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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

Université de Paris, AP-HP, French Alliance for Cardiovascular Trials (FACT), INSERM U1148, Paris, France. Cardiology Department, University Hospital, IDIS, CIBERCV, University of Santiago de Compostela, Santiago de Compostela, Spain. Université de Paris, AP-HP, Hôpital Européen Georges Pompidou, French Alliance for Cardiovascular Trials (FACT), Paris, France. Institut Cœur Poumon, Centre Hospitalier Universitaire de Lille, Faculté de Médecine de Lille, Université de Lille, Institut Pasteur de Lille, Inserm U1011, Lille, France. French Alliance for Cardiovascular Trials (FACT), Paris, France. Department of Clinical Pharmacology and Clinical Research Platform of the East of Paris (URC-CRC-CRB), AP-HP, Hôpital St Antoine, Paris, France. AP-HP Health Economics Research Unit, Hotel Dieu Hospital, INSERM UMR 1153 CRESS, Paris, France. Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clinic, Barcelona, Spain. Servicio de Cardiología, Hospital Universitario Gregorio Marañón, CIBERCV, Universidad Europea, Universidad Complutense, Madrid, Spain. Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), INSERM UMRS 1166, Paris, France. University Hospital Bellvitge, Heart Disease Institute, Barcelona, Spain. Université Côte d'Azur, CHU de Nice, Hôpital Pasteur 1, Service de Cardiologie, Nice, France. Àrea del Medicament, Hospital Clínic of Barcelona, University of Barcelona, Barcelona, Spain. Clinical Pharmacology Service, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain. AP-HP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, France. Department of Clinical Pharmacology-Clinical Research Platform (URCEST-CRB-CRCEST), AP-HP, Hôpital Saint Antoine, French Alliance for Cardiovascular Trials (FACT), Sorbonne-Université, Paris, France. Royal Brompton Hospital, Imperial College, London, United Kingdom.

Jama. 2021;325(6):552-560
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PICO Summary

Population

Patients with myocardial infarction enrolled in the REALITY trial (n= 668).

Intervention

Restrictive transfusion strategy, haemoglobin <8 g/dL (n= 342).

Comparison

Liberal transfusion strategy, haemoglobin <10 g/dL (n = 324).

Outcome

Among the patients in the restrictive transfusion group, 122 (35.7%) received transfusion, compared to 323 (99.7%) patients in the liberal transfusion group. At 30 days, major adverse cardiovascular events occurred in 36 patients (11.0%) in the restrictive group and in 45 patients (14.0%) in the liberal group. 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.
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.
Study details
Language : eng
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine