Long-term follow-up and safety assessment of angiogenic gene therapy trial VIF-CAD: Transcatheter intramyocardial administration of a bicistronic plasmid expressing VEGF-A165/bFGF cDNA for the treatment of refractory coronary artery disease.
Am Heart J
; 215: 78-82, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-31288177
ABSTRACT
There have been a number of angiogenic gene therapy trials, yielding mixed results as to efficacy, but demonstrating uniform short-term treatment safety. Data regarding long-term safety of angiogenic gene therapy are limited. Double-blind VIF-CAD trial (NCT00620217) assessed myocardial perfusion and clinical data in 52 refractory coronary artery disease (CAD) patients randomized into treatment (VIF; nâ¯=â¯33) and Placebo (nâ¯=â¯19) arms. VIF group received electromechanical system NOGA-guided intramyocardial injections of VEGF-A165/bFGF plasmid (VIF) into ischemic regions, while the Placebo group-placebo plasmid injections. Full 1-year follow-up data have been published. This study presents the results of over 10-year (median 133 months, range 95-149) safety follow-up of VIF-CAD patients. Overall, 12 (36.4%) patients died in VIF and 8 (42.1%) in Placebo group (Pâ¯=â¯.68). Cardiovascular mortality was 12/33 (36.4%) in the VIF group and 6/19 (31.6%) in Placebo group (Pâ¯=â¯.73). Two Placebo patients died due to malignancies, but no VIF patients (Pâ¯=â¯.17). The Kaplan-Meier curves of combined endpoint cardiovascular mortality, myocardial infarction and stroke were similar for both patient groups (Pâ¯=â¯.71). Odds ratio of Placebo group increasing (reaching a worse) their CCS class versus VIF was non-significant (OR 1.28, 95% CIâ¯=â¯0.66-2.45; Pâ¯=â¯.47). However, CCS class improved in time irrespectively of treatment-OR of reaching a less favorable CCS class per each year of follow-up was 0.74 (95% CI 0.685-0.792; Pâ¯<â¯.0001, pooled data). There were no differences in readmission rates. Intramyocardial VEGF-A165/bFGF plasmid administration appears safe, with no evidence of an increase in the incidence of death, malignancy, myocardial infarction or stroke during 10-year follow-up in this limited patient population.
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Base de dados:
MEDLINE
Assunto principal:
Doença da Artéria Coronariana
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Cateterismo Cardíaco
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Terapia Genética
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Fator 2 de Crescimento de Fibroblastos
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Produtos do Gene vif
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Fator A de Crescimento do Endotélio Vascular
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article