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

Should clopidogrel be prescribed indefinitely in patients who have received drug eluting stents for the treatment of CAD?

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:

Clopidogrel for 1 year post drug eluting stent implantation versus indefinite use post stent

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.)

All patients who have received a drug eluting stent for obstructive coronary artery disease

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

Subgroups according to anatomical location of implanted stent (major epicardial vessel [left anterior descending artery versus left circumflex artery versus right coronary artery] versus branch arteries)

Patients with comorbidities of interest (prior myocardial infarction, stroke, or concomitant peripheral arterial disease)

Patients with CYP2C19 polymorphisms who have lower levels of the active metabolite of clopidogrel

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

All patient-related benefits, including but not limited to: improvement in anginal symptoms and quality of life; reduction in in-stent thrombosis rates, target vessel revascularization hospitalizations, mortality

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

All patient-related harms, including but not limited to: in-stent thrombosis, repeat target vessel revascularization, major adverse cardiovascular events, cardiovascular hospitalizations, cardiovascular mortality, all-cause mortality

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

AHRQ Priority Populations

• Minority groups
• Women
• 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

• Medicaid
• Medicare

Importance

Describe why this topic is important.

Most cases of stent thrombosis occur within the first 30 days after placement and the rates are similar for bare metal stents (BMS) and drug-eluting stents (DES). However, episodes of late in-stent thrombosis, as late as 3 to 4 years following DES implantation, have been reported. In randomized trials, in-stent thrombosis rates for DES are higher after one year compared with BMS. Also, the premature cessation of dual antiplatelet therapy (i.e. aspirin plus clopidogrel) is the most important risk factor for in-stent thrombosis. Therefore, the duration of stent thrombosis risk and whether longer term antiplatelet therapy would lower this risk require additional study. Meta-analyses to date have had conflicting results on whether clopidogrel should be continued for longer than 12 months. Additionally, existing trial data are underpowered to adequately answer this question and predominantly enrolled lower risk patients than those encountered in real-world settings.

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.)

This topic was ranked as a priority by a panel of stakeholders convened through the Duke EPC’s Cardiovascular Topic Identification project to recommend a research agenda for future systematic reviews within the EHC cardiovascular domain.

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:

Stakeholders considered uncertainty for clinicians and/or policy-makers as part of the ranking process, and with that criterion considered, this topic received a priority designation.

Potential Impact

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

This topic was identified by a group of stakeholders in cardiovascular disease as an area in which significant morbidity, mortality, and/or variation in resource utilization persists, and future systematic review development should be prioritized. Answers to this question are expected to inform practice and guideline development, and ultimately improve the quality of care by reducing morbidity, mortality, and costs.

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

Though no specific timeframe is applicable, this topic was identified by the stakeholder group as immediately relevant.

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

Stakeholders considered variation in clinical practice and inequities in care as part of the ranking process, and with that criterion considered, this topic received a priority designation.

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)

This topic was identified by a group of stakeholders in cardiovascular disease as an area in which significant morbidity, mortality, and/or variation in resource utilization persists, and future systematic review development should be prioritized. Answers to this question are expected to inform practice and guideline development, and ultimately improve the quality of care by reducing morbidity, mortality, and costs.

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

Involvement in the Evidence-based Practice Center Program