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Article pour les cliniciens

Liberal or Restrictive Postoperative Transfusion in Patients at High Cardiac Risk: The TOP Randomized Clinical Trial.



  • Kougias P
  • Sharath SE
  • Zhan M
  • Carson JL
  • Norman LE
  • Mi Z, et al.
JAMA. 2025 Nov 8:e2520841. doi: 10.1001/jama.2025.20841. (Original)
PMID: 41205227
Lire le résumé
Disciplines
  • - Cardiologie
    Relevance - 6/7
    Intérêt médiatique  - 6/7
  • Médecin hospitalier/Hospitaliste
    Relevance - 6/7
    Intérêt médiatique  - 6/7
  • Médecine interne (voir sous-spécialités ci-dessous)
    Relevance - 6/7
    Intérêt médiatique  - 6/7
  • Anesthésiologie
    Relevance - 6/7
    Intérêt médiatique  - 5/7
  • Chirurgie - Général
    Relevance - 6/7
    Intérêt médiatique  - 5/7
  • Surgery - Vascular
    Relevance - 6/7
    Intérêt médiatique  - 5/7
  • - Hématologie
    Relevance - 5/7
    Intérêt médiatique  - 5/7

Résumé (en anglais)

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.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03229941.


Commentaires cliniques (en anglais)

Anesthesiology

While this information is known, changing clinician behavior remains a challenge.

Anesthesiology

This is a well conducted parallel trial of 1428 adult patients in 16 centres across the USA. All patients has known IHD/previous CVA/peripheral arterial disease, underwent major vascular (91%) or general surgical procedures, and were randomised to liberal (L) (&lt;10g/dL) or restrictive (R) (&lt;7g/dL) transfusion triggers. Mean hemoglobin was 2g/dL higher in the L group at day 5 post-op. They found an overall lower morbidity and mortality than expected, leaving the study slightly underpowered. No difference was observed in the primary outcomes (all-cause mortality, MI, PCI, AKI or ischaemic stroke) (RR: 0.9 CI 0.65-1.24), an increase in cardiac complications (excluding MI) was seen in the R group, notably decompensated heart failure. The authors should be commended for this interesting and useful study showing no increase in cardiovascular morbidity and mortality in patients with increased risk. Future studies should include other types of major surgery and more female patients.

Hematology

This is not directly relevant to hematology except for transfusion medicine professionals. It is relevant to cardiology and cardio and vascular surgery.

Hematology

In the wake of the "MINT" trial (which randomized patients with myocardial infarction and suggested a benefit of liberal RBC transfusion), these results (from a surgical population at high-cardiac risk) certainly merit being highlighted.

Hospital Doctor/Hospitalists

This is an important and rigorous trial that any physician caring for postoperative patients should be familiar with. Unfortunately, the trial was underpowered to find a statistically significant difference in the primary outcome due to lower than expected event rates; however, several of the individual components of the primary outcome favored the liberal strategy, albeit not statistically significantly, and despite more than a 2 g difference in the mean hemoglobin level between the two groups. The results of this trial should lead to nuanced approaches for individual patients rather than firm conclusions about hemoglobin thresholds in postoperative patients with anemia.

Surgery - General

These results are expected.

Surgery - Vascular

As a vascular surgeon caring for high–cardiac-risk postoperative patients, I find this trial highly relevant. The methodology is solid with clear outcome adjudication and meaningful hemoglobin separation between groups. The lack of benefit from a liberal transfusion strategy reinforces current restrictive thresholds. The higher rate of non–MI cardiac complications in the restrictive group is a noteworthy signal that merits further investigation but does not outweigh the overall neutrality of the primary outcome. These findings provide valuable evidence to guide perioperative transfusion decisions in major vascular surgery.

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