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Liberal blood transfusion did not increase mortality risk in patients with heart disease
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A liberal blood transfusion strategy did not affect mortality compared with a restrictive transfusion strategy among high-risk elderly patients with a history of or risk factors for cardiovascular disease, according to results of a randomized controlled trial.
Blood transfusions may change immune function, potentially increasing risk for infections and cancer recurrence and, ultimately, affecting long-term mortality, according to study background information.
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Jeffrey L. Carson
Jeffrey L. Carson, MD, professor of medicine and chief of the division of general internal medicine at Rutgers Robert Wood Johnson Medical School, and colleagues conducted the FOCUS trial to evaluate whether a liberal transfusion strategy had an effect on long-term survival compared with a restrictive transfusion strategy.
“When we planned the FOCUS trial, there were little data to guide clinicians’ transfusion decisions,” Carson told HemOnc Today. “Furthermore, there was concern that patients with pre-existing cardiovascular disease might be especially harmed by using lower transfusion thresholds. We hypothesized that a higher threshold for blood transfusion would improve functional recovery and reduce morbidity and mortality, as compared with a more restrictive transfusion strategy.”
The trial included patients aged at least 50 years with a history of or risk factors for cardiovascular disease. Patients had postoperative hemoglobin concentrations lower than 100 g/L within 3 days of surgery to repair a hip fracture.
The analysis included 2,016 patients recruited from 47 hospitals in the United States and Canada between July 2004 and February 2009.
Researchers randomly assigned 1,007 patients to a liberal strategy in which transfusions were administered to maintain hemoglobin levels of 100 g/L or higher. The other 1,009 patients were assigned to a restrictive strategy in which a transfusion only occurred when hemoglobin levels dipped below 80 g/L or when they had symptoms of anemia.
Median follow-up was 3.1 years (range, 2.4-4.1). During that time, 841 (42%) patients died.
Results showed long-term mortality did not differ significantly between the liberal strategy and the restrictive strategy (432 deaths vs. 409 deaths; HR=1.09; 95% CI, 0.95-1.25).
“Results of other studies had suggested that transfusion was immunosuppressive, which might lead to more infections or cancer but also could reduce deaths from cardiovascular disease by delivering more oxygen to the myocardium,” Carson said. “Our results suggest that liberal transfusion does not increase the risk of death over a median follow-up of 3.1 years and does not affect the cause of death compared to [a] restrictive transfusion strategy.”
The findings also suggest alternative pathophysiological mechanisms should be sought for an apparent increased risk for death in some patient populations.
“A critical next step is to examine transfusion thresholds in patients with acute myocardial infarction since these anemic patients may be especially at risk of adverse outcomes as suggested by a recent pilot trial,” Carson said. – by Anthony SanFilippo
Disclosure: One of the researchers reports grants and personal fees from the American Orthopedic Association, Ammonett, Eli Lilly, GlaxoSmithKline, the National Heart, Lung, and Blood Institute, Novartis, OrgaNext, Regeneron and Sanofi.
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