Sodium thiosulfate, while safe to administer at reperfusion in patients presenting with a first STEMI, showed no benefits for reducing infarct size, based on findings from the GIPS-IV trial presented April 4 at ACC.22. This was the first clinical trial to test the use of sodium thiosulfate for treating myocardial infarction (MI) in humans.

The study enrolled 380 patients treated for a first MI between 2018-2021 at three health centers in the Netherlands. Half of the patients were randomly assigned to receive two doses of sodium thiosulfate via intravenous injection, one immediately upon arrival in the cardiac catheterization laboratory and one six hours later. The rest of the patients received two placebo doses.

At four months, the trial did not meet its primary endpoint –  myocardial infarct size, as measured with a cardiac MRI. There were also no significant differences in the secondary endpoints, which included left ventricular ejection fraction and NT-proBNP levels at four months and peak creatine kinase-MB. However, researchers said the drug was safe and major adverse cardiovascular events at four months were comparable in both groups.

"We were disappointed that, despite a very well conducted trial, we did not to see any effect on infarct size or any of the secondary endpoints," said Marie-Sophie de Koning, MD, the study's lead author "Based on this study, we now have evidence that sodium thiosulfate is not working. However, we cannot exclude that sodium thiosulfate could make a bigger difference in regions of the world where the quality or efficiency of heart attack treatments are lower than in the Netherlands, where patients may experience a higher infarct size overall and thus stand to benefit more from treatments that may reduce the damage to heart muscle."

Researchers said future studies could explore whether different hydrogen sulfide donors or administration strategies may have a bigger impact. "It's too early to tell whether hydrogen sulfide as a whole doesn't work for ischemia-reperfusion injury," de Koning said. "It's possible that what's needed is a stronger hydrogen sulfide donor compound or a prolonged administration after reperfusion."

Researchers did note that higher rates of nausea and vomiting around the time of administration were observed in the sodium thiosulfate group, suggesting a higher concentration of the drug might not be tolerated by patients, however. De Koning said that it could be challenging to administer other hydrogen sulfide-based treatments because of the compound's strong smell.

Clinical Topics: Invasive Cardiovascular Angiography and Intervention

Keywords: ACC Annual Scientific Session, ACC22, Myocardial Infarction, Angioplasty, Balloon, Coronary, Percutaneous Coronary Intervention

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