balloon angioplasty, stenting, and atherectomy asymptomatic PAD also is unclear. has led to the application of endovascular revascularization Selected medical therapies have been shown to improve to a wider range of patients over the past decade, both walking distance in patients with PAD, compared with among those with more severe symptoms and those with placebo. Cilostazol and pentoxifylline both work by less severe symptoms.12 Very few large clinical trials have increasing blood flow to the limb, preventing blood clots, been performed in patients with IC or CLI that aim to and widening the blood vessels. Common side effects of determine the best revascularization strategy; however, cilostazol include headache and diarrhea, and its use is many questions remain, as newer endovascular therapies contraindicated in patients with congestive heart failure; are applied to a broader population of patients. however, pentoxifylline has fewer side effects of nausea and diarrhea.9 Scope and Key Questions (KQs) Exercise Training This comparative effectiveness review was funded by the Over the past 30 years, research efforts within PAD Agency for Healthcare Research and Quality (AHRQ). have focused on the potential benefits of noninvasive The review was designed to evaluate the effectiveness therapy, such as exercise, for patients with IC. Most of available strategies—exercise, medications, studies investigate differences between supervised revascularization—used to treat patients with PAD. exercise training and standard home exercise training. With input from our Technical Expert Panel (TEP), we More recently, supervised exercise training has also been constructed KQs using the general approach of specifying compared with endovascular revascularization. the population of interest, interventions, comparators, outcomes, timing of outcomes, and settings (PICOTS). The Revascularization KQs considered in this comparative effectiveness review were: Historically, patients with IC have been treated conservatively for their leg symptoms with medical KQ 1. In adults with PAD, including asymptomatic therapy, lifestyle modification, and exercise programs.10 patients and symptomatic patients with atypical leg When IC patients continue to have symptoms despite symptoms, IC, or CLI: conservative, noninvasive treatment, then revascularization a. What is the comparative effectiveness of aspirin becomes a treatment option. For patients with CLI, and other antiplatelet agents in reducing the revascularization is often attempted to restore blood risk of adverse cardiovascular events (e.g., all- flow, improve wound healing, and prevent amputation. cause mortality, myocardial infarction, stroke, Decisions about whether to revascularize and how to cardiovascular death), functional capacity, and revascularize patients with PAD depend on a number of quality of life? factors, including patient-specific characteristics, anatomic characteristics, severity of symptoms, need for possible b. Does the effectiveness of treatments vary according repeat revascularization in the future, and patient and to the patient’s PAD classification or by subgroup physician preferences. Clinical guidelines remain vague (age, sex, race, risk factors, or comorbidities)? 2 c. What are the significant safety concerns associated ischemia)? Do the safety concerns vary by subgroup with each treatment strategy (e.g., adverse drug (age, sex, race, risk factors, comorbidities, anatomic reactions, bleeding)? Do the safety concerns vary by location of disease)? subgroup (age, sex, race, risk factors, comorbidities, KQ 3. In adults with CLI due to PAD: or PAD classification)? a. What is the comparative effectiveness of KQ 2. In adults with symptomatic PAD (atypical leg endovascular intervention (percutaneous symptoms or IC): transluminal angioplasty, atherectomy, or stents) and a. What is the comparative effectiveness of exercise surgical revascularization (endarterectomy, bypass training, medications (cilostazol, pentoxifylline), surgery) for outcomes including cardiovascular endovascular intervention (percutaneous events (e.g., all-cause mortality, myocardial transluminal angioplasty, atherectomy, or stents), infarction, stroke, cardiovascular death), amputation, and/or surgical revascularization (endarterectomy, quality of life, wound healing, analog pain scale bypass surgery) on outcomes including score, functional capacity, repeat revascularization, cardiovascular events (e.g., all-cause mortality, and vessel patency? myocardial infarction, stroke, cardiovascular b. Does the effectiveness of treatments vary by death), amputation, quality of life, wound healing, subgroup (age, sex, race, risk factors, comorbidities, analog pain scale score, functional capacity, repeat or anatomic location of disease)? revascularization, and vessel patency? c. What are the significant safety concerns associated b. Does the effectiveness of treatments vary by use with each treatment strategy (e.g., adverse of exercise and medical therapy prior to invasive drug reactions, bleeding, contrast nephropathy, management or by subgroup (age, sex, race, risk radiation exposure, infection, and periprocedural factors, comorbidities, or anatomic location of complications causing acute limb ischemia)? Do the disease)? safety concerns vary by subgroup (age, sex, race, c. What are the significant safety concerns associated risk factors, comorbidities, or anatomic location of with each treatment strategy (e.g., adverse drug disease)? reactions, bleeding, contrast
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