Ducrocq, GregoryCalvo, GonzaloGonzález Juanatey, José RamónDurand Zaleski, IsabelleAvendano Sola, CristinaPuymirat, EtienneLemesle, GillesArnáiz, Joan AlbertMartínez Sellés Oliveria Soares, ManuelREALITY investigatorsEt al.2021-02-112021-02-112021Ducrocq, 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.234531932-87370160-9289http://hdl.handle.net/11268/9842Background: 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.engInsuficiencia cardíacaTransfusión sanguíneaReacción a la transfusiónjournal article10.1002/clc.23453restricted accessSistema cardiovascularEnfermedad cardiovascularTratamiento médico