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Cardiovascular hospitalisation and death by subgroup in iron-deficient patients with heart failure treated with intravenous ferric carboxymaltose: an individual patient meta-analysis.

Session Can we teach heart failure drugs new tricks?

Speaker Stefan Anker

Event : ESC Congress 2017

  • Topic : cardiovascular pharmacology
  • Sub-topic : Pharmacology and Pharmacotherapy
  • Session type : Rapid Fire Abstracts

Authors : S D Anker (Gottingen,DE), M Boehm (Homburg/Saar,DE), J Comin-Colet (Barcelona,ES), G Filippatos (Athens,GR), B Roubert (Glattbrugg,CH), DJ Van Veldhuisen (Groningen,NL), P Ponikowski (Wroclaw,PL)

S.D. Anker1 , M. Boehm2 , J. Comin-Colet3 , G. Filippatos4 , B. Roubert5 , D.J. Van Veldhuisen6 , P. Ponikowski7 , 1University Medical Center Gottingen (UMG), Cardiology & Pneumology - Gottingen - Germany , 2University of the Saarland, Internal Medicine and Cardiology - Homburg/Saar - Germany , 3University Hospital of Bellvitge, Cardiology - Barcelona - Spain , 4Athens University Hospital Attikon, Heart Failure Unit - Athens - Greece , 5Vifor Pharma, Biometry - Glattbrugg - Switzerland , 6University Medical Center Groningen, Cardiology - Groningen - Netherlands , 7Military Hospital of Wroclaw, Heart Disease - Wroclaw - Poland ,

European Heart Journal ( 2017 ) 38 ( Supplement ), 44

Background: Treatment with intravenous (i.v.) iron as ferric carboxymaltose (FCM) has been shown to reduce the rate of cardiovascular (CV) hospitalisation and CV death in an individual patient data meta-analysis of patients with heart failure with reduced ejection fraction (HFrEF) and iron deficiency (ID). The impact of these outcomes for treatment with FCM vs placebo on key subgroups is unknown.

Purpose: To examine the rates of CV hospitalisation and CV death in subgroups for patients treated with FCM vs placebo.

Methods: An individual patient data meta-analysis was performed, based on 4 randomised, double-blind trials comparing i.v. FCM vs placebo, each of 12–52 weeks duration. Patients were analysed by age, gender, left ventricular ejection fraction (LVEF), anaemic status, transferrin saturation (TSAT) value, estimated glomerular filtration rate (eGFR), aetiology of heart failure (HF), history of diabetes, and New York Heart Association (NYHA) class at baseline. Rates of events were calculated per 100 patient years and analysed using a log-link negative binomial regression model.

Results: The analysis included 839 patients, 504 on FCM vs 335 on placebo. Rates of CV hospitalisation or CV death numerically favoured treatment with FCM in all subgroups except TSAT ≥20 with significant differences observed in patients who were ≥70 years, male, LVEF <34%, haemoglobin <12.0 g/dL, TSAT <20.0%, had renal dysfunction, HF of ischaemic aetiology, negative history of diabetes or NYHA class ≥III. (Table).

Conclusions: In patients with HFrEF and ID, treatment with i.v. FCM improves the rate of CV hospitalisation and CV death across subgroups.

Rate of CV Hospitalisation or CV Death
SubgroupNumber of patientsRate ratio FCM to placebo (95% CI)P valueInteraction P value
Age (years)
  <702471540.63 (0.34, 1.17)0.1410.847
  ≥702571810.58 (0.35, 0.96)0.034
  Male2581660.53 (0.32, 0.87)0.0130.497
  Female2461690.70 (0.37, 1.33)0.278
Median LVEF
  <34%2321280.35 (0.19, 0.64)<0.0010.026
  ≥34%2411920.87 (0.51, 1.49)0.620
  <12.0 (g/dL)2281420.38 (0.21, 0.69)0.0020.052
  ≥12.0 (g/dL)2761930.83 (0.49, 1.39)0.471
  <100 (ng/mL)4482920.66 (0.43, 1.01)0.0560.226
  ≥100 (ng/mL)56430.31 (0.10, 0.98)0.046
  <20.0%3382180.46 (0.29, 0.71)<0.0010.011
  ≥20.0%1641171.52 (0.67, 3.42)0.314
  <60 (mL/min/1.732)2161560.56 (0.34, 0.92)0.0230.474
  ≥60 (mL/min/1.732)2881790.74 (0.41, 1.35)0.324
  Non-ischaemic85580.63 (0.24, 1.62)0.3340.813
  Ischaemic3992630.55 (0.35, 0.87)0.011
  Yes71620.72 (0.32, 1.60)0.4160.597
  No4332730.56 (0.36, 0.87)0.010
NYHA Class
  ≤ II1461280.62 (0.32, 1.18)0.1420.820
  ≥ III3582070.56 (0.34, 0.92)0.022

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