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• W4224242511 abstract "HomeJournal of the American Heart AssociationVol. 11, No. 8Serial, Repeated, or Single Measurements of Natriuretic Peptides (BNP or NT‐proBNP) in Estimating Cardiovascular Risk: Is It the “Importance of Change Over Time” or “The Past Is Good, But the Present Is Better,” or Both, in Clinical Context? Open AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toOpen AccessEditorialPDF/EPUBSerial, Repeated, or Single Measurements of Natriuretic Peptides (BNP or NT‐proBNP) in Estimating Cardiovascular Risk: Is It the “Importance of Change Over Time” or “The Past Is Good, But the Present Is Better,” or Both, in Clinical Context? Wayne L. Miller, MD, PhD Wayne L. MillerWayne L. Miller * Correspondence to: Wayne L. Miller, MD, PhD, Division of Circulatory Failure, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905. E‐mail: E-mail Address: [email protected] https://orcid.org/0000-0002-0863-9509 Division of Circulatory Failure, , Department of Cardiovascular Medicine, , Mayo Clinic, , Rochester, , MN Search for more papers by this author Originally published6 Apr 2022https://doi.org/10.1161/JAHA.122.025294Journal of the American Heart Association. 2022;11:e025294This article is a commentary on the followingRisk Estimates of Imminent Cardiovascular Death and Heart Failure Hospitalization Are Improved Using Serial Natriuretic Peptide Measurements in Patients With Coronary Artery Disease and Type 2 DiabetesOther version(s) of this articleYou are viewing the most recent version of this article. Previous versions: April 6, 2022: Ahead of Print The contribution of measuring plasma concentrations of natriuretic peptides (NPs) NT‐proBNP (N‐terminal pro‐B‐type natriuretic peptide) and BNP (B‐type natriuretic peptide) to aid in diagnosis and cardiovascular risk stratification and guide therapy in patients with heart failure has been well studied. The value of such measurements has also been extended to cohorts of patients without heart failure with coronary artery disease and type 2 diabetes,1, 2 although the clinical uptake for risk assessment in patients with type 2 diabetes has been limited so far. Basic to any discussion of the evolving clinical role of NPs is a persisting issue that brings with it some controversy and ambiguity for the clinician: does a single point‐in‐time measurement of NP provide actionable prognostic and risk stratifying information or is serial NP sampling over time better suited to address this task? Because disease activity changes over time and is variable between patients and within the same patient, repeated NP measurements would be expected to provide the most actionable approach to patient management. Thus, there are studies demonstrating that changes over varying time periods (increases or decreases from baseline values or relative to specified cut‐points) carry high risk stratifying value and aid in reclassifying patients relative to their short‐ or long‐term outcomes.3, 4, 5, 6 However, additional studies support the prognostic value of single samples obtained particularly in the posthospital clinical setting of ambulatory patients.7, 8, 9, 10, 11, 12Highly relevant to this discussion is the importance of the clinical context in which NP measurements are obtained and interpreted. The prognostic value of NPs would be expected to vary whether assessing stable ambulatory low‐ or moderate‐risk patients versus high‐risk patients experiencing or recovering from an acute cardiovascular event where intervening factors such as the presence of atrial fibrillation or worsening renal function may confound the interpretation of NP levels. Additionally, the influence of biological and analytical variability needs to be taken into account.13, 14 Therefore, given that any one NP value or particular cut‐point value will not apply to every patient cohort with differing clinical features, the question may be more properly framed, in a clinical sense, not as which is better but rather what is being asked of the NP data for the patient‐specific clinical context and how do these values apply in real‐world clinical practice where patient follow‐up and testing can be highly variable and not controlled as in the setting of clinical trials.Here is where Wolsk and colleagues in the current issue of the Journal of the American Heart Association (JAHA)15 add to this discussion by providing their findings from a post hoc analysis of data from the ELIXA (Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment with Lixisenatide) trial.16 They assessed the prognostic significance of serial (2 samples, baseline and 6 months) NT‐proBNP and BNP concentrations in a high‐risk ambulatory patient cohort with type 2 diabetes, coronary artery disease, and history of a recent coronary event (within 6 months of study screening). The study intent was to determine the incremental predictive value of 2 serial NP measurements obtained at baseline (time 0) and 6 months and another paired set at 18 and 24 months after study randomization (primary outcome events were determined within a relatively short 6‐month period following NP measurements). This was compared with single point‐in‐time NP measurements obtained at study randomization and at 18 months post randomization (both were considered baseline samples for this aspect of the analysis) with 6‐month follow‐up intervals for determining primary end point events. The study end point was cardiovascular death or heart failure hospitalization. The study cohort contained 5393 patients with 6911 paired samples (1518 patients contributed 2 separate 6‐month observation periods). Six‐month follow‐up intervals were 0 to 6 months from randomization and 18 to 24 months post randomization for the outcome analyses. A total of 136 outcome events occurred—reflecting 2.5% of the cohort with a majority of events (74%) occurring not unexpectedly in the 0 to 6‐month period from randomization.The study findings importantly support a risk stratifying contribution of NP measurements in a cohort of patients without heart failure and, therefore, an incremental value of the results is the association of NP concentrations with short‐term risk in ambulatory patients with coronary artery disease and type 2 diabetes, a high‐risk group. The current study shows that a single NP measurement is highly predictive in the context of short‐term 6‐month follow‐up without an absolute necessity of serial sampling. This is consistent with previously reported data from the same ELIXA trial1 where the median follow‐up time was, however, 26 months showing baseline NP levels alone were as predictive of death as a model of combined standard risk factors. Similar findings were reported from the ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) trial.2 Therefore, having a past NP measurement appears to be of long‐term predictive value. The current data of Wolsk et al., however, provide additional granular insight by demonstrating where serial NP measurements are most helpful and that is to refine the predictive value of a prior or baseline NP sample in the short‐term measurement interval of 6 months, a valuable contribution to patient management. Further, and importantly, the findings demonstrate that the most current NP value was the most informative overall in predicting the 6‐month combined end point—as stated by the authors, “most of the predictive information was provided by the current (most recent) sample.” Past NP measurements are good, but from a practical perspective the most temporally available value is likely going to be most actionable in modifying the patient’s clinical course. Additionally, study findings suggest that NP values older than 6 months diminish in their predictive capacity, which would seem to have the largest impact on the value of serial measurements. Although serial NP measurements refined the predictive risk and reclassified ~50% of patients in this study, a time frame of 6‐month measurement intervals may not conveniently fit with real‐world clinical practice and, therefore, if the predictive value of NP measurements declines as the follow‐up period extends, it becomes more difficult to interpret and integrate the contribution of NP levels with other clinical factors and ongoing events.What can we learn from the post hoc analysis by Wolsk and colleagues? Importantly, their findings point to recognizing that we should be proactive, not reactive, in asking what information we want to gather from NP data and then to ask over what time frame do we expect these data to retain their value. If predictive value diminishes over longer time intervals between NP measurements as would be expected with changes in disease activity particularly in higher risk patients, should we then define serial measurements in terms of short‐term measurement intervals such as 6 months and differentiate these from more remote longer interval repeat NP measurements that effectively function as new single point‐in‐time measurements? Although this issue is yet to be resolved, how does it factor into clinical practice? This again leads to the significance of clinical context in that in low‐risk stable patients based on standard clinical risk factor assessment it may be sufficient to measure a single baseline NP concentration to determine if the patient is in a higher risk group based on NT level and if not or only modestly elevated above an a priori identified cut‐point, then serial values are not likely to be of substantial incremental value. In contrast, in higher risk patients such as the cohort described by Wolsk et al. a baseline NP value would likely support high risk and such patients are likely to have close follow‐up, adjustments in medical therapy or other interventions, or to experience clinical decompensation where short‐interval serial NP values can help assess change in risk (for the better, for the worse, or no change). The most valuable NP measurement, however, in this context is the temporally most current NP value, which helps define the “in‐the‐moment” risk and inform direction for the more immediate plan of management. Finally, the study by Wolsk et al. also reminds us that NPs, whether serial or single point‐in‐time measurements, need to be viewed in the complete context of other clinical factors and not solely as standalone testing. We still have more to learn regarding the optimal use of biomarkers such as the NPs to identify risk where it was not anticipated clinically and most important to guide modifications in therapy and management based upon biomarker values or changes in biomarker values with the ultimate goal of improving outcomes for our patients with cardiovascular disease and threatening comorbidities.DisclosuresNone.Footnotes* Correspondence to: Wayne L. Miller, MD, PhD, Division of Circulatory Failure, Department of Cardiovascular Medicine, Mayo Clinic, 200 First Street, SW, Rochester, MN 55905. E‐mail: miller.[email protected]eduThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.For Disclosures, see page 3.See Article by Wolsk et al.References1 Wolsk E, Claggett B, Pfeffer MA, Diaz R, Dickstein K, Gerstein HC, Lawson FC, Lewis EF, Maggioni AP, McMurray JJV, et al. Role of B‐type natriuretic peptide and N‐terminal prohormone BNP as predictors of cardiovascular morbidity and mortality in patients with a recent coronary event and type 2 diabetes mellitus. J Am Heart Assoc. 2017; 6:e004743. doi: 10.1161/JAHA.116.004743LinkGoogle Scholar2 Malachias MVB, Jhund PS, Claggett BL, Wijkman MO, Bentley‐Lewis R, Chaturvedi N, Desai AS, Haffner SM, Parving H‐H, Prescott MF, et al. NT‐proBNP by itself predicts death and cardiovascular events in high‐risk patients with type 2 diabetes mellitus. J Am Heart Assoc. 2020; 9:e017462. doi: 10.1161/JAHA.120.017462LinkGoogle Scholar3 Masson S, Latini R, Anand IS, Barlera S, Angelici L, Vago T, Tognoni G, Cohn JN. Prognostic value of changes in N‐terminal pro‐brain natriuretic peptide in Val‐HeFT (Valsartan Heart Failure Trial). J Am Coll Cardiol. 2008; 52:997–1003. doi: 10.1016/j.jacc.2008.04.069CrossrefMedlineGoogle Scholar4 Latini R, Masson S, Wong M, Barlera S, Carretta E, Staszewsky L, Vago T, Maggioni AP, Anand IS, Tan LB, et al.; for the Val‐HeFT Investigators . Incremental prognostic value of changes in B‐type natriuretic peptide in heart failure. Am J Med. 2006; 119:70.e23–70.e30. doi: 10.1016/j.amjmed.2005.08.041CrossrefGoogle Scholar5 Miller WL, Hartman KA, Burritt MF, Grill DE, Rodeheffer RJ, Burnett JC, Jaffe AS. Serial biomarker measurements in ambulatory patients with chronic heart failure: the importance of change over time. Circulation. 2007; 116:249–257. doi: 10.1161/CIRCULATIONAHA.107.694562LinkGoogle Scholar6 deFilippi CR, Christenson RH, Gottdiener JS, Kop WJ, Seliger SL. Dynamic cardiovascular risk assessment in elderly people. The role of repeated N‐terminal pro‐B‐type natriuretic peptide testing. J Am Coll Cardiol. 2010; 55:441–450. doi: 10.1016/j.jacc.2009.07.069CrossrefMedlineGoogle Scholar7 Bettencourt P, Azevedo A, Pimenta J, Frioes F, Ferreira S, Ferreira A. N‐terminal‐pro‐brain natriuretic peptide predicts outcome after hospital discharge in heart failure patients. Circulation. 2004; 110:2168–2174. doi: 10.1161/01.CIR.0000144310.04433.BELinkGoogle Scholar8 O’Brien RJ, Squire IB, Demme B, Davies JE, Ng LL. Pre‐discharge, but not admission, levels of NT‐proBNP predict adverse prognosis following acute LVF. Eur J Heart Fail. 2003; 5:499–506. doi: 10.1016/S1388‐9842(03)00098‐9CrossrefMedlineGoogle Scholar9 Clerico A, Emdin M. Diagnostic accuracy and prognostic relevance of the measurement of cardiac natriuretic peptides: a review. Clin Chem. 2004; 50:33–50. doi: 10.1373/clinchem.2003.024760CrossrefMedlineGoogle Scholar10 Ishii J, Nomura M, Nakamura Y, Naruse H, Mori Y, Ishikawa T, Ando T, Kurokawa H, Kondo T, Nagamura Y, et al. Risk stratification using a combination of cardiac troponin T and brain natriuretic peptide in patients hospitalized for worsening chronic heart failure. Am J Cardiol. 2002; 89:691–695. doi: 10.1016/S0002‐9149(01)02341‐4CrossrefMedlineGoogle Scholar11 Wang TJ, Larson MG, Levy D, Benjamin EJ, Leip EP, Omland T, Wolf PA, Vasan RS. Plasma natriuretic peptide levels and the risk of cardiovascular events and death. N Engl J Med. 2004; 350:655–663. doi: 10.1056/NEJMoa031994CrossrefMedlineGoogle Scholar12 de Lemos JA, Morrow DA, Bentley JH, Omland T, Sabatine MS, McCabe CH, Hall C, Cannon CP, Braunwald E. The prognostic value of B‐type natriuretic peptide in patients with acute coronary syndromes. N Engl J Med. 2001; 345:1014–1021. doi: 10.1056/NEJMoa011053CrossrefMedlineGoogle Scholar13 Miller WL, Hartman KA, Grill DE, Burnett JC, Jaffe AS. Only large reductions in natriuretic peptide concentrations (BNP and NT‐proBNP) are associated with improved outcomes in ambulatory patients with chronic heart failure. Clin Chem. 2009; 55:78–84. doi: 10.1373/clinchem.2008.108928CrossrefMedlineGoogle Scholar14 O’Hanlon R, O’Shea P, Ledwidge M, O’Loughlin C, Lange S, Conlon C, Phelan D, Cunningham S, McDonald K. The biologic variability of B‐type natriuretic peptide and N‐terminal pro‐B‐type natriuretic peptide in stable heart failure patients. J Card Fail. 2007; 13:50–55. doi: 10.1016/j.cardfail.2006.09.003CrossrefMedlineGoogle Scholar15 Wolsk E, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber L, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, et al. Risk estimates of imminent cardiovascular death and heart failure hospitalization are improved using serial natriuretic peptide measurements in patients with coronary artery disease and type 2 diabetes. J Am Heart Assoc. 2022; 11:e021327. doi: 10.1161/JAHA.121.021327LinkGoogle Scholar16 Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, et al. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. N Engl J Med. 2015; 373:2247–2257. doi: 10.1056/NEJMoa1509225CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesRisk Estimates of Imminent Cardiovascular Death and Heart Failure Hospitalization Are Improved Using Serial Natriuretic Peptide Measurements in Patients With Coronary Artery Disease and Type 2 DiabetesEmil Wolsk, et al. Journal of the American Heart Association. 2022;11 April 19, 2022Vol 11, Issue 8Article InformationMetrics Copyright © 2022 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.122.025294PMID: 35383469 Originally publishedApril 6, 2022 Keywordsnatriuretic peptide measurementsprognosisrisk managementeditorialsclinical contextPDF download SubjectsBiomarkersClinical Studies" @default.
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• W4224242511 title "Serial, Repeated, or Single Measurements of Natriuretic Peptides (BNP or NT‐proBNP) in Estimating Cardiovascular Risk: Is It the “Importance of Change Over Time” or “The Past Is Good, But the Present Is Better,” or Both, in Clinical Context?" @default.
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