Iron deficiency treatment in patients with myocardial infarction: an open-label, prospective study of the efficacy of intravenous iron versus oral iron therapy to evaluate the impact on left ventricular systolic function in patients with myocardial infarction (OPERA-MI)

Aim. To determine the efficacy of intravenous ferric carboxymaltose (FCM) compared with oral iron (ferrous sulfate (FS)) on left ventricular (LV) systolic function, assessed by the left ventricular (LV) wall motion score index (WMSI) using echocardiography, in patients with myocardial infarction (MI) and iron deficiency (ID). Material and methods. The study included 322 patients with MI, of whom 199 patients had ID and 123 patients did not. Patients with ID were randomized into 2 groups (FCM and FS therapy). All patients were assessed for LV WMSI and quality of life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) at enrollment and after 3, 6, and 12 months. The follow-up period was 12 months. The primary endpoint was any decrease in LV WMSI over 12 months. Results. Over 12 months, primary endpoint occurred in 53 (53,5%) patients in the FCM group, and in 58 (58%) patients in the FS group, and in 46 (46,5%) patients in the control group without ID (p>0,05). The proportion of patients with a KCCQ score increase by ≥5 points in the FCM group at the 3-month visit was 36,4%, while in the FS group — 18%, and 17,2% of patients in the control group (p=0,002). At all visits, the proportion of patients with a score increase by ≥5 points were significantly higher in the FCM group compared to the FS group. The proportion of patients with a significant increase in the score by ≥10 points was significantly higher in the FCM group at visits 6 (40,4% vs 19% in the FS, p<0,001) and 12 months (45,5% vs 22% in the FS group, p=0,003). Conclusion. Treatment of patients with MI and ID with iron preparations resulted in a similar incidence of primary endpoint in all following groups: FCM group, FS group, and in patients with MI without ID. There was no advantage of any iron preparation. Treatment with FCM was associated with a significant improvement in patients’ quality of life.