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

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.

• Authors: Justin A Ezekowitz, Yinggan Zheng, Alain Cohen-Solal, Vojtěch Melenovský, Jorge Escobedo, Javed Butler, Adrian F Hernandez, Carolyn S P Lam, Christopher M O'Connor, Burkert Pieske, Piotr Ponikowski, Adriaan A Voors, Christopher deFilippi, Cynthia M Westerhout, Ciaran McMullan, Lothar Roessig, Paul W Armstrong
• Journal: Circulation (Circulation) Vol. 144 Issue 18 Pg. 1489-1499 (11 02 2021) ISSN: 1524-4539 [Electronic] United States
• PMID: 34432985 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Hemoglobins

Topics

• Aged
• Female
• Heart Failure (epidemiology, therapy)
• Hemoglobins (metabolism)
• Humans
• Male
• Stroke Volume
• Treatment Outcome
• World Health Organization