title: Clinical outcome 2 years after intracoronary administration of bone marrow-derived progenitor cells in acute myocardial infarction.
abstract: 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).
  
  
  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.
authors.affiliation: J W Goethe Universität, Division of Cardiology, Frankfurt, Germany.
authors.forename: Birgit
authors.initials: B
authors.lastname: Assmus
authors.forename: Andreas
authors.initials: A
authors.lastname: Rolf
authors.forename: Sandra
authors.initials: S
authors.lastname: Erbs
authors.forename: Albrecht
authors.initials: A
authors.lastname: Elsässer
authors.forename: Werner
authors.initials: W
authors.lastname: Haberbosch
authors.forename: Rainer
authors.initials: R
authors.lastname: Hambrecht
authors.forename: Harald
authors.initials: H
authors.lastname: Tillmanns
authors.forename: Jiangtao
authors.initials: J
authors.lastname: Yu
authors.forename: Roberto
authors.initials: R
authors.lastname: Corti
authors.forename: Detlef G
authors.initials: DG
authors.lastname: Mathey
authors.forename: Christian W
authors.initials: CW
authors.lastname: Hamm
authors.forename: Tim
authors.initials: T
authors.lastname: Süselbeck
authors.forename: Torsten
authors.initials: T
authors.lastname: Tonn
authors.forename: Stefanie
authors.initials: S
authors.lastname: Dimmeler
authors.forename: Thorsten
authors.initials: T
authors.lastname: Dill
authors.forename: Andreas M
authors.initials: AM
authors.lastname: Zeiher
authors.forename: Volker
authors.initials: V
authors.lastname: Schächinger
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003331:Coronary Vessels; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000601:surgery*; D033581:Stem Cell Transplantation; D013234:Stem Cells; D016896:Treatment Outcome