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Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial

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dc.contributor.author Ducrocq, Gregory
dc.contributor.author Calvo, Gonzalo
dc.contributor.author González Juanatey, José Ramón
dc.contributor.author Durand Zaleski, Isabelle
dc.contributor.author Avendano Sola, Cristina
dc.contributor.author Puymirat, Etienne
dc.contributor.author Lemesle, Gilles
dc.contributor.author Arnáiz, Joan Albert
dc.contributor.author Martínez Sellés Oliveria Soares, Manuel
dc.contributor.author REALITY investigators
dc.contributor.author Et al.
dc.date.accessioned 2021-02-11T19:25:26Z
dc.date.available 2021-02-11T19:25:26Z
dc.date.issued 2021
dc.identifier.citation Ducrocq, G., Calvo, G., González-Juanatey, J. R., Durand-Zaleski, I., Avendano-Sola, C., Puymirat, E., Lemesle, G., Arnáiz, J. A., Martínez-Sellés, M., Rousseau, A., Cachanado, M., Vicaut, E., Silvain, J., Karam, C., Danchin, N., Simón, T., Steg, P. G., & REALITY investigators (2021). Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial. Clinical Cardiology, 44(2), 143–150. https://doi.org/10.1002/clc.23453 spa
dc.identifier.issn 1932-8737
dc.identifier.issn 0160-9289
dc.identifier.uri http://hdl.handle.net/11268/9842
dc.description.abstract Background: Anemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear. Hypothesis: We hypothesized that a "restrictive" transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a "liberal" transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly. Methods: REALITY is an international, randomized, multicenter, open-label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year. Results: The trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost-effectiveness of the restrictive strategy at a threshold of €50 000 per quality-adjusted life year. Conclusions: REALITY will provide important guidance on the management of patients with AMI and anemia. spa
dc.description.sponsorship Sin financiación spa
dc.language.iso eng spa
dc.subject.other Insuficiencia cardíaca spa
dc.subject.other Transfusión sanguínea spa
dc.subject.other Reacción a la transfusión spa
dc.title Restrictive vs liberal red blood cell transfusion strategies in patients with acute myocardial infarction and anemia: Rationale and design of the REALITY trial spa
dc.type article spa
dc.description.impact 2.248 JCR (2019) Q3, 76/138 Cardiac & Cardiovascular Systems spa
dc.description.impact 1.263 SJR (2019) Q1, 72/362 Cardiology and Cardiovascular Medicine spa
dc.description.impact No data IDR 2019 spa
dc.identifier.doi 10.1002/clc.23453
dc.rights.accessRights closedAccess spa
dc.subject.unesco Sistema cardiovascular spa
dc.subject.unesco Enfermedad cardiovascular spa
dc.subject.unesco Tratamiento médico spa
dc.description.filiation UEM spa
dc.relation.publisherversion http://ezproxy.universidadeuropea.es/login?url=http:/ /dx.doi.org/10.1002/clc.23453 spa
dc.peerreviewed Si spa


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