{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,1]],"date-time":"2026-02-01T09:55:11Z","timestamp":1769939711506,"version":"3.49.0"},"reference-count":17,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Intern Med"],"published-print":{"date-parts":[[2025,5,1]]},"abstract":"<jats:sec><jats:title>Importance<\/jats:title><jats:p>In 2013, the Trial to Assess Chelation Therapy (TACT) reported that in 1708 patients with stable coronary disease and prior myocardial infarction (MI), oral multivitamins and multiminerals (OMVMs), in a factorial design with edetate disodium (EDTA) chelation therapy, did not reduce cardiovascular events relative to placebo OMVMs, but active EDTA combined with active OMVMs was superior to placebo OMVM\/placebo EDTA.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objective<\/jats:title><jats:p>To compare OMVM vs placebo in terms of efficacy for reducing major adverse cardiovascular events in patients with diabetes and prior MI.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design, Setting, and Participants<\/jats:title><jats:p>The TACT2 randomized, multicenter double-masked 2\u2009\u00d7\u20092 factorial clinical trial took place across 88 sites in the US and Canada. Participants were 50 years or older, had diabetes, and had an MI 6 weeks ago or more. TACT2 participants were enrolled between September 2016 and December 2020. Data were collected between October 2016 and June 2023.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Six caplets daily of a 28 component OMVM or matching OMVM placebo, and 40 weekly infusions of an EDTA-based chelation solution or matching placebo, in a 1:1:1:1 allocation ratio.<\/jats:p><\/jats:sec><jats:sec><jats:title>Main Outcomes and Measures<\/jats:title><jats:p>The primary end point was the composite of all-cause mortality, MI, stroke, coronary revascularization, or hospitalization for unstable angina.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 1000 participants were randomized (500 in the active OMVM group and 500 in the placebo group). The median (IQR) age was 67 (60-72) years, and 730 (73%) were male. Median (IQR) follow-up was 48 (34-58) months. The primary end point occurred in 175 participants (35%) in the active OMVM group and 175 (35%) in the placebo group (hazard ratio [HR], 0.99 [95% CI, 0.80-1.22]; <jats:italic>P<\/jats:italic>\u2009=\u2009.92). The 5-year event rate for the primary end point in the EDTA chelation\u2009+\u2009active OMVM group was 34.0%; in the EDTA chelation\u2009+\u2009placebo OMVM group, 35.7%; in the placebo infusion\u2009+\u2009active OMVM group, 36.0%; and in the placebo infusion\u2009+\u2009placebo OMVM group, 34.3%. The comparison of the active infusion\u2009+\u2009active OMVM with the placebo infusion\u2009+\u2009placebo OMVM was not significant (HR, 0.91 [95% CI, 0.67-1.23]; <jats:italic>P<\/jats:italic>\u2009=\u2009.54). Although nonsignificant, there was a numerically higher event rate of MI, stroke, mortality from cardiovascular causes in the active OMVM compared to placebo OMVM group.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions and Relevance<\/jats:title><jats:p>The results of this randomized clinical trial demonstrated that, for participants with chronic coronary disease, diabetes, and a previous MI, high-dose OMVM alone or in conjunction with EDTA-based chelation did not reduce cardiovascular events.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial Registration<\/jats:title><jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/www.clinicaltrials.gov\/study\/NCT02733185\">NCT02733185<\/jats:ext-link><\/jats:p><\/jats:sec>","DOI":"10.1001\/jamainternmed.2024.8408","type":"journal-article","created":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T16:02:12Z","timestamp":1741017732000},"page":"540","source":"Crossref","is-referenced-by-count":4,"title":["Multivitamins After Myocardial Infarction in Patients With Diabetes"],"prefix":"10.1001","volume":"185","author":[{"given":"Francisco","family":"Ujueta","sequence":"first","affiliation":[{"name":"Brigham and Women\u2019s Hospital Division of Cardiovascular Medicine, Boston, Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gervasio A.","family":"Lamas","sequence":"additional","affiliation":[{"name":"Columbia University Division of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kevin J.","family":"Anstrom","sequence":"additional","affiliation":[{"name":"Gillings School of Global Public Health, University of North Carolina, Chapel Hill"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ana","family":"Navas-Acien","sequence":"additional","affiliation":[{"name":"Department of Environmental Health Sciences, Columbia University Mailman School of Public Health, New York, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robin","family":"Boineau","sequence":"additional","affiliation":[{"name":"National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yves","family":"Rosenberg","sequence":"additional","affiliation":[{"name":"National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mario","family":"Stylianou","sequence":"additional","affiliation":[{"name":"National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa L. 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