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Examining the Treatment and Management of Ischemic Heart Disease in Women

Examining the Treatment and Management of Ischemic Heart Disease in Women. John E. Clark, PharmD, MS, FASHP. Clinical Consultant Clinical Pharmacare Solutions, LLC. Learning Objectives. Review the prevalence of ischemic heart disease (IHD) in the US

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Examining the Treatment and Management of Ischemic Heart Disease in Women

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  1. Examining the Treatment and Management of Ischemic Heart Disease in Women John E. Clark, PharmD, MS, FASHP. Clinical Consultant Clinical Pharmacare Solutions, LLC

  2. Learning Objectives • Review the prevalence of ischemic heart disease (IHD) in the US • Discuss economic impact of suboptimal diagnosis and management of IHD • Examine gender differences in clinical presentation and diagnosis of IHD • Identify limitations to the diagnosis and management of IHD • Review current and proposed IHD management strategies according to individual patient presentation

  3. ‡ Since 1984, Women Are the Majority Impacted by Cardiovascular Disease 550 500 450 Deaths in Thousands 450 350 79 80 85 90 95 00 06 Years Males Females CVD mortality trends for males and females (United States: 1979-2006). Source: NCHS. The overall comparability for CVD between the ICD/9 (1979-1998) and ICD/10 (1999-2006). No comparability rations were applied. Lloyd-Jones et al. Circulation. 2010;121:e46-215 ..

  4. ‡ Coronary Artery Disease in Men and Women *Severe CAD includes left main stenosis 50%, three-vessel disease with 70% stenosis or two-vessel disease including proximal left anterior descending stenosis of 70%. Kreatsoulas et al. J Intern Med. 2010;268:66-74.

  5. Angina Increases the Cost of CAD Care CAD Without Angina CAD With Angina Health Care Costs for Patients With Angina Are Twice as High Patients With Angina Were More Likely to Visit Emergency Room & Be Hospitalized Average Annual Cost per Patient, US$ Proportion of Patients During the Year Following Diagnosis, % $22,004 43% $11,530 27% 12% 10% Emergency Room Visits Hospitalizations This claims-based analysis consisted of 140,001 managed-care patients with CAD and 25,535 patients with a diagnosis of angina and multiple prescriptions of antianginal medications between 2001 and 2004. CAD = coronary artery disease. Kempf J, et al. Circulation. 2006;113:e810. Abstract P114.

  6. Ischemic Heart Disease in Women Is Associated with Significant US Healthcare Costs • Five year CV death or MI rates (P<0.0001) • Non-obstructive CAD: 4% • 3 Vessel CAD: 38% • Five year rates of hospitalization for angina (P<0.0001) • Non-obstructive CAD: 20% • 3 Vessel CAD: 55% Five-Year Cardiovascular Costs Shaw LJ, et al. Circulation. 2006; 114:894-904

  7. Women Have More Adverse Outcomes Compared to Men Angina ~2x  morbidity/mortality1 MI ~1.5x  1-year mortality1 CABG ~2x  morbidity/mortality2 CAD Heart failure ~2x  incidence1 1Pepine. J Am Coll Cardiol. 2004;43:1727-1730. 2Vaccarino et al. Circulation. 2002;105:1176-1181.

  8. Women with Ischemic Heart Disease • Women are more likely than men to have non chest pain symptoms of ischemic heart disease (IHD) • Angina is the predominant initial and subsequent presentation of IHD in women (versus MI, sudden death in men) • When presenting with initial MI, women are more likely than men to have had antecedent stable angina • Compared to men, women presenting with IHD • Older •  Hypertension, diabetes, heart failure •  Likelihood prior MI, myocardial revascularization • Population-based studies: comparable prevalence of stable angina in both women and men Wenger. Curr Cardiol Report. 2010;12(4):307-314.

  9. Chronic Stable Angina

  10. Chronic Angina Overview • Classic angina is characterized by discomfort or pain in the chest, jaw, shoulder, back, or arm • Anginal symptoms typically occur with exertion or psychological stress and are relieved by rest or nitroglycerin • There is increasing awareness that symptoms of ischemia frequently manifest differently in women, the elderly, and in patients with diabetes Alexander KP, et al. J Am Coll Cardiol. 1998;32:1657-1664; Ellis K, et al. Manual of Cardiovascular Medicine. 2nd ed. 2004; Gibbons RJ, et al. J Am Coll Cardiol. 2003;1-126; McSweeney JC, et al. Circulation. 2003;108:2619-2623.

  11. Burden of Chronic Angina in the U.S. • More than 10 million Americans have chronic angina1 • 500,000 new cases diagnosed per year • 213 per 100,000 annual incidence in > 30 year-age group2 • ~50% experience angina as the initial sign of CAD2 • ~50% of patients diagnosed with MI have prior angina2 • Angina post-revascularization is not uncommon2 • At 5 year follow-up point, > 25% of patients experience angina despite PCI and optimal medical therapy for CAD & angina3 1 Rosamond W, et al. Heart Disease and Stroke Statistics – 2009 Update. Circulation. 2009;117:e1-e161. 2 Gibbons RJ, et al.ACC/AHA 2002 guideline update for the management of patients with chronic stable angina. P5. Available at: http://acc.org/qualityandscience/clinical/guidelines/stable/stable_clean.pdf 3 Boden WE, et al.Optimal Medical Therapy with or without PCI for Stable Coronary Disease. N Engl J Med. 2007;356:1510.

  12. Symptoms of Chronic AnginaAffect Patient Activity • Patients with angina may curtail activity to avoid anginal episodes • Physical exertion & emotional stress trigger angina • Many patients consider angina a warning to slow down • Patients with CAD and anginal symptoms score lower on the angina pectoris QOL questionnaire than those without symptoms • Sedentary patients may have significant CAD but may not report anginal symptoms because of their lack of activity CAD = coronary artery disease; QOL = quality of life. Chestnut LG, et al. Med Decis Making. 1996;16:65-77; Maddox TM, et al. Arch Intern Med. 2008;168:1310-1316; Marquis P, et al. Eur Heart J. 1995;16:1554-1560.

  13. Symptoms Other Than Classic Anginal Chest Pain Are Common in Stable Ischemic Heart Disease • In addition to chest pain or discomfort, other symptoms of ischemia on exertion are common, including: • Shortness of breath • Fatigue, weakness • Lightheadedness • Diaphoresis • Nausea, indigestion • Symptoms of ischemia other than chest pain are referred to as anginal equivalents • Women, the elderly, and patients with diabetes are more likely to present with non-pain symptoms Alexander KP, et al. J Am Coll Cardiol. 1998;32:1657-1664; Ellis K, et al. Manual of Cardiovascular Medicine. 2nd ed. 2004; Gibbons RJ, et al. J Am Coll Cardiol. 2003;1-126; McSweeney JC, et al. Circulation. 2003;108:2619-2623.

  14. Pain Symptoms Occur at the End of the Ischemic Cascade Pain/Angina ECG   Diastolic Filling ST alterations Contraction Magnitude of Ischemia Systolic Dysfunction Relaxation Diastolic Dysfunction Biochemical Alterations 0 30 Stress Duration (sec) ECG = electrocardiogram. Adapted from Kern MJ. In: Braunwald’s Heart Disease. 7th ed. 2005.

  15. Contractility Oxygen Demand Heart Rate LV Wall Tension Systolic Pressure Volume Overload Myocardial Ischemia: Unbalanced Oxygen Supply and Demand Coronary Blood Flow Oxygen Supply Coronary Perfusion Pressure Coronary Vascular Resistance Ischemia External Compression Intrinsic Regulation LV = left ventricular. Kern MJ. In: Braunwald’s Heart Disease. 7th ed. 2005. Naik H, et al. In: Lilly L, ed. Pathophysiology of Heart Disease. 4th ed. Baltimore, MD: Lippincott, Williams & Wilkins; 2007:141-167.

  16. Angina Disease Severity Classification

  17. Angina Classification:The Canadian Cardiovascular Society Grading System www.ccs.ca. Accessed 5/8/11.

  18. Frequency of CCS Class Angina Symptoms According to Sex and Age Women with severe CAD (by angiography) were more likely to have CCS Class IV angina (56.7%) compared to men (47.8%), p<0.01 Kreatsoulas et al. J Int Med. 2010;268(1):66-74.

  19. Angina, Health Status, and 2-Year Survival Observational study of 5558 CAD patients to evaluate the prognostic utility of the Seattle Angina Questionnaire (SAQ) 2-Year Kaplan-Meier Survival Curves by Range of SAQ Physical Limitation Score 100 95 Survival, % 90 Severe Moderate Mild 85 Minimal p < 0.0001 80 0 6 12 18 24 Time (Months) SAQ scores were predictive of time to death throughout the 2-year follow-up period SAQ = Seattle Angina Questionnaire. Spertus JA, et al. Circulation. 2002;106:43-49.

  20. Diagnosis

  21. Women describe symptoms of exercise-induced ischemia differently than men In an analysis of 132 patients with evidence of ischemia on myocardial perfusion imaging, women reported more non–pain symptoms than men Men n = 94 Women n = 38 Most Common Non-pain Symptoms Reported by Women 76% Shortness of breath 67% Fatigue 52% 66% Tightness in chest 45% 55% Palpitations 26% 50% Weakness 23% 40% Diagnosis of Stable Ischemic Heart Disease May Be More Challenging in Women Than in Men D’Antono B, et al. Am Heart J. 2006;151:813-819.

  22. Hypothetical New Understanding of Ischemic Heart Disease in Women Shaw et al. J Am Coll Cardiol. 2009;54:1561-1575.

  23. Diagnostic Accuracy in Women of Non-Invasive Testing in Obstructive CAD 1Kwok et al. Am J Cardiol.1999;83:660-666. 2Cheitlin et al. J Am Coll Cardiol. 2003;42:954-970. 3Amanullah et al. Am J Cardiol. 1997;80:132-137. 4Di Carli et al. Circulation. 2007:115:1464-1480.

  24. ‡ Typical Angina Is Less Accurate and Precise At Indicating Coronary Artery Disease in Women* * Each value represent the percent  standard error of the per cent, calculated from the prevalence of angiographic coronary-artery disease in symptomatic patients and the prevalence of coronary-artery stenosis at autopsy. Diamond and Forrester. New Engl J Med. 1979;300:1350-1358.

  25. Assessment of Myocardial Ischemia and Obstructive Coronary Disease in Women • Utility of the Exercise ECG in Women • Up to 50% women cannot achieve >5 mets of exercise • Exercise ECG variables include – exertional chest pain, ST segment duration and treadmill time • Exercise capacity in an independent predictor of death in asymptomatic women Makaryus AN et al. Cardiology in Rieview 2007;15:279-287 In press . Leuzzi C. Nutr Metab Cardiovasc Dis 2010 .

  26. Outcomes

  27. Women Ischemic Syndrome Evaluation (WISE) Study CAD = coronary artery disease; NHLBI = National Heart, Lung and Blood Institute; NIH = Nationals Institutes of Health. Johnson BD, et al. Eur Heart J. 2006;27:1408-1415; Reis SE, et al. Am Heart J. 2001;141:735-741.

  28. WISE: Persistent Chest Pain in Women Predicts Future CV Events 1 N = 673 women with chest pain at baseline 0.9 Without CAD HR 1.89 (1.06–3.39)p = 0.03 Event-Free Survival, % 0.8 0.7 With CAD HR 1.17 (0.76–1.80)p = 0.49 0.6 0 1 2 3 4 5 6 Years From PChP Diagnosis (at 1 y) Neither PChPNo CAD No PChPCAD PChP CAD Women with no evidence of epicardial obstructive disease by angiography and persistent chest pain were at higher risk for future cardiovascular events HR = hazard ratio; PChP = persistent chest pain; WISE = Women Ischemic Syndrome Evaluation. Johnson BD, et al. Eur Heart J. 2006;27:1408-1415.

  29. ‡ Five Year Rates of Cardiovascular Outcomes:Asymptomatic Women versus Symptomatic Women CAD, coronary artery disease; CHF, congestive heart failure; CV, cardiovascular causes; MI, myocardial infarction; WISE, Women’s Ischemia Syndrome Evaluation: WTH, St James Women Take Heart Program aAdjusted for age, race, body mass index, systolic blood pressure, diabetes mellitus, education, employment, family history of CAD, smoking history, and the metabolic syndrome. bCompares the WTH cohort with the WISE cohort who had normal coronary arteries. cConsists of MI, hospitalization for heart failure, stroke, or cardiovascular death. dConsists of MI, hospitalization for heart failure, stroke, or death due to any cause. Gulati et al. Arch Intern Med. 2009;169(9):843-850.

  30. Management Strategies

  31. Treating Chronic Angina: What are the Goals? …the goal of treatment should be complete, or nearly complete, elimination of anginal chest pain and return to normal activities and a functional capacity of CCS class I angina … with minimal side effects of therapy. Gibbons RJ, et al. ACC/AHA 2002 Guideline Update for the Management of Patients with Chronic Stable Angina.

  32. Management of Chronic Stable Angina Lifestyle Intervention Prevent Death & MI Reduce Symptoms Revascularization Pharmacotherapy Evidence-based Therapies for Risk Reduction CAD = coronary artery disease. Gibbons RJ, et al. J Am Coll Cardiol.2003:1-126.

  33. Anti-ischemic Strategies for Managing Angina Initial Therapy Pharmacotherapy PCI CABG Persistent or Recurrent Ischemia Antianginal Drug Therapy(up-titrate/add additional agents) Repeat Revascularization (if possible) CABG = coronary artery bypass graft; PCI = percutaneous coronary intervention. Gibbons RJ, et al. J Am Coll Cardiol. 2003;41:159-168.

  34. Pharmacotherapy for Chronic Stable Angina • Disease-Modifying Therapies to Prevent MI and Death • Aspirin • Statins • ACE inhibitors/ARBs • Beta-blockers* • To Relieve Angina and Reduce Ischemia • Beta-blockers • Calcium channel blockers • Nitrates • *For patients with previous MI and/or LV dysfunction Smith SC Jr, et al. Circulation. 2006:113;2326-2372.Gibbons RJ, et al. ACC/AHA 2002 guidelines. www.acc.org/qualityandscience/clinical/guidelines/stable/stable_clean.pdf.

  35. Classes of Antianginal Drugs *Actions of the individual drugs in this class vary. Naik H, et al. In: Lilly L, ed. Pathophysiology of Heart Disease. 4th ed. Baltimore, MD: Lippincott, Williams & Wilkins;2007:141-167; Vadnais DS, Wenger NK. Clinical Medicine: Therapeutics. 2009;1:871-887.

  36. O2 Supply O2 Demand Coronary blood flow Heart rate Arterial pressure Venous return Myocardial contractility Therapy Beta-blockers DHP CCBs Non-DHP CCBs Long-acting nitrates Revascularization 1 / 2 2 2 2 Physiologic Effects of Antianginal Treatments / 1Less reflex tachycardia with amlodipine. 2Specific data not available. CCB = calcium channel blocker; DHP = dihydropyridine Bagger JP, et al. Cardiovasc Drugs Ther. 1997;11(3):479-484.Gibbons RJ, et al. ACC/AHA 2002 Chronic Angina Guidelines. 2003;41:159-168. Kerins DM, et al. In: Hardman JG, Limbird LE, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: The McGraw-Hill Companies; 2001:843-870. Lilly L, ed. Pathophysiology of Heart Disease. 4th ed. Baltimore, MD: Lippincott, Williams & Wilkins; 2007:141-167.

  37. ‡ Gender Differences in ClinicalManagement of Angina Daly et al. Circulation. 2006;113:490-498.

  38. Gender Differences in Clinical Management of Angina • Despite evidence and guidelines supporting risk reduction, women with obstructive CAD receive suboptimal treatment • Revascularization, and/or medical therapies • 30% of women with chest pain, normal angiogram, and endothelial dysfunction develop obstructive CAD during 10 year follow up2 • In addition to routine diagnostic testing, identification of compromised functional capacity and evidence of ischemia as markers of an adverse prognosis are also needed3 1Bugiardini et al. Curr Vasc Pharmacol 2010;8:276-284. 2Bugiardini et al. Circulation. 2004;109:2518-2523. 3Shaw et al. J Am Coll Cardiol. 2009;54:1561-1575.

  39. Under-diagnosis and Less Aggressive Treatment of Angina by Gender Clinical Management of Angina Pectoris by Gender Wenger NK, et al. Clin Pharmacol Ther. 2008; 83:37-51 Crilly M, et al. BMC Health Services Res. 2007;7:142

  40. Summary • Despite decreased prevalence of obstructive CAD, women are at greater risk of IHD than men • Women more commonly present with non chest pain symptoms of IHD • Differences in gender outcome and symptoms could be related to underlying pathology • Women are under-diagnosed with IHD and are more likely to receive suboptimal care

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