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Primary Care Today

Primary Care Today Educational Conference and Medical Exposition Toronto, Ontario / May 8-10, 2008. Adapted from a presentation by: Alan D. Bell, MD, MCFP Humber River Regional Hospital Toronto, Ontario.

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Primary Care Today

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  1. Primary Care Today Educational Conference and Medical ExpositionToronto, Ontario / May 8-10, 2008 Adapted from a presentation by: Alan D. Bell, MD, MCFP Humber River Regional Hospital Toronto, Ontario

  2. The Optimal Management of Diffuse Vascular Disease: Clinical Implications of the Landmark REACH Registry

  3. Program Rationale Atherothrombosis remains the leading cause of death worldwide accounting for 47% of North American Mortality In Canada there is one stroke every 10 minutes and 1 heart attack every 7 minutes Need for Canadian primary care physicians to learn more about the management of patients with diffuse vascular disease Suboptimal Risk Factor Management in C/V disease 42% of high risk atherothrombotic patients in REACH were not on evidence based risk reduction “triple therapy” 58% of Canadian high risk hypertensives NOT at goal BP in REACH were on fewer than 3 drugs

  4. Learning Objectives At the end of this session, participants should be able to: • Understand the epidemiology and burden of atherothrombosis • Understand the importance of registries and discuss the clinical implications of the REACH Registry • Describe the consequences of PAD and apply Canadian guidelines for the management of PAD • Identify patients with diffuse vascular disease and implement strategies for the prevention of atherothrombotic events in these patients REACH: Reduction of Atherothrombosis for Continued Health; PAD: peripheral arterial disease

  5. Question 1 Which of the following are typical characteristics a Registry? Registries examine the effects of a specific intervention Registries usually have more exclusion criteria compared to randomized trials Registries tell us about “real world” characteristics and outcomes Registry results are less reliable than randomized trial results All of the above 

  6. What is a Registry? • Organized system that collects data for scientific, clinical, or policy purposes • Complements RCTs by determining real-world outcomes • Generally do not: • Have restrictive inclusion or exclusion criteria • Specify what therapy the health care provider must adhere to • Often used to evaluate outcomes for diverse purposes: • Natural history of a disease • Real-world effectiveness of therapies, etc. RCTs: randomized controlled trials

  7. Example of a Registry:Framingham Heart Study • Started in 1948 • Objective:identify the common factors or characteristics that contribute to cardiovascular disease • 5209 men and women, ages 30-62, from Framingham, Massachusetts • Examinations every 2 years • Over 50 years of follow-up NHLBI. Framingham Heart Study. Available at: www.nhlbi.nih.gov/about/framingham Accessed January 22, 2008.

  8. Framingham Heart Study:Atherothrombosis Reduces Life Expectancy • In the FHS, healthy individuals aged 60 years who did not have atherothrombosis were expected to live a further 20 years to the age of 80 • Comparatively, patients with a history of MI lived 9.2 fewer years • Those with a history of CVA lived 12 fewer years 9.2Feweryears 20 12 Feweryears Life Expectancy (Years) CVA: cerebrovascular accident Adapted from Bakhai A. Pharmacoeconomics 2004;22(suppl 4):11-18.

  9. Framingham Heart Study:

  10. Cardiovascular Event Ratesin >68,000 Outpatients with AtherothrombosisRegistry Results

  11. REACH: Purpose • Describe the characteristics and management of patients at high risk of atherothrombosis with and without symptomatic manifestations in any vascular bed • Assess long-term risk of atherothrombotic events • Compare outcomes • Assess the amount of “cross-risk” • Assess the impact of “diffuse vascular disease” • Define predictors of risk Adapted from Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  12. At least of four criteria At least atherothrombotic risk factors Inclusion Criteria • Documented cerebrovascular diseaseIschemic stroke orTIA • Documentedcoronary diseaseAngina, MI, angioplasty/stent/bypass • Documented historicalor current intermittentclaudication associatedwith ABI* <0.9 • Male ³65 yearsor female ³70 years • Current smoking>15 cigarettes/day • Type I or II diabetes • Hypercholesterolemia • Diabetic nephropathy • Hypertension • ABI <0.9 in eitherleg at rest • Asymptomatic carotidstenosis ³70% • Presence of at leastone carotid plaque Must include Signed Written Informed Consent Patients aged ≥45 years 1 3 *ABI: Ankle Brachial Index Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  13. 1,976 REACH Registry: >67,000 Patients from 5,473 Sites* in 44 Countries 5,656 17,886 27,746 5,048 5,903 846 North America 1,931 Latin America Western Europe 2,872 Eastern Europe Middle East *up to 15 patients/site (up to 20 in the US) Asia (incl. Japan) Australia Adapted from Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  14. REACH Registry Timeline Dec 2003 to June 2004 June 2007 to June 2008 Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  15. What Does REACH Add to Our Current Understanding of Atherothrombosis? • Global registry • Stable outpatients • Large number of primary-care patients • Includes multiple risk factor andmanifest vascular disease patients in all 3 vascular beds • 4 years of follow-up Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  16. Published 11th Jan 2006: Bhatt DL, et al, for the REACH Registry Investigators. JAMA 2006;295(2):180-9. Baseline Data

  17. REACH:Significant Proportion of the Symptomatic Population has Diffuse Vascular Disease* Prevalence of disease in arterial beds (% of total) Single arterial bed: 65.9% CAD Alone 44.6 CVD Alone 16.6 PAD Alone 4.7 Diffuse vascular disease: 15.9% CAD: coronary artery disease PAD: peripheral arterial disease CVD: cerebrovascular disease CAD + CVD 8.4 CAD + PAD 4.7 CVD + PAD 1.2 CAD + CVD + PAD 1.6 Multiple risk factors: 18.3% 0 10 20 30 40 50 60 70 Patients (%) Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  18. REACH: Patient Characteristics at Baseline % of population Symptomatic(n=55,499) Total (n=67,888) Multiple RF only (n=12,389) Mean age (SD) yr 68.5 (10.1) 68.4 (10.1) 69.0 (9.8) Men 63.7 66.9 49.5 Diabetes 44.3 37.5 74.9 Hypertension 81.8 80.0 90.3 Hypercholesterolemia 72.4 70.2 82.2 Overweight (BMI 25 to < 30) 39.8 40.9 35.0 Obesity (BMI ≥ 30) 30.2 27.4 42.4 Former smoker 41.6 44.6 28.4 Current smoker 15.3 14.4 19.2 Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  19. Physician profile Follow-up available (%) N=63,129 General practice (N=24,441) 36.7 74.7 Internist (N=22,244) 32.8 12.3 Cardiologist (N=9,390) 14.0 9.7 Angiologist (N=771) 1.1 Vascular surgeon (N=1,480) 2.2 Neurologist (N=6,353) 9.4 3.2 Endocrinologist (N=1,987) 3.0 Other (N=533) 0.8 Physician Profile

  20. REACH: Risk Factors are Consistently Found Across All Disease Subpopulations* Risk factor prevalence, by subpopulation (%) 100 CAD population 83.3 CVD population 81 80.3 77.0 80 PAD population 66.7 58.2 60 Patients (%) 44.2 38.3 37.4 40 29.9 23.8 24.5 23.7 20 14.3 13.0 0 Treated Treated hyper- Treated diabetes Obesity(BMI ≥ 30) Current smoker hypertension cholesterolemia Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  21. Diffuse Vascular Disease • How often do patients have manifest disease in more than one vascular bed?

  22. 25% of the 40,258 patients with CAD also have atherothrombotic disease in other arterial territories (%s are of total population) Multiple risk factors only population Patients with CAD = 59.3% of the REACH Registry population CAD 44.6% 8.4% CVD 1.6% 4.7% CAD=coronary artery disease PAD=peripheral arterial disease CVD=cerebrovascular disease PAD • Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  23. 40% of the 18,843 patients with CVD also haveatherothrombotic disease in other arterial territories (%s are of total population) Multiple risk factors only population Patients with CVD = 27.8% of the REACH Registry population CAD 8.4% CVD 1.6% 16.6% 1.2% CAD=coronary artery disease PAD=peripheral arterial disease CVD=cerebrovascular disease PAD • Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  24. 60% of the 8,273 patients with PAD also haveatherothrombotic disease in other arterial territories (%s are of total population) Multiple risk factors only population CAD Patients with PAD = 12.2% of the total REACH Registry population CVD 1.6% 4.7% 1.2% CAD=coronary artery disease PAD=peripheral arterial disease CVD=cerebrovascular disease PAD 4.7% • Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

  25. 1-Year Outcomes

  26. REACH:1-year Event Curves for CV Death, MI, Stroke & Combined Endpoints 4.24% of these stable patients had an event within 1 year 5.0 n=64,977 4.5 Non-fatal stroke Non-fatal MI infarction 4.0 CV death/MI/stroke CV death 3.5 3.0 42% 10 year risk Event distribution function (%) 2.5 2.0 1.5 1.0 0.5 0.0 0 1 2 3 4 5 6 7 8 9 10 11 12 Time in months Steg PG et al, on behalf of the REACH Registry Investigators. JAMA 2007;297(11):1197-1206.

  27. REACH 1-year CV Event Rates: Symptomatic vs Multiple Risk Factor Only % of population Symptomatic(n=53,390) Total (n=64,977) Multiple RF only (n=11,766) Death all cause 2.6 2.8 1.5 CV death 1.7 1.8 0.8 Non-fatal MI 1.1 1.2 0.8 Non-fatal stroke 1.7 1.9 0.8 CV death/MI/stroke 4.2 4.7 2.2 CV death/MI/stroke/ hospitalization for atherothrombotic events* 12.8 14.4 5.3 *Such as TIA, unstable angina, worsening of PAD; adjusted for age and gender Steg PG et al, on behalf of the REACH Registry Investigators. JAMA 2007;297(11):1197-1206.

  28. 1-year cardiovascular event rates as function of number of symptomatic disease locations* All p values <0.001 *Pts with ³3 risk factors but no symptoms are counted as 0, even in the presence of asymptomatic carotid plaque or reduced ABI**TIA, unstable angina, other ischemic arterial event including worsening of peripheral arterial disease

  29. Other outcomes leading to hospitalization since baseline Total (N=63,129) Symptomatic (N=51,685) CAD (N=37,542) CVD (N=17,451) PAD (N=7,674) Multiple RF only (N=11,444) Unstable angina 4.2 4.9 6.3 3.4 4.5 1.1 TIA 1.4 1.5 1.2 3.2 1.8 0.6 Other ischemic arterial event (including worsening of PAD) 1.3 1.5 1.5 1.5 4.1 0.5 Chronic heart failure 3.1 3.4 4.2 3.2 4.1 1.4 Bleeding (leading to hospitalization and transfusion) 0.8 0.9 0.9 0.9 1.3 0.5

  30. Major adverse event rates at one year as a function of age: total population Rates adjusted for risk factors

  31. North America (N=25,302) Latin America (N=1,718) Western Europe (N=16,487) Eastern Europe (N=5,579) Middle East (N=818) Asia (N=5,559) Australia (N=2,822) Japan (N=4,844) CV death 1.4 1.8 1.5 2.2 2.4 1.5 1.5 0.7 Non-fatal MI 1.3 0.9 1.1 1.2 2.2 0.8 1.0 0.8 Non-fatal stroke 1.1 2.5 1.5 3.5 2.1 2.3 1.0 1.6 CV death/MI/ stroke 3.7 4.9 3.7 6.8 6.3 4.5 3.2 3.0 CV death/MI/ stroke/ hospitalization for atherothrombotic events* 11.4 13.6 14.2 21.6 18.0 10.0 11.3 6.3 Geographical Variation of 1-year Cardiovascular Event Rates *TIA, unstable angina, other ischemic arterial event including worsening of peripheral arterial disease

  32. Undertreatment of Risk Factors at Study Entry Bhatt DL, et al. JAMA 2006;295(2):180-9.

  33. Take-Home Messages • 1-year REACH results reveal: • High rate of CV death, MI, and stroke (4.24%) in this “stable” outpatient population • Similar risk factor profiles regardless of vascular bed involved • Significant proportion of symptomatic patients with diffuse vascular disease • Rates increase markedly with the number of symptomatic disease locations (CV death/MI/stroke) • 1.5% (risk factors only) • 7.1% (triple location)

  34. Atherothrombosis

  35. Atherothrombosis has Multiple Manifestations Ischemic stroke Transient ischemic attack (TIA) Myocardial infarction (MI) • Angina: • Stable • Unstable • Peripheral arterial disease (PAD): • Intermittent claudication Rest pain Gangrene Necrosis Adapted from Drouet L. Cerebrovasc Dis 2002;13(suppl 1):1–6.

  36. Atherothrombosis: A Generalized and Progressive Disease Atherosclerosis Unstable angina MI Ischemic stroke/TIA Critical leg ischemia Intermittent claudication CV death ACS Thrombosis Stable angina/Intermittent claudication Adapted from Libby P. Circulation 2001;104(3):365-372.

  37. What Types of Lesions Cause MI? Coronary stenosis severity prior to MI 100 100 14% 80 80 18% 60 60 68% Coronary Events (%) 40 40 20 20 0 0 Ambrose1988 Little1988 Nobuyoshi1991 Giroud1992 All 4studies <50% 50%-70% >70% Falk E et al. Circulation 1995;92:657-71.

  38. Pathology: Plaque Fissuring

  39. AIDS 5.1 Pulmonary disease 6 Injuries 9.1 Cancer 12.6 Infectious disease 17.8 Vascular Disease* is a Leading Cause of Death Worldwide† Leading Causes Of Death, Worldwide (% of all deaths) Vascular disease* 28.7 0 5 10 15 20 25 30 Mortality (%) *Ischemic heart disease, cerebrovascular disease, inflammatory heart disease and hypertensive heart disease †Worldwide defined as Member States by World Health Organization (WHO) Region (Africa, Americas, Eastern Mediterranean, European, South-East Asia and Western Pacific) AIDS: acquired immune deficiency syndrome WHO. 2002. Available at: www.who.int/whr/2002/en/whr02_en.pdf

  40. Atherothrombosis: Epidemiology Epidemiology of Atherothrombotic Manifestations in Canada

  41. Peripheral Arterial Diseaseand theCanadian PAD Guidelines

  42. Question 2 How common is peripheral arterial disease (PAD) in your practice? I hardly ever see it – It’s a specialist disease I have a few patient’s, but it’s much less common than coronary disease Since I’ve been screening for it I can’t believe how common it is! I don’t know, because I have no way to test for it I don’t look for it because none of my patients ever died of a “leg attack”

  43. PAD: Epidemiology • Often asymptomatic, under-diagnosed, under-recognized, and under-treated • 16% of North America and Europe has PAD, corresponding to 27 million people • Of these, 16.5 million are asymptomatic Gupta A. In: Abramson BL, et al. Can J Cardiol 2005;21(12):997-1006.

  44. CCS Guidelines: Diagnosis of PAD Roussin A, et al. Can J Cardiol. 2005;21(12):997–1006.

  45. Edinburgh Questionnaire • Do you get a pain or discomfort in you leg(s) when you walk? • YES • Does this pain ever begin when you are standing still or sitting? • NO • Do you get it when you walk uphill or hurry? • YES • Do you get it when you walk at an ordinary pace on level ground? • YES • What happens to it if you stand still? • Pain usually disappears in 10 minutes or less • Where do you get this pain or discomfort? • Patient marks calf and/or thigh and/or buttock 91.3% Sensitive 99.3% specific Leng GC, et al. J Clin Epidemiol. 1992;45:1101–1109.

  46. Right-arm systolic pressure Left-arm systolic pressure INTERPRETATION OF ABI >1.30 0.91-1.30 0.41-0.90 0.00-0.40 Noncompressible Normal Mild-to-moderate peripheral arterial disease Severe peripheral arterial disease DP PT DP PT Left-ankle systolic pressure Right-ankle systolic pressure Measuring ABI Adapted from Roussin A, et al. Can J Cardiol 2005;21(12):997-1006.

  47. Question 3 Which of the following are TRUE regarding symptomatic PAD? 30% will suffer a fatal vascular event within 5 years Ankle / Brachial Index (ABI) is sensitive and specific enough to make the diagnosis of PAD Severity of disease and mortality may be predicted by ABI Exercise programs can improve claudication symptoms All of the above 

  48. Consequences of PAD may be Local and Systemic • Local consequences in the leg include: • Intermittent claudication • Tissue loss including sepsis and major amputations • PAD is a marker of disease in other vascular beds • Fatal and non-fatal cerebral and coronary vascular events REACH: Reduction of Atherothrombosis for Continued Health

  49. Patients with Previous Atherothrombotic Events are at Increased Risk of Further Events * Sudden death defined as death documented within 1 hour and attributed to coronary heart disease (CHD). † Includes only fatal MI and other coronary heart disease (CHD) death; does not include non-fatal MI. 1. Kannel WB. J Cardiovasc Risk1994;1(4):333–339.; 2. Wilterdink JL, et al. Arch Neurol 1992;49(8):857–863. 3. Adult Treatment Panel II. Circulation 1994;89(3):1333–1363. 4. Criqui MH, et al. N Engl J Med 1992;326(6):381–386.

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