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Management of CAD in the Very Elderly

Management of CAD in the Very Elderly. Ralph Brindis , MD, MPH, FACC, FSCAI Vice President, American College of Cardiology Senior Advisor for Cardiovascular Disease, Northern California Kaiser Clinical Professor of Medicine, University of California, San Francisco

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Management of CAD in the Very Elderly

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  1. Management of CAD in the Very Elderly Ralph Brindis, MD, MPH, FACC, FSCAI Vice President, American College of Cardiology Senior Advisor for Cardiovascular Disease, Northern California Kaiser Clinical Professor of Medicine, University of California, San Francisco 6th Annual Oregon Cardiovascular Symposium May 30, 2009

  2. Presenter Disclosure Information Ralph Brindis, MD MPH FACC SCAI The following relationships exist related to this presentation: No relationships to disclose

  3. Institute of Medicine Priorities for America • We must overhaul the system to create care to ensure it is: Safe, Timely, Equitable, Efficient, Evidence-based and Patient-centered • Care should… • Be customized to patients’ needs and values • Have the patient be the source of control • Enable knowledge to be shared freely Institute of Medicine, Crossing the Quality Chasm: A New Health System for the Twenty-first Century Adams, K & Corrigan,JM. Priority Areas for National Action: Transforming Health Care Quality, IOM 2003

  4. Defining Quality of ACS/CAD Care in Elderly • Timely • Elderly present later and more ‘atypically’ • Effective and safe • Both effectiveness and safety may change with pt age • In particular, alterations in drug clearance • Need adequate enrollment of elderly in clinical studies • Cost-effective • Need to assure that benefits of ‘one more drug’ truly additive • But, elderly’s higher risk usually leads to more CE care • Equitable • Once defined need to guard against ‘ageism’ in decisions • Patient centered, rational • Need to individualize treatment for both pt’s clinical features and health preferences

  5. The Graying of America Institute for the Future, Health and Health Care 2010 (2000) 1995 2010 2030

  6. Growth in US 80+ Population YEAR US Census Bureau 1992

  7. Management of the Elderly – Life is Long ! • A person who reaches age 65 has a life expectancy of 85 years • What are the odds that he/she will live beyond age 85? • 50% • Consider a 65-year old couple • What is the likelihood that one or both will live to age 97? • 25% - How Not to Outlive Your Savings; MetLife Insurance 2004 Wall Street Journal, Sept 30th, 2004

  8. Estimated Prevalence of Cardiovascular Disease by Age and Gender in U.S. Percentage of Population NHANES III

  9. The Magnitude of CVD in Older Persons

  10. AHA Consensus Group on Management of ACS in the Elderly 30-day mortality by age (continuous function)* STEMI Non-STEMI Age 85 – 30% mortality Age 85 – 15% mortality Age 65 – 10% mortality Age 65 – 5% mortality *Based on clinical trials in approx 250,000 patients

  11. Challenges in Evidence Based Medicine Advanced CAD Elderly Community Trials Guidelines Comorbidity Disease Severity 60 68.3 Age Karen Alexander, DCRI

  12. Management of Advanced CAD and the Elderly – Some Questions to Consider • Is using appropriate anti-thrombotic and anti-ischemic therapies (as suggested by the guidelines) appropriate in the very elderly ? • What is the experience with an early cath strategy in the elderly and those with complex CAD ? • Have drug-eluting stents (DES) in PCI changed the therapeutic landscape ?

  13. Older CV Patients are “Different” • Reduced cardiovascular reserve • Decreased vascular compliance • Increased myocardial stiffness • -adrenergic responsiveness + impaired sinus node • Higher burden of comorbid illness • “frailness” • Altered pharmacodynamics and pharmacokinetics • Decline in creatinine clearance, hepatic metabolism • Altered volume of distribution (adipose tissue) • Altered clotting mechanisms • Reduced stem cell repair

  14. Concomitant Co-morbid Illness in ACS in Older Persons % of population

  15. Altered Hemostasis and Inflammatory Markers • ↓ Blood vessel integrity and response to injury • Amyloidangiopathy • Platelets • Turn over slower; older platelets are less ‘sticky’ • t-PA release enhanced with age (desmopressin) • ↑ Thrombin generation with age • ↑ Fibrinogen, ↑ Factors IX/X • D-dimer and inflammatory markers increased with age, and frailty J Thrombosis and Hemostasis, Lakatta Circ 2003, GudnasonJThrombosis and Hemostasis

  16. Patient Case • 85 year old female, small NSTEMI, 3 vessel disease • How to proceed? • Interventionalist – PCI • Surgeon – CABG • General Cardiologist – medication • Patient - Are they even in the decision making process??

  17. Traditional Approach Treatment of Heart “Evidence-based Care” Few comorbidities, Unlimited reserve Rx yields expected results Outcomes Death, MI Geriatric Approach Treatment of Host “Personalized Care” Multiple comorbidities, reserve variability Rx triggers complex effects Outcomes Death, MI Physical Function Independence Cognitive Abilities Are We Practicing Geriatric Cardiology? “Yes and No” Parmley, JACC 1997; 29: 217-8

  18. Treating CAD in 2009 OMT Alone CABG Surgery Patient with CAD undergoing Cath Outcomes: Health Status Compliance BMS PCI DES Can better informing patients improve compliance and safety?

  19. Goals of Coronary Revascularization • Positively impact longevity/mortality • Improvement in health status/symptoms • Ability to influence either is not equal for all clinical scenarios • Longevity gains limited to selective patient scenarios - PCI vs CABG

  20. Complex Trade-offs • Clinical Questions: • Optimal medical therapy?, PCI ?, DES/BMS?, CABG? • 1, 2, or 3 vessel, LMCA involvement and % stenosis? • Anatomy suitable? • Severity of ischemia? • Diabetic? • LV function and concomitant valvular disease? • Other co-morbidities? • Prior PCI or CABG? • Potential future elective non-cardiac surgery? • Patient ability for maintaining clopidogrel adherence?

  21. Complex Trade-offs • Practice Environment • Is this case appropriate for PCI? • How does this case impact interventionalist’s procedural volume ( >75/year)? • How does this case contribute to interventionalist’s mortality rate and other performance measures? • Is there Public Reporting of PCI outcomes? • How does this case impact referral cardiologist and the interventionist’s efficiency report? • Malpractice fears? • Fee for service “driver”

  22. Complex Trade-offs • Society • Payment system rewards procedures • Quantity not Quality • Growth in medical costs • Future – episode of care bundling & chronic disease management reimbursement • Patient • Quality of life • Impact of procedure and medications • Cost – co-pays and medications • Timing - impact on life events • Patient preference

  23. Changing State of the Science • Literature for PCI, CABG, and medical therapy constantly changing over time with new RCTs and therapies – very challenging to compare and accurately assess • AHRQ review (2006) of PCI and CABG found roughly similar benefits and outcomes with various caveats based on patient and type of outcome (LM, LV dysfunction, 3 vessel, and DM favoring CABG)

  24. Dual Goals of Management of CAD

  25. 2007 ACC/AHA UA/NSTEMI Guideline Revision Selection of Strategy:Invasive Versus Conservative Strategy • An early invasive strategy is indicated in initially stabilized patients (without serious comorbidities or contraindications to such procedures) who have an elevated risk for clinical events (I, A). Scores indicating elevated risk include combinations of the following: • Recurrent angina/ischemia at rest or during low-level activities • Elevated cardiac biomarkers • New/presumably new ST-segment depression • Signs or symptoms of HF or new/worsening mitral regurgitation • High-risk findings from noninvasive testing • Hemodynamic instability • Sustained ventricular tachycardia • PCI within 6 months • Prior CABG • High risk score • LVEF <0.40 Anderson JL, et al. J Am Coll Cardiol. 2007;50:652-726.

  26. ASA Clopidogrel β-blockers ACE inhibitors/ARBs Aldosterone blockade (↓EF) Statin Regardless of baseline LDL-C Initiated prior to discharge Goal LDL-C <100 mg/dL LDL <70 mg/dL is reasonable Treatment of triglycerides and non–HDL-C useful If TG 200-499 mg/dL, non–HDL-C should be <130 mg/dL TG 500 mg/dL, fibrate or niacin before LDL-C lowering to prevent pancreatitis Reasonable to encourage increased consumption of omega-3 fatty acids for risk reduction – IIb (B) 2007 ACC/AHA UA/NSTEMI Guideline Revision Secondary Prevention: Additional Recommendations Anderson JL, et al. J Am Coll Cardiol. 2007;50:652-726.

  27. What the Guidelines Don’t Specify • Contraindications for therapies • Ideal dosing of concomitant anti-thrombin and anti-platelet therapies • How to safely use invasive procedures together with multiple anticoagulants • How to treat high-risk populations • Advanced elderly • Renal Insufficiency

  28. Invasive vs. Conservative Management of UA/NSTEMI in TACTICS-TIMI 18 Stratified by Age Death or Non-Fatal MI 30 Days 6 Months OR=0.94 p=0.79 OR=0.61 *p=0.018 OR=0.78 p=0.37 OR=0.56 *p=0.019 * * (%) (%)

  29. Efficacy of Invasive Strategy Across Age Subgroupsin TACTICS-TIMI 18 Death, MI at 6 Months CON INVOR (%) (%) 4.8 5.0 1.07 9.1 7.6 0.82 10.3 7.8 0.73 21.6 10.8 0.44* *p=0.016 Age Group (n) Age  55 (716) Age >55-65 (614) Age >65-75 (612) Age > 75 (278) 0 0.5 1 1.5 2.0 INV Better CONS Better

  30. Major Bleeding According to Treatment Strategy Stratified by Age Group in TACTICS-TIMI 18 CON INV OR=2.25 OR=0.73 OR=1.38 OR=2.55 p=0.10 p=0.367 p=0.25 *p=0.009 (%) Age Group: (n) 55 >55-65 >65-75 >75 (716) (614) (612) (278)

  31. Therapeutic Implications of the TACTICS-TIMI 18 Results Stratified by Age Death or Nonfatal MI at 6 mo Absolute RR Relative RR NNT per 1000 Pts (%) Age < 65 4 6 250 Age  65* 48 39 21 Age  55 -2 -7 -- Age >55-65 15 18 67 Age >65-75 25 27 40 Age >75* 108 56 9 *p < 0.05 , others p = NS

  32. Survival Free of Death from Any Cause and Myocardial Infarction Stable Angina 1.0 Optimal Medical Therapy (OMT) 0.9 0.8 PCI +OMT Hazard ratio: 1.05 95% CI (0.87-1.27)P = 0.62 0.7 0.6 0.5 0.0 0 1 2 3 4 5 6 7 Years Number at Risk Medical Therapy 1138 1017 959 834 638 408 192 30 PCI 1149 1013 952 833 637 417 200 35

  33. Conclusions • STABLE CAD: PCI as an initial management strategy in the setting of stable CAD has not been shown to reduce the incidence of Death or MI or mortality • PCI has not been shown to prolong life expectancy • PCI added to OMT was more effective in reducing ischemia and improving angina than OMT, particularly in patients with moderate-to-severe pre-rx ischemia • Most patients will have improvement in anginal status whether treated initially with PCI+OMT or OMT alone

  34. Reinforces existing ACC/AHA clinical practice guidelines, which state that PCI can be safely deferred in patients with stable CAD, even in those with extensive, multivessel involvement and inducible ischemia, provided that intensive, multifaceted medical therapy is instituted and maintained Optimal medical therapy and aggressive management of multiple treatment targets without initial PCI can be implemented safely in the majority of patients with stable CAD—two-thirds of whom may not require even a first revascularization during long-term follow-up Implications

  35. Rates of Death or MI by Extent of Ischemia Reduction Shaw LJ et al. Circulation 2008;117:1283-91 RR = 0.47 (95% CI 0.23-0.95) Ischemia Reduction≥5% Ischemia Reduction<5%

  36. CABG vs PCI in Diabetics Mortality in Pts with Multivessel Disease Time-Dependent Meta-Analysis • Significant survival benefit w/CABG over 4 years • Benefit somewhat attenuated and highly uncertain at 6.5 yrs Hoffman SN et al. JACC 2003;41:1293-304

  37. Changing State of the Science SYNTAX 2008 Randomization between CABG versus PCI with DES in patients with Triple-Vessel and/or Left Main Disease • Not powered enough to make true inferences among the very elderly • Only one year follow-up

  38. SYNTAX Trial Design + 62 EU Sites 23 US Sites Heart Team (surgeon & interventionalist) All Pts with de novo 3VD and/or LM disease (N=4,337) Total enrollment N=3075 Amenable for both treatment options Amenable for only one treatment approach • Treatment preference (9.4%) • Referring MD or pts. refused informed consent (7.0%) • Inclusion/exclusion (4.7%) • Withdrew before consent (4.3%) • Other (1.8%) • Medical treatment (1.2%) Stratification: LM and Diabetes DM 28.2% NonDM 71.8% Stratification: LM and Diabetes DM 28.5% Non DM 71.5% Randomized Arms N=1800 Two Registry Arms N=1275 Randomized Arms n=1800 Two Registry Arms PCI N=198 PCI all captured w/ follow up CABG N=1077 CABG n=1077 CABG 2500 750 w/ f/u CABG n=897 TAXUS n=903 PCI n=198 TAXUS* N=903 vs CABG N=897 no f/u n=428 5yr f/u n=649 71% enrolled (N=3,075) vs LM 33.7% 3VD 66.3% LM 34.6% 3VD 65.4% *TAXUS Express

  39. There is ‘3-vessel disease’ and ‘3-vessel disease’ LM 99% LAD 70-90% RCA2 70-90% Patient 1 Patient 2 LCx 70-90% LAD 99% LCx 100% SYNTAX SCORE 52 SYNTAX SCORE 21 Patient 1 Patient 2 RCA3 70-90% RCA 100%

  40. SYNTAX Primary EndpointRandomized trial The primary clinical endpoint is the 12 Month major Cardiovascular or Cerebrovascular event rate (MACCE *) MACCE is defined as: All cause Death Cerebrovascular Accident (CVA/Stroke) Documented Myocardial Infarction (ARC definition) Any Repeat Revascularization (PCI and/or CABG) *ARC MACCE definition Circ 2007; 115:2344-2351

  41. CABG TAXUS 12 Month Subgroup MACCE Rates Patients (%) 3VD (All) N=1095 LM+3VD N=258 All LMN=705 LM isolatedN=91 LM+1VDN=138 LM+2VDN=218

  42. Conclusions: In the randomized SYNTAX cohort, there were comparable overall safety outcomes (Death, CVA, MI,) in CABG and PCI patients at 12 months (7.7 vs. 7.6 %). There was a significantly higher rate of revascularization in the PCI group (13.7 vs. 5.9 %), and a significantly higher rate of CVA in the CABG group (2.2 vs. 0.6 %). Overall MACCE in the PCI group was higher (17.8 vs.12.1 %) due to an excess of redo revascularization compared with CABG. Per protocol rates of symptomatic graft occlusion and stent thrombosis were similar. The SYNTAX score will help stratify patients for the appropriate revascularization option.

  43. CABG or PCI for LMCA in Octogenarians • 249 pts >80 yonon-randomized - CABG or PCI • 2 year follow up • PCI pts- older, higher Creatinine, lower ej.fx., higher EuroSCORE and more ACS presentation • DES 48% of PCI patients • Death/MI 35% PCI, 30% CABG • MACCE free survival: 57% PCI vs. 65% CABG • EuroSCORE independent predictor of MACCE Rodes-Cabau, Circulation 2008;118:2374-2381.

  44. CABG or PCI for LMCA in Octogenarians • PCI : 6.7% 30 day mortality, 12.5% 30 day MI • CABG : 8.3% 30 day mortality, 17.2% 30 day MI • 30 day MACCE : 18% PCI vs 28% CABG • CABG - higher new onset atrial fibrillation, renal failure, bleeding requiring transfusions, longer hospital stay. Rodes-Cabau, Circulation 2008;118:2374-2381.

  45. PCI vs CABG for LMCA in Very Elderly (>80) Death or MI and MACCE • Figure 1. Risk of cardiac death or MI (A) and MACCE (B) at a mean follow-up of 23 months in the whole cohort and in the subgroups identified according to the quartiles of the propensity score as a function of treatment: PCI vs CABG. Values are expressed as 95% CI. Rodes-Cabau, Circulation 2008;118:2374-2381.

  46. PCI vs CABG for LMCA in Very Elderly (>80) Cardiac Death or MI-free Survival Curves • Figure 2. Cardiac death– or MI-free survival curves (A) and MACCE-free survival curves (B) constructed with Cox regression analysis adjusted for propensity score Rodes-Cabau, Circulation 2008;118:2374-2381

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