Evolution of NT-proBNP During Prerandomization Screening in VICTORIA: Implications for Clinical Outcomes and Efficacy of Vericiguat-Reference-Cited by-同舟云学术

Evolution of NT-proBNP During Prerandomization Screening in VICTORIA: Implications for Clinical Outcomes and Efficacy of Vericiguat

Published:2023-10 Issue:10 Volume:16 Page:
ISSN:1941-3289
Container-title:Circulation: Heart Failure
language:en
Short-container-title:Circ: Heart Failure

Author:

Armstrong Paul W.¹^ORCID,Zheng Yinggan¹,Lund Lars H.²^ORCID,Butler Javed³^ORCID,Troughton Richard W.⁴^ORCID,Emdin Michele⁵^ORCID,Lam Carolyn S.P.⁶^ORCID,Ponikowski Piotr⁷^ORCID,Blaustein Robert O.⁸,O’Connor Christopher M.⁹,Roessig Lothar¹⁰,Voors Adriaan A.¹¹^ORCID,Ezekowitz Justin A.¹^ORCID,Westerhout Cynthia M.¹^ORCID,

Affiliation:

1. Canadian VIGOUR Centre, University of Alberta, Edmonton, AB, Canada (P.W.A., Y.Z., J.A.E., C.M.W.).

2. Karolinska Institutet and Karolinska University Hospital, Stockholm, Sweden (L.H.L.).

3. Baylor Scott and White Research Institute, Dallas, TX (J.B.).

4. University of Otago, Christchurch, New Zealand (R.W.T.).

5. Health Science Interdisciplinary Center, Scuola Superiore Sant’Anna, Pisa, Italy (M.E.).

6. National Heart Centre Singapore and Duke-National University of Singapore (C.S.P.L.).

7. Wroclaw Medical University, Poland (P.P.).

8. Merck & Co Inc, Rahway, NJ (R.O.B.).

9. Innova Heart and Vascular Institute, Falls Church, VA (C.M.O.).

10. Bayer AG, Wuppertal, Germany (L.R.).

11. Department of Cardiology, University of Groningen, University Medical Center of Groningen, the Netherlands (A.A.V.).

Abstract

BACKGROUND: Selecting high-risk patients with heart failure with potentially modifiable cardiovascular events is a priority. Our objective was to evaluate NT-proBNP (N-terminal pro-B-type natriuretic peptide) changes during a 30-day screening to establish (1) the frequency and direction of changes; (2) whether a relationship exists between changes in NT-proBNP and the primary composite outcome of cardiovascular death and heart failure hospitalization; and (3) whether changes in NT-proBNP relate to vericiguat’s clinical benefit. METHODS: VICTORIA (A Study of Vericiguat in Participants With Heart Failure With Reduced Ejection Fraction) randomized 5050 patients with heart failure with reduced ejection fraction and a recent worsening heart failure event. We studied 3821 patients who had NT-proBNP measured during screening and at randomization. RESULTS: Sixteen hundred exhibited a >20% reduction, 1412 had ≤20% change, and 809 showed a >20% rise in NT-proBNP levels. As compared with the primary composite outcome of 28.4/100 patient-years (497 events; 31.1%) in patients with a >20% decline in NT-proBNP, those with >20% during screening had worse outcomes; 48.8/100 patient-years (359 events; 44.4%); adjusted hazard ratio, 1.61 (95% CI, 1.39–1.85). Those patients with a ≤20% change in NT-proBNP had intermediate outcomes; 39.2/100 patient-years (564 events; 39.9%); adjusted hazard ratio, 1.33 (95% CI, 1.17–1.51). No relationship existed between NT-proBNP changes during screening and vericiguat’s effect on cardiovascular death and heart failure hospitalization. CONCLUSIONS: Substantial differences occurred in the rates of cardiovascular death and heart failure hospitalization, especially in patients with a >20% change in NT-proBNP levels during screening interval. Sequential NT-proBNP levels add important prognostic information meriting consideration in future heart failure trials. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02861534.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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