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

Authors

Jeffrey L. Carson, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Maria Mori Brooks, University of Pittsburgh School of Public Health, Pittsburgh, PA.
Bernard R. Chaitman, St Louis University School of Medicine, St Louis, MO.
John H. Alexander, Duke Clinical Research Institute, Durham, NC.
Shaun G. Goodman, St. Michael's Hospital, University of Toronto, Toronto Canada; Canadian VIGOUR Centre, University of Alberta, Edmonton, Alberta, Canada.
Marnie Bertolet, University of Pittsburgh School of Public Health, Pittsburgh, PA.
J Dawn Abbott, Warren Alpert Medical School. Brown University, Providence, RI.
Howard A. Cooper, Westchester Medical Center, Valhalla, NY.
Sunil V. Rao, Durham VA Medical Center, Durham, NC; NYU Langone Health, New York, NY.
Darrell J. Triulzi, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Dean A. Fergusson, Ottawa Hospital Research Institute Ottawa, Ontario, Canada.
William J. Kostis, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Helaine Noveck, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ.
Tabassome Simon, Hopital Saint Antoine, Paris, France.
Philippe Gabriel Steg, Université Paris-Cité, Paris, France.
Andrew P. DeFilippis, Vanderbilt University, Nashville, TN.
Andrew M. Goldsweig, University of Nebraska Medical Center, Omaha, NE.
Renato D. Lopes, Brazilian Clinical Research Institute, São Paulo, Brazil; Duke Clinical Research Institute, Durham, NC.
Harvey White, Green Lane Clinical Coordinating Centre Ltd, Auckland, New Zealand.
Caroline Alsweiler, Green Lane Clinical Coordinating Centre Ltd, Auckland, New Zealand.
Erin Morton, Finders University, Adelaide, Australia.
Paul C. Hébert, Centre de Recherche du Centre Hosp. Universitaire de Montréal, Montréal, Québec, Canada.
Farhad Abtahian, Rochester Regional HealthFollow

Department

Cardiology

Document Type

Article

Publication Title

American Heart Journal

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.

First Page

120

Last Page

129

DOI

10.1016/j.ahj.2022.11.015

Volume

257

Publication Date

3-1-2023

Comments

Farhad Abtahian of Rochester Regional Health System is a contributor for this article.

See full list of authors and contributors at journal website.

PubMed ID

36417955

Share

COinS