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Abstract
BackgroundAnemia is common in patients with acute myocardial infarction (AMI), and is an independent predictor of mortality. The optimal transfusion strategy in these patients is unclear.HypothesisWe hypothesized that a “restrictive” transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a “liberal” transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly.MethodsREALITY is an international, randomized, multicenter, open‐label trial comparing a restrictive vs a liberal transfusion strategy in patients with AMI and anemia. The primary outcome is the incremental cost‐effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all‐cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion. Secondary outcomes include the ICER at 1 year, and MACE (and its components) at 30 days and at 1 year.ResultsThe trial aimed to enroll 630 patients. Based on estimated event rates of 11% in the restrictive group and 15% in the liberal group, this number will provide 80% power to demonstrate clinical noninferiority of the restrictive group, with a noninferiority margin corresponding to a relative risk equal to 1.25. The sample size will also provide 80% power to show the cost‐effectiveness of the restrictive strategy at a threshold of €50 000 per quality‐adjusted life year.ConclusionsREALITY will provide important guidance on the management of patients with AMI and anemia.
Highlights
Anemia is common in patients with acute myocardial infarction (AMI),[1] and is an independent predictor of cardiac events and increased mortality.[1,2,3,4] The association with increased mortality is strong, with a relative increase in mortality exceeding 20% for each 1 g/dL decrement in hemoglobin below 14 g/dL.[2]
The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using the primary composite clinical outcome of major adverse cardiovascular events (MACE; comprising all-cause death, nonfatal stroke, nonfatal recurrent myocardial infarction, or emergency revascularization prompted by ischemia) as the effectiveness criterion
The primary outcome is the incremental cost-effectiveness ratio (ICER) at 30 days, using major adverse cardiovascular events (MACE) as the effectiveness criterion
Summary
Anemia is common in patients with acute myocardial infarction (AMI),[1] and is an independent predictor of cardiac events and increased mortality.[1,2,3,4] The association with increased mortality is strong, with a relative increase in mortality exceeding 20% for each 1 g/dL decrement in hemoglobin below 14 g/dL.[2] The antiplatelet and anticoagulant drugs used for the treatment of patients with AMI increase the risk of bleeding, which in turn increases the risk of ischemia and death Whether this risk can be overcome by transfusion is debated. Hypothesis: We hypothesized that a “restrictive” transfusion strategy (triggered by hemoglobin ≤8 g/dL) is clinically noninferior to a “liberal” transfusion strategy (triggered by hemoglobin ≤10 g/dL), but is less costly.
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