1. Rationale and Design for the Myocardial Ischemia and Transfusion (MINT) Randomized Clinical Trial
- Author
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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 Alsweiler, Erin Morton, Paul C. Hébert, Shahab Ghafghazi, Frances Wood, Mark Menegus, Barry Uretsky, Srikanth Vallurupalli, Gregory Maniatis, Luis Gruberg, Robert Roswell, Joseph Rossi, Farhad Abtahian, Meechai Tessalee, Gregory Barsness, Herbert Aronow, Kodangudi Ramanathan, Mark Schmidhofer, Friederike Keating, Michael Carson, Michael Kontos, Mansoor Qureshi, Stacey Clegg, Warren Laskey, Tamar Polonsky, Rajesh Gupta, Mujeeb Abdul Sheikh, Lynne Uhl, Paul Mullen, Arthur Bracey, William Matthai, Christopher Stowell, David Dudzinski, Gregary Marhefka, Perry Weinstock, William Lawson, Norma Keller, Eugene Yuriditsky, Michael Thomas, Alice Jacobs, Claudia Hochberg, Omar Siddiqi, Joshua Schulman-Marcus, Mikhail Torosoff, Michael Gitter, Xuming Dai, Jay Traverse, Eric McCamant, Jason Scott, Rajesh Swaminathan, Sunil Rao, Adam Salisbury, David Landers, Ganesh Raveendran, Ramin Ebrahimi, Richard Bach, Joseph Delehanty, Raj C. Shah, Sorin Brener, Jonathan Doroshow, Adriano Caixeta, Dalton Precoma, Frederico Toledo Campo Dall'Orto, Pedro Beraldo De Andrade, Marianna Dracoulakis, Lília Nigro Maia, Luiz Eduardo Fontelles Ritt, Alexandre Quadros, Dário Celestino Sobral Filho, Fernando De Martino, Thao Huynh, Greg Schnell, Manohara Senaratne, Vikas Tandon, John Neary, David Laflamme, Jean-Pierre Dery, Kevin Bainey, Richard Haichin, Payam Dehghani, Ata Ur Rehman Quraishi, Brian J. Potter, François Martin Carrier, Michael Goldfarb, Christopher Fordyce, Ying Tung Sia, Benoit Daneault, Mina Madan, Terry McPherson, John Ducas, Kunal Minhas, Neil Brass, Akshay Bagai, Simon Robinson, Vladimír Džavík, Razi Khan, Nicolas Michaud, Gabriel Steg, Gregory Ducrocq, Etienne Puymirat, Gilles Lemesle, Emile Ferrari, Benoit Lattuca, Johanne Silvain, Gérald Vanzetto, Laura Cetran, Thibault Lhermusier, Yves Cottin, Yann Rosamel, Denis Angoulvant, Jean Guillaume Dillinger, Christophe Thuaire, Batric Popovic, Eric Durand, Claire Bouleti, François Roubille, Laurent Delorme, Ian Crozier, Jocelyne Benatar, Samraj Nandra, Ian Ternouth, Nick Fisher, David Brieger, and Graham Hillis
- Subjects
Cardiology and Cardiovascular Medicine - Abstract
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.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 hemoglobin10 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 endpoint is a composite of all-cause death or recurrent MI through 30 days following randomization. Secondary endpoints 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 endpoints.The MINT trial will inform RBC transfusion practice in patients with acute MI.
- Published
- 2022