PMID- 21633921 OWN - NLM STAT- MEDLINE DCOM- 20120112 LR - 20211020 IS - 1861-0692 (Electronic) IS - 1861-0684 (Linking) VI - 100 IP - 10 DP - 2011 Oct TI - Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction (TOPCARE-AMI): final 5-year results suggest long-term safety and efficacy. PG - 925-34 LID - 10.1007/s00392-011-0327-y [doi] AB - BACKGROUND: Limited data is available for investigating the long-term safety and effects of intracoronary progenitor cell therapy in patients with acute myocardial infarction (AMI). OBJECTIVE: To assess the clinical course, NT-proBNP and MRI data as objective markers of cardiac function of the TOPCARE-AMI patients at 5-year follow-up. DESIGN: The TOPCARE-AMI trial was the first randomized study investigating the effects of intracoronary infusion of circulating (CPC) or bone marrow-derived progenitor cells (BMC) in 59 patients with successfully reperfused AMI. RESULTS: Five-year follow-up data were completed in 55 patients, 3 patients were lost to follow-up. None of the patients showed any signs of intramyocardial calcification or tumors at 5 years. One patient died during the initial hospitalization, no patient was rehospitalized for heart failure and 16 patients underwent target vessel revascularization (TVR). Only two TVRs occurred later than 1 year after cell administration making it very unlikely that the infused cells accelerate atherosclerotic disease progression. Serum levels of NT-proBNP remained significantly reduced at the 5-year follow-up indicating the absence of heart failure. MRI subgroup analysis in 31 patients documented a persistent improvement of LV ejection fraction (from 46 +/- 10% at baseline to 57 +/- 10% at 5 years, p < 0.001)). Simultaneously, there was a reduction (p < 0.001) in functional infarct size measured as late enhancement volume normalized to LV mass. However, whereas LV end-systolic volume remained stable, LV end-diastolic volume increased significantly. CONCLUSIONS: The 5-year follow-up of the TOPCARE-AMI trial provides reassurance with respect to the long-term safety of intracoronary cell therapy and suggests favorable effects on LV function. FAU - Leistner, David M AU - Leistner DM AD - Division of Cardiology, Department of Medicine III, Goethe University Frankfurt, Germany. FAU - Fischer-Rasokat, Ulrich AU - Fischer-Rasokat U FAU - Honold, Jorg AU - Honold J FAU - Seeger, Florian H AU - Seeger FH FAU - Schachinger, Volker AU - Schachinger V FAU - Lehmann, Ralf AU - Lehmann R FAU - Martin, Hans AU - Martin H FAU - Burck, Iris AU - Burck I FAU - Urbich, Carmen AU - Urbich C FAU - Dimmeler, Stefanie AU - Dimmeler S FAU - Zeiher, Andreas M AU - Zeiher AM FAU - Assmus, Birgit AU - Assmus B LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20110603 PL - Germany TA - Clin Res Cardiol JT - Clinical research in cardiology : official journal of the German Cardiac Society JID - 101264123 RN - 0 (Biomarkers) RN - 0 (Peptide Fragments) RN - 0 (Platelet Aggregation Inhibitors) RN - 0 (pro-brain natriuretic peptide (1-76)) RN - 114471-18-0 (Natriuretic Peptide, Brain) SB - IM MH - Adult MH - *Angioplasty, Balloon, Coronary/adverse effects/instrumentation/mortality MH - Biomarkers/blood MH - Combined Modality Therapy MH - Disease-Free Survival MH - Germany MH - Humans MH - Kaplan-Meier Estimate MH - Magnetic Resonance Imaging MH - Middle Aged MH - Myocardial Infarction/blood/mortality/pathology/physiopathology/*therapy MH - Myocardium/*pathology MH - Natriuretic Peptide, Brain/blood MH - Peptide Fragments/blood MH - Pilot Projects MH - Platelet Aggregation Inhibitors/therapeutic use MH - Recovery of Function MH - *Regeneration MH - *Stem Cell Transplantation/adverse effects/mortality MH - Stents MH - Stroke Volume MH - Time Factors MH - Treatment Outcome MH - Ventricular Function, Left EDAT- 2011/06/03 06:00 MHDA- 2012/01/13 06:00 CRDT- 2011/06/03 06:00 PHST- 2010/12/02 00:00 [received] PHST- 2011/05/23 00:00 [accepted] PHST- 2011/06/03 06:00 [entrez] PHST- 2011/06/03 06:00 [pubmed] PHST- 2012/01/13 06:00 [medline] AID - 10.1007/s00392-011-0327-y [doi] PST - ppublish SO - Clin Res Cardiol. 2011 Oct;100(10):925-34. doi: 10.1007/s00392-011-0327-y. Epub 2011 Jun 3.