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

• Published in: Circulation (New York, N.Y.) Vol. 144; no. 18; pp. 1489 - 1499
• Main Authors: Ezekowitz, Justin A, Zheng, Yinggan, Cohen-Solal, Alain, Melenovský, Vojtěch, Escobedo, Jorge, Butler, Javed, Hernandez, Adrian F, Lam, Carolyn S P, O'Connor, Christopher M, Pieske, Burkert, Ponikowski, Piotr, Voors, Adriaan A, deFilippi, Christopher, Westerhout, Cynthia M, McMullan, Ciaran, Roessig, Lothar, Armstrong, Paul W
• Format: Journal Article
• Language: English
• Published: United States American Heart Association 02.11.2021
• Subjects: Aged; Cardiology and cardiovascular system; Female; Heart Failure - epidemiology; Heart Failure - therapy; Hemoglobins - metabolism; Human health and pathology; Humans; Life Sciences; Male; Stroke Volume; Treatment Outcome; World Health Organization; hemoglobins; heart failure; vericiguat; anemia
• ISSN: 0009-7322; 1524-4539
• DOI: 10.1161/CIRCULATIONAHA.121.056797

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. 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. 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 ( <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. 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.