FOCUS

Population

• Patients 50 years of age or older with a history of or risk factors for cardiovascular disease and a hemoglobin level below 10 g per deciliter after hip-fracture surgery.

Intervention

Liberal transfusion strategy using a hemoglobin threshold of 10 g per deciliter (median 2 units of red cells).

Comparator

Restrictive transfusion strategy: transfusion for symptoms of anemia or at physician discretion for a hemoglobin level below 8 g per deciliter (median 0 units of red cells).

Key results

• The primary outcome occurred in 35.2% with the liberal strategy vs 34.7% with the restrictive strategy; odds ratio in the liberal-strategy group 1.01 (95% CI 0.84-1.22); absolute risk difference 0.5 percentage points (95% CI -3.7 to 4.7).
• A median of 2 red-cell units were transfused in the liberal-strategy group and none in the restrictive-strategy group.
• In-hospital acute coronary syndrome or death was 4.3% vs 5.2% (absolute risk difference -0.9%; 99% CI -3.3 to 1.6). Death at 60 days was 7.6% vs 6.6% (absolute risk difference 1.0%; 99% CI -1.9 to 4.0).
• The rates of other complications were similar in the two groups.

Harms

• In-hospital acute coronary syndrome or death did not differ in a way that excluded no effect (4.3% liberal vs 5.2% restrictive; absolute risk difference -0.9%; 99% CI -3.3 to 1.6).
• The rates of other complications were similar in the two groups.

Practice impact

• After hip-fracture surgery in older adults at cardiovascular risk, a restrictive strategy is a reasonable default; the liberal 10 g/dL threshold did not improve the primary 60-day outcome.
• The restrictive arm still allowed transfusion for symptoms of anemia or at physician discretion when hemoglobin was below 8 g/dL.

Applicability

• Most applicable to patients 50 years or older with cardiovascular disease or risk factors and hemoglobin below 10 g per deciliter after hip-fracture surgery.

Limitations

• The trial starts after hip-fracture surgery in patients already below 10 g per deciliter; it does not test transfusion during active bleeding.
• In-hospital acute coronary syndrome or death and 60-day death were reported with 99% confidence intervals that included no difference.
• The restrictive strategy was not a hard 8 g/dL cutoff for every patient; symptoms and physician discretion were allowed.

Common misinterpretations

• FOCUS is not a license to withhold blood from a symptomatic patient. The restrictive strategy transfused for symptoms of anemia.
• A null primary result is not evidence that transfusion is never useful; it is evidence that targeting 10 g/dL did not improve this 60-day functional composite.