NEW YORK (Reuters Health) - Gene therapy with naked plasmid DNA encoding for vascular endothelial growth factor-2 (VEGF-2) continues to reduce angina for 2 years, investigators report. However, death, MI and revascularization are more frequent during the second year, probably reflecting the severity of underlying disease.
Dr. Richard A. Schatz, at the Scripps Clinic in La Jolla, California, and his associates previously reported favorable 1-year outcomes in this phase I trial that involved treatment of 30 patients with severe, refractory angina pectoris (see Reuters Health report, September 4, 2003). VEGF-2 DNA was injected via thoracotomy into regions of ischemic myocardium; one patient died immediately after the procedure.
In their current study, published in the February issue of the Journal of Interventional Cardiology, the researchers report on 2-year outcomes.
The average Canadian Cardiovascular Society angina class decreased from 3.6 at baseline to 1.3 after 1 year. At 24 months, the mean angina class was 1.5 (p < 0.05). Although all patients had class III or IV angina prior to the procedure, currently only three had class III angina, while 23 had class I or II angina at 24 months.
During the first year, one patient had an MI and two underwent revascularization. During the second year, there were four MIs, five revascularization procedures, and three deaths.
“Adverse clinical events...are more frequent after the first year, and are most likely due to progression of disease in remote areas of the heart in a high-risk population with aggressive disease,” Dr. Schatz and his associates conclude.
The authors note that a large phase III trial is now being planned to determine the efficacy of VEGF-2 gene therapy in a similar patient population.
Source: J Interven Cardiol 2005;18:27-31. [ Google search on this article ]
MeSH Headings:Biological Therapy: Genetic Engineering: Genetic Techniques: Investigative Techniques: Therapeutics: Gene Therapy: Endothelial Growth Factors: Analytical, Diagnostic and Therapeutic Techniques and EquipmentCopyright © 2002 Reuters Limited. All rights reserved. Republication or redistribution of Reuters content, including by framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world.
