PMID- 32340315
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20200928
IS  - 2077-0383 (Print)
IS  - 2077-0383 (Electronic)
IS  - 2077-0383 (Linking)
VI  - 9
IP  - 4
DP  - 2020 Apr 23
TI  - The Effects of Granulocyte Colony-Stimulating Factor in Patients with a Large 
      Anterior Wall Acute Myocardial Infarction to Prevent Left Ventricular Remodeling: 
      A 10-Year Follow-Up of the RIGENERA Study.
LID - 10.3390/jcm9041214 [doi]
LID - 1214
AB  - BACKGROUND: the RIGENERA trial assessed the efficacy of granulocyte-colony 
      stimulating factor (G-CSF) in the improvement of clinical outcomes in patients 
      with severe acute myocardial infarction. However, there is no evidence available 
      regarding the long-term safety and efficacy of this treatment. METHODS: in order 
      to evaluate the long-term effects on the incidence of major adverse events, on 
      the symptom burden, on the quality of life and the mean life expectancy and on 
      the left ventricular (LV) function, we performed a clinical and echocardiographic 
      evaluation together with an assessment using the Minnesota Living with Heart 
      Failure Questionnaire (MLHFQ) and the Seattle Heart Failure Model (SHFM) at 
      10-years follow-up, in the patients cohorts enrolled in the RIGENERA trial. 
      RESULTS: thirty-two patients were eligible for the prospective clinical and 
      echocardiography analyses. A significant reduction in adverse LV remodeling was 
      observed in G-CSF group compared to controls, 9% vs. 48% (p = 0.030). The New 
      York Heart Association (NYHA) functional class was lower in G-CSF group vs. 
      controls (p = 0.040), with lower burden of symptoms and higher quality of life (p 
      = 0.049). The mean life expectancy was significantly higher in G-CSF group 
      compared to controls (15 +/- 4 years vs. 12 +/- 4 years, p = 0.046. No difference was 
      found in the incidence of major adverse events. CONCLUSIONS: this longest 
      available follow-up on G-CSF treatment in patients with severe acute myocardial 
      infarction (AMI) showed that this treatment was safe and associated with a 
      reduction of adverse LV remodeling and higher quality of life, in comparison with 
      standard-of-care treatment.
FAU - Leone, Antonio Maria
AU  - Leone AM
AUID- ORCID: 0000-0002-1276-9883
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario 
      Agostino Gemelli, IRCCS, Universita Cattolica del Sacro Cuore, Largo A. Gemelli 
      8, 00168 Rome, Italy.
FAU - D'Amario, Domenico
AU  - D'Amario D
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario 
      Agostino Gemelli, IRCCS, Universita Cattolica del Sacro Cuore, Largo A. Gemelli 
      8, 00168 Rome, Italy.
FAU - Cannata, Francesco
AU  - Cannata F
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Graziani, Francesca
AU  - Graziani F
AUID- ORCID: 0000-0002-4520-5689
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario 
      Agostino Gemelli, IRCCS, Universita Cattolica del Sacro Cuore, Largo A. Gemelli 
      8, 00168 Rome, Italy.
FAU - Borovac, Josip A
AU  - Borovac JA
AUID- ORCID: 0000-0002-4878-8146
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Leone, Giuseppe
AU  - Leone G
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - De Stefano, Valerio
AU  - De Stefano V
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Basile, Eloisa
AU  - Basile E
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Siracusano, Andrea
AU  - Siracusano A
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Galiuto, Leonarda
AU  - Galiuto L
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Locorotondo, Gabriella
AU  - Locorotondo G
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario 
      Agostino Gemelli, IRCCS, Universita Cattolica del Sacro Cuore, Largo A. Gemelli 
      8, 00168 Rome, Italy.
FAU - Porto, Italo
AU  - Porto I
AD  - Department of Cardiovascular Sciences, Fondazione Policlinico Universitario 
      Agostino Gemelli, IRCCS, Universita Cattolica del Sacro Cuore, Largo A. Gemelli 
      8, 00168 Rome, Italy.
FAU - Vergallo, Rocco
AU  - Vergallo R
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Canonico, Francesco
AU  - Canonico F
AUID- ORCID: 0000-0001-6936-4548
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Restivo, Attilio
AU  - Restivo A
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Rebuzzi, Antonio Giuseppe
AU  - Rebuzzi AG
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
FAU - Crea, Filippo
AU  - Crea F
AD  - Universita Cattolica del Sacro Cuore, 00168 Rome, Italy.
LA  - eng
GR  - MIUR- PRIN 2010/Ministero dell'Istruzione, dell'Universita e della Ricerca/
GR  - unrestricted grant/Banca d'Italia/
PT  - Journal Article
DEP - 20200423
PL  - Switzerland
TA  - J Clin Med
JT  - Journal of clinical medicine
JID - 101606588
PMC - PMC7230316
OTO - NOTNLM
OT  - G-CSF
OT  - granulocyte colony-stimulating factor
OT  - left ventricular remodeling
OT  - long-term effects
OT  - myocardial infarction
OT  - quality of life
COIS- A.M.L. received speaking honoraria from Bracco Imaging. The other authors have no 
      conflict of interest to disclose.
EDAT- 2020/04/29 06:00
MHDA- 2020/04/29 06:01
PMCR- 2020/04/23
CRDT- 2020/04/29 06:00
PHST- 2020/03/29 00:00 [received]
PHST- 2020/04/18 00:00 [revised]
PHST- 2020/04/20 00:00 [accepted]
PHST- 2020/04/29 06:00 [entrez]
PHST- 2020/04/29 06:00 [pubmed]
PHST- 2020/04/29 06:01 [medline]
PHST- 2020/04/23 00:00 [pmc-release]
AID - jcm9041214 [pii]
AID - jcm-09-01214 [pii]
AID - 10.3390/jcm9041214 [doi]
PST - epublish
SO  - J Clin Med. 2020 Apr 23;9(4):1214. doi: 10.3390/jcm9041214.