Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA) - Archive ouverte HAL Access content directly
Journal Articles Circulation Year : 2023

Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA)

(1) , (1) , (2, 3) , (4) , (5) , (6) , (7) , (8) , (7, 9) , (10, 11) , (12) , (13) , (9) , (1) , (14) , (15) , (1)
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Adrian F Hernandez
Adriaan A Voors
Cynthia M Westerhout
Paul W Armstrong

Abstract

Background: In the VICTORIA trial (Vericiguat Global Study in Patients with Heart Failure with Reduced Ejection Fraction), anemia occurred more often in patients treated with vericiguat (7.6%) than with placebo (5.7%). We explored the association between vericiguat, randomization hemoglobin, development of anemia, and whether the benefit of vericiguat related to baseline hemoglobin. Methods: Anemia was defined as hemoglobin <13.0 g/dL in men and <12.0 g/dL in women (World Health Organization Anemia). Adverse events reported as anemia were also evaluated. We assessed the risk-adjusted relationship between hemoglobin and hematocrit with the primary outcome (composite of cardiovascular death or heart failure hospitalization) and the time-updated hemoglobin relationship to outcomes. Results: At baseline, 1719 (35.7%) patients had World Health Organization anemia; median hemoglobin was 13.4 g/L (25th, 75th percentile: 12.1, 14.7 g/dL). At 16 weeks from randomization, 1643 patients had World Health Organization anemia (284 new for vericiguat and 219 for placebo), which occurred more often with vericiguat than placebo (P<0.001). After 16 weeks, no further decline in hemoglobin occurred over 96 weeks of follow-up and the ratio of hemoglobin/hematocrit remained constant. Overall, adverse event anemia occurred in 342 patients (7.1%). A lower hemoglobin was unrelated to the treatment benefit of vericiguat (versus placebo) on the primary outcome. In addition, analysis of time-updated hemoglobin revealed no association with the treatment effect of vericiguat (versus placebo) on the primary outcome. Conclusions: Anemia was common at randomization and lower hemoglobin was associated with a greater frequency of clinical events. Although vericiguat modestly lowered hemoglobin by 16 weeks, this effect did not further progress nor was it related to the treatment benefit of vericiguat. Registration: URL: https://www.clinicaltrials.gov: Unique identifier: NCT02861534.
Embargoed file
Embargoed file
Ne sera jamais visible

Dates and versions

inserm-03934690 , version 1 (11-01-2023)

Identifiers

Cite

Justin A Ezekowitz, Yinggan Zheng, Alain Cohen-Solal, Vojtěch Melenovský, Jorge Escobedo, et al.. Hemoglobin and Clinical Outcomes in the Vericiguat Global Study in Patients With Heart Failure and Reduced Ejection Fraction (VICTORIA). Circulation, 2023, 144 (18), pp.1489 - 1499. ⟨10.1161/circulationaha.121.056797⟩. ⟨inserm-03934690⟩
0 View
0 Download

Altmetric

Share

Gmail Facebook Twitter LinkedIn More