Revascularization for Patients with HFrEF: CABG and PCI and the Concept of Myocardial Viability

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1 Revascularization for Patients with HFrEF: CABG and PCI and the Concept of Myocardial Viability 22nd Annual Heart Failure 2018: an Update on Therapy April 2018 Eric J. Velazquez, MD, FACP, FACC, FASE, FAHA Professor of Medicine Duke University Health System Duke Clinical Research Institute

2 Revascularization for HFrEF Representative Case What we knew then What we know now STICH Main Hypotheses Patient Selection What we still need to learn Role for PCI in HFrEF? Personal reflections All Rights Reserved, Duke Medicine 2007

3 Mr. S 12/2002-1/2003 A 57 yo M initially seen by vascular surgery due to non-healing foot ulcer requiring BKA Admitted with progressive dyspnea and LE edema to OSH and transferred to DUMC for further evaluation PMH PVD s/p R BKA, DM, HL, HTN PEX JVP ~12 cm H 2 0, b/l decreased breath sounds/rales, 1-2 pitting edema Labs Na 127, scr 1.2, Hct 40, Alb 3.0 EKG NSR, no Q waves or acute ST segment deviation/t wave abnormalities All Rights Reserved, Duke Medicine 2007

4 All Rights Reserved, Duke Medicine 2007 Mr. S 1/2003

5 All Rights Reserved, Duke Medicine 2007 Mr. S 1/2003

6 All Rights Reserved, Duke Medicine 2007 Mr. S 1/2003

7 All Rights Reserved, Duke Medicine 2007 Mr. S 1/2003

8 Mr. S Inpatient 1/2003 Aggressively diuresed and discharged on beta-blocker, ACEI, digoxin, furosemide, baby ASA and simvastatin Clinic 4/2003 Continued to complain of dyspnea and orthopnea and was grossly volume overloaded by PEX despite OMT Randomized to CABG + MED as part of the STICH protocol and underwent 3vCABG (i.e., LIMA-LAD, SVG->OMT1, SVG->L PDA) on 5/2003 with an uneventful post-operative course All Rights Reserved, Duke Medicine 2007

9 All Rights Reserved, Duke Medicine 2007 Mr. S 6/2004

10 All Rights Reserved, Duke Medicine 2007 Mr. S 6/2004

11 Mr. S 2004-Present Continues to follow in clinic every 6-12 months and remains NYHA functional class I on OMT Has not been admitted for HF since undergoing CABG in 2004, has not undergone repeat LHC/PCI, and has not had a TTE ordered since 2009 All Rights Reserved, Duke Medicine 2007

12 Revascularization for HFrEF Representative Case What we knew then What we know now STICH Main Hypotheses Patient Selection What we still need to learn Personal reflections All Rights Reserved, Duke Medicine 2007

13 Ischemic Cardiomyopathy Ischemic cardiomyopathy first described by Burch in 1970 myocardial dysfunction that results from occlusive coronary disease apparently, once damage has occurred to the extent of the ischemic cardiomyopathy described the disease is irreversible even with absolute bed rest Burch et al Am Heart J 1972 All Rights Reserved, Duke Medicine 2007

14 All Rights Reserved, Duke Medicine 2007 Am J Cardiol 1974

15 CASS Enrollment CAD 70% stenosis LAD / LCx / RCA 50% stenosis LM LV function LVEF 35% Operative procedure 54 days post-randomization Circulation 1983 All Rights Reserved, Duke Medicine 2007

16 CASS RCT: Reduced LVEF Subset (EF 35-50%) Proportion Surviving 1-Vessel Disease 2-Vessel Disease 3-Vessel Disease CABG CABG CABG No.3 Statins, Medicine ACEi, ARBs, Medicine MRAs, ICDs, Medicine CRTs p= p=0.40 p= Medical.82 Therapy in CASS: S 11M Limited ASA and Beta-Blockers 8S 9M 1S 4M 28S 26S 13S 35M 31M 15M Year S 37S 23S 36M 29M 16M Passamani et al. NEJM 1985 All Rights Reserved, Duke Medicine 2007

17 CASS Registry: LVEF < 35% 631 patients excluded from CASS RCT After 3 years, limiting symptom was: Medical Surgical Angina 26% 0% Dyspnea 36% 30% Fatigue 18% 40%* After 3 years, survival was: In those presenting with angina 68% 84%* In those presenting with CHF 55% 55% Alderman et al. Circulation 1983 All Rights Reserved, Duke Medicine 2007

18 All Rights Reserved, Duke Medicine 2007

19 All Rights Reserved, Duke Medicine 2007 NC Med J 1991

20 All Rights Reserved, Duke Medicine 2007 Am J Cardiol 2002

21 2002 Surgical Revascularization? HF is increasingly prevalent; CAD is the most common associated etiology Substantial improvements in GDMT Risks and benefits of cardiac surgery among patients with HFrEF and CAD compared to medical therapy never studied The role of symptoms and/or myocardial imaging to select revascularization candidates unclear All Rights Reserved, Duke Medicine 2007

22 Outline: Revascularization in HFrEF What we knew then What we know now STICH Patient Selection What we still need to learn Personal reflections All Rights Reserved, Duke Medicine 2007

23 Surgical Treatment of IsChemic Heart Failure Trial Surgical Revascularization Hypothesis In patients with HF, LVD and CAD amenable to surgical revascularization, CABG added to intensive MED will decrease all-cause mortality compared to MED alone. Surgical Ventricular Reconstruction Hypothesis In patients with HF, LVD and CAD amenable to CABG and SVR, SVR added to CABG with MED will decrease all cause mortality and cardiac hospitalization compared to CABG alone. Velazquez EJ et al. JTCVS 2007 All Rights Reserved, Duke Medicine 2007

24 Inclusion Criteria LVEF 0.35 within 3 months of trial entry CAD suitable for CABG MED eligible Absence of left main CAD as defined by an intraluminal stenosis of 50% Absence of CCS III angina or greater (angina markedly limiting ordinary activity) SVR eligible Dominant LV anterior akinesia/dyskinesia Experienced surgeon Velazquez EJ et al. JTCVS 2007

25 Major Exclusion Criteria Recent acute MI (within 30 days) judged to be an important cause of LVD Cardiogenic shock (within 72 hours of randomization) Plan for percutaneous intervention of CAD Aortic valve disease clearly indicating the need for aortic valve repair or replacement Velazquez EJ et al. JTCVS 2007

26 Revascularization Hypothesis Conduct 1,212 Subjects Randomized CABG + MED n = 610 Randomization MED n = 602 Age (median) 60 years; 12% women Prior MI 77%; Diabetes 39% Baseline NYHA II-IV 89% LVEF 28% and ESVI 78 ml/m 2 (median) Multi-vessel disease 74%; Proximal LAD 68% Velazquez EJ et al. New Engl J Med 2016

27 CABG Conduct Variable Randomized to CABG (N=610) CABG received no (%) 555 (91) Time to CABG, days Median (IQR) 10 (5, 16) Performed electively % 95 Arterial conduits 1, % 91 Total conduits 3, % 56 Velazquez EJ et al. New Engl J Med 2016

28 Medication Use Medication All Patients Randomized (N=1212) Baseline Last Follow-Up Aspirin or clopidogrel, % ACE inhibitor or ARB, % Beta-blocker, % Statin, % Loop Diuretics, % K+ Sparing Diuretics, % Velazquez EJ et al. New Engl J Med 2016

29 Study Conduct 1,212 Subjects Randomized CABG + MED n = 610 Randomization MED n = 602 n = 13 Withdrew or lost n = 12 Withdrew or lost Analyzed n = 610 (100%) Final Analysis Median Follow-up 9.8 yrs. Max. Follow-up 13.4 yrs. Analyzed n = 602 (100%) Velazquez EJ et al. New Engl J Med 2016

30 All-cause Mortality NNT = 14 MED CABG Velazquez EJ et al. New Engl J Med 2016

31 Cardiovascular Mortality NNT = 11 Velazquez EJ et al. New Engl J Med 2016

32 All-cause Mortality or Cardiovascular Hospitalization NNT = 10 Velazquez EJ et al. New Engl J Med 2016

33 Other Outcomes Outcomes CABG (N=610) MED (N=602) Hazard Ratio (95% CI) (CABG vs. MED P- value Death or heart failure hospitalization 404 (66.2%) 450 (74.8%) 0.81 (0.71, 0.93) Death or all-cause hospitalization 506 (83.0%) 538 (89.4%) 0.81 (0.71, 0.91) Death or revascularization (PCI or CABG) 388 (63.6%) 478 (79.4%) 0.63 (0.55, 0.73) <0.001 Death or non-fatal myocardial infarction 376 (61.6%) 409 (67.9%) 0.86(0.74, 0.98) Death or non-fatal stroke 367 (60.2%) 406 (67.4%) 0.85 (0.74, 0.98) Velazquez EJ et al. New Engl J Med 2016

34 KCCQ Overall Summary Score: % of Pts with Significant Change (>5) 100 CABG + MED MED Alone 80 P = months 12 months 24 months 36 months Mark D et al. Ann Intern Med 2015

35 All-cause Mortality as Treated NNT = 9 Velazquez EJ et al. N Engl J Med 2016

36 Outline: Revascularization in HFrEF What we knew then What we know now STICH Main Hypotheses Patient Selection What we still need to learn Role for PCI in HFrEF? Personal reflections All Rights Reserved, Duke Medicine 2007

37 Diabetes and Treatment: All-Cause Mortality and CV Hospitalization MacDonald M et al. Eur J HF 2015

38 Mortality According to Angina and Treatment Arm Jolicour M J et al. JACC 2015

39 Ischemia and All-Cause Mortality Panza et al. JACC 2013

40 Interaction Between Ischemia and Treatment All-Cause Mortality Panza et al. JACC 2013

41 Myocardial Viability and Mortality Mortality Rate Without viability With viability Without Viability With Viability HR 95% CI P , Years from Randomization Variables Associated with Mortality Chi- Square Risk score < LV ejection fraction Multivariable p < LV EDVI < LV ESVI < Myocardial Viability Univariate

42 Baseline Characteristics: Patients With and Without Myocardial Viability 100 Previous MI p< LVEF p< LVEDVI p<0.001 LVESVI p<0.001 Percent Ejection Fraction (%) LV Volume Index (ml / m 2 ) With myocardial viability Without myocardial viability

43 Interaction Between Viability and Treatment: All-Cause Mortality Without Viability With Viability Subgroup N Deaths HR 95% CI Without Viability , 1.18 Interaction P value With Viability , CABG Better MED Better Bonow RO et al. N Engl J Med 2011

44 Interaction of Viability and Treatment Endpoint Events Treatment p value Mortality 236 As randomized As treated Mortality or CV hospitalization 422 As randomized As treated CV mortality 187 As randomized As treated 0.261

45 Viability after STICH: Controversy Brews Miellnicizuk L & Beanlands R 2012 Velazquez EJ 2012 All Rights Reserved, Duke Medicine 2007

46 Viability is dominated by other mechanisms in setting of GDMT + Viability + LVEF Ischemic LVSD CABG Survival Other Freedom from recurrent (fatal) MI, SCD All Rights Reserved, Duke Medicine 2007

47 All Rights Reserved, Duke Medicine 2007 Carson Pet al. J Am Coll Cardiol HF 2013

48 Effect of CABG vs MED on LVEF at 4 months Velazquez EJ et al. AHA Scientific Sessions 2014

49 LVEF Recovery Not Related to CABG Survival LVEF Improved No Improvement Failure to improve LVEF is not related to post -CABG HF symptoms Angina Survival Samady H et al. Circulation 1999 All Rights Reserved, Duke Medicine 2007

50 CABG leads to earlier and greater benefit in those at higher risk A) 3v CAD B) EF <27% C) LVESVI >79 ml/m2 Panza J et al., JACC 2014

51 Higher risk leads to earlier and increasing benefit Panza J et al., JACC 2014

52 Cause of Death by Age Age Quartiles Q1 Q2 Q3 Q4 (Age 54 years) (n=330) (54<Age 60 years) (n=295) (60<Age 67 years) (n=279) (Age>67 years) (n=308) All cause, % CV, % Non-CV, % Unknown, % Petrie M Velazquez EJ. Circulation 2016

53 Effect of CABG vs. GDMT on Cardiovascular Mortality by Age Petrie M Velazquez EJ. Circulation 2016

54 Outline: Revascularization in HFrEF What we knew then What we know now STICH Main Hypotheses Patient Selection What we still need to learn Personal reflections All Rights Reserved, Duke Medicine 2007

55 What do we know about PCI in HFrEF? No RCTS of PCI in chronic HFrEF Very few patients with HFrEF in CABG vs PCI RCTs SYNTAX included ~5% with any HF and ~ 2% with an LVEF < 30% FREEDOM included 2.6% with LVEF < 40% Very few patients with HFrEF in RCTs of PCI vs. MED COURAGE excluded patients with LVEF < 30% All Rights Reserved, Duke Medicine 2007

56 CABG Compared to PCI with Stenting 3 VD All patients Patients with EF < 40% Patients with EF 40% Disease of nonproximal LAD artery Stenting group CABG group Unadj. hazard ratio (95% CI) 0.89 ( ) 0.61 ( ) 0.94 ( ) Adj. hazard ratio (95% CI) 0.74 ( ) 0.64 ( ) 0.76 ( ) Disease of proximal LAD artery Stenting group CABG group Unadjusted HR (95% CI) 0.67 ( ) 0.55 ( ) ) Adjusted HR (95% CI) 0.64 ( ) 0.68 ( ) 0.60 ( ) Hannan EL et al. N Engl J Med All Rights Reserved, Duke Medicine 2007

57 Target Lesion Failure (Death/MI or Revasc) Remains Common Kereiakes DJ et al. JAMA Card 2017 All Rights Reserved, Duke Medicine 2007

58 Starting the next chapter Wolff G et al. Circ HF 2017 All Rights Reserved, Duke Medicine 2007

59 PCI vs MED in HF N = 700 Inclusion Criteria Chronic heart failure LVEF<35% Extensive CAD (BCIS Jeopardy Score>6) At least 4 segments of viable myocardium Heart team does not recommend CABG Exclusion Criteria Acute HF CCS 3 HB<9 egfr<25 Primary Endpoint Death, MI and HF hospitalization All Rights Reserved, Duke Medicine 2007

60 Revascularization for HFrEF What we knew then What we know now STICH Main Hypotheses Patient Selection What we still need to learn Personal reflections All Rights Reserved, Duke Medicine 2007

61 Revascularization in Ischemic Cardiomyopathy 2018: Implications (so far) Extent of CAD should be assessed and GDMT optimized for all patients presenting with HFrEF CABG improves survival with less morbidity Viability, angina and ischemia status should not define candidacy for CABG in HFrEF Patients at higher risk due to the extent of CAD, LVSD and remodeling have a greater (earlier) reward with CABG CABG mechanisms of benefit are multifactorial PCI not well studied in HFrEF; RCT data needed All Rights Reserved, Duke Medicine 2007

62 Putting it Together Velazquez EJ, Bonow RO JACC 2015

63 HF and CAD Opportunities for Improvement All Rights Reserved, Duke Medicine 2007

64 All Rights Reserved, Duke Medicine 2007 Ann Thor Surg 2012

65 All Rights Reserved, Duke Medicine 2007 STICH to STICHES A 17-year Odyssey

66 STICH Investigators Zabrze, Poland

67 All Rights Reserved, Duke Medicine 2007

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