Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.

Peripheral Artery Disease (PAD)

• defined as peripheral artery disease of the lower extremities

1. Does aspirin reduce the risk of adverse cardiovascular events (MI, stroke, cardiovascular death) in patients with PAD? Is there a differential benefit in symptomatic and asymptomatic PAD patients?

2. Is clopidogrel more effective than aspirin in reducing adverse cardiovascular events in PAD? 3) Is endovascular intervention (PTA, stents) more effective than exercise therapy in improving walking distance in patients with intermittent claudication? 4) Is endovascular intervention as effective as bypass surgery in maintaining amputation-free survival in patients with critical limb ischemia?

Does your question include a comparison of different health care approaches? (If no, your topic will still be considered.)

yes

If yes, explain the specific technologies, devices, drugs, or interventions you would like to see compared:

For questions 1 and 2, comparisons between no antiplatelet therapy and aspirin; and comparison of two different antiplatelet therapies.

For questions 3 and 4, comparisons between exercise therapy and endovascular intervention for claudication; and comparison of endovascular intervention and bypass surgery for critical limb ischemia.

What patients or group(s) of patients does your question apply to? (Please include specific details such as age range, gender, coexisting diagnoses, and indications for therapy.)

Co-morbid/multi-morbid patients with PAD

Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)

Minorities, Women

Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)

Improvements in mortality and morbidity and quality of life

Describe any health-related risks, side effects, or harms that you are concerned about.

Bleeding risks associated with anti-platelet therapy in patients with PAD and co-morbid disease

Appropriateness for EHC Program

Does your question include a health care drug, intervention, device, or technology available (or likely to be available) in the U.S.?

yes

Which priority area(s) and population(s) does this topic apply to? (check all that apply)

EHC Priority Conditions (updated in 2008)

• Cardiovascular disease, including stroke and hypertension
• Diabetes mellitus

AHRQ Priority Populations

• Minority groups
• Elderly
• Individuals with special health care needs, including individuals with disabilities or who need chronic care or end-of-life health care

Federal Health Care Program

None

Importance

Describe why this topic is important.

PAD is prevalent, affecting approximately 8-10 million persons in the US. It is associated with a 5 fold increased risk of adverse cardiovascular events. It is important to determine whether anti-platelet therapy is effective in reducing cardiovascular events and if so, which agent is most effective. In addition, quality of life is affected by PAD. It is important to determine the most effective therapies for improving functional capacity and for limb preservation in patients with PAD.

What specifically motivated you to ask this question? (For example, you are developing a clinical guideline, working with a policy with large uncertainty about the appropriate approach, costly intervention, new research you have read, items in the media you may have seen, a clinical practice dilemma you know of, etc.)

A clinical practice guideline is being developed.

Does your question represent uncertainty for clinicians and/or policy-makers? (For example, variations in clinical care, controversy in what constitutes appropriate clinical care, or a policy decision.)

yes

If yes, please explain:

The benefit of anti-platelet therapy in patients with PAD and the comparative effectiveness of exercise versus endovascular intervention for relieving claudication and of surgical versus endovascular revascularization to salvage ischemic limbs are uncertain.

Potential Impact

How will an answer to your research question be used or help inform decisions for you or your group?

Evidence gathered, collated, and reviewed will inform clinical practice guideline recommendations.

Describe the timeframe in which an answer to your question is needed.

6-8 months

Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.

Nominator Information

Other Information About You: (optional)

Please choose a description that best describes your role or perspective: (you may select more than one category if appropriate)

Evidence gathered, collated, and reviewed will inform clinical practice guideline recommendations.

Are you making a suggestion as an individual or on behalf of an organization?

Organization

Please tell us how you heard about the Effective Health Care Program