Cardiovascular Ischemic Event Rates in Outpatients With Symptomatic Atherothrombosis or Risk Factors in the United States: Insights From the REACH Registry Kim A. Eagle, Alan T. Hirsch, Robert M. Califf, Mark J. Alberts, P. Gabriel Steg, Christopher P. Cannon, Danielle M. Brennan, Deepak L. Bhatt, on behalf of the REACH Registry Investigators

Global REACH Registry: Study Design Information shown may differ slightly from the published trial design owing to a subsequent protocol amendment

Global REACH Registry Objectives Primary Objective: To explore the impact of both classic and new risk factors on the prevalence of cardiovascular (CV) ischemic events among patients with, or at high risk for, atherothrombotic disease, on an international basis Additional Aim: Assess use of risk management strategies and 1-, 2-, 3- and 4-year 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;151(4):786.e1-10.

Global REACH Registry Inclusion Criteria Documented cerebrovascular disease Ischemic stroke or TIA (CVD) Documented coronary disease Angina, MI, angioplasty/ stent/bypass (CAD) Documented historical or current intermittent claudication associated with ABI <0.9 (PAD) Male aged 65 years or female aged 70 years Current smoking >15 cigarettes/day Type 1 or 2 diabetes Hypercholesterolemia Diabetic nephropathy Hypertension ABI <0.9 in either leg at rest Asymptomatic carotid stenosis 70% Presence of at least one carotid plaque Must include: Signed written informed consent Patients aged ≥45 years At least of four criteria At least atherothrombotic risk factors 1 3 ABI, ankle-brachial index; MI, myocardial infarction; TIA, transient ischemic attack. 1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

Global REACH Registry Exclusion Criteria Anticipated difficulty in patient returning for follow-up visit Patient is currently hospitalized Patient is currently participating in a clinical trial 1. Bhatt DL et al, on behalf of the REACH Registry Investigators. JAMA 2006;295(2):180-189.

Global REACH Registry Timeline Baseline Follow-up at 12  3 months Follow-up at 24  3 months Follow-up at 33  3 months Follow-up at 45  3 months Timing* Dec 2003 to June 2004 From baseline time Last follow-up March 2006 June 2006 to June 2007 June 2007 to June 2008 Required Data Subject Data Form: Section 1 Subject Data Form: Section 2 (progression since baseline) Subject Data Form: Section 3 (progression since last follow-up) Subject Data Form: Section 4 Subject Data Form: Section 5 Patient details, history and clinical examination Regular medications Employment status Clinical outcomes Vascular interventions *Timelines are for worldwide participation; local timelines will be shorter

Global Physician Selection Participating physicians Pre-defined at start of Registry Based on local practice population General practitioners, specialists Mainly office-based, some hospital representation Representative of: Local environment Country geography How were they selected? What is their profile? 1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

Main Specialty Breakdown of US Practitioner Involvement (n=1,599) 3.5% GP or Internist 86.8% 9.7% Cardiologist Endocrinologist, Neurologist, Vascular Surgeon, Angioloist, Other Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

Global Patient Selection: Patients Fitting Inclusion Criteria Recruitment at each site Maximum 20 per site Within overall Registry timelines Patient inclusion criteria Documented atherothrombotic disease, or with ≥3 atherothrombotic risk factors Real-life setting How were they selected? What is their profile? 1. Ohman EM et al, on behalf of the REACH Registry Investigators. Am Heart J 2006;151(4):786.e1-10.

REACH Registry: US Baseline Results Data shown may differ slightly from published abstracts owing to a subsequent database lock

US Patient Characteristics at Baseline % of population Symptomatic (n=19,069) Total (n=25,686) Multiple RF only (n=6,617) Mean age (SD), yr 70.0 (10.4) 70.3 (10.4) 69.2 (10.3) Men 57.0 60.7 46.4 Diabetes 51.7 43.6 74.7 Hypertension 87.5 85.7 92.9 Hypercholesterolemia 82.6 80.7 87.8 Overweight (BMI ≥25, <30) 35.8 37.3 31.5 Obesity (BMI ≥30) 42.1 38.8 51.6 Former smoker 43.1 47.2 31.3 Current smoker 14.4 13.4 17.3 BMI, body mass index; RF, risk factors; SD, standard deviation. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Vascular Disease Profile CAD only (62%) CAD + CVD (11%) CVD only (15%) CVD + PAD (1%) PAD only (4%) PAD + CAD (6%) CAD + CVD + PAD (2%) Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Risk Factor Prevalence by Vascular Disease (%) CAD population 88.1 88.0 85.7 84.2 CVD population 79.1 PAD population 71.8 52.7 Patients (%) 44.1 44.4 39.8 35.8 35.2 21.4 14.3 12.5 Treated Treated Hyper- Treated Diabetes Obesity (BMI ≥30) Current Smoker Hypertension cholesterolemia Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Medication Use at Baseline % of population Symptomatic (n=19,069) Total (n=25,686) Multiple RF only (n=6,617) ≥1 Antihypertensive Agent 93.9 93.7 94.5 ≥1 Antiplatelet Agent 76.5 81.7 61.6 Any Antithrombotic Agent 85.1 91.3 66.9 ≥1 Antidiabetic Agent 47.0 38.9 70.6 ≥1 Lipid-Lowering Agent 83.9 82.8 86.9 Nitrates/Other Antiaginals 18.7 24.2 2.6 Claudication Medications 5.1 6.2 1.9 Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

US Medication Use by Vascular Disease (%) CAD population CVD population PAD population 94.8 92.5 93.1 91.8 91.9 90.0 86.4 83.2 80.9 81.6 77.7 73.5 Patients (%) 47.9 39.3 39.4 ≥1 Antihyper- tensive Agent ≥1 Antiplatelet Agent Any Antithrom- botic Agent ≥1 Antidiabetic Agent ≥1 Lipid-Lowering Agent Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

REACH Registry: US One-Year Follow-up Analysis Data shown may differ slightly from published abstracts owing to a subsequent database lock

Cumulative Event Rates for the US REACH Population Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

One-Year Outcomes for the US REACH Population 15.4 12.8 13.1 10.7 6.6 5.1 4.3 5.0 2.3 2.9 2.6 1.8 1.7 1.6 1.6 1.4 1.5 1.3 1.1 0.8 0.6 All values are adjusted for age and sex. Error bars represent 95% confidence intervals. Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

One-Year Outcomes for the US REACH Population by Vascular Disease All values are adjusted for age and sex. Error bars represent 95% confidence intervals. 25.8 23.0 20.5 21.1 17.2 18.1 11.9 9.7 14.2 9.9 11.8 10.9 12.2 8.6 5.0 8.1 6.1 6.5 6.8 4.0 3.0 5.5 3.0 2.2 4.0 5.0 1.6 3.3 3.0 3.7 1.1 3.3 3.7 2.6 2.8 2.3 2.3 1.5 1.9 2.5 2.3 0.7 1.7 1.3 0.7 1.5 1.4 0.7 0.8 Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

One-Year Outcomes for the US REACH Population by Ethnic Group All values are adjusted for age and sex. Error bars represent 95% confidence intervals. 14.4 14.0 12.7 12.2 10.7 12.9 11.4 10.6 5.1 4.6 4.4 4.2 2.4 2.4 2.0 2.4 1.7 1.5 2.6 1.9 1.6 1.1 1.1 1.4 1.3 1.6 1.5 1.3 Eagle KA et al, on behalf of the REACH Registry Investigators. Crit Pathw Cardiol 2009;8(2):XXX-XXX.

Participating organizations The REACH Registry is sponsored jointly by and endorsed by

For further information on the REACH Registry go to: http://www.REACHRegistry.org