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Dallas, Nov 13-6, 2013 No Disclosures

High Risk Population Subclinical Disease (HRP ) & Post-MI (Polypill) Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures. High Risk Population Subclinical Disease (HRP). 1. Vulnerable Plaque – Invasive Approach ?

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Dallas, Nov 13-6, 2013 No Disclosures

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  1. High Risk PopulationSubclinical Disease (HRP) & Post-MI (Polypill)Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures

  2. High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

  3. 1. Vulnerable Plaque ? B) Mild at Angiography,Significant at IVUS & Pathology STABLE PLAQUE Angiogr.,IVUS UNSTABLE PLAQUE Angiogr.,IVUS,Pathology RUPTURED PLAQUE Pathology Modified from G Niccoli et. al. JACC Cardiovasc Img. 2013;6:1108 GW Stone, J Narula JACC: Cardiov. Imag. 2013:6;1124 A Arbab-Zadeh, M Nakano, R Virmani, V Fuster, et. al. Circ. 2012;125:1147

  4. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease D Butler. Nature. 2011;477:261 (UN. NCD). At Present R. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030 V Fuster, BB Kelly, R Vedanthan , Circulation. 2011;123:1671

  5. High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

  6. High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

  7. 2.Vulnerable Patient – Non-invasive Burden A) Large Population & Silent Disease D Butler. Nature. 2011;477:261 (UN. NCD). At Present R. Beaglehole et. al. Lancet 2008;372:1988 - > 30% Across, 2030 V Fuster, BB Kelly, R Vedanthan , Circulation. 2011;123:1671

  8. High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

  9. PESA & AWHS HRP > 55y, 40-54y, n= 8,000 , FU 0,3,6 y N=6000 FU 3y B). c). Life Style & Imaging ? Pesa Systemic Score a). Predictive ? b). Economics ? Omics (Framingham) Telomeres (S.blot, qPCR, Fresh)

  10. Carotid Plaque Burden, mm3 3D US - Manual Sweep 2D vs Transducer Focal structure into the arterial lumenof at least 0.5 mm or 50%of surrounding IMT value. 37%missed at Classical 2D CardioSCORE-R7-ApoA1,Apo B, B2M, CEA, CRP, Lp(a),Transferrin H Sillesen, P Muntendam, E Falk, V Fuster et.al JACC Imag. 2012;7:681. .

  11. Calcification of the Coronary Arteries (CAC)

  12. 1. Cross Interaction Between Carotid Plaque Area & CAC IMT vs Focal: + Ilio-Femoral: +++ (n = 1480) (n = 1477) (n = 1479) (n = 1478) Carotid Plaque Area Quartiles U Baber, R Mehran, E Falk, V Fuster et al, 2013

  13. 2. PESA Systemic Score With Age And Gender (N=2578, Age 40-54yo, 35% Women) LJ Jimenez Borregueva, AI Fernandez Ortiz, V Fuster et. al. 2013

  14. 3a.Cumulative MACE by Framingham Score 15.0 P-value<.0001 10.0 Cumulative Incidence, % 5.0 0.0 0 365 730 1095 Number at risk Analysis time, Days Low Risk 2049 1786 1603 555 Intermediate Risk 2445 2207 2023 737 High Risk 1337 1229 1124 402 U Baber, R Mehran, E Falk, V Fuster et al, 2013

  15. 3b.Cumulative MACE by 2D US Carotid Plaque 10.0 P-value<.0001 Cumulative Incidence, % 5.0 0.0 0 500 1000 Analysis time, Days No Plaque Tertile 1 Tertile 2 Tertile 3 U Baber, R Mehran, E Falk, V Fuster et al, 2013

  16. 3c.Cumulative MACE by Coronary Calcium Score P-value<.0001 15.0 10.0 Cumulative Incidence, % 5.0 0.0 0 365 730 1095 Analysis time, Days CAC 0 CAC 0-100 CAC 100-400 CAC > 400 U Baber, R Mehran, E Falk, V Fuster et al, 2013

  17. 4a. Reclassification:incorrect, correct

  18. 4b.2D-US Transducer + CAC Impact on Events (Intermediate FRS Group) CACS U Baber, R Mehran, E Falk, V Fuster et al, 2013

  19. High Risk Population Subclinical Disease (HRP) 1. Vulnerable Plaque – Invasive Approach ? A) Restricted Population with Complex Disease B) Mild Angiography, Significant IVUS & Pathology 2. Vulnerable Patient – Non-invasive Burden Approach A) Large Population with Silent Disease B) RF + Burden of Disease at 3D-US & CAC C) What is next ? Background of FREEDOM – Autopsy, Ex Vivo, Imaging Data From FREEDOM – “No FREEDOM of Choice” Strict Data From FREEDOM – 3 Exceptions of Choice? Post FREEDOM Challenges – Timing, Polypill, Hybrid

  20. PESA & AWHS HRP > 55y, 40-54y, n= 8,000 , FU 0,3,6 y N=7000 FU 3y C1). a). Predictive ? b). Economics ? c).Life Style & Imaging ? Pesa Systemic Score e). Omics (Framingham) Telomeres(S.blot, qPCR, Fresh) d).5 More Yrs of Follow-Up

  21. C2). In-vivo, Diabetic Carotid - PET/MRI RR Moustafa, J Rudd et. al. Circ Cardiov. Imag. 2010;3:536 R Corti & V Fuster EHJ 2011 (April 19) JD Spence. Circ. 2013;127:739 Diffuse: Inflammatory / Lipid – Transcr. Doppler:M-emboli / Stroke

  22. C3). DBD & Traditional CV Risk Factors White Matter Lesion Volume and Cognitive Decline 1. V Novak, I Hajjar. Nat. Rev. Cardiol. 2010;7:686(HMS) 2. WB White et al.Circ 2011;124:2312 (Farmington,Yale) 3. AHA/ASA, Stroke 2011; 42:2672 - WHO - Dementia report2012 4. JB Toledo et al. Brain July 10, 2013 5. C Russo et. al. Circ. 2013;128:1105 6. JR Kizer Circ 2013;128:1045 Ischemia affects 60 to 90% of patients with Alzheimer’s

  23. C4). Aging / Senescence Cellular Telomere & Telomerase 1 3 B Niemann et. al. JACC 2011; 57: 577. R Madonna, R De Caterina et. al EHJ 2011;32:1190 (Houston &Chieti, Italy) JC Kovacic, EG Nabel, V Fuster – Circ. 2011;123:1650 F Fyhrquist et al., Nat Rev Cardiol 2013; 10:274 – Healthy Lifestyle

  24. High Risk PopulationSubclinical Disease (HRP) & Post-MI (Polypill)Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures

  25. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  26. 1)Major Documents on Global CV Health Promoting Cardiovascular Health in the Developing World; A Critical Challenge to Achieve Global Health. Ed. V Fuster and B Kelly. IOM of the Natl. Academies. Natl . Academies Press. Washington DC.2010.

  27. 2) Promoting Cardiovascular Health Worldwide 2012 Circ. 2011;123:1671 Scientific American, May 2014 (In Press) 2012

  28. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  29. 1) Low-Compliance vs Low-Adherence Definition of Terms Compliance, Implies Passive Participation by The Patient (Life Style or Behavior, fluctuates). Adherence, Implies Active Participation by The Patient (Drugs, around the Clock) JM Castellano, R Copeland-Halperin, V Fuster, Global Health. 2013;8:263 L Osterberg, et. al. N Engl J Med. 2005;353:487. GN Varghese et. al. Drug Benefit Trends. 2008;20:17. National Council on Patient Information and Education. August 2007.

  30. 2).TRIALS TARGETS FOR RISK FACTOR CONTROL? Risk Factors - Proportion of Participants at Goal % – 1 year Trials LDL SBP DBP Hb A1C Meet Goals Base FU BARI-2D 75 56 70 52 1420 COURAGE 51 55 55 59 1219 FREEDOM55 63 53 551220 Freedom, Bari-2D, Courage Investigators, 2013 (In Press) PURE (S Yusuf et al.) Lancet 2011; Aug 28 - Poor Countries,7% !!! NHANES, AHA, NHLBI-JNC-7, NHLBI-NCEP P Muntner, V Fuster et al., AHJ 2011; 161: 719

  31. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  32. 1) Projected Impact Of Polypill Use Among US Adults: Adherence and a 9 Year Event Rate – CAD & Stroke P Muntner, V Fuster, M Woodward et. al. Am Heart J. 2011;161:719 WHO. Adherence to Long-Term: evidence for Action, 2003 S Schuster et.al. Z Kardiol.1997;86:273- N Danchin et.al AHJ 2005;150:1147

  33. 2) The Cost of Low-Adherence in the US could be up to $300 Billion Each Year Medication Adherence May Lead to Lower Health Care Use and Costs Despite Increased Drug Spending New England Health Institute (NEHI) Research Brief: August 2009. MC Roebuck, et al. Health Aff. 2011;30(1):91 – MI-FREE AHA Nov 2011

  34. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  35. 1) TENETS OF LOW ADHERENCE TO MEDICATIONS –“NO” There is no such thing as a “non-adherent personality.”1 Patients - 83%- don’t tellphysicians of their adherence. Physicians -74%- believe their patients are adherent.2 Adherence to prescription medications is largely not related to compliance or self-care and lifestyle.3 Effects of demographics - age, gender, education, & income - on adherence are small.4 1D Hevey. 2007 2KL Lapane Am J Manag Care 2007;13:613 - AL Goldberg, Soc Sci Med 1998;47:1873 3CA McHurney, Curr Med Res Opin 2009; 25:21 4MR DiMateo , Med Care 2004; 42:200

  36. 2) TENETS OF LOW ADHERENCE TO MEDICATIONS –“YES” • Patients want to know why the medication is prescribed, duration, possible side effects, what could happen if they don’t take it, and cost / affordability.5 • Health care professionals should communicate less poorly on prescription medications - av. 49 sec, appropiate 3%.6 • Taking medications is a decision-making process. Patients actively decide about their medications.7 • 5CA McHurney, Cur Med Res Opin 2009;25:215 • BJ Bailey, Progr Cardiov Nurs 1997; 12:23 - DK Ziegler, Arch Int Med 2001;161:706 • 6 DM Tarn, Patient Educ Cours 2008; 72:311, Arch Int Med 2006; 166:1855 • 7SL William, Clin Interv Aging 2007; 25:453

  37. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  38. 1).The Adherence Estimator For a New Prescription Concerns Commitment Cost CA McHorney. Curr Med Res Opin. 2009;25(1):215 Medication Adherence. Merck 2011.

  39. 2). Who Should Focus on These Patients and Promote Adherence Medication Adherence. Merck 2011.

  40. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  41. 1)CNIC-FERRERPOLYPILL FOR 2ary PREVENTION. FOCUS 1 & 2 ASA, Statin, ACE-Inhibitor Argentina Brazil Paraguay Italy Spain G Sanz, V Fuster Am. H J 2011;162:811 Semin.Thor.Cardiov.Surg 2011;23:24 Nature Rev Cardiology, 2013-In Press UMPIRE: High Risk, Two Polypills as FOCUS +Hctz or Atenolol vs Usual Care 86% Adherence vs 65%, Lower BP and LDL-C - Events NS --- JAMA 2013;310:918

  42. 2). POLYPILL STUDIES PUBLISHED OR IN COURSE CompanyPolypillActive components Red Heart Pill 1ASA 75 mg, Lisinopril 10 mg, Dr Reddy’sSecondary PreventionSimv. 20 mg, Aten. 50 mg India UMPIRE Red Heart Pill 2ASA 75 mg, Lisinopril 10 mg, Primary PreventionSimv. 20 mg, Hctz. 12.5 mg CardiaRamitorvaASA 100 mg, Simv 20 mg,Ram 5mg IndiaPrimary PreventionAten. 50 mg, Hctz. 12.5 mg ZyduscadilaZycadASA 75 mg, Atorv. 10 mg, IndiaSecondary PreventionRam 5mg, Metoprolol 50 mg Polyran 1ASA 81 mg, Atorv. 20 mg, Alborz DarouPrim / Secon. Prevention?Enalapril 5mg, Hctz 25 mg Iran Polyran 2ASA 81 mg, Ator 20 mg, Prim / Secon. Prevention?Valsartan 40mg, Hctz 25 mg CNIC-FERRERTrinomiaASA 100 mg, Simv. 40 mg, SpainSecondary preventionRam 2.5 / 5 / 10 mg

  43. Post-MI Polypll – 14 Comments Compliance / Adherence ( Rx ) & Economics 1. From Warnings to Promoting Health (2) 2. Low-Compliance vs Low-Adherence Definition, Quantification Worldwide (2) Clinical & Economic Impact of Low Adherence (2) The Causes or 7 Tenets of Low-Adherence (2) 3. Aiming at New Approaches The Adherence Estimator & Communication (2) Polypill & Adherence (2) A Community Call (2)

  44. 1) A Community Call Population Ageing & Cost The Lancet NCD Action (G Alleyne et. al.) Lancet. 2013;381:566

  45. 2) A Community Call The Message A. Compliance & Adherence are a Marathon, Not a Sprint B. Compliance & Adherence are the Key Drivers Enabling Patients to Achieve Their Treatment Goals World Health Organization 2003-2011

  46. High Risk Population Subclinical Disease (HRP) & MI (Polypill)Valentin Fuster, M.D., Ph.D. Dallas, Nov 13-6, 2013 No Disclosures

  47. U Baber, R Mehran, V Fuster et al, 2013

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