Treatment Of Preserved Cardiac Function Heart Failure with an Aldosterone antagonist (TOPCAT) AHA Nov 18, 2014 Update on Randomized Trials

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1 Treatment Of Preserved Cardiac Function Heart Failure with an Aldosterone antagonist (TOPCAT) AHA Nov 18, 2014 Update on Randomized Trials Marc A. Pfeffer, MD, PhD; Brian Claggett, PhD; Susan F. Assmann, PhD; Robin Boineau, MD; Inder S. Anand, MD; Nadine Clausell, MD, PhD; Akshay S. Desai, MD, MPH; Rafael Diaz, MD; Jerome L. Fleg, MD; Ivan Gordeev, MD; John F. Heitner, MD; Eldrin F. Lewis, MD, MPH; Eileen O Meara, MD; Jean-Lucien Rouleau, MD; Jeffery L. Probstfield, MD; Tamaz Shaburishvili, MD, PhD; Sanjiv J. Shah, MD; Scott D. Solomon, MD; Nancy K. Sweitzer, MD, PhD; Sonja M. McKinlay, PhD; Bertram Pitt, MD On behalf of TOPCAT Investigators ClinTrials.gov NCT HHS Contract # HHSN C

2 TOPCAT International (6), double-blind, placebo-controlled RCT Pts: Symptomatic Heart Failure, Age 50, LVEF 45%, stratified according to: Hospitalization within the past year for management of heart failure, or Elevated natriuretic peptides (BNP 100 pg/ml or NT-proBNP 360 pg/ml) Rz: 1:1 to either Spironolactone (15, 30, 45 mg daily) or matching Placebo Primary Outcome: Composite of CV mortality, HF Hospitalization, or Aborted Cardiac Arrest Stats: 80% power to detect a 20% relative reduction in primary events: 551 adjudicated primary events (approximately 3,515 subjects), using log-rank test, two-sided p<0.05, ITT Rationale and design: (A. Desai, Am Heart J 2011) Primary Results: (Pitt, NEJM 2014)

3 1 Outcome (CV Death, HF Hosp, or Resuscitated Cardiac Arrest) 351/1723 (20.4%) Placebo Spironolactone HR = 0.89 ( ) p= /1722 (18.6%) (AHA 2013, NEJM 2014)

4 Summary Spironolactone (N = 1722) Placebo (N = 1723) HR (95% CI) Primary Outcome 320 (18.6%) 5.9/100pt-yr 351 (20.4%) 6.6/100pt-yr 0.89 ( ) P=0.138 Hospitalization for Heart Failure 206 (12.0%) 3.8/100pt-yr 245 (14.2%) 4.6/100pt-yr 0.83 ( ) P=0.042 Multiple HF Hosp P<0.01 Conclusions: TOPCAT population with HFpEF: Rx with spironolactone did not alter the 1 composite Reductions in heart failure hospitalizations were observed Use of spironolactone in these patients requires careful monitoring of K + and creatinine AHA 2013

5 Placebo Rates: Primary Outcome, by region Americas N=1767 (51%) US: N=1151 Canada: N=326 Brazil: N=167 Argentina: N= per 100 pt-yr Placebo: 280/881 (31.8%) Russia/Georgia N=1678 (49%) Russia: N=1066 Rep Georgia: N= per 100 pt-yr Placebo: 71/842 (8.4%) AHA 2013

6 Clinical Outcomes by Region (Irrespective of Treatment) Outcome Primary Outcome CV Mortality Hospitalization for Heart Failure Aborted Cardiac Arrest All-Cause Mortality [rate per 100 patient-years] Americas N = 1767 Russia/Georgia N = 1678 Regional Difference 522 (29.5%) 149 (8.9%) [11.5] [2.4] < (12.6%) 113 (6.7%) [4.3] [1.8] < (22.6%) 51 (3.0%) [8.8] [0.8] < (0.3%) 2 (0.1%) (21.8%) 141 (8.4%) [7.1] [2.1] <0.001 Circ Epub ahead of print

7 Baseline by Region Variable* NYHA Class II III Americas N = 1767(51%) Russia/Georgia N = 1678(49%) 59.2% 68.6% % 30.5% LVEF % 58 (53, 64) 55 (50, 60) <0.001 Stratum Hosp. for HF 55% 89% <0.001 Natriuretic Peptide** 45% 11% Age 72 (64, 79) 66 (59, 71) <0.001 Female 50% 53% 0.05 Hypertension 90% 93% Any Cardiovascular Disease 46% 72% <0.001 Myocardial Infarction 20% 32% <0.001 Stroke 9% 6% Atrial Fibrillation 42% 28% <0.001 Diabetes Mellitus 45% 20% <0.001 Smoking (current) 7% 14% <0.001 p *Reported as % or median (Q1, Q3) **(BNP 100 pg/ml or NT-proBNP 360 pg/ml) AHA 2014

8 Baseline by Region Variable* Americas N = 1767 Russia/Georgia N = 1678 Systolic Blood Pressure 129 (118, 138) 130 (120, 140) <0.001 Diastolic Blood Pressure 70 (62, 80) 80 (80, 85) <0.001 Heart Rate 68 (61, 76) 68 (62, 75) NS BMI (kg/m 2 ) 33 (28, 38) 29 (27, 33) <0.001 egfr (ml/min/1.73m 2 ) < 60 (ml/min/1.73m 2 ) 61 (49, 77) 48% 69 (58, 81) 28% p <0.001 <0.001 Serum Potassium (meq/l) 4.2 (3.9, 4.5) 4.4 (4.1, 4.7) <0.001 Hemoglobin (g/dl) 12.8 (11.7, 14.0) 13.7 (12.6, 14.8) <0.001 Medications ACE-I or ARB 79% 90% <0.001 Beta-blocker 79% 77% NS Diuretic 89% 74% <0.001 Statin 65% 39% <0.001 Warfarin 34% 12% <0.001 *Reported as % or median (Q1, Q3) AHA 2014

9 Baseline by Region Variable* Americas N = 1767 Russia/Georgia N = 1678 Systolic Blood Pressure 129 (118, 138) 130 (120, 140) <0.001 Diastolic Blood Pressure 70 (62, 80) 80 (80, 85) <0.001 Heart Rate 68 (61, 76) 68 (62, 75) NS BMI (kg/m 2 ) 33 (28, 38) 29 (27, 33) <0.001 egfr (ml/min/1.73m 2 ) < 60 (ml/min/1.73m 2 ) 61 (49, 77) 48% 69 (58, 81) 28% p <0.001 <0.001 Serum Potassium (meq/l) 4.2 (3.9, 4.5) 4.4 (4.1, 4.7) <0.001 Hemoglobin (g/dl) 12.8 (11.7, 14.0) 13.7 (12.6, 14.8) <0.001 Medications ACE-I or ARB 79% 90% <0.001 Beta-blocker 79% 77% NS Diuretic 89% 74% <0.001 Statin 65% 39% <0.001 Warfarin 34% 12% <0.001 In full manuscript (Circ online), 34 of 38 baseline characteristics were significantly different *Reported as % or median (Q1, Q3) Circ Epub ahead of print

10 Baseline by Region Variable* Americas N = 1767 Russia/Georgia N = 1678 Systolic Blood Pressure 129 (118, 138) 130 (120, 140) <0.001 Diastolic Blood Pressure 70 (62, 80) 80 (80, 85) <0.001 Heart Rate 68 (61, 76) 68 (62, 75) NS BMI (kg/m 2 ) 33 (28, 38) 29 (27, 33) <0.001 egfr (ml/min/1.73m 2 ) < 60 (ml/min/1.73m 2 ) 61 (49, 77) 48% 69 (58, 81) 28% <0.001 <0.001 Serum Potassium (meq/l) 4.2 (3.9, 4.5) 4.4 (4.1, 4.7) <0.001 Hemoglobin (g/dl) 12.8 (11.7, 14.0) 13.7 (12.6, 14.8) <0.001 Medications ACE-I or ARB 79% 90% <0.001 Beta-blocker 79% 77% NS Diuretic 89% 74% <0.001 Statin 65% 39% <0.001 Warfarin 34% 12% <0.001 In full manuscript (Circ online), 34 of 38 baseline characteristics were significantly different Within each Region, all variables similar by treatment arm p *Reported as % or median (Q1, Q3) Circ Epub ahead of print

11 Patient Participation by Region Americas N = 1767 Russia/Georgia N = 1678 Mean follow-up: 2.9 years 3.7 years Unknown Vital Status 37 (2.1%) 95 (5.7%) Month 8 Reported Daily Dose Spiro (N=866) Americas N = 1767 Placebo (N=846) Russia/Georgia N = 1678 Spiro (N=823) Placebo (N=830) Average Dose* 21.7 mg 25.9 mg 28.4 mg 29.5 mg * Treatment delta differs by region (p=0.001) Circ Epub ahead of print

12 Potassium Outcome Americas N = 1767 (18,727 samples) Spiro (N = 886) Placebo (N = 881) Russia/Georgia N = 1678 (20,344 samples) Spiro (N = 836) Placebo (N = 842) Hyperkalemia 1 (K 5.5) 223 (25%) 78 (9%) 99 (12%) 79 (9%) OR=3.46; 95% CI: ( ) OR=1.30; 95% CI: ( ) Hypokalemia 1 (K<3.5) 135 (15%) 231 (26%) 144 (17%) 163 (19%) OR=0.51; 95% CI: ( ) OR=0.87; 95% CI: ( ) In addition, regional differences in changes in potassium by treatment persisted, with adjustment for baseline K, age, egfr, DM, ACE/ARB use, enrollment stratum (p<0.001) 1 Any report during study; Circ Epub ahead of print

13 Creatinine Americas N = 1767 Russia/Georgia N = 1678 Outcome Spiro (N = 886) Placebo (N = 881) Spiro (N = 836) Placebo (N = 842) Doubling of creatinine (18%) 102 (12%) 17 (2%) 18 (2%) HR = 1.60; 95% CI: ( ) HR = 0.95; 95% CI: ( ) Creatinine 3.0 mg/dl 87 (10%) 80 (9%) 2 (0.2%) 4 (0.4%) HR = 1.10; 95% CI: ( ) HR = 0.50; 95% CI: ( ) In addition, regional differences in changes in creatinine by treatment persisted, with adjustment for baseline K, age, egfr, DM, ACE/ARB use, enrollment stratum (p<0.001) 2 Doubling of creatinine to above upper limit of normal Circ Epub ahead of print

14 Creatinine Americas N = 1767 Russia/Georgia N = 1678 Outcome Spiro (N = 886) Placebo (N = 881) Spiro (N = 836) Placebo (N = 842) Doubling of creatinine (18%) 102 (12%) 17 (2%) 18 (2%) HR = 1.60; 95% CI: ( ) HR = 0.95; 95% CI: ( ) Creatinine 3.0 mg/dl 87 (10%) 80 (9%) 2 (0.2%) 4 (0.4%) Dialysis: HR = ; (2%) 95% CI: ( ) 32(4%) HR 1 = (0.1%) 0.50; 95% CI: ( ) 0 In addition, regional differences in changes in creatinine by treatment persisted, with adjustment for baseline K, age, egfr, DM, ACE/ARB use, enrollment stratum (p<0.001) 2 Doubling of creatinine to above upper limit of normal

15 Systolic Blood Pressure Change by Region -0.6 mm Hg Average SBP Change (Spiro-Placebo) Russia/Georgia N = mmhg (NS) Circ Epub ahead of print

16 Systolic Blood Pressure Change by Region -0.6 mm Hg -4.2 mm Hg Americas N = 1767 Russia/Georgia N = 1678 Average SBP Change (Spiro-Placebo) -4.2 mmhg (p<0.001) -0.6 mmhg (NS) SBP delta differed by region (p<0.001), adjusted Circ Epub ahead of print

17 Exploratory-Post Hoc: Placebo vs. Spiro by Region Primary Outcome US, Canada, Argentina, Brazil HR=0.82 ( ) Placebo: 280/881 (31.8%) Spiro: 242/886 (27.3%) Interaction p=0.122 Russia, Rep Georgia HR=1.10 ( ) Spiro: 78/836 (9.3%) Placebo: 71/842 (8.4%) AHA 2013

18 Clinical Outcomes by Region (By Treatment Arm) Outcome Spiro (N = 886) Americas N = 1767 Placebo (N = 881) HR (95% CI) p-value Spiro (N = 836) Russia/Georgia N = 1678 Placebo (N = 842) HR (95% CI) p-value 1 Outcome 242 (27%) 280 (32%) 0.82* ( ) 78 (9%) 71 (8%) 1.10 ( ) CV Mortality 96 (11%) 127 (14%) 0.74* ( ) 64 (8%) 49 (6%) 1.31 ( ) Hosp. for HF 184 (21%) 216 (25%) 0.82* ( ) 22 (3%) 29 (3%) 0.76 ( ) Total HF Hosps. (# events) IRR = 0.75* ( ) IRR=0.83 ( ) *95% CI excludes 1.00 Circ Epub ahead of print

19 Clinical Outcomes by Region (By Treatment Arm) Outcome Spiro (N = 886) Americas N = 1767 Placebo (N = 881) HR (95% CI) p-value Spiro (N = 836) Russia/Georgia N = 1678 Placebo (N = 842) HR (95% CI) p-value All-Cause Mortality 178 (20%) 207 (23%) 0.83 ( ) 74 (9%) 67 (8%) 1.12 ( ) All-Cause Hospitalization 526 (59%) 535 (61%) 0.94 ( ) 240 (29%) 257 (31%) 0.92 ( ) Myocardial Infarction 48 (5%) 46 (5%) 1.01 ( ) 17 (2%) 18 (2%) 0.95 ( ) Stroke 38 (4%) 39 (4%) 0.94 ( ) 19 (2%) 21 (2%) 0.91 ( ) Circ Epub ahead of print

20 Post Hoc Analysis By Region Differences in:

21 Post Hoc Analysis By Region Differences in: Patient Populations

22 Post Hoc Analysis By Region Differences in: Patient Populations Prognosis

23 Post Hoc Analysis By Region Differences in: Patient Populations Prognosis Responses to Spiro: K+ Creatinine Blood Pressure

24 Post Hoc Analysis By Region Differences in: Patient Populations Prognosis Responses to Spiro: K+ Creatinine Blood Pressure

25 Post Hoc Analysis By Region Differences in: Patient Populations Prognosis Responses to Spiro: K+ Creatinine Blood Pressure Rz to spiro associated with reduced CV death and HF hospitalizations, in pts from the Americas

26 Post Hoc Analysis By Region Differences in: Patient Populations Prognosis Responses to Spiro: K+ Creatinine Blood Pressure Rz to spiro associated with reduced CV death and HF hospitalizations, in pts from the Americas Thank you! Circ Epub ahead of print

27

28 Serious Adverse Events (SAEs) Any SAE: Americas: Spiro (63%) vs. Placebo (65%) R/G: Spiro (33%) vs. Placebo (33%) No treatment difference within either region, but major differences between regions.

29 Stratum Does Not Explain Regional Differences Outcome BNP Stratum [event rate, per 100py] Primary 8.1 Amer. R/G (n=791) (n=190) events 13 events Hosp. Stratum Amer. R/G (n=976) (n=1488) events 136 events HF Hosp events 0 events 262 events 51 events Mortality events 15 events 230 events 126 events

30 BNP Treatment Effect? Outcome Treatment Effect HR (95% CI) BNP Stratum Amer. R/G (n=791) (n=190) Hosp. Stratum Amer. R/G (n=976) (n=1488) Primary HR=0.63 HR=1.35 HR=0.92 HR=1.07 (0.47, 0.85) (0.44, 4.13) (0.74, 1.14) (0.77, 1.50) HF Hosp HR=0.66 No events HR=0.89 HR=0.77 (0.47, 0.93) (0.70, 1.13) (0.44, 1.34) Mortality HR=0.75 HR=0.96 HR=0.88 HR=1.13 (0.55, 1.03) (0.35, 2.65) (0.68, 1.14) (0.80, 1.60)

31 BNP Treatment Effect? In patients enrolled via the BNP stratum in the Americas (n=686): Treatment Effect for Primary Outcome HR=0.46 (0.26, 0.79) for patients with BNP or NT-proBNP values below the median HR=0.84 (0.55, 1.28) for patients with BNP or NT-proBNP values above the median

32 Potassium Creatinine change by Region

33 Event Rates by Country (irrespective of therapy) Country Primary Event Rate Mortality United States 12.2 (11.0, 13.5) 6.7 (5.9, 7.6) Brazil 11.4 (8.2, 15.9) 10.1 (7.2, 14.2) Canada 10.6 (8.7, 12.9) 7.2 (5.8, 9.1) Argentina 7.7 (5.3, 11.2) 8.0 (5.6, 11.5) Russia 3.2 (2.7, 3.9) 2.7 (2.3, 3.3) Georgia 1.2 (0.8, 1.7) 1.2 (0.8, 1.7)

34 Event Rates by Country (irrespective of therapy) Primary Outcome All-cause Death

35 Patient Participation by Region Americas N = 1767 Russia/Georgia N = 1678 Mean follow-up: 2.9 years 3.7 years Unknown Vital Status 37 (2.1%) 95 (5.7%) Month 8 Reported Daily Dose 0 mg Spiro (N=866) 212 (24.5%) Americas N = 1767 Placebo (N=846) 160 (18.9%) Russia/Georgia N = 1678 Spiro (N=823) 59 (7.2%) Placebo (N=830) 61 (7.3%) 15 mg 194 (22.4%) 105 (12.4%) 83 (10.1%) 38 (4.6%) 30 mg 319 (36.8%) 386 (45.6%) 570 (69.3%) 597 (71.9%) 45 mg 141 (16.3%) 195 (23.0%) 111 (13.5%) 134 (16.1%) Average Dose* 21.7 mg 25.9 mg 28.4 mg 29.5 mg * Treatment delta differs by region (p=0.001) Circ Epub ahead of print

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