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

Gregory Ducrocq, Gonzalo Calvo, José Ramón González-Juanatey, Isabelle Durand-Zaleski, Cristina Avendano-Sola, Etienne Puymirat, Gilles Lemesle, Joan Albert Arnaiz, Manuel Martínez-Sellés, Alexandra Rousseau, Marine Cachanado, Eric Vicaut, Johanne Silvain, Carma Karam, Nicolas Danchin, Tabassome Simon, Philippe Gabriel Steg, REALITY investigators, Gregory Ducrocq, Gonzalo Calvo, José Ramón González-Juanatey, Isabelle Durand-Zaleski, Cristina Avendano-Sola, Etienne Puymirat, Gilles Lemesle, Joan Albert Arnaiz, Manuel Martínez-Sellés, Alexandra Rousseau, Marine Cachanado, Eric Vicaut, Johanne Silvain, Carma Karam, Nicolas Danchin, Tabassome Simon, Philippe Gabriel Steg, REALITY investigators

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.

Keywords: acute myocardial infarction; anemia; cost effectiveness; transfusion.

Conflict of interest statement

Dr Ducrocq reports speaker's and/or consulting fees from Amgen, Astra Zeneca, Bayer, BMS, Janssen, Sanofi, and Terumo; is a member of the CEC for Sanofi and Novo Nordisk; and has received travel fees from Astra Zeneca, Biotronik, Bayer, and BMS.

Dr Steg reports grants and nonfinancial support (cochair of the ODYSSEY OUTCOMES trial; as such, he received no personal fees, but his institution has received funding for the time he has devoted to trial coordination, and he has received support for travel related to trial meetings) from Sanofi; research grants and personal fees from Bayer (Steering Committee MARINER, grant for epidemiological study), Merck (speaker fees, grant for epidemiological studies), Sanofi (cochair of the ODYSSEY OUTCOMES trial; cochair of the SCORED trial; consulting, speaking), Servier (Chair of the CLARIFY registry; grant for epidemiological research), and Amarin (executive steering committee for the REDUCE‐IT trial [Disease Reduction of Cardiovascular Events With Icosapent Ethyl‐Intervention Trial]; consulting); and personal fees from Amgen, Bristol‐Myers Squibb, Boehringer Ingelheim, Pfizer, Novartis, Regeneron Pharmaceuticals, Lilly, and AstraZeneca. Dr Steg also has a European application number/patent number, issued on 26 October 2016 (no. 15712241.7), for a method for reducing cardiovascular risk.

© 2020 The Authors. Clinical Cardiology published by Wiley Periodicals LLC.

Figures

FIGURE 1
FIGURE 1
REALITY trial flow chart. AMI, acute myocardial infarction; RBC, red blood cell

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