REALITY
Trial question
Is a restrictive blood transfusion strategy noninferior to a liberal blood transfusion strategy in patients with acute MI and anemia?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
42.0% female
58.0% male
N = 666
666 patients (281 female, 385 male).
Inclusion criteria: adult patients with MI and anemia.
Key exclusion criteria: shock; MI occurring after PCI or CABG; life-threatening or massive ongoing bleeding; blood transfusion in the past 30 days; and malignant hematologic disease.
Interventions
N=342 a restrictive strategy (transfusion triggered by hemoglobin ≤ 8 g/dL).
N=324 a liberal strategy (transfusion triggered by hemoglobin ≤ 10 g/dL).
Primary outcome
Composite outcome of death, stroke, recurrent MI, or emergency revascularization prompted by ischemia at 30 days
11%
14%
14.0 %
10.5 %
7.0 %
3.5 %
0.0 %
A restrictive
strategy
A liberal
strategy
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in composite outcome of death, stroke, recurrent MI, or emergency revascularization prompted by ischemia at 30 days (11% vs. 14%; ARD -3, 95% CI -8.4 to 2.4).
Safety outcomes
No significant difference in adverse events.
Conclusion
In adult patients with MI and anemia, a restrictive strategy was noninferior to a liberal strategy with respect to the composite outcome of death, stroke, recurrent myocardial infarction, or emergency revascularization prompted by ischemia at 30 days.
Reference
Gregory Ducrocq, Jose R Gonzalez-Juanatey, Etienne Puymirat et al. 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. JAMA. 2021 Feb 9;325(6):552-560.
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