American Heart Association Annual Scientific Sessions; Orlando, Florida: 14–18 November 2009
MedWire News: A liberal strategy of red blood cell transfusion in cases of moderate anemia does not result in better postoperative cardiovascular (CV) outcomes compared with a more restrictive strategy of transfusion based primarily on symptomatic anemia in elderly surgical patients, FOCUS trial results show.
However, potential functional improvements after surgery, as a result of the more liberal transfusion strategy, could yet tip the balance in its favor. This primary aim of FOCUS (Transfusion Trigger Trial for Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair) is still under analysis.
Presenting results for secondary CV outcomes of FOCUS at the American Heart Association annual sessions in Orlando, Florida, Jeffrey Carson (University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, New Brunswick, USA) explained: “The decision to transfuse after surgery in patients with CV disease is difficult in the absence of symptoms, as silent myocardial ischemia may be precipitated by myocardial ischemia.”
FOCUS included 2016 elderly patients, aged an average of 82 years, who were undergoing hip fracture repair and had existing CV disease or CV risk factors (diabetes, hypertension, tobacco use, hyperlipidemia, or chronic renal insufficiency) and hemoglobin (Hgb) levels below 10 g/dl. Patients were randomly assigned to a symptomatic transfusion protocol or a 10 g/dl transfusion protocol.
In the symptomatic transfusion (restrictive strategy) arm, patients received transfusion if they had symptoms including cardiac chest pain, heart failure, orthostatic hypertension or unexplained tachycardia unresponsive to a fluid challenge. Transfusion was also permitted, but not mandatory, in patients with Hgb levels below 8 g/dl in this group. In the 10 g/dl transfusion (liberal strategy) arm, patients received transfusions to keep Hgb levels above 10 g/dl, regardless of symptoms.
Carson reported that a total of 652 units of RBCs were transfused in the symptomatic group compared with 1866 units in the 10 g/dl group, with a median of 0 versus 2 units used in each patient.
There was no difference between groups in the secondary composite CV endpoint of myocardial infarction (MI), unstable angina, or mortality during hospitalization between the two groups, at 5.2% and 4.3% in symptomatic and 10 g/dl arms, respectively (hazard ratio=0.82; 99% CI: 0.48-1.42).
There was also no difference between the groups in rates of in-hospital MI and death individually or in isolated in-hospital troponin elevations.
Summing up, Carson noted: “Transfusion for symptoms or Hgb below 8 g/dl conserved blood and there was a large difference in the amount of blood used between groups.”
Commenting on the results, the invited discussant for the trial Paul Armstrong (University of Alberta, Edmonton, Canada) questioned the generalizability of the findings, given that only 14% of patients screened for inclusion were randomized.
He concluded that, for now, more than one trigger will continue to influence clinicians faced with the problem of low Hgb after hip surgery, and these will have to be placed in the context of what the patient “brings to the table,” such as the magnitude and rate of Hgb decline and concomitant medications, in order to decide logically how to proceed.
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