- Briefly describe a specific question, or set of related questions, about a health care test or treatment that this program should consider.
Key Questions For patients with stable angina (stable coronary artery disease, chronic angina),
- what is the comparative effectiveness of percutaneous coronary intervention (PCI) plus optimal medical therapy (OMT) compared to OMT in reducing the risk of death and non-fatal MI and secondarily revascularization rates and re-hospitalization and in improving quality of life (short and long-term)?
- does the comparative effectiveness of PCI plus OMT compared to OMT vary for patient subgroups based on demographic factors (e.g., age, sex, race) or indicators of adverse risk (e.g., recent myocardial infarction with or without subsequent angina, severity of coronary artery disease or number of vessels involved +/- left anterior descending artery)?
- what are the harms from PCI plus OMT compared to OMT alone?
Patient group/population:
- Adults (> 18 years old) with stable angina (chronic coronary artery disease)
- Exclusions based on currently accepted indicators for an invasive treatment strategy (e.g., ACC/AHA guidelines):
- Persistent Canadian Cardiovascular Society (CCS) class IV angina (inability to perform any physical activity without discomfort; angina symptoms may be present at rest)with medical treatment
-Markedly positive stress test (i.e., Duke treadmill score of -11 or less,associated with an estimated annual mortality of > 3%)
- Ejection fraction < 30%
- Revasculariztion within the previous 6 months
Intervention(s):
- Percutaneous Coronary Intervention (PCI) – stenting (bare metal or drug eluting) or angioplasty
Comparator(s):
- Optimal medical therapy (OMT) (currently recommended in the ACC/AHA guideline)
Outcome(s):
Primary:
- Death (all cause and CHD)
- Non-fatal myocardial infarction (MI)
- Death or non-fatal MI Secondary:
- Quality of life (short and long-term)?
- Revascularization rates
- Re-hospitalization rates
- 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:
See above
- 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.)
See above
- Are there subgroups of patients that your question might apply to? (For example, an ethnic group, stage or severity of a disease.)
See above
- Describe the health-related benefits you are interested in. (For example, improvements in patient symptoms or problems from treatment or diagnosis.)
See above
- Describe any health-related risks, side effects, or harms that you are concerned about.
See above
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)
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- EHC Priority Conditions (updated in 2008)
- Cardiovascular disease, including stroke and hypertension
- AHRQ Priority Populations
- Low income groups
- Minority groups
- Women
- Elderly
- Federal Health Care Program
- Medicaid
- Medicare
Importance
- Describe why this topic is important.
Ischemic heart disease (IHD) is the most common, chronic, life-threatening illness in the United States. Sixteen million individuals have IHD, >9 million have angina pectoris, and >8 million have sustained a myocardial infarction (MI). The 2006 weighted national estimate of mean cost of PCI, based HCUP NIS data, was $16,089, and the estimated mean charge was $48,392. Given the significant cost of PCI, it is important to assess the effectiveness of PCI compared to OMT for stable angina to inform policy decisions.
- 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.)
We performed a best evidence review of published systematic reviews/meta-analyses and found that they arrive at different conclusions due to variations in scope and methodology. This creates confusion for clinicians, patients, and policy makers that may not understand why these reviews come to different conclusion. In addition, it impossible to determine if there are important differences in subgroups of patients based on demographic factors (e.g., age, sex, race) or indicators of adverse risk (e.g., recent myocardial infarction with or without subsequent angina, severity of coronary artery disease or number of vessels involved +/- left anterior descending artery) based on published information about the original randomized controlled trials. A rigorous meta-analysis that if free from potential conflicts of interest would be of value in settling current conflicting messages from prior meta-analyses. This may even require a patient level meta-analysis, especially to address questions about patient subgroups. Moreover, the interventions, PCI and OMT, have evolved over the years and this is difficult to account for without a patient level or a cumulative meta-analysis.
- Katritsis DG, Ioannidis JP. Percutaneous coronary intervention versus conservative therapy in nonacute coronary artery disease: a meta-analysis. Circulation. 2005 Jun 7;111(22):2906-12.
- Schomig A, Mehilli J, de Waha A, Seyfarth M, Pache J, Kastrati A. A meta-analysis of 17 randomized trials of a percutaneous coronary intervention-based strategy in patients with stable coronary artery disease. J Am Coll Cardiol. 2008 Sep 9;52(11):894-904.
- Katritsis DG, Ioannidis JP. PCI for stable coronary disease. N Engl J Med. 2007 Jul 26;357(4):414-5; author reply 7-8.
- Jeremias A, Kaul S, Rosengart TK, Gruberg L, Brown DL. The Impact of Revascularization on Mortality in Patients with Nonacute Coronary Artery Disease. Am J Med. 2009; 122; 152-161.
- 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:
See 1 above
Potential Impact
- How will an answer to your research question be used or help inform decisions for you or your group?
It will help resolve some of the uncertainty that existed after the best evidence review and put Medicaid policy-makers on stronger footing if they implement strategies to limit PCI and enhance OMT for patient with stable angina.
- Describe the timeframe in which an answer to your question is needed.
1-2 years
- Describe any health disparities, inequities, or impact on vulnerable populations your question applies to.
Answers to our questions will assist Medicaid programs in allocating scarce resource and potentially improve medical management of angina for a vulnerable population.
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)
It will help resolve some of the uncertainty that existed after the best evidence review and put Medicaid policy-makers on stronger footing if they implement strategies to limit PCI and enhance OMT for patient with stable angina.
- 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
