title: VEGF gene therapy for angiogenesis in refractory angina: phase I/II clinical trial.
abstract: OBJECTIVE
  Safety, feasibility and early myocardial angiogenic effects evaluation of transthoracic intramyocardial phVEGF165 administration for refractory angina in no option patients.
  
  
  METHODS
  Cohort study, in which 13 patients with refractory angina under optimized clinical treatment where included, after cineangiograms had been evaluated and found unfeasible by surgeon and interventional cardiologist. Intramyocardial injections of 5 mL solution containing plasmidial VEGF165 where done over the ischemic area of myocardium identified by previous SPECT/Sestamibi scan. Evaluations included a SPECT scan, stress test, Minnesota QOL questionnaire and NYHA functional class and CCS angina class determinations.
  
  
  RESULTS
  There were no deaths or new interventions during the study period. There were no significant variations in SPECT scans, QOL scores and stress tests results during medical treatment in the included patients. After the 3rd post operative month, there was improvement in SPECT segmental scores, SSS (18.38 ± 7.51 vs. 15.31 ± 7.29, P = 0.003) and SRS (11.92 ± 7.49 vs. 8.53 ± 6.68, P = 0.002). The ischemic area extension, however, had non-significant variation (23.38 ± 13.12% vs. 20.08 ± 13.88%, P = 0.1). Stress tests METs varied from 7.66 ± 4.47 pre to 10.29 ± 4.36 METs post-op (P = 0.08). QOL score improved from 48.23 ± 18.35 pre to 30.15 ± 20.13 post-op points (P = 0.02). NYHA class was 3.15 ± 0.38 pre vs. 1.77 ± 0.83 post-op (P = 0.001) and angina CCS class, 3.08 ± 0.64 vs. 1.77 ± 0.83 (P = 0.001).
  
  
  CONCLUSIONS
  Intramyocardial VEGF165 therapy for refractory angina, in this small trial of no option patients, resulted feasible and safe. Early clinical and scintilographic data showed improvements in symptoms and myocardial perfusion, with regression of ischemia severity in treated areas.
authors.affiliation: Instituto de Cardiologia do Rio Grande do Sul/Fundação Universitária de Cardiologia, Porto Alegre, RS, Brazil.
authors.forename: Renato A K
authors.initials: RA
authors.lastname: Kalil
authors.forename: Felipe Borsu de
authors.initials: FB
authors.lastname: Salles
authors.forename: Imarilde Inês
authors.initials: II
authors.lastname: Giusti
authors.forename: Clarissa Garcia
authors.initials: CG
authors.lastname: Rodrigues
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Han
authors.forename: Roberto Tofani
authors.initials: RT
authors.lastname: Sant'Anna
authors.forename: Eduardo
authors.initials: E
authors.lastname: Ludwig
authors.forename: Gabriel
authors.initials: G
authors.lastname: Grossman
authors.forename: Paulo Roberto Lunardi
authors.initials: PR
authors.lastname: Prates
authors.forename: João Ricardo Michelin
authors.initials: JR
authors.lastname: Sant'anna
authors.forename: Guaracy Fernandes
authors.initials: GF
authors.lastname: Teixeira Filho
authors.forename: Nance Beyer
authors.initials: NB
authors.lastname: Nardi
authors.forename: Ivo Abrahão
authors.initials: IA
authors.lastname: Nesralla
mesh_terms: D000787:Angina Pectoris / Q000628:therapy*; D043925:Angiogenesis Inducing Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D015316:Genetic Therapy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000628:therapy*; D010957:Plasmids / Q000008:administration & dosage; D012720:Severity of Illness Index; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000008:administration & dosage* / Q000009:adverse effects / Q000235:genetics*
chemical_list: D043925:Angiogenesis Inducing Agents; D042461:Vascular Endothelial Growth Factor A