High Doses of Vascular Endothelial Growth Factor 165 Safely, but Transiently, Improve Myocardial Perfusion in No-Option Ischemic Disease

High Doses of Vascular Endothelial Growth Factor 165 Safely, but Transiently, Improve Myocardial Perfusion in No-Option Ischemic Disease

Author Giusti, Imarilde I. Google Scholar
Rodrigues, Clarissa G. Google Scholar
Salles, Felipe B. Google Scholar
Sant'Anna, Roberto T. Google Scholar
Eibel, Bruna Google Scholar
Han, Sang W. Autor UNIFESP Google Scholar
Ludwig, Eduardo Google Scholar
Grossman, Gabriel Google Scholar
Prates, Paulo Roberto L. Google Scholar
Sant'Anna, Joao Ricardo M. Google Scholar
Teixeira Filho, Guaracy F. Google Scholar
Markoski, Melissa M. Google Scholar
Nesralla, Ivo A. Google Scholar
Nardi, Nance B. Google Scholar
Kalil, Renato A. K. Google Scholar
Institution Fundacao Univ Cardiol
Duke Univ
Universidade Federal de São Paulo (UNIFESP)
Univ Fed Ciencias Saude Porto Alegre
Abstract Gene therapy can induce angiogenesis in ischemic tissues. the aim of this study was to assess safety, feasibility, and results, both clinical and on myocardial perfusion, of gene therapy in refractory angina. This was a phase I/II, prospective, temporal-controlled series, clinical trial. Thirteen patients were maintained for minimum 6 months under optimized clinical management, and then received intramyocardial injections of 2000 mu g plasmid vascular endothelial growth factor 165 and were followed by single-photon emission computed tomography (SPECT), treadmill tests, Minnesota quality of life questionnaire (QOL), and New York Heart Association (NYHA) functional plus Canadian Cardiovascular Society (CCS) angina classifications. There were no deaths, early or late. During the optimized clinical treatment, we observed worsening of rest ischemia scores on SPECT (p < 0.05). After treatment, there was a transitory increase in myocardial perfusion at the third-month SPECT under stress (pre-operative [pre-op] 18.38 +/- 7.51 vs. 3 months 15.31 +/- 7.30; p < 0.01) and at the sixth month under rest (pre-op 13.23 +/- 7.98 vs. 6 months: 16.92 +/- 7.27; p < 0.01). One year after, there were improvements in treadmill test steps (pre-op 2.46 +/- 2.07 vs. 12 months 4.15 +/- 2.23; p < 0.01) and oxygen consumption (pre-op 7.66 +/- 4.47 vs. 12 months 10.89 +/- 4.65; p < 0.05), QOL (pre-op 48.23 +/- 18.35 vs. 12 months 28.31 +/- 18.14; p < 0.01) scores, and CCS (pre-op 3 [3-3.5] vs. 12 months 2 [1-2.5]; p < 0.01) and NYHA (pre-op 3 [3-3] vs. 2 [2-2] vs. 12 months 2 [1-2]; p < 0.01) classes. Gene therapy demonstrated to be feasible and safe in this advanced ischemic cardiomyopathy patient sample. There were improvements in clinical evaluation parameters, and a transitory increase in myocardial perfusion detectable by SPECT scintigraphy. Clinical Trial Registration: NCT00744315 http://clinicaltrials.gov/
Language English
Sponsor Fundacao de Amparo a Pesquisa do Estado do Rio Grande do Sul (FAPERGS; State of Rio Grande do Sul Research Foundation)
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Date 2013-10-01
Published in Human Gene Therapy Methods. New Rochelle: Mary Ann Liebert, Inc, v. 24, n. 5, p. 298-306, 2013.
ISSN 1946-6536 (Sherpa/Romeo, impact factor)
Publisher Mary Ann Liebert, Inc
Extent 298-306
Origin http://dx.doi.org/10.1089/hgtb.2012.221
Access rights Closed access
Type Article
Web of Science ID WOS:000336911000003
URI http://repositorio.unifesp.br/handle/11600/36849

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