PREVENT-TAHA8 Study Dataset: Prevention of Acute Myocardial Infarction-Induced Heart Failure by Intracoronary Infusion of Mesenchymal Stem Cells: A Phase III Randomized Clinical Trial

Recent meta-analyses of clinical trials have indicated that stem cell therapy may reduce the incidence of heart failure (HF) following acute myocardial infarction (AMI). However, no clinical trials have directly investigated this question. The PREVENT-TAHA8 trial is a multicenter, single-blinded, randomized, and superiority phase III trial. Patients with first ST-elevation AMI and a left ventricular ejection fraction (LVEF) below 40% were enrolled and randomized in a 1:2 ratio (intervention to control) to receive either an intracoronary infusion of allogenic Wharton’s jelly-derived mesenchymal stem cells (WJ-MSCs) within 3-7 days post-AMI or standard care. The primary endpoint was rehospitalization due to HF. Secondary endpoints included all-cause mortality, cardiovascular mortality, and rehospitalization due to myocardial infarction (MI). To the best of our knowledge, this is the largest trial in regenerative cardiology involving AMI patients and the only one using mesenchymal stem cells (MSCs) with clinical endpoints, as opposed to surrogate markers such as LVEF. Intracoronary infusion of WJ-MSCs significantly reduced the risk of rehospitalization due to HF, as well as the composite endpoint of mortality and rehospitalization due to HF or MI, in patients following AMI, suggesting that this technique may serve as a valuable adjunctive procedure for post-MI patients to prevent the development of HF and reduce the risk of future adverse events.Trial Registration: The PREVENT-TAHA8 clinical trial is registered on ClinicalTrials.gov under the identifier NCT05043610. Detailed information about the trial can be accessed at https://clinicaltrials.gov/ct2/show/NCT05043610.