Anemia frequently ensues after major surgery, and postoperative hemoglobin management is a critical factor in patient recovery. The current recommendations on transfusion are for a restrictive approach, offering transfusions only to patients whose hemoglobin level falls below 7 g/dL. The safety of this restrictive threshold has been uncertain for patients at high risk for cardiac complications. Concerns have persisted that reduced oxygen-carrying capacity may trigger ischemic events in these individuals.
This was a randomized, single-blind, clinical superiority trial conducted at 16 Veterans Affairs Medical Centers in the United States. A total of 1428 veterans aged 18 years and above who were at high cardiac risk and who underwent major vascular or general surgical operations were enrolled from February 2018 to March 2023. After surgery, participants with a postoperative hemoglobin level below 10 g/dL were randomized in a 1:1 ratio to a liberal transfusion strategy (triggered at <10 g/dL, n=714) or to a restrictive strategy (triggered at <7 g/dL, n=714). The primary outcome was a composite of all-cause death, myocardial infarction, coronary revascularization, acute kidney injury, or ischemic stroke within 90 days of randomization. Secondary outcomes included cardiac complications other than myocardial infarction, such as arrhythmias, heart failure, and nonfatal cardiac arrest.
Results
Of the 1424 veterans in the final analysis, the mean age was 69.9 ± 7.9 years; 97.8% were male, 18.8% were Black, 4.1% were Hispanic, and 75.2% were White.
Fully 91.1% of the total patients (1297 patients) underwent vascular surgical procedures.
The mean hemoglobin difference between groups on day 5 after randomization was 2.0 g/dL, confirming clear separation between the transfusion strategies.
The primary composite outcome occurred in 9.1% (61 of 670) of patients in the liberal group compared with 10.1% (71 of 700) in the restrictive group (relative risk [RR] 0.90; 95% CI, 0.65–1.24), with no statistically significant difference.
One of the five secondary endpoints, cardiac complications excluding myocardial infarction, occurred in 5.9% (38 of 647) of patients in the liberal group compared with 9.9% (67 of 678) in the restrictive group (RR 0.59; 99% CI, 0.36–0.98), indicating a modest reduction in minor cardiac complications.
For high-cardiac-risk patients undergoing major vascular or general surgery, a liberal transfusion strategy (Hb <10 g/dL) did not reduce 90-day mortality or major ischemic event rates compared to a restrictive strategy (Hb <7 g/dL). The study confirms that a conservative threshold for transfusion remains safe and effective, with no added survival benefit to be accrued from liberal transfusion.
Reference:
Kougias P, Sharath SE, Zhan M, et al. Liberal or Restrictive Postoperative Transfusion in Patients at High Cardiac Risk: The TOP Randomized Clinical Trial. JAMA. Published online November 08, 2025. doi:10.1001/jama.2025.20841
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