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Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function
 

Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function

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  • Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function Case Summary: Angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II-receptor blockers (ARBs) are proven therapies that reduce morbidity and mortality in patients with left ventricular systolic dysfunction (LVSD) with   chronic heart failure,   and   have also shown   to reduce the progression of nephropathy in patients with   diabetes mellitus   and proteinuria. It is less clear how ACEIs contribute to the reduction of cardiovascular events in patients with stable IHD who also have preserved left ventricular systolic function (LVSF), as determined by a left ventricular ejection fraction (LVEF) >40%. These patients have relatively intact LVSF, yet may present with chest pain (angina pectoris) brought on by emotional or physical stress. These symptoms are usually due to one or more clogged or diseased arteries that result in reduced blood flow and oxygen supply to the heart. Therapies shown to reduce the risk for cardiovascular events in IHD patients include aspirin, statins, beta-blockers, and dual anti-platelet therapy. Other agents used for symptomatic relief include nitrates and calcium channel blockers (CCB). A revascularization procedure to circumvent or treat a blocked vessel is another therapeutic option for patients unresponsive or intolerant to these medications. A patient will need prolonged treatment with these medications to reduce anginal symptoms, increase quality of life, and reduce the risk of fatal and nonfatal cardiovascular events. A comparative effectiveness review was conducted to synthesize the evidence surrounding the additional cardiovascular benefits from adding ACEIs and/or ARB therapy to the long-term care regimens of stable IHD patients with intact LVSF, and if those benefits outweigh the potential side effects of these drugs. This case study will seek to evaluate ACEIs and/or ARBs in stable ischemic heart disease patients with preserved LVSF. References:   Garg R and Yusuf S. Collaborative Group on ACE Inhibitor Trials. Overview of randomized trials of angiotensin-converting enzyme inhibitors on mortality and morbidity in patients with heart failure. JAMA 1995;273:1450-6. Available at: http://www.ncbi.nlm.nih.gov/pubmed/7654275. Survival of Myocardial Infarction Long-Term Evaluation (SMILE) Study Investigators. The effect of the angiotensin-converting enzyme inhibitor zofenopril on mortality and morbidity after anterior myocardial infarction. N Engl J Med 1995;332:80-5. Available at: http://www.ncbi.nlm.nih.gov/pubmed/7990904. TRAndolapril Cardiac Evaluation (TRACE) Study Group. A clinical trial of the angiotensin-converting-enzyme inhibitor trandolapril in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 1995;333:1670-6. Available at: http://www.ncbi.nlm.nih.gov/pubmed/7477219. Cohn JN, Tognoni G, for the Valsartan Heart Failure Trial Investigators. A Randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001;345:1667-75. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11759645. McMurray JJ, Ostergren J, Swedberg K, for the CHARM Investigators. Effects of candesartan in patients with chronic heart failure and reduced left-ventricular systolic function taking angiotensin-converting-enzyme inhibitors: the CHARM-Added trial. Lancet 2003;362:767-71. Available at: http://www.ncbi.nlm.nih.gov/pubmed/13678869. Pfeffer MA, Swedberg K, Granger CB, for the CHARM Investigators. Effects of candesartan on mortality and morbidity in patients with chronic heart failure: the CHARM-Overall programme. Lancet 2003;362:759-66. Available at: http://www.ncbi.nlm.nih.gov/pubmed/13678868. Pfeffer MA, McMurray JJ, Velazquez EJ, for the Valsartan in Acute Myocardial infarction Trial Investigators. Valsartan, captopril, or both in myocardial infarction complicated by heart failure, left ventricular dysfunction, or both. N Engl J Med 2003;349:1893-906. Available at: http://www.ncbi.nlm.nih.gov/pubmed/14610160. Pitt B, Poole-Wilson PA, Segal R, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomized trial: the Losartan Heart Failure Survival Study (ELITE II). Lancet 2000;355:1582-7. Available at: http://www.ncbi.nlm.nih.gov/pubmed/10821361. Brenner BM, Cooper ME, De Zeeuw D et al. Effect of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001;345:861-9. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11565518. Lewis EJ, Hunsicker LG, Bain RP, Rohde RD. The effect of angiotensin-converting-enzyme inhibition on diabetic nephropathy. The Collaborative Study Group. N Engl J Med 1993;329:1456-62. Available at: http://www.ncbi.nlm.nih.gov/pubmed/8413456. Parving HH, Lehnert H, Br ö chner-Mortensen J, Gomis R,Andersen S, Arner P; Irbesartan in Patients with Type 2 Diabetes and Microalbuminuria Study Group. The effect of irbesartan on the development of diabetic nephropathy in patients with type 2 diabetes. N Engl J Med 2001;345:870-8. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11565519. Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease. Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335. Bhatt AB, Stone PH. Current strategies for the prevention of angina in patients with stable coronary artery disease. Curr Opin Cardiol. Sep 2006;21(5):492-502. Available at: http://www.ncbi.nlm.nih.gov/pubmed/16900014. Brugts JJ, Danser AH, de Maat MP, et al. Pharmacogenetics of ACE inhibition in stable coronary artery disease: steps towards tailored drug therapy. Curr Opin Cardiol. Jul 2008;23(4):296-301. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18520711. Jawad E, Arora R. Chronic stable angina pectoris. Dis Mon Sep 2008;54(9):671-689. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18725007 .
  • Case Overview Patient is a 55-year old male with a history of stable ischemic heart disease. He had a percutaneous coronary intervention (PCI) with a stent to the left anterior descending (LAD) coronary artery six months ago. He has a history of hypertension. He is currently asymptomatic. His current medication regimen includes aspirin 81 mg po daily, simvastatin 80 mg po daily, clopidogrel 75 mg po daily, and metoprolol 50 mg po daily.
  • Physical Examination On physical examination, the patient has a blood pressure of 138/85 mm Hg, his heart rate is 65 bpm, his lungs are clear to auscultation, and his heart exam reveals a normal S1 and S2, no S3 or S4 gallop, and a 1/6 early systolic ejection murmur present in the right upper sterna border. An echocardiogram obtained two months ago for auscultation of a systolic murmur revealed mild aortic sclerosis but no significant valvular pathology.   The ejection fraction was 50-55% with mild hypokinesis of the distal anterior wall. His LDL-C was 65 mg/dl, Cr 1.1 mg/dl, and potassium 4.2 mmol/L.
  • Clinical Decision Considering that the patient ’ s history of stable ischemic heart disease puts him at risk for future recurrent cardiac events and after considering current evidence and guidelines, is it reasonable to consider adding an ACEI to this patient's standard medical therapy? Discussion of answers: Correct. The updated metaanalysis in the CER titled, Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease supports the addition of an ACEI to the regimen of this patient to help lower his risk of future recurrent cardiovascular events. In addition, ACC/AHA guidelines on management of patients with chronic stable angina also suggest use of ACE inhibitors [Class IIa recommendation with level of evidence (B)] as a reasonable option in a patient like this. Incorrect. According to available evidence and updated guidelines, the addition of an ACEI to the regimen of this patient is a reasonable consideration at this time. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335. Fraker TD Jr, Fihn SD, for the 2002 Chronic Stable Angina Writing Committee. 2007 chronic angina focused update of the ACC/AHA 2002 guidelines for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines Writing Group to develop the focused update of the 2002 guidelines for the management of patients with chronic stable angina. J Am Coll Cardiol . 2007;50:2264-74. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18061078.
  • Pharmacologic Effects of Antagonists on the Renin-Angiotensin-Aldosterone System Despite standard therapy, patients with stable ischemic heart disease and preserved left ventricular systolic function continue to be at risk for future cardiovascular events. The Renin-Angiotensin-Aldosterone System (RAAS) is critical for regulating blood pressure, electrolyte balance, and fluid volume homeostasis and plays a pivotal role in the pathogenesis of hypertension, congestive heart failure, and diabetic nephropathy. Pharmacological antagonists of this system include angiotensin-converting enzyme inhibitors (ACEIs) and angiotensin II-receptor blockers (ARBs). These drugs block adverse effects of the RAAS by blocking the activity of angiotensin II through different mechanisms: ACEIs act on the RAAS by blocking the conversion of angiotensin I into angiotensin II and inhibiting the breakdown of bradykinin, which is a potent vasodilator. ARBs block the angiotensin II type-1 receptor and reduce the pharmacologic effects of angiotensin II, regardless of whether angiotensin II is created by the angiotensin-converting enzyme or by pathways independent of this enzyme. ACEIs and ARBs may potentially provide several pharmacological effects over and above that of blood pressure reduction alone, which may impact cardiovascular events. Through angiotensin II type-1 receptors, angiotensin II may have these potentially harmful activities: Induction of aldosterone production, which can cause sodium retention and increased fluid retention that may lead to increased blood pressure. Increased aldosterone production, which can lead to pathogenic remodeling (i.e., atherosclerosis and fibrosis). Constriction of blood vessels, which can lead to increased blood pressure. Potential reduction in the availability of nitric oxide through the production of free radicals and the induction of endothelial dysfunction that may impact endothelial wall integrity. References: Ceconi C, Fox KM, Remme WJ, et al, for the EUROPA Investigators and the PERTINENT Investigators and the Statistical Committee. ACE inhibition with perindopril and endothelial function. Results of a substudy of the EUROPA study: PERTINENT. Cardiovasc Res 2007;73:237-46. Available at: http://www.ncbi.nlm.nih.gov/pubmed/17140552 . Faxon DP, Fuster V, Libby P, et al, for the American Heart Association. Atherosclerotic Vascular Disease Conference: Writing Group III: pathophysiology. Circulation 2004;109:2617-25. Available at: http://www.ncbi.nlm.nih.gov/pubmed/15173044 . Schmidt-Ott KM, Kagiyama S, Philips I. The multiple actions of angiotensin II in atherosclerosis. Regul Pept 2000;93:65-77. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11033054 . Song JC, White CM. Pharmacologic, pharmacokinetic, and therapeutic differences among angiotensin II receptor antagonists. Pharmacotherapy 2000;20:130-9. Available at: http://www.ncbi.nlm.nih.gov/pubmed/10678291 . Song JC, White CM. Clinical pharmacokinetics and selective pharmacodynamics of new angiotensin-converting enzyme inhibitors: an update. Clin Pharmacokinet. 2002;41:207-24. Available at: http://www.ncbi.nlm.nih.gov/pubmed/11929321 . Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18. (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I.) Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Harmful Activities of Angiotensin II Through the stimulation of angiotensin II type-1 receptors, angiotensin II may have several potentially harmful activities including: Discussion of answers: Incorrect. Harmful effects of angiotensin II include those described in a,b,c, and d. Incorrect. Harmful effects of angiotensin II include those described in a,b,c, and d. Incorrect. Harmful effects of angiotensin II include those described in a,b,c, and d. Incorrect. Harmful effects of angiotensin II include those described in a,b,c, and d. Correct. Angiotensin II can have all of these harmful effects. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Discussion: Treatment You suggest that this patient consider the possibility of adding an ACEI to his current regimen. You review with him a guide titled, “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease, from the Effective Health Care Program website at: effectivehealthcare.ahrq.gov. (update when available). You explain to him that the guide is based on a review of multiple studies about the medicine for patients with his condition. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov. Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Discussion: Informed Decisionmaking To help the patient make an informed decision about adding an ACEI or an ARB, you: Discussion of answers: Incorrect. While the statement is true, this action is incomplete. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action. Incorrect. While the statement is true, this action is incomplete. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action. Incorrect. While the statement is true, this action is incomplete. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action. Incorrect. While the statement is true, this action is incomplete. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action. Incorrect. While the statement is true, this action is incomplete. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action. Correct. Shared decisionmaking involves a discussion with the patient about benefits and harms, and where available, the associated probabilities of those outcomes, combined with the individual patient ’ s health status and personal preferences, in order to weigh the options and find an agreed course of action.   References : Briss P, Rimer B, Reilley B, Coates RC, et. al. Promoting informed decisions about cancer screening in communities and healthcare systems. Am J Prev Med 2004; 26(1), 67 – 80. Available at: http://www.ncbi.nlm.nih.gov/pubmed/14700715. Sheridan SL, Harris RP, Woolf SH. Shared decision making about screening and chemoprevention: A suggested approach from the U.S. Preventative Services Task Force. Am J Prev Med 2004; 26(1), 56 – 66. Available at: http://www.ncbi.nlm.nih.gov/pubmed/14700714.
  • Patient Discussion: Potential Benefits of ACEIs You explain that current research shows there is good evidence that adding an ACEI to his usual care may offer him: Discussion of answers: Incorrect. ACEIs reduce the risk of mortality, nonfatal myocardial infarction, as well as heart failure-related hospitalizations. Incorrect. ACEIs reduce the risk of mortality, nonfatal myocardial infarction, as well as heart failure-related hospitalizations. Incorrect. ACEIs reduce the risk of mortality, nonfatal myocardial infarction, as well as heart failure-related hospitalizations. Correct. According to the CER titled, Comparative Effectiveness of Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease, there is high level evidence that the addition of ACEI to standard therapy for these patients reduces risk of mortality (absolute risk reduction (ARR) = 1.1, 13% relative risk reduction (RRR), and number needed to treat (NNT) = 91), nonfatal myocardial infarction (ARR = 1.1, 17% RRR, and NNT = 91), and heart failure-related hospitalizations (ARR = 0.6, 22% RRR, and NNT = 167). Additionally, adding an ACEI to the standard therapy of a stable ischemic heart disease patient with preserved left ventricular systolic function reduces their relative risk of having future revascularizations by 10% (ARR = 1.3 and NNT = 77). References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Discussion: Potential Benefits of ACEIs In explaining the evidence of benefits, the patient asks, “ So if I take this, I won ’ t have another heart attack? ” You:   Discussion of answers: Incorrect. The evidence of outcome should be discussed when available so that the patient understands the benefits and harms, and where available, the associated probabilities of those outcomes. Using a pictograph may be helpful in communicating numerical concepts. Incorrect. The evidence of outcome should be discussed when available so that the patient understands the benefits and harms, and where available, the associated probabilities of those outcomes. Using a pictograph may be helpful in communicating numerical concepts. Correct. The evidence of outcomes should be discussed when available so that the patient understands the benefits and harms, and where available, the associated probabilities of those outcomes. Using a pictograph may be helpful in communicating numerical concepts. Incorrect. The evidence of outcome should be discussed when available so that the patient understands the benefits and harms, and where available, the associated probabilities of those outcomes. Using a pictograph may be helpful in communicating numerical concepts. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov . Zikmund-Fisher BJ, Ubel PA, Smith DM, Derry HA, et. el. Communicating Side Effects in a Tamoxifen Prophylaxis Decision Aid: The Dibiasing Influence of Pictographs. Patient Educ Couns. 2008 November: 73(2) 209-214. Available at: http://www.ncbi.nlm.nih.gov/pubmed/18602242.
  • Patient Discussion: Potential Harms of ACEIs You then discuss the possible risks of adverse effects from taking an ACEI, so that the patient can weigh the benefits and harms with you to determine an appropriate decision. You explain that research has found that he may experience:   Discussion of answers: Incorrect. The addition of ACEIs to standard therapy for stable ischemic heart disease patients increases the risk for syncope, cough, and hyperkalemia. Incorrect. According to available research, the risk of hypotension is similar with ACE inhibitor therapy vs. placebo in patients with stable ischemic heart disease. Incorrect. The addition of ACEIs to standard therapy for stable ischemic heart disease patients increases the risk for syncope, cough, and hyperkalemia. Incorrect. According to available research, ACE inhibitors reduce the need for future revascularizations better than placebo in patients with stable ischemic heart disease. Correct. There is low level evidence that the addition of an ACEI to standard therapy for patients with stable ischemic heart disease increased their risk of syncope, cough, and hyperkalemia. However, adverse event reporting was not consistent across trials. Several trials included pre-randomization run-in periods where candidates who were intolerant to the study drug were excluded. This may limit the applicability of the harms data for the overall stable ischemic heart disease population. Nonetheless, the frequency of these adverse events was relatively low across all trials evaluated: syncope (2.1%), cough (15%), and hyperkalemia (5.7%). Angioedema occurred at a rate of 0.1% in the trials evaluated and is a potentially serious adverse event. A 2007 AHRQ review of ACEIs and ARBs states that angioedema, a rare but potentially serious reaction, had been reported in several studies. Patients who are or may become pregnant while taking ACEIs or ARBs should also be made aware of the risk of birth defects caused by these drugs. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335. Matchar DB, McCrory DC, Orlando LA, Patel MR, Patel UD, Patwardhan MB, Powers B, Samsa GP, Gray RN. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors (ACEIs) and Angiotensin II Receptor Antagonists (ARBs) for Treating Essential Hypertension . Comparative Effectiveness Review No. 10. (Prepared by Duke Evidence-based Practice Center under Contract No. 290-02-0025.) Rockville, MD: Agency for Healthcare Research and Quality. November 2007. Available at: http://www.effectivehealthcare.ahrq.gov/reports/final.cfm.
  • Shared Decisionmaking: Considering Patient Values In reviewing the decision with the patient to add an ACEI to their standard therapy, you: Discussion of answers: Incorrect. While this answer is true, it is not the only answer that you would give in this situation to help the patient make an informed decision. Incorrect. While this answer is true, it is not the only answer that you would give in this situation to help the patient make an informed decision. Incorrect. While this answer is true, it is not the only answer that you would give in this situation to help the patient make an informed decision. Incorrect. While this answer is true, it is not the only answer that you would give in this situation to help the patient make an informed decision. Correct. Helping the patient make an informed decision involves a discussion of the possible benefits in comparison to the potential adverse events in relation to the patients values and lifestyle. References: Briss P, Rimer B, Reilley B, Coates RC, et. al. Promoting informed decisions about cancer screening in communities and healthcare systems. Am J Prev Med 2004; 26(1), 67 – 80. Available at: http://www.ncbi.nlm.nih.gov/pubmed/14700715 . Sheridan SL, Harris RP, Woolf SH. Shared decision making about screening and chemoprevention: A suggested approach from the U.S. Preventative Services Task Force. Am J Prev Med 2004; 26(1), 56 – 66. Available at: http://www.ncbi.nlm.nih.gov/pubmed/14700714.
  • Patient Discussion At this point in the discussion you explain to him that this medication is being given in order to reduce the risk of future cardiac events even further than if he was only taking his usual medication. You counsel the patient to call you immediately if he experiences any of the adverse effects such as swelling of the lips or mouth area, which could indicate the patient has developed angioedema. You give him his own copy of the consumer guide titled, “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease, to take home with him to review and keep these important adverse effects in mind. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov. Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Discussion: Other Treatments The patient points out that the guide refers to drugs called ARBs as well as ACEIs. He mentions that if taking an ACEI is good, why are you not prescribing an ARB as well as an ACEI? Discussion of answers: Incorrect. The addition of a combination of ACEI/ARB to standard therapy for patients with stable ischemic heart disease has no clinical benefits and is associated with increased harms. Incorrect. Results from the ONTARGET trial indicate that ACEIs do not significantly differ from ARBs in any measured clinical outcome. Correct. Available evidence indicates there are no clinical benefits and a significant increase in harms for an ACEI/ARB combination in this patient population. Incorrect. Available evidence indicates there are no clinical benefits and a significant increase in harms for an ACEI/ARB combination in this patient population. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov. Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Discussion The patient asks about the source of the information that you have given him, and you explain it is a summary of a large analysis done at a university that included many studies on the benefits and harms of adding an ACEI and/or ARB to standard therapies for patients with stable ischemic heart disease and preserved LVSF. This information was summarized in a way that would allow patients to make decisions with their doctors regarding their course of treatment. You counsel him to take this guide ( “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease ) home to share with his family, refer to it from time to time to remind him why he's taking the drugs, and refer to it for descriptions of the adverse effects. After this discussion, you and your patient determine that the decreased risk of nonfatal heart attack, stroke, and death are worth the risk of possibly getting a cough, high levels of potassium, or suddenly fainting. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Treatment Decision Considering the patient ’ s values and his decision that the benefits outweigh the risk of harms in his situation, what do you decide to start him on? Discussion of answers: Correct. ACEIs are the only choice here that would be indicated in this patient at this time. Incorrect. Only an ACEI would be indicated in this patient at this time. Incorrect. Only an ACEI would be indicated in this patient at this time. Incorrect. Only an ACEI would be indicated in this patient at this time. References: Coleman CI, Baker WL, Kluger J, et al . Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Adverse Events from ACEIs This patient is sent home with his medications and the consumer summary guide ( “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease), which he can continue to refer to in the event of questions. In six weeks, he returns to your office with a dry persistent cough that keeps him up at night. He has been referring to the the consumer summary guide and wonders if there are any other drugs he can take to help him. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov. Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Followup After reviewing the evidence presented in the Clinician's Guide titled, Adding ACEIs and/or ARBs to Standard Therapy for Stable Ischemic Heart Disease: Benefits and Harms , which medication is an acceptable alternative for a patient with stable ischemic heart disease with preserved left ventricular systolic function who is intolerant to an ACEI? Discussion of answers: Incorrect. Beta-blockers, aspirin, and alpha-blockers are not acceptable alternatives to an ACEI. Correct. Evidence from the TELMISARTAN trial indicates that a majority of patients who were intolerant to ACEIs were intolerant due to cough. These patients were then started on an ARB that turned out to be an acceptable alternative. Incorrect. Beta-blockers, aspirin, and alpha-blockers are not acceptable alternatives to an ACEI. Incorrect. Beta-blockers, aspirin, and alpha-blockers are not acceptable alternatives to an ACEI. References: Adding ACEIs and/or ARBs to Standard Therapy for Stable Ischemic Heart Disease: Benefits and Harms . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-3. May 2010. Available at: http:// www.effectivehealthcare.ahrq.gov . Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Followup: Potential Benefits of ARBs Upon further review of the consumer guide with the patient, you discuss with him the potential benefits of taking an ARB which are: Discussion of answers: Correct. Evidence suggests that ARBs can lower the composite risk of cardiovascular mortality, nonfatal myocardial infarction, or stroke better than placebo (12% relative risk reduction, number needed to treat = 56; absolute risk reduction = 1.8). Incorrect. Evidence suggests that ARBs can lower the composite risk of cardiovascular mortality, nonfatal myocardial infarction, or stroke better than placebo. Incorrect. Evidence suggests that ARBs can lower the composite risk of cardiovascular mortality, nonfatal myocardial infarction, or stroke better than placebo. Incorrect. Evidence suggests that ARBs can lower the composite risk of cardiovascular mortality, nonfatal myocardial infarction, or stroke better than placebo. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Patient Followup: Potential Harms of ARBs The patient asks you about the adverse effects of taking an ARB. After reviewing the clinician guide, you inform him that there is only low level evidence available about patients such as himself who are taking an ARB due to intolerable adverse effects from ACEIs. Taking an ARB may increase his risk of what? Discussion of answers: Correct. There is low level evidence indicating that patients who are intolerant to ACEIs may have a higher risk of hyperkalemia when they start on an ARB. Incorrect. In stable ischemic heart disease patients with preserved LVSF who were started on an ARB due to ACEI intolerance, there was an increased incidence of hyperkalemia compared to the placebo group. Incorrect. In stable ischemic heart disease patients with preserved LVSF who were started on an ARB due to ACEI intolerance, there was an increased incidence of hyperkalemia compared to the placebo group. Incorrect. In stable ischemic heart disease patients with preserved LVSF who were started on an ARB due to ACEI intolerance, there was an increased incidence of hyperkalemia compared to the placebo group. References: Coleman CI, Baker WL, Kluger J, et al. Comparative Effectiveness of Angiotensin-Converting Enzyme Inhibitors or Angiotensin II-Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease . Comparative Effectiveness Review No. 18 (Prepared by the University of Connecticut/Hartford Hospital Evidence-based Practice Center under Contract No. 290-2007-10067-I). Rockville, MD: Agency for Healthcare Research and Quality; October 2009. Available at: http://effectivehealthcare.ahrq.gov/index.cfm/search-for-guides-reviews-and-reports/?pageaction=displayproduct&productID=335.
  • Closing Remarks After discussing the potential benefits and the small risk of adverse effects, and considering his experience with the ACEI, you decide to start him on the ARB and schedule him a followup visit. After reviewing the consumer summary guide again with him, you remind him of the benefits and potential harms of taking an ARB. Once he is comfortable with this decision, you remind him to refer to the guide he has when he has questions regarding his treatment. In his next regularly scheduled visit, you will review his medications and ask him about any symptoms and any further questions he may have. References: “ ACE Inhibitors ” and “ ARBs ” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease . Rockville, MD: Agency for Healthcare Research and Quality. AHRQ Pub. No. 10-EHC002-A. May 2010. Available at: http://www.effectivehealthcare.ahrq.gov.

Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function Presentation Transcript

  • Management of the Patient with Stable Ischemic Heart Disease and Preserved Left Ventricular Systolic Function Prepared for: Agency for Healthcare Research and Quality (AHRQ) www.ahrq.gov
    • Patient is a 55-year old male with a history of stable ischemic heart disease.
    • He S/P: percutaneous coronary intervention (PCI) with a stent to the left anterior descending (LAD) coronary artery six months ago.
    • His past medical history is significant for hypertension.
    • His current medication regimen includes:
      • Aspirin 81 mg po daily
      • Simvastatin 80 mg po daily
      • Clopidogrel 75 mg po daily
      • Metoprolol 50 mg po daily
    • ROS: He is currently without chest pain, dyspnea at rest or with exertion, or any anginal equivalents.
    Case Overview
    • Initial exam:
      • BP is 138/85 mm Hg
      • HR 65 bpm
      • Lungs are clear to auscultation
      • Heart exam reveals:
        • A normal S1 and S2
        • No S3 or S4 gallop present
        • A 1/6 early systolic ejection murmur present in the right upper sterna border
    • Lab results:
      • Echocardiogram (2 months ago):
        • Obtained for auscultation of a systolic murmur revealed mild aortic sclerosis but no significant valvular pathology
        • Ejection fraction of 50-55% with mild hypokinesis of the distal anterior wall
      • LDL-C was 65 mg/dl, Cr 1.1 mg/dl, and potassium 4.2 mmol/L
    Physical Examination
    • Considering that the patient’s history of stable ischemic heart disease puts him at risk for future recurrent cardiac events and after considering current evidence and guidelines, is it reasonable to consider adding an ACEI to this patient's standard medical therapy?
    • Yes
    • No
    Clinical Decision
  • Pharmacologic Effects of Antagonists on the Renin-Angiotensin-Aldosterone System Angiotensinogen Angiotensin I Angiotensin II Kininogen Bradykinin Inactive Ceconi C, et al. Cardiovasc Res 2007;73:237-46; Faxon DP, et al. Circulation 2004;109:2617-2625; Schmidt-Ott KM, et al. Regul Pept 2000; 93:65-77; Song JC, White CM. Pharmacotherapy 2000;20:130-9; Song JC, White CM. Clin Pharmacokinet 2002;41:207-24; Coleman CI, et al. AHRQ Comparative Effectiveness Review No. 18. October 2009. Angiotensin-converting enzyme Renin Kallikrein Kininase II Angiotensin-converting enzyme inhibitor Angiotensin II-receptor blocker Angiotensin II Type I Receptors Stimulatory signal Reaction Inhibitory pharmacologic effect LEGEND
    • Through the stimulation of angiotensin II type-1 receptors, angiotensin II may have several potentially harmful activities including:
    • Induction of aldosterone production, which can cause sodium retention and increased fluid retention that, in turn, leads to an increase in blood pressure.
    • Increased aldosterone production, which can possibly lead to promotion of pathogenic remodeling (i.e., atherosclerosis and fibrosis).
    • Constriction of blood vessels, which can lead to increased blood pressure.
    • Potential reduction in the availability of nitric oxide through the production of free radicals and the induction of endothelial dysfunction.
    • All the above.
    Harmful Activities of Angiotensin II
    • You suggest to this patient that they discuss the possibility of adding an ACEI to his current medications.
    • In order to do this, you review with him a patient guide titled, “ ACE Inhibitors” and “ARBs” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease , from the Effective Health Care Program website at: http://effectivehealthcare.ahrq.gov.
    • You explain to him that the guide is based on a review of multiple studies about specific medications for patients with stable ischemic heart disease.
    Patient Discussion: Treatment
    • To help the patient make an informed decision about adding an ACEI or an ARB, you:
    • Tell the patient about the evidence of the benefits and harms for ACEI , or of ARBs if you suspect he is intolerant to ACEI
    • Discuss the evidence in light of the patient’s personal medical history, current lab results, and examination findings
    • Discuss the impact that adding an additional medication would have on the patient’s lifestyle, ensuring that the patient would adhere to the regimen
    • Discuss the cost of the medication and the impact the additional cost might have on the patient, ensuring that the cost of the medication might not impact adherence
    • Discuss the likelihood of benefits and adverse effects, if they are known, and incorporate his personal preferences into weighing the individual benefits and risks when agreeing on a course of action
    • All of the above
    Patient Discussion: Informed Decisionmaking
    • You explain that current research shows there is good evidence that adding an ACEI to his usual care may offer him:
    • Reduced risk of mortality
    • Reduced risk of nonfatal myocardial infarction
    • Reduced risk of heart failure-related hospitalizations
    • All the above
    Patient Discussion: Potential Benefits of ACEIs
    • In explaining the evidence of benefits, the patient asks, “If I take this, I won’t have another heart attack?” You:
    • Agree with him and write the prescription.
    • Caution him that the studies are generalized and that the evidence may not apply to his specific case.
    • Show him the pictograph in the consumer guide titled, “ ACE Inhibitors” and “ARBs” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease , of the evidence concerning the modest likelihood of benefit so that he can see the probability of facing a fatal heart attack with or without the medicine. Review the likelihood of the other benefits using the same pictograph as a model.
    • Explain to him that the likelihood of benefit is minimal, and that taking an ACEI may not make that much of a difference.
    Patient Discussion: Potential Benefits of ACEIs
    • You then discuss the possible risks of adverse effects from taking an ACEI, so that the patient can weigh the benefits and harms with you to determine an appropriate decision. You explain that research has found that he may experience:
    • Nothing
    • Hypotension 
    • Hypertension
    • Need for future revascularizations
    • Syncope, cough, and hyperkalemia
    Patient Discussion: Potential Harms of ACEIs
    • In reviewing the decision with the patient to add an ACEI to their standard therapy, you:
    • Discuss the likelihood of benefit this medication would have for this patient.
    • Discuss the likelihood of adverse events this medication might have for this patient.
    • Discuss the impact that adding an additional medication would have on the patient’s lifestyle, ensuring that the patient would adhere to the regimen.
    • Discuss the cost of the medication and the impact the additional cost might have on the patient, ensuring that the cost of the medication might not impact adherence.
    • All of the above.
    Shared Decisionmaking: Considering Patient Values
    • At this point in the discussion you explain to him that this medication is being given in order to reduce the risk of future cardiac events even further than if he was only taking his usual medication.
    • You counsel the patient to call you immediately if he experiences any of the adverse effects such as swelling of the lips or mouth area, which could indicate the patient has developed angioedema.
    • You give him his own copy of the consumer guide titled, “ ACE Inhibitors” and “ARBs” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease , to take home with him to review and keep these important adverse effects in mind.
    Patient Discussion
    • The patient points out that the guide refers to drugs called ARBs as well as ACEIs. He mentions that if taking an ACEI is good, why are you not prescribing an ARB as well as an ACEI?
    • You realize he is correct and add an ARB to his prescription. 
    • Because ACEIs have been proven to be significantly better than ARBs. 
    • The risks of taking a combination of ACEI/ARB outweigh the benefits for patients with stable ischemic heart disease and preserved LVSF. 
    • None of the above.
    Patient Discussion: Other Treatments
      • The patient asks about the source of the information that you have given him, and you explain it is a summary of a large analysis done at a university that included many studies on the benefits and harms of adding an ACEI and/or ARB to standard therapies for patients with stable ischemic heart disease and preserved LVSF.
      • This information was summarized in a way that would allow patients to make decisions with their doctors regarding their course of treatment.
      • You counsel him to take this guide (“ ACE Inhibitors” and “ARBs” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease ) home to share with his family, refer to it from time to time to remind him why he's taking the drugs, and refer to it for descriptions of the adverse effects.
      • After this discussion, you and your patient determine that the decreased risk of nonfatal heart attack, stroke, and death are worth the risk of possibly getting a cough, high levels of potassium, or suddenly fainting.
    Patient Discussion
    • Considering the patient’s values and his decision that the benefits outweigh the risk of harms in his situation, what do you decide to start him on?
    • ACE Inhibitor
    • Alpha-blocker
    • Telmisartan
    • ACE Inhibitor + ARB
    Treatment Decision
    • This patient is sent home with his medications and the consumer summary guide “ ACE Inhibitors” and “ARBs” To Protect Your Heart? A Guide for Patients Being Treated for Stable Coronary Heart Disease ), which he can continue to refer to in the event of questions.
    • In six weeks, he returns to your office with a dry persistent cough that keeps him up at night.
    • He has been referring to the consumer summary guide and wonders if there are any other drugs he can take to help him.
    Adverse Events from ACEIs
    • After reviewing the evidence presented in the Clinician's Guide titled, Adding ACEIs and/or ARBs to Standard Therapy for Stable Ischemic Heart Disease: Benefits and Harms , which medication is an acceptable alternative for a patient with stable ischemic heart disease with preserved left ventricular systolic function who is intolerant to an ACEI?
    • Beta-blocker 
    • ARB 
    • Aspirin
    • Alpha-blocker
    Patient Followup
    • Upon further review of the consumer guide with the patient, you discuss with him the potential benefits of taking an ARB which are:
    • Decreased risk of one or more of the following: cardiovascular mortality, nonfatal myocardial infarction, or stroke. 
    • Decreased rate of angina-related hospitalizations.
    • Decreased risk of blood dyscrasias.
    • Decreased risk of new atrial fibrillation.
    Patient Followup: Potential Benefits of ARBs
    • The patient asks you about the adverse effects of taking an ARB. After reviewing the clinician guide, you inform him that there is only low level evidence available about patients such as himself who are taking an ARB due to intolerable adverse effects from ACEIs. Taking an ARB may increase his risk of what?
    • Hyperkalemia.  
    • Cough.
    • Cardiovascular-related mortality.
    • Revascularization.
    Patient Followup: Potential Harms of ARBs
    • After discussing the potential benefits and the small risk of adverse effects, and considering his experience with the ACEI, you decide to start him on the ARB and schedule him a followup visit.
    • After reviewing the consumer summary guide again with him, you remind him of the benefits and potential harms of taking an ARB.
    • Once he is comfortable with this decision, you remind him to refer to the guide he has when he has questions regarding his treatment.
    • In his next regularly scheduled visit, you will review his medications and ask him about any symptoms and any further questions he may have.
    Closing Remarks