title: Long term outcome after mononuclear bone marrow or peripheral blood cells infusion after myocardial infarction.
abstract: OBJECTIVE
  This study reports the long-term follow-up of the randomised controlled HEBE trial. The HEBE study is a multicentre trial that randomised 200 patients with large first acute myocardial infarction (AMI) treated with primary percutaneous coronary intervention to either intracoronary infusion of bone marrow mononuclear cells (BMMCs) (n=69), peripheral blood mononuclear cells (PBMCs) (n=66) or standard therapy (n=65).
  
  
  METHODS
  In addition to 3-5 days, and 4 months after AMI, all patients underwent cardiac MRI after 2 years. A follow-up for 5 years after AMI was performed to assess clinical adverse events, including death, myocardial reinfarction and hospitalisation for heart failure.
  
  
  RESULTS
  Of the 200 patients enrolled, 9 patients died and 12 patients were lost to follow-up at 5 years after AMI. BMMC group showed less increase in LV end-diastolic volume (LVEDV) (3.5±16.9 mL/m(2)) compared with (11.2±19.8 mL/m(2), p=0.03) in the control group, with no difference between the PBMC group (9.2±20.9 mL/m(2)) and controls (p=0.69). Moreover, the BMMC group showed a trend for decrease in LV end systolic volume (-1.8±15.0 mL/m(2)) as compared with controls (3.0±16.3 mL/m(2), p=0.07), with again no difference between PBMC (3.3±18.8 mL/m(2)) and controls (p=0.66). The combined endpoint of death and hospitalisation for heart failure was non-significantly less frequent in the BMMC group compared with the control group (n=4 vs n=1, p=0.20), with no difference between PBMC and controls (n=6 vs n=4, p=0.74). The composite endpoint of death or recurrent myocardial infarction was significantly higher in the PBMC group compared with controls (14 patients vs 3 patients, p=0.008), with no difference between the BMMC group and controls (2 vs 3 patients, p=0.67).
  
  
  CONCLUSIONS
  Long-term follow-up of the HEBE trial showed that increase in LVEDV was lower in the BMMC group. This study supports the long-term safety of intracoronary BMMC therapy. However, major clinical cardiovascular adverse events were significantly more frequent in the PBMC group.
  
  
  BACKGROUND
  The Netherlands Trial Register #NTR166 (http://www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (http://isrctn.org).
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Interuniversity Cardiology Institute of the Netherlands, Utrecht, The Netherlands.
authors.forename: Ronak
authors.initials: R
authors.lastname: Delewi
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Anja M
authors.initials: AM
authors.lastname: van der Laan
authors.affiliation: Interuniversity Cardiology Institute of the Netherlands, Utrecht, The Netherlands Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Lourens F H J
authors.initials: LF
authors.lastname: Robbers
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Alexander
authors.initials: A
authors.lastname: Hirsch
authors.affiliation: Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Robin
authors.initials: R
authors.lastname: Nijveldt
authors.affiliation: Thorax Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: Pieter A
authors.initials: PA
authors.lastname: van der Vleuten
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jan G P
authors.initials: JG
authors.lastname: Tijssen
authors.affiliation: Thorax Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
authors.forename: René A
authors.initials: RA
authors.lastname: Tio
authors.affiliation: Department of Cardiology, University Hospital Maastricht, Maastricht, The Netherlands.
authors.forename: Johannes
authors.initials: J
authors.lastname: Waltenberger
authors.affiliation: Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands.
authors.forename: Jurrien M
authors.initials: JM
authors.lastname: Ten Berg
authors.affiliation: Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands.
authors.forename: Pieter A
authors.initials: PA
authors.lastname: Doevendans
authors.affiliation: Department of Cardiology, University Medical Center St Radboud, Nijmegen, The Netherlands.
authors.forename: Helmut R
authors.initials: HR
authors.lastname: Gehlmann
authors.affiliation: Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands.
authors.forename: Albert C
authors.initials: AC
authors.lastname: van Rossum
authors.affiliation: Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Jan J
authors.initials: JJ
authors.lastname: Piek
authors.affiliation: Department of Cardiology, Thorax Center, Erasmus University Medical Center, Rotterdam, The Netherlands.
authors.forename: Felix
authors.initials: F
authors.lastname: Zijlstra
mesh_terms: D016026:Bone Marrow Transplantation; D005260:Female; D005500:Follow-Up Studies; D006352:Heart Ventricles / Q000473:pathology; D006801:Humans; D007963:Leukocytes, Mononuclear / Q000637:transplantation*; D019028:Magnetic Resonance Imaging, Cine; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D062645:Percutaneous Coronary Intervention; D012008:Recurrence; D018487:Ventricular Dysfunction, Left / Q000453:epidemiology / Q000473:pathology