Rationale and design for the myocardial ischemia and transfusion (MINT) randomized clinical trial

Jeffrey L. Carson, Maria Mori Brooks, Bernard R. Chaitman, John H. Alexander, Shaun G. Goodman, Marnie Bertolet, J. Dawn Abbott, Howard A. Cooper, Sunil V. Rao, Darrell J. Triulzi, Dean A. Fergusson, William J. Kostis, Helaine Noveck, Tabassome Simon, Philippe Gabriel Steg, Andrew P. DeFilippis, Andrew M. Goldsweig, Renato D. Lopes, Harvey White, Caroline AlsweilerErin Morton, Paul C. Hébert, MINT Investigators

Research output: Contribution to journalArticlepeer-review

8 Citations (Scopus)

Abstract

BACKGROUND: Accumulating evidence from clinical trials suggests that a lower (restrictive) hemoglobin threshold (<8 g/dL) for red blood cell (RBC) transfusion, compared with a higher (liberal) threshold (≥10 g/dL) is safe. However, in anemic patients with acute myocardial infarction (MI), maintaining a higher hemoglobin level may increase oxygen delivery to vulnerable myocardium resulting in improved clinical outcomes. Conversely, RBC transfusion may result in increased blood viscosity, vascular inflammation, and reduction in available nitric oxide resulting in worse clinical outcomes. We hypothesize that a liberal transfusion strategy would improve clinical outcomes as compared to a more restrictive strategy. METHODS: We will enroll 3500 patients with acute MI (type 1, 2, 4b or 4c) as defined by the Third Universal Definition of MI and a hemoglobin <10 g/dL at 144 centers in the United States, Canada, France, Brazil, New Zealand, and Australia. We randomly assign trial participants to a liberal or restrictive transfusion strategy. Participants assigned to the liberal strategy receive transfusion of RBCs sufficient to raise their hemoglobin to at least 10 g/dL. Participants assigned to the restrictive strategy are permitted to receive transfusion of RBCs if the hemoglobin falls below 8 g/dL or for persistent angina despite medical therapy. We will contact each participant at 30 days to assess clinical outcomes and at 180 days to ascertain vital status. The primary end point is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary end points include all-cause mortality at 30 days, recurrent adjudicated MI, and the composite outcome of all-cause mortality, nonfatal recurrent MI, ischemia driven unscheduled coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting), or readmission to the hospital for ischemic cardiac diagnosis within 30 days. The trial will assess multiple tertiary end points. CONCLUSIONS: The MINT trial will inform RBC transfusion practice in patients with acute MI.

Original languageEnglish
Pages (from-to)120-129
Number of pages10
JournalAmerican Heart Journal
Volume257
DOIs
Publication statusPublished - Mar 2023

Keywords

  • myocardial ischemia
  • myocardial transfusion
  • acute myocardial infarction
  • hemoglobin
  • randomized clinical trial

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