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Original article
Long term outcome after mononuclear bone marrow or peripheral blood cells infusion after myocardial infarction
  1. Ronak Delewi1,2,
  2. Anja M van der Laan1,
  3. Lourens F H J Robbers2,3,
  4. Alexander Hirsch1,
  5. Robin Nijveldt3,
  6. Pieter A van der Vleuten4,
  7. Jan G P Tijssen1,
  8. René A Tio4,
  9. Johannes Waltenberger5,
  10. Jurrien M ten Berg6,
  11. Pieter A Doevendans7,
  12. Helmut R Gehlmann8,
  13. Albert C van Rossum3,
  14. Jan J Piek1,
  15. Felix Zijlstra9,
  16. on behalf of the HEBE investigators
  1. 1Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands
  2. 2Interuniversity Cardiology Institute of the Netherlands, Utrecht, The Netherlands
  3. 3Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands
  4. 4Thorax Center, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
  5. 5Department of Cardiology, University Hospital Maastricht, Maastricht, The Netherlands
  6. 6Department of Cardiology, St Antonius Hospital, Nieuwegein, The Netherlands
  7. 7Department of Cardiology, University Medical Center Utrecht, Utrecht, The Netherlands
  8. 8Department of Cardiology, University Medical Center St Radboud, Nijmegen, The Netherlands
  9. 9Department of Cardiology, Thorax Center, Erasmus University Medical Center, Rotterdam, The Netherlands
  1. Correspondence to Dr R Delewi, Department of Cardiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, Amsterdam 1105AZ, The Netherlands; r.delewi{at}amc.nl

Abstract

Objectives 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/m2) compared with (11.2±19.8 mL/m2, p=0.03) in the control group, with no difference between the PBMC group (9.2±20.9 mL/m2) and controls (p=0.69). Moreover, the BMMC group showed a trend for decrease in LV end systolic volume (−1.8±15.0 mL/m2) as compared with controls (3.0±16.3 mL/m2, p=0.07), with again no difference between PBMC (3.3±18.8 mL/m2) 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.

Trial registration number The Netherlands Trial Register #NTR166 (http://www.trialregister.nl) and the International Standard Randomised Controlled Trial, #ISRCTN95796863 (http://isrctn.org).

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