Economic evaluation of restrictive vs. liberal transfusion strategy following acute myocardial infarction (REALITY): trial-based cost–effectiveness and cost–utility analyses

Author:

Durand-Zaleski Isabelle12ORCID,Ducrocq Gregory3ORCID,Mimouni Maroua1,Frenkiel Jerome1,Avendano-Solá Cristina4,Gonzalez-Juanatey Jose R5,Ferrari Emile6ORCID,Lemesle Gilles7ORCID,Puymirat Etienne8ORCID,Berard Laurence9ORCID,Cachanado Marine9ORCID,Arnaiz Joan Albert10ORCID,Martínez-Sellés Manuel11,Silvain Johanne12ORCID,Ariza-Solé Albert13ORCID,Calvo Gonzalo14ORCID,Danchin Nicolas15ORCID,Paco Sandra9,Drouet Elodie9ORCID,Abergel Helene3,Rousseau Alexandra9,Simon Tabassome9ORCID,Steg Philippe Gabriel3ORCID

Affiliation:

1. AP-HP Health Economics Research Unit, Hotel Dieu Hospital , place du parvis de Notre Dame 75004, Paris, France

2. INSERM UMR 1153 CRESS , Paris, France

3. Université de Paris , AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, 75018, Paris, France

4. Clinical Pharmacology Service, Hospital Universitario Puerta de Hierro-Majadahonda , Madrid, Spain

5. Cardiology Department, University Hospital, IDIS, CIBERCV, University of Santiago de Compostela , Santiago de Compostela, Spain

6. Université Côte d'Azur, and CHU de Nice , Hôpital Pasteur 1, Service de Cardiologie, 06001, Nice, France

7. 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

8. Université de Paris, AP-HP, Hôpital Européen Georges Pompidou , French Alliance for Cardiovascular Trials (FACT), 75015, Paris, France

9. Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST) , AP-HP, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials (FACT), Sorbonne-Université, 75012, Paris, France

10. Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clinic , Barcelona, Spain

11. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, and Universidad Europea, Universidad Complutense , Madrid, Spain

12. Sorbonne Université, ACTION Study Group, Institut de Cardiologie , Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, 75013, Paris, France

13. University Hospital Bellvitge, Heart Disease Institute , Barcelona, Spain

14. Àrea del Medicament, Hospital Clínic of Barcelona, University of Barcelona , Barcelona, Spain

15. Université de Paris , AP-HP, Hôpital Européen Georges Pompidou, French Alliance for Cardiovascular Trials (FACT), 75015, Paris, France

Abstract

Abstract Aims To estimate the cost–effectiveness and cost–utility ratios of a restrictive vs. liberal transfusion strategy in acute myocardial infarction (AMI) patients with anaemia. Methods and results Patients (n = 666) with AMI and haemoglobin 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 on 648 patients from the per-protocol population. The outcomes were 30-day and 1-year cost-effectiveness, with major adverse cardiovascular events (MACEs) averted as the effectiveness outcome. and a 1-year cost–utility ratio. The 30-day incremental cost–effectiveness ratio was €33 065 saved per additional MACE averted with the restrictive vs. 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 quality-adjusted life year gained; however, the cumulated MACE was 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 AMI and anaemia, 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 non-inferiority on MACE was no longer maintained. Trial Registration ClinicalTrials.gov Identifier: NCT02648113. One sentence summary The use of a restrictive transfusion strategy in patients with acute myocardial infarction is associated with lower healthcare costs, but more evidence is needed to ascertain its long-term clinical impact.

Funder

Spanish Ministry of Economy and Competitiveness

Publisher

Oxford University Press (OUP)

Subject

Cardiology and Cardiovascular Medicine,Health Policy

Reference20 articles.

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2. Impact of red blood cell transfusion on platelet activation and aggregation in healthy volunteers: results of the TRANSFUSION study;Silvain;Eur Heart J,2010

3. Impact of red blood cell transfusion on platelet aggregation and inflammatory response in anemic coronary and noncoronary patients: the TRANSFUSION-2 study (impact of transfusion of red blood cell on platelet activation and aggregation studied with flow cytometry use and light transmission aggregometry);Silvain;J Am Coll Cardiol,2014

4. REALITY investigators. Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: rationale and design of the REALITY trial;Ducrocq;Clin Cardiol,2021

5. Effect of a restrictive vs liberal blood transfusion strategy on major cardiovascular events among patients with acute myocardial infarction and anemia: the REALITY randomized clinical trial;Ducrocq;JAMA,2021

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