Accumulating evidence from clinical trials suggests that a restrictive transfusion strategy is safe in most clinicalsettings. However, a low oxygen carrying capacity from moderate anemia may be deleterious in patients withcardiac ischemia. The potential for harm associated with anemia in patients with acute symptomatic coronarydisease is supported by pathophysiological data that maintaining higher hemoglobin levels could benefit theischemic heart by increasing oxygen delivery. Furthermore, results of the 110 patient MINT pilot trial foundthat all-cause mortality at 30 days was less frequent with a liberal transfusion strategy, 1 patient (1.8%),compared with a restrictive transfusion strategy, 7 patients (13.0%), (p=0.032). Systematic reviews of clinicaltrials evaluating transfusion strategies in patients with known ischemic heart disease document the absence ofhigh quality data which has resulted in an ongoing controversy. The lack of high quality evidence to guidetransfusions in patients with acute myocardial infarction has been cited in several major guidelines as well asby an NIH expert panel. Despite this, blood transfusions are being used as a negative indicator of quality ofcare by major organizations driving the adoption of restrictive strategies. The potential for adverse outcomes isreal and immediate.In this multicenter pragmatic trial, we will activate 40 clinical centers and will randomly allocate 3500 patients atrisk of myocardial ischemia with acute myocardial infarction and hemoglobin concentration less than 10 g/dL tobe treated either according to a restrictive or liberal blood transfusion strategy. Our Primary Aim will be todetermine whether a liberal transfusion threshold strategy (10 g/dL) is superior and will result in lower rates ofeither all cause mortality or acute myocardial infarction within 30 days following randomization as comparedwith a restrictive transfusion threshold strategy (8 g/dL). Our secondary aims will examine the effect of a liberaltransfusion strategy compared with a restrictive transfusion strategy on adverse outcomes of transfusionrelated to volume overload, thrombotic risk and modified immunity. We will compare 30-day rates ofcongestive heart failure, thromboembolism, and pneumonia. We will also compare rates of 30-day death,myocardial infarction, and unscheduled revascularization, as well as hospital length of stay, and readmission tothe hospital. We will contact the patients at 6 months to determine if the early effects on mortality aresustained or possibly enhanced.RelevanceMINT is positioned to determine the threshold for blood transfusions in patients with acute myocardial infarctionto minimize death and subsequent heart attacks. Given the high incidence of acute ischemic heart disease,the results of MINT can shape clinical practice.
|Effective start/end date||9/1/16 → 5/31/21|
- National Institutes of Health (NIH)