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.

Abstract

Importance:

The optimal transfusion strategy in patients with acute myocardial infarction and anemia is unclear.

Objective:

To determine whether a restrictive transfusion strategy would be clinically noninferior to a liberal strategy.

Design, Setting, and Participants:

Open-label, noninferiority, randomized trial conducted in 35 hospitals in France and Spain including 668 patients with myocardial infarction and hemoglobin level between 7 and 10 g/dL. Enrollment could be considered at any time during the index admission for myocardial infarction. The first participant was enrolled in March 2016 and the last was enrolled in September 2019. The final 30-day follow-up was accrued in November 2019.

Interventions:

Patients were randomly assigned to undergo a restrictive (transfusion triggered by hemoglobin ≤8; n = 342) or a liberal (transfusion triggered by hemoglobin ≤10 g/dL; n = 324) transfusion strategy.

Main Outcomes and Measures:

The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% CI for the relative risk of the primary outcome be less than 1.25. The secondary outcomes included the individual components of the primary outcome.

Results:

Among 668 patients who were randomized, 666 patients (median [interquartile range] age, 77 [69-84] years; 281 [42.2%] women) completed the 30-day follow-up, including 342 in the restrictive transfusion group (122 [35.7%] received transfusion; 342 total units of packed red blood cells transfused) and 324 in the liberal transfusion group (323 [99.7%] received transfusion; 758 total units transfused). At 30 days, MACE occurred in 36 patients (11.0% [95% CI, 7.5%-14.6%]) in the restrictive group and in 45 patients (14.0% [95% CI, 10.0%-17.9%]) in the liberal group (difference, -3.0% [95% CI, -8.4% to 2.4%]). The relative risk of the primary outcome was 0.79 (1-sided 97.5% CI, 0.00-1.19), meeting the prespecified noninferiority criterion. In the restrictive vs liberal group, all-cause death occurred in 5.6% vs 7.7% of patients, recurrent myocardial infarction occurred in 2.1% vs 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% vs 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups.

Conclusions and Relevance:

Among patients with acute myocardial infarction and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. However, the CI included what may be a clinically important harm.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02648113.

• Authors: Gregory Ducrocq, Jose R Gonzalez-Juanatey, Etienne Puymirat, Gilles Lemesle, Marine Cachanado, Isabelle Durand-Zaleski, Joan Albert Arnaiz, Manuel Martínez-Sellés, Johanne Silvain, Albert Ariza-Solé, Emile Ferrari, Gonzalo Calvo, Nicolas Danchin, Cristina Avendaño-Solá, Jerome Frenkiel, Alexandra Rousseau, Eric Vicaut, Tabassome Simon, Philippe Gabriel Steg, REALITY Investigators
• Journal: JAMA (JAMA) Vol. 325 Issue 6 Pg. 552-560 (02 09 2021) ISSN: 1538-3598 [Electronic] United States
• PMID: 33560322 (Publication Type: Comparative Study, Equivalence Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Hemoglobins

Topics

• Aged
• Aged, 80 and over
• Anemia (complications, therapy)
• Blood Transfusion
• Cardiovascular Diseases (epidemiology, prevention & control)
• Female
• Hemoglobins (analysis)
• Humans
• Male
• Myocardial Infarction (blood, complications, therapy)