1. Morteza Naghavi, M.D. Society for Heart Attack Prevention and Eradication (SHAPE) Detection and Treatment of Asymptomatic Atherosclerosis for Primary Prevention of CVD SHAPE 2012 Summit AHA 2012 Satellite Symposium November 2, 2012 Cedars Sinai Medical Center Los Angeles, California

5. http://www.theheart.org/article/1459893.do

6. The Problem

7. > 15 Million Heart Attacks Each Year Source: World Heart Federation The AEHA 2005 VP Summit

8. Unpredicted

9. In >50% of victims, the first symptom of asymptomatic atherosclerosis is a sudden cardiac death or acute MI.

10. Men Women 010203040506070 Patients Diagnosed with CHD (%) Murabito et al Circulation 1993 Sudden Cardiac Death or Acute MI as Initial Presentation of CHD 62% 42%

11. Of 136,905 patients hospitalized with CAD, 77% had normal LDL levels below 130 mg/dl Modified from Sachdeva et al. AHJ, Vol 157, 111-117 Jan 2009 Chapter 1: Preventive Cardiology; the SHAPE of the Future in Naghavi et al. Asymptomatic Atherosclerosis: Pathophysiology, Detection and Treatment. Humana Press, 2009

12. Modified from Sachdeva et al. AHJ, Vol 157, 111-117 Jan 2009 Chapter 1: Preventive Cardiology; the SHAPE of the Future in Naghavi et al. Asymptomatic Atherosclerosis: Pathophysiology, Detection and Treatment. Humana Press, 2009 Of 136,905 patients hospitalized with CAD, 45.4% had normal HDL levels above 40 mg/dl

13. Of 136,905 patients hospitalized with CAD, 61.8% had normal triglyceride levels below 150 mg/dl Modified from Sachdeva et al. AHJ, Vol 157, 111-117 Jan 2009 Chapter 1: Preventive Cardiology; the SHAPE of the Future in Naghavi et al. Asymptomatic Atherosclerosis: Pathophysiology, Detection and Treatment. Humana Press, 2009

14. Slide Source: Lipids Online www.lipidsonline.org 1998 – 2002. 222 patients with 1 st acute MI, no prior CAD, no DM. Men <55 y/o (75%), Women <65. 40% hypertensive 10 yr risk >20% Goal LDL<100 mg/dL (optional < 70 mg/dL) 6% 12% 8% 10% 18% 61% 9% 70% would qualify for statin Rx % of total would not qualify for statin Rx 10 yr risk 10 - 20% Goal LDL<130 mg/dL (optional < 100 mg/dL) 10 yr risk <10% Goal LDL<160 mg/dL High Risk Lower / Moderate RiskModerately High Risk What was NCEP risk before the MI? Would they have received statin therapy or more intensive statin therapy? 75% would not qualify for statin Rx. Traditional Risk Factors Miss the Majority of High Risk Patients Akosah et al. JACC 2003:41 1475-9

15. Relying on risk factors of atherosclerosis (i.e. cholesterol & blood pressure) mislead physicians and patients. A direct assessment of atherosclerosis is needed. CONCLUSION:

16. Sir Winston Churchill, 91 Sir Winston Churchill, 91  Jim Fixx, 53  Jim Fixx, 53  Who Has More Cardiovascular Risk Factors?

17. Philip Alexander Poole-Wilson death with 66 years March 4, 2009 Two weeks after Update in Cardiology In Davos Helmut Drexler death with 58 years Unexpected Sudden Death of Famous Cardiologists

18. Status Quo IS Unacceptable Bottom Line:

19. CVD Genotyping? Naghavi et al. Circulation. 2003;108:1664 ~50% Apparently Healthy People (New) ~50% CHD Patients (Recurrent)

20. CVD Genotyping? Naghavi et al. Circulation. 2003;108:1664 ~50% Apparently Healthy People (New) ~50% CHD Patients (Recurrent)

21. Naghavi et. al. Circulation Journal Vol108, No14; October 7, 2003 The Vulnerable Patient Consensus Statement Preceding the SHAPE Initiative

22. Naghavi et. al. Circulation Journal Vol108, No14; October 7, 2003 The Vulnerable Patient Consensus Statement Preceding the SHAPE Initiative

23. First SHAPE Symposium

24. SHAPE Task Force Meeting

25. SHAPE Guidelines Published

27. Existing Guidelines (Status Quo): Screen for Risk Factors of Atherosclerosis Treat Risk Factors of Atherosclerosis The SHAPE Guidelines: Screen for Atherosclerosis (the Disease) Regardless of Risk Factors Treat based on the Severity of the Disease and its Risk Factors SHAPE v.s. Status Quo

30. Based on the paper by Pepe e. al. Am J Epidemiol 2004; 159:882-890. ROC Curve, its AUC and Corresponding Odds Ratio hs-CRP LDL HDL Smoking Hypertension Diabetes etc. Risk Factors

32. Based on the paper by Pepe e. al. Am J Epidemiol 2004; 159:882-890. ROC Curve, its AUC and Corresponding Odds Ratio hs-CRP LDL HDL Smoking Hypertension Diabetes etc. CAC +FRS IMT+FRS Structural Risk Factors

34. Based on the paper by Pepe e. al. Am J Epidemiol 2004; 159:882-890. ROC Curve, its AUC and Corresponding Odds Ratio hs-CRP LDL HDL Smoking Hypertension Diabetes etc. CAC +FRS IMT+FRS Structural Risk Factors Combined structural & functional?

37. 1: No history of angina, heart attack, stroke, or peripheral arterial disease. 2: Population over age 75y is considered high risk and must receive therapy without testing for atherosclerosis. 3: Must not have any of the following: Chol>200 mg/dl, blood pressure >120/80 mmHg, diabetes, smoking, family history, metabolic syndrome. 4: Pending the development of standard practice guidelines. 5: High cholesterol, high blood pressure, diabetes, smoking, family history, metabolic syndrome. 6: For stroke prevention, follow existing guidelines.

38. Very Low Risk 2 CACS =0 Intermediate Risk 2 CACS 100-399 &<75th% High Risk CACS  400 or  75th% SHAPE II Guidelines– Under Discussions Step 1 Step 2 Step 3 Calculate 10yr Risk using Risk Calculators such as Framingham Risk Score 1 Diabetics >40yr or family history of premature coronary artery disease Optional 10y Risk <6% 10yr Risk >20% 10y Risk 6%-20% Coronary Artery Calcium Scan (CACS) Atherosclerosis Test Carotid IMT & Plaque CIMT <75 th % or Plaque<1.5mm CIMT >75th% and (or?) Plaque>1.5mm No test: Follow Preventive Recommendations as in High Risk No test: Follow Preventive Recommendations as in Low Risk 2 Elevate to High Risk if 1.4<Ankel Brachail Index <0.9 1 http://www.framinghamheartstudy.org/risk/hrdcoronary.html Low Risk 2 CACS <100 &<75 th % +++++ <160 mg/dl <130 mg/dl <100 mg/dl <75 mg/dl No RXRx Intensive RX Diet,Exercise, Smoking Cessation, BP and Diabetes Control Consider LDL Target Consider HDL and TG Rx See the SHAPE II Task Force report for further cardiac imaging tests in selected High Risk individuals.

39. Coronary Artery Calcium Score (CACS) or Carotid Plaque Burden 0 Carotid Plaque Carotid Plaque Lowest Tertile Carotid Plaque Highest Tertile Carotid Plaque Middle Tertile Carotid Plaque CACS 100-399 &<75 th % CACS>400 or >75 th % Lowest Risk Low Risk High Risk Intermediate Risk SHAPE II Guidelines– Under Discussions

40. Some of the Members of the SHAPE Task Force (left to right): Drs Budoff, Falk, Rumberger, Naghavi, Fayad, Hecht, and Berman

41. Current National Preventive Care Reimbursement Policies Do Not Match the Burden of the Problem Inadequate & Disproportionate

43. Why do we screen for asymptomatic cancers but ignore asymptomatic CVD?

44. <$100 for # 1 killer >$1000 for # 2 Killer

48. Number (per year) Estimated Impact of SHAPE (Sensitivity Analysis Range) Estimated Change in Cost CVD Deaths910,600↓10% (5%-25%) ($1.2 b) MI (prevalence)7,200,000↓ 25% (5%-35%) ($18.0 b) Chest Pain Symptoms (ER visits)6,500,000↓ 5% (2.5%-25%) ($4.1 b) Hospital Discharge for Primary Diagnosis of CVD6,373,000↑ 10% (5%-25%) $3.8 b Hospital Discharge for Primary Diagnosis of CHD970,000↓ 10% (5%-25%) ($9.9 b) Cholesterol Lowering Therapy↑ 50 % (50%-65%) 8.00 b CV Imaging8,700,000↑ 10% (5%-25%) $358 m Angiography6,800,000↑ 15% - CTA (2.5%-25%) $600 m PCI (percutaneous coronary interventions per year)657,000↓ 10% (5%-50%) ($580 m) CABS (coronary artery bypass surgeries per year)515,000↓ 5% (2.5%-50%) ($672 m) Total Δ in Cost ($21.5 b) Cost Effectiveness of the SHAPE Guidelines

50. poly pills

51. WWW.SHAPESOCIETY.ORG

52. The 1 st SHAPE Textbook Released at the ACC 2010