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.

中文翻译：

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Vericiguat 全球研究在心力衰竭和射血分数降低患者中的血红蛋白和临床结果 (VICTORIA)

背景：在 VICTORIA 试验（射血分数降低的心力衰竭患者的 Vericiguat 全球研究）中，与安慰剂 (5.7%) 相比，接受 Vericiguat 治疗的患者 (7.6%) 更常发生贫血。我们探讨了 vericiguat、随机化血红蛋白、贫血发展之间的关联，以及 vericiguat 的益处是否与基线血红蛋白相关。方法：贫血被定义为男性血红蛋白 <13.0 g/dL 和女性 <12.0 g/dL（世界卫生组织组织贫血）。还评估了报告为贫血的不良事件。我们评估了血红蛋白和血细胞比容与主要结局（心血管死亡或心力衰竭住院的组合）之间的风险调整关系以及时间更新的血红蛋白与结局的关系。结果：基线时，1719 (3​​5. 7%) 患者患有世界卫生组织贫血症；中位血红蛋白为 13.4 g/L（第 25、75 个百分位：12.1、14.7 g/dL）。在随机分组后 16 周时，1643 名患者患有世界卫生组织贫血（维利呱新出现 284 例，安慰剂出现 219 例），与安慰剂相比，维利呱更常发生这种情况（磷<0.001)。16 周后，在 96 周的随访中血红蛋白没有进一步下降，血红蛋白/血细胞比容的比率保持不变。总体而言，342 名患者 (7.1%) 发生了不良事件贫血。较低的血红蛋白与 vericiguat（相对于安慰剂）对主要结果的治疗益处无关。此外，对时间更新的血红蛋白的分析显示，vericiguat（相对于安慰剂）对主要结局的治疗效果没有关联。结论：随机分组时贫血很常见，较低的血红蛋白与更高频率的临床事件相关。尽管 vericiguat 在 16 周内适度降低血红蛋白，但这种效果没有进一步发展，也​​与 vericiguat 的治疗益处无关。注册：URL：https://www.clinicaltrials.gov：唯一标识符：NCT02861534。