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. 2023 Aug 23;8(10):1285-1294.
doi: 10.1016/j.jacbts.2023.06.001. eCollection 2023 Oct.

Sodium Thiosulfate in Acute Myocardial Infarction: A Randomized Clinical Trial

Marie-Sophie L Y de Koning  1 , Paulien van Dorp  1 , Solmaz Assa  1 , Gabija Pundziute-Do Prado  1 , Michiel Voskuil  2 , Rutger L Anthonio  3 , Duco Veen  4   5 , Tim Leiner  6   7 , Anita J Sibeijn-Kuiper  8 , Harry van Goor  9 , Dirk J van Veldhuisen  1 , Peter van der Meer  1 , Robin Nijveldt  10 , Erik Lipšic  1 , Pim van der Harst  1   2
Affiliations

Sodium Thiosulfate in Acute Myocardial Infarction: A Randomized Clinical Trial

Marie-Sophie L Y de Koning et al. JACC Basic Transl Sci. .

Abstract

In this proof-of-principle trial, the hypothesis was investigated that sodium thiosulfate (STS), a potent antioxidant and hydrogen sulfide donor, reduces reperfusion injury. A total of 373 patients presenting with a first ST-segment elevation myocardial infarction received either 12.5 g STS intravenously or matching placebo at arrival at the hospital and 6 hours later. The primary outcome, infarct size, measured by cardiac magnetic resonance at 4 months after randomization, did not differ between the treatment arms. Secondary outcomes were comparable as well, suggesting no clinical benefit of STS in this population at relatively low risk for large infarction.

Keywords: clinical trial; hydrogen sulfide; ischemia-reperfusion injury; myocardial infarction; randomized controlled trial; thiosulfates.

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Conflict of interest statement

This study is supported by a grant of the Netherlands Organization for Health Research and Development and the Dutch Heart Foundation (ZonMW; project No: 95105012), Siemens health care GmbH (Push project IPA No.10), and the University Medical Centre Groningen. The subsidizers had no role in the design and conduct of the study, study analyses, drafting or editing of the manuscript, and its final contents. Dr Anthonio has received a Biotronic Teaching Grant, a Sanofi CTCue license for 1 year, and payment for Abiomed Impella Webcast; and Amgen paid for attendance at the New York Cardiovascular Symposium 2019. Dr van der Meer has received consultancy fees and/or grants from Novartis, Novo Nordisk, Vifor Pharma, AstraZeneca, Pfizer, Pharmacosmos, Pharma Nord and Ionis. Dr Nijveldt has received unrestricted research grants from Biotronik and Philips; and has received speaker fees from Sanofi Genzyme and Bayer. Dr Lipsic has received an educational grant from Abbott Medical. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

None
Graphical abstract
Figure 1
Figure 1
Primary and Secondary Outcomes by Allocated Treatment Violin plots showing medians (solid line) and 25th and 75th percentiles (dashed line) for the primary outcome, infarct size at 4 months follow-up, and secondary outcomes in patients treated with sodium thiosulfate (STS) (red) and patients treated with placebo (navy). No significant differences were observed between treatment arms, suggesting no clinical benefit of STS in this relatively low-risk study population. CK-MB = creatine kinase myocardial band; LVEF = left ventricular ejection fraction; NT-proBNP = N-terminal pro–B-type natriuretic peptide.
Figure 2
Figure 2
Effect of Sodium Thiosulfate on Infarct Size Across Prespecified Subgroups Forest plot depicting the estimated treatment effect of sodium thiosulfate on the primary outcome infarct size at 4-month follow-up across prespecified subgroups (age ≤ median [61 years] vs age > median; male vs female; anterior myocardial infarction vs nonanterior myocardial infarction; singe-vessel disease vs multivessel disease; ischemic time ≤ median [141 minutes] vs > the median; TIMI flow pre-PCI 0-1 vs. 2-3; and time from start of study medication to PCI ≤ median [16 minutes] vs > the median). Treatment effects of STS were consistent across all subgroups (P for interaction all >0.05). PCI = percutaneous coronary intervention; STS = sodium thiosulfate: TIMI = Thrombolysis In Myocardial Infarction.
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