Post Hoc Analysis of the PARADIGM Heart Failure Trial:

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1 Post Hoc Analysis of the PARADIGM Heart Failure Trial: Pulse Pressure and Outcomes in Heart Failure with Reduced Ejection Fraction Chen-Huan Chen, M.D. Professor, Department of Medicine, National Yang-Ming University Chief, Division of Faculty Development Department of Medical Education, Taipei Veterans General Hospital

2 Disclosures Served as an advisor or consultant for: Novartis Pharmaceuticals Corporation; Served as a speaker or a member of a speakers bureau for: AstraZeneca; Pfizer Inc.; Bayer AG; Bristol-Myers Squibb Company; Boehringer Ingelheim Pharmaceuticals, Inc.; Daiichi Sankyo, Inc.; Novartis Pharmaceuticals Corporation; SERVIER; Merck & Co., Inc.; Sanofi; TAKEDA Pharmaceuticals International; Received grants for clinical research from: Microlife Co., Ltd., and National Yang-Ming University have signed a contract for transfer of the noninvasive central blood pressure technique. The contract of technology transfer includes research funding for conducting the validation study.

3 Determinants of Pulse Pressure A high PP may be due to: Stroke volume Arterial stiffness Wave reflection Diabetologia 2008;51:527 39

4 Increased PP and Risk of Heart Failure in the Elderly The community-based East Boston Senior Health Project, East Boston, Mass A total of 1621 men and women (age, years) free of CHF were followed up for 3.8 years. For each 10-mm Hg elevation in PP, there was a 14% increase in risk of CHF (95% confidence interval, ; P =.003) JAMA. 1999;281:634-9

5 Increased PP May Help Identify Hypertensive Patients at High Risk for Overt CHF 2040 free-living Framingham Heart Study participants (mean age, 61 years [range, 50 to 79 years]) Ann Intern Med. 2003;138:10-6

6 Low PP and Grave Survival in Patients with Decompensated HFrEF 489 patients with decompensated heart failure. Am J Cardiol. 2004;93:785-8

7 PP and Outcomes in HFrEF: EPHESUS Variables All-Cause Death CV Death Whole population (events/patients) 1017/ /6551 Age per 5-y increment 1.20 ( ) 1.21 ( ) PP per 5-mm Hg increment 0.95 ( ) 0.94 ( ) LVEF per 2% increment 0.92 ( ) 0.91 ( ) PWV substudy (events/patients) 28/306 26/306 Age per 5-y increment NS NS PWV per m/s increment 1.16 ( )* 1.16 ( )* LVEF per 2% increment 0.84 ( ) 0.84 ( ) Hypertension. 2014;63:105-11

8 JACC Heart Fail. 2016;4:42-9 Eur Heart J 2015; 36, JACC Heart Fail. 2016;4:50-4 Pulse Pressure and Mortality in HFrEF and HFpEF

9 PARADIGM-HF Men and women with a LVEF 40%, HF in NYHA class II-IV and a plasma B-type natriuretic peptide (BNP) 150 pg/ml (or N- terminal pro-bnp [NTproBNP] 600 pg/ml) were included Eligible patients were randomised to enalapril 10 mg bid or sacubitril/valsartan 200 mg bid The primary endpoint was cardiovascular (CV) death or HF hospitalisation Overall, sacubitril/valsartan reduced the primary composite by 20% (HR 0.80, 95% CI ; p= )

10 PP and Outcomes in PARADIGM-HF Background It is uncertain whether a high PP still implies increased arterial stiffness and left ventricular afterload, is detrimental to patients with compensated HFrEF, and thus may become a therapeutic target. To investigate whether baseline PP or change in PP during treatment predict outcomes in patients with HFrEF Whether sacubitril/valsartan s effect on outcomes varies by PP at baseline

11 Baseline Characteristics according to Baseline PP group PP1 <40 mmhg (n = 2936) PP2 41 and < 55 mmhg (n = 3554) PP3 55 mmhg (n = 1909) P value Age, (years) 61±12 64±11 68±10 < Women, N (%) 602 (21%) 754 (21%) 476 (25%) SBP, (mmhg) 110±9 122±11 138±14 < Ischemic etiology, N (%) 1591 (54.2%) 2202 (62.0%) 1243 (65.1%) < Ejection fraction, (%) 29±6 30±6 30±6 < NT-proBNP (pg/ml), median (IQR) (905,3418) (863,3087) (888,3189) Hypertension, N(%) 1776 (61%) 2580 (73%) 1584 (83%) < Diabetes N(%) 845 (29%) 1274 (36%) 788 (41%) < Myocardial Infarction, N (%) 1155 (39%) 1614 (45%) 865 (45%) < Prior Hosp for HF, N(%) 1878 (64%) 2266 (64%) 1130 (59%)

12 Impact of PP at Randomization on Outcomes Outcomes Primary outcome (composite of CV death and HHF) PP1 PP2 Hazard ratio (95% CI) 1.05 (0.94, 1.17) 1.00 (-) PP (0.97, 1.26) Secondary outcome: Death from CV causes PP (0.91, 1.21) PP (-) PP (0.90, 1.26) HHF PP (0.91, 1.22) PP (-) PP (1.01, 1.43) Death from any causes PP (0.93, 1.20) PP (-) PP (0.86, 1.17) P-value Hazard Ratio low PP (PP1, <=40 mmhg) mid-range PP (PP2, mmhg) high PP (PP3, >=55 mmhg)

13 Impact of PP at Month 4 Visit on Outcomes Outcomes Primary outcome (composite of CV death and HHF) PP1 PP2 Hazard ratio (95% CI) 1.28 (1.13, 1.44) 1.00 (-) PP (0.89, 1.16) Secondary outcome: Death from CV causes PP (1.26, 1.69) PP (-) PP (0.79, 1.11) HHF PP (0.97, 1.34) PP (-) PP (0.92, 1.29) Death from any causes PP (1.24, 1.62) PP (-) PP3 1.0 (0.86, 1.16) P-value < < Hazard Ratio low PP (PP1, <=40 mmhg) mid-range PP (PP2, mmhg) high PP (PP3, >=55 mmhg)

14 Impact of Change in PP on Outcomes Outcomes Primary outcome (composite of CV death and HHF) dpp1 dpp2 Hazard ratio (95% CI) 1.20 (1.06, 1.35) 1.00 (-) dpp (0.75, 0.97) Secondary outcome: Death from CV causes dpp (1.16, 1.57) dpp (-) dpp (0.67, 0.92) HHF dpp (0.87, 1.21) dpp (-) dpp (0.73, 1.00) Death from any causes dpp (1.12, 1.47) dpp (-) dpp (0.72, 0.95) P-value < < < decrease (dpp1, <-5 mmhg) Hazard Ratio no change (dpp2, within +/- 5 mmhg) increase (dpp3, >5 mmhg)

15 Baseline PP and Outcomes: Comparison between Sacubitril/valsartan and Enalapril Baseline PP Sacubitril/valsartan : Number of events/number in group (%) Enalapril: Number of events/number in group (%) Hazard Ratio (95% CI) with Enalapril as ref. p-value All patients 911/4169 (21.85%) 1113/4192 (26.55%) 0.81 (0.74, 0.88) < PP1 319/1449 (22.02%) 394/1474 (26.73%) 0.83 (0.72, 0.97) PP2 378/1743 (21.69%) 460/1792 (25.67%) 0.81 (0.71, 0.93) PP3 214/977 (21.9%) 259/926 (27.97%) 0.73 (0.61, 0.87)

16 Changes in PP and Outcomes: Comparison between Sacubitril/valsartan and Enalapril: Change in PP Sacubitril/valsartan : Number of events/number in group (%) Enalapril: Number of events/number in group (%) Hazard Ratio (95% CI) with Enalapril as ref. p-value All patients 715/3894 (18.36%) 853/3846 (22.18%) 0.82 (0.75, 0.91) < dpp1 232/1194 (19.43%) 278/1024 (27.15%) 0.69 (0.58, 0.82) < dpp2 294/1561 (18.83%) 316/1457 (21.69%) 0.86 (0.74, 1.01) dpp3 189/1139 (16.59%) 259/1365 (18.97%) 0.87 (0.72, 1.05)

17 Change in PP between Sacubitril/valsartan and Enalapril in 4 months after Randomization 2 Change in PP (mmhg) (P<0.001) -1 sacubitril/valsartan enalapril

18 Summary In PARADIGM-HF, higher or lower baseline PP was not significantly associated an increase or decrease of the primary endpoint. An increase in PP at month 4 visit was significantly associated with a decrease, and a decrease in PP with an increase in the risk of the primary endpoint. An increase in PP on treatment may indicate a better outcome and a decrease in PP may indicate a worse outcome in patients with HFrEF. Sacubitril/valsartan reduced PP more than enalapril. The effect of sacubitril/valsartan on outcomes was consistent over the range of baseline PP and was irrespective of the change in PP. The benefit of sacubitril/valsartan over enalapril appeared to be more remarkable in patients with a decrease in PP, a subgroup with worse prognosis.

19 Conclusions The risk of outcomes did not vary by PP at baseline in PARADIGM-HF. In contrast, an increase or decrease of PP during treatment may indicate a better or worse outcome in HFrEF, possibly reflecting an improving or worsening of left ventricular function. Sacubitril/valsartan might be better than enalapril in improving arterial stiffness, which might contribute to the better outcomes.

20 謝謝 追求學術卓越 邁向國際一流

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