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Eight-year safety follow-up of coronary artery disease patients after local intracoronary VEGF gene transfer.
Gene Ther. 2009 May; 16(5):629-34.GT

Abstract

Vascular endothelial growth factor (VEGF) has been shown to stimulate angiogenesis and myocardial perfusion. The short-term safety of VEGF gene therapy is excellent. However, there are only limited results regarding the long-term effects. The Kuopio Angiogenesis Trial (KAT) studied the efficiency and short-term safety of the local VEGF-A(165) gene transfer in 103 patients with coronary artery disease. Three patient groups received either VEGF as an adenoviral (n=37), or as a plasmid/liposome vector (n=28), or as a placebo (n=38), during coronary angioplasty and stenting (percutaneous coronary intervention, PCI)AQ1. The aim of this study was to examine the long-term effects and safety of VEGF gene therapy. Patients were interviewed by telephone or with a questionnaire on their current status of health, coronary and other cardiovascular events and symptoms, working ability, exercise tolerance, other diseases, such as cancer and diabetes, as well as their personal experience of the treatment. Causes of death were clarified from hospital records. The total follow-up time was 8.1 years (range 6.9-9.7 years). Overall 82% of the patients were reached across the study. Eight (7.5%) of the patients died during the follow-up, but there was no significant difference in mortality between the groups (3/32 vs 2/26 vs 3/31 VEGF-adenovirus vs VEGF-plasmid/liposome vs placebo, respectively; P=0.88). The incidence of major adverse cardiovascular events (MACEs) (10 vs 11 vs 15; P=0.85), cancer (1 vs 4 vs 2; P=0.38) or diabetes (2 vs 2 vs 2; P=0.97) did not differ between the groups. Local intracoronary VEGF gene transfer is safe and does not increase the risk of MACE, arrhythmias, cancer, diabetes or other diseases.

Authors+Show Affiliations

Department of Medicine, Kuopio University Hospital, Kuopio, Finland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19212427

Citation

Hedman, M, et al. "Eight-year Safety Follow-up of Coronary Artery Disease Patients After Local Intracoronary VEGF Gene Transfer." Gene Therapy, vol. 16, no. 5, 2009, pp. 629-34.
Hedman M, Muona K, Hedman A, et al. Eight-year safety follow-up of coronary artery disease patients after local intracoronary VEGF gene transfer. Gene Ther. 2009;16(5):629-34.
Hedman, M., Muona, K., Hedman, A., Kivelä, A., Syvänne, M., Eränen, J., Rantala, A., Stjernvall, J., Nieminen, M. S., Hartikainen, J., & Ylä-Herttuala, S. (2009). Eight-year safety follow-up of coronary artery disease patients after local intracoronary VEGF gene transfer. Gene Therapy, 16(5), 629-34. https://doi.org/10.1038/gt.2009.4
Hedman M, et al. Eight-year Safety Follow-up of Coronary Artery Disease Patients After Local Intracoronary VEGF Gene Transfer. Gene Ther. 2009;16(5):629-34. PubMed PMID: 19212427.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Eight-year safety follow-up of coronary artery disease patients after local intracoronary VEGF gene transfer. AU - Hedman,M, AU - Muona,K, AU - Hedman,A, AU - Kivelä,A, AU - Syvänne,M, AU - Eränen,J, AU - Rantala,A, AU - Stjernvall,J, AU - Nieminen,M S, AU - Hartikainen,J, AU - Ylä-Herttuala,S, Y1 - 2009/02/12/ PY - 2009/2/13/entrez PY - 2009/2/13/pubmed PY - 2010/5/13/medline SP - 629 EP - 34 JF - Gene therapy JO - Gene Ther. VL - 16 IS - 5 N2 - Vascular endothelial growth factor (VEGF) has been shown to stimulate angiogenesis and myocardial perfusion. The short-term safety of VEGF gene therapy is excellent. However, there are only limited results regarding the long-term effects. The Kuopio Angiogenesis Trial (KAT) studied the efficiency and short-term safety of the local VEGF-A(165) gene transfer in 103 patients with coronary artery disease. Three patient groups received either VEGF as an adenoviral (n=37), or as a plasmid/liposome vector (n=28), or as a placebo (n=38), during coronary angioplasty and stenting (percutaneous coronary intervention, PCI)AQ1. The aim of this study was to examine the long-term effects and safety of VEGF gene therapy. Patients were interviewed by telephone or with a questionnaire on their current status of health, coronary and other cardiovascular events and symptoms, working ability, exercise tolerance, other diseases, such as cancer and diabetes, as well as their personal experience of the treatment. Causes of death were clarified from hospital records. The total follow-up time was 8.1 years (range 6.9-9.7 years). Overall 82% of the patients were reached across the study. Eight (7.5%) of the patients died during the follow-up, but there was no significant difference in mortality between the groups (3/32 vs 2/26 vs 3/31 VEGF-adenovirus vs VEGF-plasmid/liposome vs placebo, respectively; P=0.88). The incidence of major adverse cardiovascular events (MACEs) (10 vs 11 vs 15; P=0.85), cancer (1 vs 4 vs 2; P=0.38) or diabetes (2 vs 2 vs 2; P=0.97) did not differ between the groups. Local intracoronary VEGF gene transfer is safe and does not increase the risk of MACE, arrhythmias, cancer, diabetes or other diseases. SN - 1476-5462 UR - https://www.unboundmedicine.com/medline/citation/19212427/Eight_year_safety_follow_up_of_coronary_artery_disease_patients_after_local_intracoronary_VEGF_gene_transfer_ L2 - http://dx.doi.org/10.1038/gt.2009.4 DB - PRIME DP - Unbound Medicine ER -