Language

English

Publication Date

12-23-2025

Journal

JAMA

DOI

10.1001/jama.2025.20841

PMID

41205227

PMCID

PMC12596742

PubMedCentral® Posted Date

11-8-2025

PubMedCentral® Full Text Version

Post-print

Abstract

Importance: Postoperative red blood cell transfusion guidelines recommend transfusion for hemoglobin levels less than 7 g/dL. However, the safety of this strategy in patients at high risk of cardiac events undergoing major operations remains unclear.

Objective: To evaluate the risk of death or major ischemic events within 90 days after a liberal transfusion strategy compared with a restrictive transfusion strategy in patients at high risk of cardiac events who had undergone major vascular or general surgery operations and developed postoperative anemia.

Design, setting, and participants: This parallel, single-blind, randomized clinical superiority trial included 1428 veterans (≥18 y) at high cardiac risk undergoing major vascular or general surgery operations. Participants were enrolled from February 2018 to March 2023 across 16 Veterans Affairs Medical Centers in the US.

Interventions: Seven hundred fourteen participants with postoperative hemoglobin less than 10 g/dL were randomized to a liberal strategy (transfusion trigger at hemoglobin level < 10 g/dL) and 714 to a restrictive strategy (transfusion trigger at hemoglobin < 7 g/dL).

Main outcomes and measures: The primary end point was a composite of all-cause death, myocardial infarction, coronary revascularization, acute kidney failure, or ischemic stroke within 90 days after randomization. Secondary end points included a composite of cardiac complications other than myocardial infarction (arrhythmias, heart failure, and nonfatal cardiac arrest).

Results: Of the 1424 analyzed veterans (mean age, 69.9 [SD, 7.9] years; 1393 male [97.8%]; 268 Black [18.8%]; 48 Hispanic [4.1%]; 1071 White [75.2%]), 1297 (91.1%) underwent vascular surgical procedures. The mean hemoglobin difference between transfusion strategies was 2.0 g/dL on day 5 after randomization. The primary outcome rate in the liberal group was 9.1% (61 of 670) compared with 10.1% (71 of 700) in the restrictive group (relative risk, 0.90; 95% CI, 0.65-1.24). The secondary end point of cardiac complications without myocardial infarction, which was 1 of 5 secondary end points, occurred in 5.9% (38 of 647) of patients in the liberal group and 9.9% (67 of 678) of patients in the restrictive group (relative risk, 0.59; 99% CI, 0.36-0.98).

Conclusions and relevance: After major vascular or general surgery operations among patients at high risk of a cardiac event, a liberal transfusion strategy did not reduce 90-day death or major ischemic outcome rates compared with a restrictive strategy.\

Keywords

Aged, Female, Humans, Male, Middle Aged, Anemia, Erythrocyte Transfusion, Hemoglobins, Hospital Mortality, Ischemic Stroke, Myocardial Infarction, Postoperative Care, Postoperative Complications, Practice Guidelines as Topic, Risk Assessment, Single-Blind Method, Surgical Procedures, Operative

Comments

Trial registration: ClinicalTrials.gov Identifier: NCT03229941.

Published Open-Access

yes

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