1. IHS SDPI COMPETITIVE GRANT PROGRAM CVD RISK REDUCTION DEMONSTRATION PROJECT WHAT IS THE EVIDENCE? HOW ARE WE DOING? HOW CAN WE DO BETTER? Karl Hammermeister, MD January 11, 2005 1

2. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 2

3. WHAT IS CVD RISK REDUCTION? REDUCING MAJOR VASCULAR EVENTS – ACUTE CORONARY SYNDROMES ACUTE MYOCARDIAL INFARCTION UNSTABLE ANGINA – CORONARY REVASCULARIZATION – STROKE & TIA – CEREBRAL REVASCULARIZATION – ACUTE LIMB ISCHEMIA AND AMPUTATION – AORTIC AND PERIPHERAL REVASCULARIZATION PROCEDURES 3

4. CVD RISK FACTORS REVERSIBLE RISK FACTORS – Smoking – Hypertension – Dyslipidemia – Sedentary life style – Diabetes? NON-REVERSIBLE RISK FACTORS – Genes – Age – Gender NOVEL RISK FACTORS – Infection/Inflammation (c-reactive protein) – Homocysteine 4

5. DROP IN CAD MORTALITY Unal B, et al. Circulation 2004;109:1101-1107 5

6. MECHANISMS OF IMPROVED OUTCOMES: I Unal B, et al. Circulation 2004;109:1101-1107 6

7. MECHANISMS OF IMPROVED OUTCOMES: II Unal B, et al. Circulation 2004;109:1101-11077

8. AGE-ADJUSTED HEART DISEASE MORTALITY Trends in Indian Health, 2000 From Howard BV, Raymer T. Overview of Cardiovascular Disease in American Indians and Alaskan Natives 8

9. CVD MORTALITY IN AMERICAN INDIANS Howard BV, et al. Circulation 1999;99:2389-2395 9

10. RISK FACTORS FOR CVD IN AMERICAN INDIANS Howard BV, et al. Circulation 1999;99:2389-2395 10

11. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 11

12. Distribution of Systolic Blood Pressure in Diabetic and Non-diabetic American Indians Diabetic Nondiabetic Systolic blood pressure (mmHg) Diabetic From Howard BV, Raymer T. Overview of Cardiovascular Disease in American Indians and Alaskan Natives 12

13. NHANES III: Survey of 16,095 U.S. Adults 1992 - 1994 Hyman DJ, et al. NEJM 2001;345:479 - 86 13

14. BP Control: Trend over Time in Cardiovascular Health Study 5,888 Adults >65 Years Psaty BM, et al. Arch Intern Med 2002;162:2325 - 2332 14

15. Neal B. Lancet 2000;355:1955-1964 Treating Hypertension with ACE Inhibitors with ACE Inhibitors 15

16. Staessen JA, et al. Lancet 2001;358:1305-15 Meta-analysis of 62,605 Hypertensive Patients 16

17. Staessen JA, et al. Lancet 2001;358:1305-15 Meta-analysis of 62,605 Hypertensive Patients 17

18. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 18

19. RR for Total Cholesterol in Framingham vs Strong Heart Study From Howard BV, Raymer T. Overview of Cardiovascular Disease in American Indians and Alaskan Natives 19

20. HEART PROTECTION STUDY* Entry criteria (20,536 patients randomized) – Age 40 – 80 – Total cholesterol >135 mg/dl – CAD or CAD equivalent (diabetes or other vascular disease) Intervention: simvastatin 40 mg QD Vascular events per 5 years – Placebo arm:25.2% – Simvastatin arm:19.8% 21.4% reduction *Lancet 2002;360:7 20

21. SIMVASTATIN: CAUSE-SPECIFIC MORTALITY (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Cause of death Vascular 587707 Coronary 194230 Other vascular (7.6%)(9.1%) 17% SE 4 reduction 781937 (2P<0.0001) ANY VASCULAR Non-vascular 359345 Neoplastic 90114 Respiratory 8290 Other medical 1621Non-medical (5.3%)(5.6%) 5% SE 6 reduction 547570 (NS) NON-VASCULAR (12.9%)(14.7%) 13% SE 4 reduction 13281507 (2P<0.001) ALL CAUSES 0.40.60.81.01.21.4 MRC/BHF Heart Protection Study. Lancet 2002;360:7-22 21

22. SIMVASTATIN: STROKE INCIDENCE (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Type 290409 Ischaemic 5153 Haemorrhagic 103134 Unknown Severity 96119 Fatal 4251 Severe 107155 Moderate 138189 Mild 6171 Unknown (4.3%)(5.7%) 25% SE 5 reduction 444585 (2P<0.00001) ALL STROKES 0.40.60.81.01.21.4 MRC/BHF Heart Protection Study. Lancet 2002;360:7-22 22

23. (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Major coronary event 357574 Non-fatal MI 587707 Coronary death (8.7%)(11.8%) 27% SE 4 reduction 8981212 (2P<0.00001) CORONARY EVENTS Revascularisation 513725 Coronary 450532 Non-coronary (9.1%)(11.7%) 24% SE 4 reduction 9391205 (2P<0.00001) REVASCULARISATIONS 0.40.60.81.01.21.4 SIMVASTATIN: CORONARY EVENTS & REVASCULARISATION (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Major coronary event 357574 Non-fatal MI 587707 Coronary death (8.7%)(11.8%) 27% SE 4 reduction 8981212 (2P<0.00001) CORONARY EVENTS Revascularisation 513725 Coronary 450532 Non-coronary (9.1%)(11.7%) 24% SE 4 reduction 9391205 (2P<0.00001) REVASCULARISATIONS 0.40.60.81.01.21.4 MRC/BHF Heart Protection Study. Lancet 2002;360:7-22 23

24. SIMVASTATIN: MAJOR VASCULAR EVENTS (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Vascular event 8981212Major coronary 444585Any stroke 9391205Revascularisation (19.8%)(25.2%) 24% SE 3 reduction 20332585 (2P<0.00001) ANY OF ABOVE 0.40.60.81.01.21.4 MRC/BHF Heart Protection Study. Lancet 2002;360:7-22 24

25. SIMVASTATIN: MAJOR VASCULAR EVENT by LDL & TOTAL CHOLESTEROL (10269)(10267) SIMVASTATINPLACEBORate ratio & 95% CI STATIN betterPLACEBO better Lipid levels at entry LDL cholesterol (mmol/l) 598756(17.6%)(22.2%)< 3.0 (116 mg/dl) 484646(19.0%)(25.7%)  3.0 < 3.5 9511183(22.0%)(27.2%)  3.5 (135 mg/dl) Total cholesterol (mmol/l) 360472(17.7%)(23.1%)< 5.0 (193 mg/dl) 744964(18.9%)(24.5%)  5.0 < 6.0 9291149(21.6%)(26.8%)> 6.0 (323 mg/dl) 24% SE 3 reduction (2P<0.00001) 20332585(19.8%)(25.2%)ALL PATIENTS 0.40.60.81.01.21.4 MRC/BHF Heart Protection Study. Lancet 2002;360:7-22 25

26. 30% REDUCTION IN CHD FOR 30 MG/DL REDUCTION IN LDL Grundy SM, et al. Circulation 2004;110:227-239 26

27. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 27

28. SMOKING CESSATION SAVES LIVES Male smoker quits at age 35 – Adds 2.3 years additional life Female smoker quits at age 35 – Adds 1.5 years additional life 28

29. SMOKING CESSATION INTERVENTION IS COST-EFFECTIVE Intervention35-Year Old Male 35-Year Old Female Counseling Alone $700 - 1000$1200 - 2100 Counseling plus Nicotine Gum $4000 - 6000$7000 - 9000 Cost per Life-Year Added Tsevat J., et al. 1992;93:43S – 47S29

30. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 30

31. PREVALENCE OF DIABETES Strong Heart Study, by Gender and Center From Howard BV, Raymer T. Overview of Cardiovascular Disease in American Indians and Alaskan Natives 31

32. Diabetes Markedly Increases Risk of Myocardial Infarction Sowers, JR. Arch Intern Med 2004;164:1850-57 32

33. Beneficial Effects of Tight Blood Pressure Control in Diabetics Sowers, JR. Arch Intern Med 2004;164:1850-5733

34. Beneficial Effects of Tight Blood Pressure Control in Diabetics Sowers, JR. Arch Intern Med 2004;164:1850-57 34

35. Treatment Algorithm for Hypertensive Diabetics Sowers, JR. Arch Intern Med 2004;164:1850-5735

36. ARBs Slow Progression of Renal Disease In Type II Diabetes Sowers, JR. Arch Intern Med 2004;164:1850-5736

37. EFFECTS OF SIMVASTATIN ON CV OUTCOMES Armitage J, et al. Cuur Opin Lipidol 2004;15(4):439-446.37

38. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 38

39. 153,305 VHA Primary Care Patients from Four Facilities CAD EQUIVALENT 39

40. LDL LOWERING: MVEs PREVENTED VHA Patients (Projected) 5-Year MVE Risk Estimated MVEs Over 5 Years Meet HPS Criteria1,193,969 Meet HPS Criteria & No Statin 479,6640.246117,786 Initiate Statin479,6640.19392,409 MVEs prevented25,377 40

41. BLOOD PRESSURE LOWERING: MVEs PREVENTED VHA Patients (Projected) 5-Year MVE Risk Estimated MVEs Over 5 Years Hypertensive1,888,46214%265,048 12 – 14 mm Hg SBP reduction 1,888,46210.2%191,827 MVEs prevented73,221 41

42. COST ESTIMATES COST ITEM UNIT COST ($) NUMBER PATIENTS HOSPITAL- IZATIONS VHA-WIDE COST/5 YR HCTZ-0.0171,888,462–58,589,530 SIMVA- STATIN –0.479479,664–419,310,280 MVEs PREVENTED $7,91198,598779,974,397 NET$302,074,587 42

43. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 43

44. Color coding for LDL and BP measurements: Gray – Measurement listed for reference only, VA-DoD IHD Guideline and/or VAH Performance Measures do not apply Green – Performance measure applicable and patient concordant Bold – Patient non-concordant with either VA-DoD guideline or VHA performance measure Bold – Systolic pressure >160 mm Hg PC-xx Marked patients are used for calculating performance rankings Patient had a visit in the evaluation time frame with provider PC-xx and patient is either assigned to PC-xx or was not yet assigned as of 6/30/2003 Problems identified on CPRS Problem List, outpatient reason for visit (OPC), or discharge summary (PTF) PCMM Assignment: blank - Patient is assigned to and had a visit with provider PC-xx None - Patient has been seen by provider PC-xx, but is not assigned to any primary care provider Name – Patient has been seen by provider PC-xx, but is assigned to other named primary care provider (PCP) (*) – Patient is assigned to PC-xx, visited with one or more other care providers, but did not see assigned care provider PC-xx in the evaluation time frame Concordance/non-concordance with VA-DoD IHD Guideline, non-concordance is highlighted VHA Performance Measures are grouped into 3 columns, non-concordance is highlighted A - Patient has active prescription for medication O - Medication ordered Legend for Performance Measure Alerts 8/4/2003 None assigned PCP (*) 44

45. CARE PROVIDER RANKING 45

46. Doe, John 123-45-6789 EBMR 46

47. EBMR CONCORDANCE SUMMARY TAB 47

48. EBMR CONCORDANCE ASSESSMENT: ALL PATIENTS 48

49. EBMR RESULTS: PRELIMINARY ANALYSIS OF BLOOD PRESSURE ANALYSIS OF BLOOD PRESSURE 49

50. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 50

51. CARDIOVASCULAR RISK REDUCTION Risk for Cardiovascular Disease (CVD) What Is the Evidence that Treating Risk Factors Lowers CVD? – Blood pressure control – Lipid management – Smoking cessation – Diabetes How Are We Doing? How Can We Do Better? Summary Discussion 51