Erythropoietin + Iron Therapy for Anemic Patients Undergoing Aortic Valve Replacement

STUDY DESIGN

Prospective randomized double blind study including patients diagnosed with severe symptomatic aortic stenosis and anemia undergoing aortic valve replacement. The patients will be identified in the cardiac surgery / aortic stenosis outpatient clinic or in the hospitalization department of the Institut Universitaire de Cardiologie et de Pneumologie de Quebec.

SAMPLE SIZE

100 patients (50 patients per group).

Inclusion criteria

• Patients ≥60-year old
• Symptomatic aortic stenosis with a clinical indication for transcatheter aortic valve replacement, regardless of simultaneous percutaneous coronary intervention
• Anemia defined according to the World Health Organization (WHO) definition 69:

• Men: Hemoglobin<130 g/L
• Women: <120 g/L

Exclusion criteria

• Contraindication for transcatheter aortic valve replacement.
• Erythropoietin treatment within last 30 days before Aortic Valve Replacement
• Known anemia due to aplasia, other hemoglobinopathy or active bleeding requiring blood transfusion within last 30 days before Aortic Valve Replacement
• Ferritin>800 µg/L
• Uncontrolled hypertension (Blood pressure>175/95 )
• Platelet count>450,000/L
• Recent myocardial infarction requiring percutaneous coronary intervention or disabling stroke (within the last 30 days)
• Dialysis patients
• Hemodynamic instability as defined as the need of hemodynamic support with inotropic drugs, intraortic balloon pump counter-pulsation or left ventricular assist device before index procedure
• Active cancer or very high risk of thromboembolic events
• Known allergy or hypersensitivity to intravenous iron or Erythropoietin therapy
• No written consent