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NT-proBNP as the gold standard biomarker in heart failure and a strong predictor of Cardiovascular risk in Type 2 diabetes mellitus (T2DM)

What is NT-proBNP?



NT-proBNP has been used in HF for over 15 years, and is considered the gold standard for testing in HF disease management.2


NT-proBNP also has an emerging and impactful use in T2DM patients, who are at an increased risk of CVD complications.3-6

Natriuretic peptides, including NT-proBNP, are produced within cardiomyocytes in response to stress, and are released after clinical triggers.1

International guidelines recommend the use of NT-proBNP for HF management

  Diagnosis of HF In-hospital management of HF Disease monitoring of chronic HF
Acute HF Chronic HF At admission At discharge
Patient profile and setting Patients presenting dyspnea in the ED Patients presenting dyspnea in ambulatory setting Acute hospitalized HF patients Patients with chronic HF in outpatient
setting
Clinical utility To rule out AHF in patients with lower levels and
rule in AHF
in patients
with higher levels		 To provide
incremental value
to clinical judgement when
the cause is unclear		 To establish
prognosis and
identification of patients with greater
risk of adverse
outcomes		 To aid discharge planning
and optimization of
GDMT to avoid early readmission		 To monitor patients’
condition to improve
outcomes
ACC/AHA 20227 Recommended (Class 1) Recommended
(Class 1)		 Can be useful
(Class 2a)		 Recommended
(Class 1)
ESC 20218 Recommended (Class I) Recommended (Class I) Recommended (Class I) Recommended (Class I) N/A
  Diagnosis of HF
Acute HF Chronic HF
Patient profile and
setting
 Patients presenting
dyspnea in the ED		 Patients presenting
dyspnea in
ambulatory setting
Clinical utility
 To rule out AHF in
patients with lower
levels and rule in AHF
in patients
with higher levels
 To provide
incremental value
to clinical judgement
when the cause is
unclear
ACC/AHA 20227 Recommended (Class 1)
ESC 20218 Recommended (Class I) Recommended
(Class I)


  In-hospital
management of HF
At admission At discharge
Patient profile and
setting		 Acute hospitalized
HF patients
Clinical utility To establish
prognosis and identification
of patients with greater
risk of adverse
outcomes		 To aid discharge
planning and
optimization of
GDMT
to avoid earlyreadmission
ACC/AHA 20227 Recommended
(Class 1)		 Can be useful
(Class 2a)
ESC 20218 Recommended (Class I) Recommended (Class I)


  Disease monitoring
of chronic HF
Patient profile and
setting		 Patients with chronic
HF in outpatient
setting
Clinical utility To monitor patients’
condition to improve
outcomes
ACC/AHA 20227 Recommended
(Class 1)
ESC 20218 N/A

NT-proBNP is a valuable initial diagnostic test for HF diagnosis

Interpretation of NT-proBNP results in patients presenting

in non-acute setting9-13

 

Roche NT-proBNP

<125pg/mL HF unlikely,

consider other diagnoses

Roche NT-proBNP

Roche NT-proBNP

>125pg/mL

HF likely,
perform

echocardiography to
confirm the diagnosis
of HF

Interpretation of NT-proBNP results in patients presenting

in non-acute setting9-13

 

Roche NT-proBNP

 

Roche NT-proBNP

<125pg/mL HF unlikely,

consider other diagnoses

Roche NT-proBNP

>125pg/mL

HF likely,
perform

echocardiography to
confirm the diagnosis
of HF

 

Interpretation of NT-proBNP results in patients presenting
in acute setting10,14,15

 

HF unlikely

Roche NT-proBNP

< 300pg/mL

Search for other symptoms

Grey zone*

Roche NT-proBNP

>300pg/mL but under

“rule-in” cut-offs

Diagnosis by imaging

HF Likely

Roche NT-proBNP

>450pg/mL if <50 years

>900pg/mL if 50–75 years

>1,800pg/mL if >75 years


 

*Results in the grey zone have to be interpreted in the clinical context as other causes beyond HF can lead to elevation of natriuretic peptides.23

  • In the acute setting, higher natriuretic peptides values should be used.10
  • Roche NT-proBNP is the only clinically validated biomarker with age specific cut-offs which helps improve the specificity and the accuracy of diagnosing HF in patients presenting acute dyspnea in the ED.14,15

NT-proBNP is a useful prognostic biomarker to assess disease severity at admission and support discharge planning in hospital settings

 
NT-proBNP should be checked at least twice at admission and before discharge16
>5,000 pg/mL

A single value of NT-proBNP >5,000pg/mL in HF patients predicts a greater risk of mortality and poor outcomes16

≥30% reduction

The reduction of NT-proBNP levels ≥30% between admission and discharge predicts better clinical outcomes16

 



NT-proBNP concentration >5,180pg/mL was strongly predictive of death by 76 days15

 

Risk stratification in dyspneic patients to ED

Adapted from Januzzi JL, et al. 2006.

 
 

Mortality twice as high in patients with reduction ≤30% vs. >30% between admission and discharge17


Kaplan–Meier curves for all-cause mortality and composite endpoint at 180 days according to the dichotomized NT-proBNP percentage reduction during hospitalization


 

 NT-proBNP reduction during hospitalization >30%

 NT-proBNP reduction during hospitalization ≤30%

Adapted from Salah K, et al. 2014.

 

NT-proBNP can be used to monitor disease progression or
patient improvement in out-patient setting

NT-proBNP value >1,000pg/mL indicates an increased risk of death or hospitalization16
 

A baseline value of NT-proBNP is needed for a new HF patient in cltinic.16 Rechecking NT-proBNP after adequate treatment is suggested16

For patients whose NT-proBNP level remain ≥1,000pg/mL after treatment, the medication for HF should be optimized, comorbidities and other reasons should be investigated16




Risk of primary endpoint if NT-proBNP value of 1,000pg/mL achieved or not achieved 1 month after randomization18

 

Adapted from Zile MR, et al. 2016.

Patients who achieved a NT-proBNP level of ≤1,000pg/mL in 1 month was associated with around 50% better CV outcomes at the 3-year follow-up 18


• Primary endpoint: the first occurrence of CV death or HF hospitalization

 
 

Effects on the risk of primary endpoint if NT-proBNP changed from baseline to 1 month after randomization*18



*Levels of NT-proBNP were measured at baseline and at 1 month **HH means that the NT-proBNP levels were both >1,000pg/mL at baseline and 1 month

HR and 95% CI for each category with HH serving as a reference18



Adapted from Zile MR, et al. 2016.

 
When using NT-proBNP for serial monitoring, change of NT-proBNP level was a significant predictor of CV death or HF hospitalization18

Roche NT-proBNP has been clinically validated to support your clinical decision making at every stage of care in HF17,19,20

 

 

There are differences in assay design (reagent antibody and methodology) and calibration method22

Not all NT-proBNP assays are the same and the result obtained from different assays are not transferable 21


 

 

With over 15 years of evidence generation and proven clinical use, you can trust Roche NT-proBNP.

 

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    Abbreviations: ACC: American College of Cardiology; AHA: American Heart Association; AHF: Acute heart failure; APAC: Asia-Pacific; ARNi: Angiotensin receptor-neprilysin inhibitor; CI: Confidence interval; CV: Cardiovascular; CVD: Cardiovascular disease; ED: Emergency department; ESC: European Society of Cardiology; GDMT: Guideline-directed medical therapy; HF: Heart failure; HFA: Heart Failure Association; HFrEF: Heart failure with reduced ejection fraction; HH: High-high; HL: High-low; HR: Hazard ratio; LH: Low-high; LL: Low-low; NT-proBNP: N terminal pro B type natriuretic peptide; N/A: Not available; NYHA: New York Heart Association; T2DM: Type 2 diabetes mellitus

     

    References:

    1. Weber M, Hamm C. Role of B-type natriuretic peptide (BNP) and NT-proBNP in clinical routine. Heart. 2006;92(6):843-849. doi:10.1136/hrt.2005.071233. 
    2.  McKie PM, Burnett JC Jr. NT-proBNP: The Gold Standard Biomarker in Heart Failure. J Am Coll Cardiol. 2016;68(22):2437-2439. doi:10.1016/j.jacc.2016.10.001. 
    3. Huelsmann M, et al. NT-proBNP has a high negative predictive value to rule-out short-term cardiovascular events in patients with diabetes mellitus. Eur Heart J. 2008;29(18):2259-2264. doi:10.1093/eurheartj/ehn334. 
    4. Huelsmann M, et al. PONTIAC (NT-proBNP selected prevention of cardiac events in a population of diabetic patients without a history of cardiac disease): a prospective randomized controlled trial. J Am Coll Cardiol. 2013;62(15):1365-1372. doi:10.1016/j.jacc.2013.05.069. 
    5. Scirica BM, et al. Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial [published correction appears in Circulation. 2015 Oct 13;132(15):e198]. Circulation. 2014;130(18):1579-1588. doi:10.1161/ CIRCULATIONAHA.114.010389. 
    6. Einarson TR, et al. Prevalence of cardiovascular disease in type 2 diabetes: a systematic literature review of scientific evidence from across the world in 2007-2017. Cardiovasc Diabetol. 2018;17(1):83. Published 2018 Jun 8. doi:10.1186/s12933-018-0728-6.
    7. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines [published correction appears in Circulation. 2022 May 3;145(18):e1033]. Circulation. 2022;145(18):e895-e1032. doi:10.1161/CIR.0000000000001063. 
    8. McDonagh TA, et al. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure [published correction appears in Eur Heart J. 2021 Oct 14;:]. Eur Heart J. 2021;42(36):3599-3726. doi:10.1093/eurheartj/ehab368.
    9. Rutten et al. https://ipccs.org/2017/12/10/epccs-practical-guidance-on-heart-failurediagnosis-and-management-in-primary-care/ (Accessed May 24 2022).
    10. Ponikowski P, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016;18(8):891-975. doi:10.1002/ejhf.592.
    11. Taylor CJ, et al. Primary care REFerral for EchocaRdiogram (REFER) in heart failure: a diagnostic accuracy study. Br J Gen Pract. 2017;67(655):e94-e102. doi:10.3399/bjgp16X688393. 
    12. Taylor et al. (2017). Efficacy and Mechanism Evaluation, No. 4.3. National Institute for Health Research. ISSN 2050-4365. 
    13. Hildebrandt P, Collinson PO, Doughty RN, et al. Age-dependent values of N-terminal pro-B-type natriuretic peptide are superior to a single cut-point for ruling out suspected systolic dysfunction in primary care. Eur Heart J. 2010;31(15):1881-1889. doi:10.1093/eurheartj/ehq163. 
    14.  Januzzi JL Jr, et al. N-Terminal Pro-B-Type Natriuretic Peptide in the Emergency Department: The ICON-RELOADED Study. J Am Coll Cardiol. 2018;71(11):1191-1200. doi:10.1016/j.jacc.2018.01.021.
    15. Januzzi JL, et al. NT-proBNP testing for diagnosis and short-term prognosis in acute destabilized heart failure: an international pooled  analysis of 1256 patients: the International Collaborative of NT-proBNP Study. Eur Heart J. 2006;27(3):330-337. doi:10.1093/eurheartj/ehi631.
    16. Lam CSP, et al. The role of N-terminal pro-B-type natriuretic peptide in prognostic evaluation of heart failure. J Chin Med Assoc. 2019;82(6):447-451. doi:10.1097/JCMA.0000000000000102.
    17. Salah K, et al. A novel discharge risk model for patients hospitalised for acute decompensated heart failure incorporating N-terminal pro-B-type natriuretic peptide levels: a European coLlaboration on Acute decompensated Heart Failure: ELAN-HF Score. Heart.  2014;100(2):115-125. doi:10.1136/heartjnl-2013-303632.\
    18. Zile MR, et al. Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure. J Am Coll Cardiol. 2016;68(22):2425-2436. doi:10.1016/j.jacc.2016.09.931.
    19. Bettencourt P, et al. N-terminal-pro-brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004;110(15):2168-2174. doi:10.1161/01.CIR.0000144310.04433.BE. 
    20. Stienen S, et al. Challenging the two concepts in determining the appropriate pre-discharge N-terminal pro-brain natriuretic peptide  treatment target in acute decompensated heart failure patients: absolute or relative discharge levels?. Eur J Heart Fail. 2015;17(9):936-944.  doi:10.1002/ejhf.320.
    21. Collin-Chavagnac D, et al. Head-to-head comparison of 10 natriuretic peptide assays. Clin Chem Lab Med. 2015;53(11):1825-1837. doi:10.1515/cclm-2014-0592. 
    22. BNP, NT-proBNP, and MR-proANP Assays: Analytical Characteristics Designated by Manufacturer IFCC Committee on Clinical Applications of Cardiac Bio-Markers (C-CB) v082318. 
    23. Kimmenade RRJ, et al. Usefulness of intermediate amino-terminal pro-brain natriuretic peptide concentrations for diagnosis and prognosis of acute heart failure. Am J Cardiol. 2006;98(3):386-390.

    MAP-2023-JUL-001

    NT-proBNP is a stronger predictor of CV event or death for T2DM patients over HbA1c and albuminuria1,2

    NT-proBNP vs. HbA1c1

    Endpoint NT-proBNP HbA1c
    HR (CI) p value HR (CI) p value
    All-cause
    mortality    		 1.0010
    (1.0005–1.0014)    		 <0.001 1.0028
    (0.7415–1.3562)    		 N.S.
    CV-
    hospitalization    		 1.0006
    (1.0003-1.0009)    		 <0.001 1.1393
    (0.9538-1.3609)    		 N.S.
      HIGHLY
    predictive
    at baseline and
    follow-up    		 NO
    predictive
    value

    Adapted from Neuhold S, et al. 2011.

    NT-proBNP vs. Albuminuria2

    Assessing the CV risk of T2DM patients with biomarker NT-proBNP in 125pg/mL cut-off3

     
     

    NT-proBNP cut-off of 125pg/mL for evaluating HF risk in selected T2DM patients4,5

    Clinical trials have shown that NT-proBNP cut-off of 125pg/mL has good

    discrimination ability in selected T2DM patients with history or at high risk for CV events.4,5

    CANVAS Study4

    Substantial overlap was observed at NT-proBNP levels >125pg/mL in patients with and without history of HF

    Higher risk of CV events observed in patients with NT-proBNP ≥125pg/mL

    MACE

    2.27x
    (95% CI: 1.69, 3.05)

    HFH

    5.40x
    (95% CI: 2.67, 10.9)

    HFH/CV death

    3.52x
    (95% CI: 2.38-5.20)

    DECLARE-TIMI 58 Study5

    Substantially higher event rates of CV/HFH observed in patients with NT-proBNP levels ≤125pg/mL


    Elevated NT-proBNP level strongly predicts HF events in T2DM patients6

    A sharp increase in NT-proBNP levels can be detected as early as 6 months

    before HF hospitalization, regardless of previous history of HF.6

    asset 23
    asset 24

    International guidelines recognize the prognostic value of NT-proBNP in DM patients7

     

    2022 AHA/ACC/HFSA Guideline

    In the patient at risk of developing HF, BNP or NT-proBNP-based screening followed by team-based care, a CV specialist, can be useful to prevent the development of LV dysfunction or new-onset HF.7

     

     
    Consensus document by the HFA of the ESC

    Proposed algorithm for screening at the risk for HF8

    Asymptomatic subjects with conditions predisposing to HF
    (e.g., hypertension or diabetes)

     

    Useful Resources

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      Abbreviations: AHA/ACC/HFSA: American Heart Association/American College of Cardiology/Heart Failure Society of America; BNP: B type natriuretic peptide; CI: Confidence interval; CV: Cardiovascular; CVD: Cardiovascular disease; DM: Diabetes mellitus; ESC: European College of Cardiology; HbA1c: Hemoglobin A1c; HF: Heart failure; HFA: Heart Failure Association; HFH: Heart failure hospitalization; HR: Hazard ratio; hs: High sensitivity; LV: Left ventricular; MACE: Major adverse cardiac events; N.S.: Not significant; NP: natriuretic peptide; NT-proBNP: N terminal pro B type natriuretic peptide; TTE: Transthoracic echocardiogram; T2DM: Type 2 diabetes mellitus; URL: Upper reference limit. 

      References:

      1. Neuhold S, et al. Eur J Clin Invest. 2011;41:1292-1298. 
      2. Clodi M, et al. Eur. J. Prev. Cardiol. 2011;19:944-951. 
      3. Huelsmann M, et al. Eur Heart J. 2008;29(18):2259-2264. doi:10.1093/eurheartj/ehn334. 
      4. Januzzi J, et al. J Am Coll Cardiol. 2020;76:2076–85. 
      5. Zelniker TA, et al. European Journal of Heart Failure. 2021;23:1026-1036.
      6. Wolsk E, et al. Circulation. 2017;136:1560-1562. doi:10.1161/CIRCULATIONAHA.117.029503.
      7. Heidenreich PA, et al. 2022 AHA/ACC/HFSA Guideline for the management of heart failure: A report of the American College of  Cardiology/American Heart Association/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation.  2022145:e895-e1032.
      8. Moura B, et al. European Journal of Heart Failure. 2021;23:1577–1596. doi:10.1002/ejhf.2339.

      MAP-2023-JUL-001