PMID- 19996415 OWN - NLM STAT- MEDLINE DCOM- 20100216 LR - 20220309 IS - 1941-3297 (Electronic) IS - 1941-3289 (Linking) VI - 3 IP - 1 DP - 2010 Jan TI - Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction. PG - 89-96 LID - 10.1161/CIRCHEARTFAILURE.108.843243 [doi] AB - BACKGROUND: The aim of this study was to investigate the clinical outcome 2 years after intracoronary administration of autologous progenitor cells in patients with acute myocardial infarction (AMI). METHODS AND RESULTS: Using a double-blind, placebo-controlled, multicenter trial design, we randomized 204 patients with successfully reperfused AMI to receive intracoronary infusion of bone marrow-derived progenitor cells (BMC) or placebo medium into the infarct artery 3 to 7 days after successful infarct reperfusion therapy. At 2 years, the cumulative end point of death, myocardial infarction, or necessity for revascularization was significantly reduced in the BMC group compared with placebo (hazard ratio, 0.58; 95% CI, 0.36 to 0.94; P=0.025). Likewise, the combined end point death and recurrence of myocardial infarction and rehospitalization for heart failure, reflecting progression toward heart failure, was significantly reduced in the BMC group (hazard ratio, 0.26; 95% CI, 0.085 to 0.77; P=0.015). Intracoronary administration of BMC remained a significant predictor of a favorable clinical outcome by Cox regression analysis when adjusted for classical predictors of poor outcome after AMI. There was no evidence of increased restenosis or atherosclerotic disease progression after BMC therapy nor any evidence of increased ventricular arrhythmias or neoplasms. In addition, regional left ventricular contractility of infarcted segments, as assessed by MRI in a subgroup of patients at 2-year follow-up, was significantly higher in the BMC group compared with the placebo group (P<0.001). CONCLUSIONS: Intracoronary administration of BMC is associated with a significant reduction of the occurrence of major adverse cardiovascular events maintained for 2 years after AMI. Moreover, functional improvements after BMC therapy may persist for at least 2 years. Larger studies focusing on clinical event rates are warranted to confirm the effects of BMC administration on mortality and progression of heart failure in patients with AMIs. Clinical Trial Registration- clinicaltrials.gov. Identifier: NCT00279175. FAU - Assmus, Birgit AU - Assmus B AD - J W Goethe Universitat, Division of Cardiology, Frankfurt, Germany. FAU - Rolf, Andreas AU - Rolf A FAU - Erbs, Sandra AU - Erbs S FAU - Elsasser, Albrecht AU - Elsasser A FAU - Haberbosch, Werner AU - Haberbosch W FAU - Hambrecht, Rainer AU - Hambrecht R FAU - Tillmanns, Harald AU - Tillmanns H FAU - Yu, Jiangtao AU - Yu J FAU - Corti, Roberto AU - Corti R FAU - Mathey, Detlef G AU - Mathey DG FAU - Hamm, Christian W AU - Hamm CW FAU - Suselbeck, Tim AU - Suselbeck T FAU - Tonn, Torsten AU - Tonn T FAU - Dimmeler, Stefanie AU - Dimmeler S FAU - Dill, Thorsten AU - Dill T FAU - Zeiher, Andreas M AU - Zeiher AM FAU - Schachinger, Volker AU - Schachinger V CN - REPAIR-AMI Investigators LA - eng SI - ClinicalTrials.gov/NCT00279175 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20091208 PL - United States TA - Circ Heart Fail JT - Circulation. Heart failure JID - 101479941 SB - IM MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Coronary Vessels MH - Double-Blind Method MH - Female MH - Humans MH - Male MH - Middle Aged MH - Myocardial Infarction/*surgery MH - *Stem Cell Transplantation MH - Stem Cells MH - Treatment Outcome EDAT- 2009/12/10 06:00 MHDA- 2010/02/17 06:00 CRDT- 2009/12/10 06:00 PHST- 2009/12/10 06:00 [entrez] PHST- 2009/12/10 06:00 [pubmed] PHST- 2010/02/17 06:00 [medline] AID - CIRCHEARTFAILURE.108.843243 [pii] AID - 10.1161/CIRCHEARTFAILURE.108.843243 [doi] PST - ppublish SO - Circ Heart Fail. 2010 Jan;3(1):89-96. doi: 10.1161/CIRCHEARTFAILURE.108.843243. Epub 2009 Dec 8.