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Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors and/or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Patients With Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function

Slides: 25–29 of 29
This slide summarizes the seven trials that were evaluated in the Comparative Effectiveness Review (CER) to assess the benefits and harms of adding an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II-receptor blocker (ARB) to standard medical therapy, as opposed to standard medical therapy alone, in patients with stable ischemic heart disease who are in close proximity to a revascularization procedure. The patient population in these trials ranged from small (n = 91) to moderate (n = 2,553) in size. Typically, ACEIs were administered within a week after a revascularization procedure (as listed in the slide); in one trial, an ARB was given within 7 to 14 days before coronary stenting. In many of these trials, these treatment modalities were chosen to assess their impact on restenosis after these revascularization procedures. For detailed information on these trials, refer to the original comparative effectiveness review available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.

Characteristics of Trials Evaluating the Addition of an ACEI or an ARB to Standard Medical Therapy (SMT) Versus SMT Alone Close to a Revascularization Procedure

Overall, there was no significant clinical benefit to the addition of an ACEI or an ARB to standard medical therapy close to a revascularization procedure with regard to total mortality, cardiovascular mortality, nonfatal myocardial infarction, stroke, the composite of the previous three outcomes, atrial fibrillation, angina-related hospitalizations, or heart failure-related hospitalizations. The strength of this evidence was rated “low-moderate” in the comparative effectiveness review. Additionally, there was evidence of an increase in adverse events. The seven clinical trials assessed in this analysis revealed that hypotension increased 5.5% in the control group and 12% of those taking ACEIs. Additional revascularization procedures were needed in 11% of the patients who started an ACEI or an ARB close to a revascularization procedure and in 6% of those who initiated only standard medical therapy.

Analysis of Trials That Tested the Addition of an ACEI or an ARB to Standard Medical Therapy (SMT) Versus SMT Alone Close to a Revascularization Procedure

The decision to add an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) to the standard treatment regimen for patients with stable ischemic heart disease (IHD) and preserved left ventricular systolic function should be considered on a case-by-case basis by both the attending physician and the patient. This chart summarizes the benefits and harms associated with therapies that include ACEIs, ARBs, or both. For a detailed analysis of the benefits of adding an ACEI or ARB to standard medical therapy, see the complete comparative effectiveness review available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335. 

*In reviewing the benefits and harms listed in the table:

 

An important point to consider is that while many of the trials included in these analyses reported harms data, adverse event reporting was not consistent across the trials. Additionally, several trials included a prerandomization run-in period, during which candidates who could not tolerate the trial drug were excluded. This may limit the applicability of the harms data to the entire IHD population. For specific details on trials that were evaluated, please refer to the original comparative effectiveness review, on which this slide talk is based (available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productid=334).

 

Note: Angioedema, a rare but potentially serious reaction, has been reported in several trials. Patients who are or may become pregnant while taking an ACEI or an ARB should be made aware of the risk of birth defects caused by these drugs.

This information is taken from the 2007 report, Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBS) for Treating Essential Hypertension, written by the Duke Evidence-Based Practice Center and funded by AHRQ. The report can be viewed at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=45&returnpage=.

Identifying Trade-offs for Your Patients: Summary of Results on Comparative Effectiveness of Adding ACEIs and/or ARBs to Standard Medical Therapy

In the trials that this Comparative Effectiveness Review (CER) was based on, only a few had detailed subanalyses of disease or patient characteristics that correlated with the improved patient outcomes derived from adding an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) to the treatment regimen of patients with stable ischemic heart disease (IHD) and preserved left ventricular systolic function (LVSF). In addition, harms data were not available for many of the subpopulation analyses. Therefore, this evidence should be used mainly to generate hypotheses. From the subpopulation analyses, it is clear that more evidence is needed to determine whether there are patient characteristics or clinical factors that can determine whether patients with stable IHD and preserved LVSF will benefit more or less from the addition of an ACEI or an ARB to their standard therapies. Gender, diabetic status, the presence or absence of hypertension, the presence or absence of specific concomitant therapies, or a patient’s history of revascularization are all potential factors that may play a role in responsiveness to ACEIs or ARBs. Additional meta-analyses and clinical trials are needed to determine the benefits and harms of ACEIs and ARBs to these different subpopulations of patients.

Gaps in Knowledge About ACEIs and ARBs as Treatment for Stable Ischemic Heart Disease With Preserved Left Ventricular Systolic Function

Deciding to add an angiotensin-converting enzyme inhibitor (ACEI) or and angiotensin II-receptor blocker (ARB) to your patient’s treatment regimen is a small but important part of the relationship between you and your patient who has stable ischemic heart disease with preserved left ventricular systolic function.

Steps in the Informed Decisionmaking Process for Adding an ACEI or an ARB to Standard Medical Therapy for Stable Ischemic Heart Disease With Preserved Left Ventricular Systolic Function

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