252Cardiovascular and renal outcomes in iron-deficient patients with HFrEF and renal dysfunction treated with i.v. ferric carboxymaltose: An individual patient data meta-analysis

Abstract

Background: The combination of heart failure (HF) and renal dysfunction carries an unfavorable prognosis for progression of both conditions which may be exacerbated by iron deficiency (ID). Purpose: To examine cardiac and renal outcomes following i.v. iron therapy with ferric carboxymaltose (FCM) in iron‐deficient patients with HF and reduced ejection fraction (HFrEF) and renal dysfunction. Methods: An individual patient data meta‐analysis was performed, based on 4 randomized, double‐blind trials comparing i.v. FCM vs placebo, each of 12‐52 weeks' duration. Analyzed patients were ambulatory HFrEF patients (NYHA class II/III) with ID and estimated GFR (eGFR, CKD‐EPI) <60mL/min/1.73m2. Rates of events were calculated per 100 patient years and analyzed using a log‐link negative binomial regression model. Results: The analysis included 372 patients (FCM 216, placebo 156; 194 males). Mean baseline values were age 72 years, LVEF 33%, ferritin 62ng/mL, TSAT 17.7%, Hb 12.0g/dl. Rate ratios (RR) were significantly lower with FCM vs placebo for cardiovascular (CV) hospitalization and CV death, hospitalization for any CV reason or any death, hospitalization for any CV reason and hospitalization for worsening HF all‐cause mortality was similar (Figure). Mean baseline eGFR was 43mL/min/1.73m2 in both groups. The mean (SE) change in eGFR from baseline was improved in the FCM group versus placebo: the change was 1.2 (1.2) mL/min/1.73m2 higher in the FCM group vs placebo at week 4 (p=0.333), 2.1 (1.5) mL/min/1.73m2 higher at week 12 (p=0.157) and 1.6 (1.4)mL/min/1.73m2 higher at week 24 (p=0.241) (least square values). Median hospital stay due to worsening HF was 8.5 vs 13 days with FCM vs placebo, respectively. The incidence of adverse events, and study drug‐related adverse events leading to study drug withdrawal, was similar between groups (both calculated per 100 patient years). Conclusions: Ambulatory, iron‐deficient HFrEF patients with renal dysfunction experience improved outcomes, fewer days in hospital for worsening HF following iron therapy with i.v. FCM. (Figure Presented).