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The REACH Registry

The REACH Registry. An International, Prospective Observational Study in Subjects at Risk of Atherothrombotic Events in an Outpatient Setting. Outline. Background Burden of Disease Risk of Atherothrombosis REACH Registry Background Rationale and Objectives Design

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The REACH Registry

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  1. The REACH Registry An International, Prospective Observational Study in Subjects at Risk of Atherothrombotic Events in an Outpatient Setting

  2. Outline • Background • Burden of Disease • Risk of Atherothrombosis • REACH Registry Background • Rationale and Objectives • Design • REACH Registry Baseline Results • High Prevalence of Polyvascular Disease • Undertreatment of Patients with Atherothrombosis Worldwide • REACH Registry Today and Beyond • Publications to Date • Upcoming Analyses and Data Availability • Participating Organizations and Scientific Committees

  3. Background

  4. Burden of Disease

  5. Atherothrombosis – a Generalized and Progressive Disease Process1,2 Thrombosis UA MI Ischemic stroke/TIA Vascular death ACS Stable angina UA=unstable angina; MI=myocardial infarction; ACS=acute coronary syndrome; TIA=transient ischemic attack 1. Adapted from Libby P. Circulation 2001; 104: 365–372. 2. Drouet L. Cerebrovasc Dis 2002; 13(Suppl 1): 1–6.

  6. Major Role of Platelets in Atherothrombosis1 Normal platelets in flowing blood Platelets adhering to damaged endothelium and undergoing activation Aggregation of platelets intoa thrombus Platelet thrombus Platelets adhering to subendothelial space Platelets Endothelial cells Subendothelial space 1. Adapted from: Ferguson JJ. In: Ferguson JJ, Chronos N, Harrington RA (Eds). Antiplatelet Therapy in Clinical Practice. London: Martin Dunitz; 2000: 15–35.

  7. Major Manifestations of Atherothrombosis1 Cerebrovascular disease (Cerebrovasc Dis) Coronary artery disease (CAD) Peripheral arterial disease (PAD) 1. Viles-Gonzalez JF. Eur Heart J 2004; 25: 1197–1207.

  8. Cardiovascular Disease is the Leading Cause of Death Worldwide1 HIV/AIDS 5 Pulmonary disease 7 Injuries 9 Cancer 13 Infectious and parasitic diseases 19 Cardiovascular disease* 29 0 5 10 15 20 25 30 Percentage of total deaths in 2002 *Ischemic heart disease, cerebrovascular disease, hypertensive heart disease, inflammatory heart disease and rheumatic heart disease 1. The World Health Report 2004. WHO Geneva, 2004. Available at: http://www.who.int/whr/2004/en/. Accessed January 2006.

  9. Atherothrombosis Significantly Shortens Life Expectancy1 Analysis of data from the Framingham Heart Study:Average remaining life expectancy for males aged 60 years 7.7 years 9.2 years 12.0 years 20 16 12 Time (years) 8 4 0 Healthy History of any cardiovascular disease* History of acute MI History of stroke *Including coronary heart disease, cerebrovascular accident, congestive heart failure and intermittent claudication 1. Peeters A et al. Eur Heart J 2002; 23: 458466.

  10. Risk of Atherothrombosis

  11. 26.2%† Atherothrombosis is Often Found in More Than One Arterial Bed*1 Cardiovascular disease Cerebrovascular disease 7.4% 24.7% 29.9% 3.3% 3.8% 11.8% A total of ~26% of patients had manifestations of atherothrombosis in more than one arterial bed 19.2% PAD *Data from the Clopidogrel versus Aspirin in Patients at Risk of Ischemic Events (CAPRIE) study (n=19,185) †Total does not add up because of rounding 1. Coccheri S. Eur Heart J 1998; 19(Suppl): 227.

  12. Ischemic stroke 2–3 X (includes angina and sudden death*)1 9 X2 MI 5–7 X (includes death)3 3–4 X(includes TIA)1 PAD 4 X (includes only fatal MI and other CHD death†)4 2–3 X (includes TIA)2 Patients with Previous Atherothrombotic Events are at Increased Risk of Further Events Increased risk versus general population Stroke MI *Sudden death defined as death documented within one hour and attributed to coronary heart disease (CHD) †Includes only fatal MI and other CHD death; does not include non-fatal MI • Kannel WB. J Cardiovasc Risk 1994; 1: 333–339. • Wilterdink JI et al. Arch Neurol 1992; 49: 857–863. • Adult Treatment Panel II. Circulation 1994; 89: 1333–1363. • Criqui MH et al. N Engl J Med 1992; 326: 381–386.

  13. Risk Factors can Create High Risk of MI and Stroke, Even With No History of These Events1 Independent risk factors: • Male aged 65 yearsor female aged 70 years • Current smoking>15 cigarettes/day • Type 1 or 2diabetes • Hypercholesterolemia • Diabetic nephropathy • Hypertension • ABI <0.9 in eitherleg at rest • Asymptomatic carotidstenosis 70% • Presence of at leastone carotid plaque Increased risk of atherothrombotic events 1. Bhatt DL et al. Am Heart J 2004; 140: 263–268.

  14. Risk of CHD Increased in Patients with Multiple Risk Factors1 70 Men 60 Women 50 40 Estimated 10-year CHD rate (%) 30 20 10 0 0 1 2 3 4 5 6 Number of risk factors* *Risk factors: hypertension; hypercholesterolemia; dyslipidemia; diabetes; smoking; left ventricular hypertrophy 1. Kannel WB. Hypertens Res 1995; 18: 181–196.

  15. Many Risk Factors are Easily Identified1,2 1. Grundy SM. Am J Cardiol 2001; 88(Suppl): 8E11E. 2. Ferdinand KC et al. Curr Med Res Opin 2005; 21: 10911097.

  16. REACH Registry: Background

  17. REACH Registry: Rationale and Objectives

  18. REACH Registry: a Global Observational Study of around 68,000 Patients in 44 Countries Who Are at High Risk of Atherothrombosis1 • Rationale • Evaluation of atherothrombosis is still limited because previous surveys have: • Focused on studying specific risk factors, or ‘single’ manifestations of the disease (e.g. heart disease) • Focused mostly on hospitalized or hospital-treated patients with stringent inclusion criteria • Been conducted in either North America or Europe 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  19. REACH Registry: a Global Observational Study of around 68,000 Patients in 44 Countries Who Are at High Risk of Atherothrombosis1 • The REACH Registry should have these added advantages: • The most globally inclusive and geographically extensive registry of patients at high risk of heart attack and stroke • Includes a broad spectrum of patient types – with or without a previous history of disease • Provides data from a ‘real world’ setting, reflecting daily practice 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  20. REACH Registry: Objectives1 Primary objectives are: Compile international data set to extend knowledge of atherothrombotic risk factors and ischemic events in the outpatient setting Provide a better understanding of the prevalence and clinical consequences of atherothrombosis in a wide range of patients from different parts of the world Important intermediate investigations have included: Assess use of risk management strategies and 18- to 24-month outcomes in a broad outpatient population encompassing various geographic regions and physician specialties 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  21. Improving the Management of Cardiovascular Disease Risk Guideline recommendations by which REACH Registry patients are benchmarked 1. Pearson TA et al.Circulation 2002; 106: 388391. 2. De Backer G et al. Eur Heart J 2003; 24: 16011610. 3. American Diabetes Association. Diabetes Care 2005; 28: S4S36. 4. Adult Treatment Panel III. National Institutes of Health, Publication No. 02-5215, September 2002.

  22. What do we hope the REACH Registry will achieve? REACH is the most geographically and ethnically diverse atherothrombotic population yet surveyed, providing the most accurate view to date of burden of disease and long-term prognosis for patients at high risk for atherothrombotic events With up to four years of clinical follow-up, the REACH Registry will • provide long-term insights into real-world event rates, treatment patterns and outcomes • help to improve assessment and management of stroke, heart attack and associated risk factors

  23. REACH Registry: Design

  24. REACH Registry Timeline *Timelines are for worldwide participation; local timelines will be shorter

  25. REACH Registry Inclusion Criteria1 • Documented cerebrovascular diseaseIschemic stroke or TIA • Documentedcoronary diseaseAngina, MI, angioplasty/stent/bypass • Documented historicalor current intermittentclaudication associatedwith ABI <0.9 • Male aged 65 yearsor female aged 70 years • Current smoking>15 cigarettes/day • Type 1 or 2diabetes • Hypercholesterolemia • Diabetic nephropathy • Hypertension • ABI <0.9 in eitherleg at rest • Asymptomatic carotidstenosis 70% • Presence of at leastone carotid plaque Must include: Signed written informed consent Patients aged ≥45 years At least of four criteria At least atherothrombotic risk factors 1 3 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  26. REACH Registry Exclusion Criteria1 • Anticipated difficulty in patient returning for follow-up visit • Patient iscurrently hospitalized • Patient iscurrently participating in a clinical trial 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  27. Physician Selection: Reflection of Each Country’s Management of Cardiovascular Risk1 How were they selected? What is their profile? • Participating physicians • Pre-defined at start of Registry • Based on local practice population • General practitioners (GPs), specialists • Mainly office-based, some hospital representation • Representative of: • Local environment • Country geography 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  28. Patient Selection: Patients Fitting Inclusion Criteria1 How were they selected? What is their profile? • Patients • Recruitment at each site • Maximum per site determined at local level (subject to central guidelines) • Within overall Registry timelines • Patient inclusion criteria • Documented atherothrombotic disease, or with at least 3 atherothrombotic risk factors • Real-life setting 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  29. REACH Registry:Baseline Results Data shown may differ slightly from published abstractsowing to a subsequent database lock

  30. Aims of the Baseline Analysis1 • Aim: • To determine whether atherosclerosis risk factor prevalence and treatment would demonstrate comparable patterns in many countries around the world • Conclusion: • Classic cardiovascular risk factors are consistent and common, but are largely undertreated and undercontrolled in many regions of the world 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  31. REACH Registry: Conclusions From Baseline • Cardiovascular risk profiles are common and consistent across different geographic locations and patient types:1 • Treatment goals are consistently not achieved in all patient types worldwide • Established therapies are consistently underused in high-risk populations • Women are undertreated despite commonly having more severe disease2 • The REACH Registry patients with PAD have:3 • A high prevalence of concomitant disease in other vascular beds • Multiple risk factors for atherothrombosis, including pre-diabetes and undiagnosed diabetes • Underutilization of appropriate medications to treat cardiovascular risk • The REACH Registry patients with cerebrovascular disease have:4 • A high prevalence of multiple risk factors for atherothrombosis and disease in other vascular beds • Underutilization of appropriate medications 1. Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006; 295(2):180-189. 2. Steg PG et al. Eur Heart J 2005; 26(Suppl): Abstract 1642. 3. Bhatt DL et al. J Am Coll Cardiol 2005; 45(3 Suppl): Abstract 1127–1196. 4. Röther J et al. International Stroke Conference 2005; late breaking abstract.

  32. A Large and Far-Reaching International Survey of Atherothrombosis*1 • Asia: 10,951 • China: 708 • Hong Kong: 175 • Indonesia: 499 • Japan: 5,048 • Malaysia: 525 • Philippines: 1,039 • Singapore: 880 • South Korea: 505 • Taiwan: 1,057 • Thailand: 515 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. †Interlatina includes Panama, Costa Rica, Dominican Republic, Ecuador, Guatemala and Peru 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  33. Broad Geographic Representation*1 Geographic location of patients included in the initial analysis1 34.6% 40.8% 16.3% 4.2% 1.2% 2.8% *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  34. Age and Gender of the Symptomatic Baseline Population*1 Age and Gender, Symptomatic Population (years, % of symptomatic population)1 *Symptomatic refers to patients with documented CAD, Cerebrovasc Dis and/or PAD; data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  35. Classic Cardiovascular Risk Factors are Consistent and Common within the Symptomatic REACH Registry Baseline Population*1 Risk Factor Prevalence, Symptomatic Population (% of symptomatic population)1 *Symptomatic refers to patients with documented Coronary artery, Cerebro and/or Peripheral Arterial Disease; data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  36. Age and Gender of the Multiple Risk Factor Population at Baseline*1 Age and Gender, Multiple Risk Factor Population (years, % of MRF population)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  37. Classic Cardiovascular Risk factors are Consistent and Common within the Multiple Risk Factor REACH Registry Baseline Population*1 Risk Factor Prevalence, Multiple Risk Factor Population (% of MRF population)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  38. Primary Care Practitioners (GPs and internists) Formed the Majority of REACH Registry investigators REACH Registry Investigators by specialty (% of total)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Ohman EM et al, on behalf of the REACH Registry Investigators.Am Heart J 2006; in press.

  39. High Prevalence of Polyvascular Disease(Disease in More Than One Arterial Bed)

  40. ~ 1/4 of Patients with CADHave Polyvascular Disease1 ~ 1/4 of the 40,258 patients with CAD also have atherothrombotic disease in other arterial territories (%s are of total population)1 RISK FACTORS ONLY Coronary Artery Dis Patients with CAD = 59.3% of the REACH Registry population 44.6% 8.4% Cerebro-vascular 1.6% 4.7% Periph Art Disease 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  41. ~ 2/5 of Patients with Cerebrovascular Disease Have Polyvascular Disease1 ~ 2/5 of the 18,843 patients with Cerebrovascular Disease also haveatherothrombotic disease in other arterial territories (%s are of total population)1 RISK FACTORS ONLY Coronary Artery Dis Patients with Cerebrovasc Dis = 27.8% of the REACH Registry population 8.4% Cerebro-vascular 1.6% 16.6% 1.2% Periph Art Disease 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  42. ~ 3/5 of Patients with Symptomatic PADHave Polyvascular Disease1 ~ 3/5 of the 8,273 patients with PAD also have atherothrombotic disease in other arterial territories (%s are of total population)1 RISK FACTORS ONLY Coronary Artery Dis Patients with PAD = 12.2% of the total REACH Registry population Cerebro-vascular 1.6% 4.7% 1.2% Periph Art Disease 4.7% 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  43. A Large Minority had Polyvascular Disease in the REACH Registry*1 Prevalence of disease in arterial beds (% of total)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  44. Undertreatment of Patients with Atherothrombosis Worldwide

  45. Undertreatment of Risk Factorsin Patients Worldwide*1 Patients not achieving target (% of regional population)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  46. Established Therapies are Consistently Underused in All Patient Types*1 Patients not receiving therapy (% of subpopulation)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  47. High Prevalence of Overweight and Obesity in Most Regions*1 Variation of overweight and obesity in the symptomatic population**(% of regional population)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock; **Symptomatic refers to patients with documented CAD, Cerebrovasc Dis and/or PAD 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  48. Overweight and Obesity Highly Prevalent in Multiple Risk Factor Patients in Most Regions*1 Variation of Overweight and Obesity in the Multiple Risk Factor REACH Registry Population (% of regional population)1 *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  49. High Prevalence of Concomitant Risk Factors in Patients with Symptomatic PAD*1 Prevalence of risk factors in the PAD population(% of subpopulation)1 †Of the 8,273 patients with symptomatic PAD, the mean age was 69.2 years and 70.7% were male *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

  50. PAD Patients are Less Likely than Other Patients to Use Established Therapies*1 Patients receiving established therapy (% of patients)1 For antihypertensives, % is of pts diagnosed hypertension or elevated blood pressure at initial examination; For oral antidiabetics, % is of pts with history of diabetes or elevated blood glucose at initial examination *Data shown may differ slightly from published abstracts owing to a subsequent database lock. 1. Bhatt DL et al, on behalf of the REACH Registry Investigators.JAMA 2006; 295(2): 180-189.

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