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Restrictive vs. Liberal Blood Transfusion Strategy for MI and Anemia
Quick Takes
- Among patients with AMI and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days.
- Although the decision to initiate transfusion should not be based on hemoglobin level alone, these results suggest there is value to a restrictive strategy, which had no apparent downside and potential benefits.
- At this time based on totality of data, a restrictive transfusion approach should be the preferred strategy in MI patients with anemia.
Study Questions:
Is a restrictive strategy of blood transfusion noninferior to a liberal strategy among patients with acute myocardial infarction (AMI) and anemia?
Methods:
The investigators conducted an open-label, noninferiority, randomized trial in 35 hospitals in France and Spain including 668 patients with MI and hemoglobin level between 7 and 10 g/dl. Enrollment could be considered at any time during the index admission for MI. 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. The primary clinical outcome was major adverse cardiovascular events (MACE; composite of all-cause death, stroke, recurrent MI, or emergency revascularization prompted by ischemia) at 30 days. Noninferiority required that the upper bound of the 1-sided 97.5% confidence interval (CI) for the relative risk of the primary outcome be <1.25. The secondary outcomes included the individual components of the primary outcome. The analysis of the primary efficacy outcome used relative risk and concordance in the noninferiority analysis between the as-randomized and the as-treated populations was required to establish noninferiority.
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 versus liberal group, all-cause death occurred in 5.6% versus 7.7% of patients, recurrent MI occurred in 2.1% versus 3.1%, emergency revascularization prompted by ischemia occurred in 1.5% versus 1.9%, and nonfatal ischemic stroke occurred in 0.6% of patients in both groups.
Conclusions:
The authors concluded that among patients with AMI and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days.
Perspective:
This open-label, randomized trial reports that among patients with AMI and anemia, a restrictive compared with a liberal transfusion strategy resulted in a noninferior rate of MACE after 30 days. Of note, the CI included what may be a clinically important harm with liberal transfusion strategy. Although the decision to initiate transfusion should not be based on hemoglobin level alone, these results suggest there is value to a restrictive strategy, which had no apparent downside. Similar results in favor of a restrictive transfusion strategy have been noted for other patient groups and at this time, based on totality of data, a restrictive transfusion approach should be the preferred strategy in MI patients with anemia.
Clinical Topics: Acute Coronary Syndromes, Cardiac Surgery, Geriatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Prevention, Cardiac Surgery and Arrhythmias, Interventions and ACS
Keywords: Acute Coronary Syndrome, Anemia, Blood Transfusion, Brain Ischemia, Erythrocytes, Geriatrics, Hemoglobins, Hemorrhage, Myocardial Infarction, Myocardial Ischemia, Myocardial Revascularization, Primary Prevention, Risk, Stroke, Vascular Diseases
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