Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease

doi:10.1016/j.ahj.2013.03.001

American Heart Journal

Volume 165, Issue 6, June 2013, Pages 964-971.e1

https://doi.org/10.1016/j.ahj.2013.03.001 Get rights and content

Background

Prior trials suggest it is safe to defer transfusion at hemoglobin levels above 7 to 8 g/dL in most patients. Patients with acute coronary syndrome may benefit from higher hemoglobin levels.

Methods

We performed a pilot trial in 110 patients with acute coronary syndrome or stable angina undergoing cardiac catheterization and a hemoglobin <10 g/dL. Patients in the liberal transfusion strategy received one or more units of blood to raise the hemoglobin level ≥10 g/dL. Patients in the restrictive transfusion strategy were permitted to receive blood for symptoms from anemia or for a hemoglobin <8 g/dL. The predefined primary outcome was the composite of death, myocardial infarction, or unscheduled revascularization 30 days post randomization.

Results

Baseline characteristics were similar between groups except age (liberal, 67.3; restrictive, 74.3). The mean number of units transfused was 1.6 in the liberal group and 0.6 in the restrictive group. The primary outcome occurred in 6 patients (10.9%) in the liberal group and 14 (25.5%) in the restrictive group (risk difference = 15.0%; 95% confidence interval of difference 0.7% to 29.3%; P = .054 and adjusted for age P = .076). Death at 30 days was less frequent in liberal group (n = 1, 1.8%) compared to restrictive group (n = 7, 13.0%; P = .032).

Conclusions

The liberal transfusion strategy was associated with a trend for fewer major cardiac events and deaths than a more restrictive strategy. These results support the feasibility of and the need for a definitive trial.

Section snippets

Study population

We enrolled patients from 8 US hospitals from March 15, 2010 to May 8, 2012 who were: (1) greater than 18 years of age; (2) had either (a) ST segment elevation myocardial infarction, (b) Non ST segment elevation myocardial infarction, (c) unstable angina, or (d) stable coronary artery disease undergoing a cardiac catheterization; and (3) had a hemoglobin concentration less than 10 g/dL at the time of random allocation.

We excluded patients who had active bleeding from cardiac catheterization

Results

A total of 1920 patients with a hemoglobin concentration less than 11 g/dL were screened. The most common reasons for exclusion (Figure 1) were the hemoglobin >10 g/dL (n = 644), patient declined (n = 198), cardiac surgery was planned within 30 days (n = 156), patient was unable to provide consent (n = 144), or severe illness (n = 139). The incidence of hemoglobin concentration <10 g/dL was 24.2%. Among patients approached, consent was obtained in 25% of patients. We randomly allocated 110

Discussion

In this multicenter pilot trial, patients transfused using a restrictive strategy had more than 2 times the rate of death, myocardial infarction or unscheduled revascularization in the first 30 days of care compared with those transfused using a liberal strategy. Although there was a trend strongly favoring the liberal arm, we believe these data should be interpreted cautiously. The study was small and the apparent impact of transfusion was much larger than expected. Furthermore, the

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A hemoglobin (Hb) level goal of 7-8 g/dL is a standard care threshold, prompting blood transfusion. The debate over whether acute myocardial infarction (MI) patients benefit from a more liberal transfusion strategy prompted a meta-analysis of relevant trials.
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Severe anemia is commonly treated with red blood cell transfusion. Clinical trials have demonstrated that a restrictive transfusion strategy of 7 to 8 g/dL is as safe as a liberal transfusion strategy of 9 to 10 g/dL in many clinical settings. Evidence is lacking for subgroups of patients, including those with preexisting coronary artery disease, acute myocardial infarction, congestive heart failure, and myelodysplastic neoplasms. We present 3 clinical vignettes that highlight the clinical challenges in caring for patients with coronary artery disease with gastrointestinal bleeding, congestive heart failure, or myelodysplastic neoplasms. We emphasize that transfusion practice should be guided by patient symptoms and preferences in conjunction with the patient’s hemoglobin concentration. Along with the transfusion decision, evaluation and management of the etiology of the anemia is essential. Iron-restricted erythropoiesis is a common cause of anemia severe enough to be considered for red blood cell transfusion but diagnosis and management of absolute iron deficiency anemia, the anemia of inflammation with functional iron deficiency, or their combination may be problematic. Intravenous iron therapy is generally the treatment of choice for absolute iron deficiency in patients with complex medical disorders, with or without coexisting functional iron deficiency.

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: T. Bruce Ferguson, Jr, MD, served as guest editor for this article.

: RCT reg #NCT01167582.

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Clinical InvestigationCoronary Artery DiseaseLiberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease

Background

Methods

Results

Conclusions

Section snippets

Study population

Results

Discussion

Lancet

Am Heart J

Am J Infect Control

Am J Cardiol

Clinical practice guideline: red blood cell transfusion in adult trauma and critical care

Crit Care Med

Red blood cell transfusion: a clinical practice guideline from the AABB*

Ann Intern Med

Hospital-acquired anemia and in-hospital mortality in patients with acute myocardial infarction

Am Heart J

Association of blood transfusion with increased mortality in myocardial infarction: a meta-analysis and diversity-adjusted study sequential analysis

JAMA internal medicine

Blood transfusions: good or bad? Confounding by indication, an underestimated problem in clinical transfusion research

Transfusion

Here we go again-blood transfusion kills patients?: Comment on “Association of blood transfusion with increased mortality in myocardial infarction: a meta-analysis and diversity-adjusted study sequential analysis”

JAMA internal medicine

Clinical Investigation
Coronary Artery Disease
Liberal versus restrictive transfusion thresholds for patients with symptomatic coronary artery disease