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Economic evaluation of Restrictive Vs. Liberal Transfusion Strategy Following Acute Myocardial Infarction (REALITY): trial-based cost effectiveness and cost utility analyses

AP-HP Health Economics Research Unit, Hotel Dieu Hospital, place du parvis de Notre Dame 75004 Paris. INSERM UMR 1153 CRESS, Paris, France. Université de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France. Clinical Pharmacology Service, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. Cardiology Department, University Hospital, IDIS, CIBERCV, University of Santiago de Compostela, Santiago de Compostela, Spain. Université Côte d'Azur, and CHU de Nice, Hôpital Pasteur 1, Service de Cardiologie, Nice, France. Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Faculté de Médecine de Lille, Université de Lille, Institut Pasteur de Lille, Inserm U1011, F-59000 Lille, France. Université de Paris, AP-HP, Hôpital Européen Georges Pompidou, French Alliance for Cardiovascular Trials (FACT), Paris, France. Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials (FACT), Sorbonne-Université, Paris, France. Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clinic, Barcelona, Spain. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, and Universidad Europea, Universidad Complutense, Madrid, Spain. Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166 Paris, France. University Hospital Bellvitge, Heart Disease Institute, Barcelona, Spain. Àrea del Medicament, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain.

European heart journal. Quality of care & clinical outcomes. 2022
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PICO Summary

Population

Acute myocardial infarction patients with anaemia, enrolled in the REALITY trial in 35 hospitals in France and Spain (n= 666).

Intervention

Restrictive transfusion strategy (n= 342).

Comparison

Liberal transfusion strategy (n= 324).

Outcome

The 30-day incremental cost-effectiveness ratio was €33,065 saved per additional major adverse cardiovascular event (MACE) averted with the restrictive versus the liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE reducing. At 1-year, the point estimate of the cost-utility ratio was €191,500 saved per quality-adjusted life year gained; however cumulated MACE were outside the pre-specified non-inferiority margin, resulting in a decremental cost effectiveness ratio with a point estimate of €72,000 saved per additional MACE with the restrictive strategy.
Abstract
AIM: To estimate the cost effectiveness and cost utility ratios of a restrictive vs liberal transfusion strategy in acute myocardial infarction (AMI) patients with anemia. METHODS AND RESULTS Patients (n = 666) with AMI and hemoglobin between 7-8 and 10 g/dL recruited in 35 hospitals in France and Spain were randomly assigned to a restrictive (n = 342) or a liberal (n = 324) transfusion strategy with 1-year prospective collection of resource utilization and quality of life using the EQ5D3L questionnaire. The economic evaluation was based upon 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular event averted (MACE) as the effectiveness outcome; and 1-year cost utility ratio.The 30-day incremental cost-effectiveness ratio was €33,065€ saved per additional MACE averted with the restrictive versus the liberal strategy, with an 84% probability for the restrictive strategy to be cost-saving and MACE reducing (i.e.dominant). At 1-year, the point estimate of the cost-utility ratio was 191,500 € saved per QALY gained; however cumulated MACE were outside the pre-specified non-inferiority margin, resulting in a decremental cost effectiveness ratio with a point estimate of €72,000 saved per additional MACE with the restrictive strategy. CONCLUSION In patients with acute myocardial infarction and anemia, the restrictive transfusion strategy was dominant (cost-saving and outcome-improving) at 30 days. At 1 year, the restrictive strategy remained cost-saving but clinical noninferiority on MACE was no longer maintained. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02648113.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine