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J Am Coll Cardiol, 2005; 45:982-988, doi:10.1016/j.jacc.2004.12.068 © 2005 by the American College of Cardiology Foundation |
,*
* Cardiac Catheterization Laboratory, University Hospital Rigshospitalet, Copenhagen, Denmark
** Department of Clinical Physiology and Nuclear Medicine, University Hospital Rigshospitalet, Copenhagen, Denmark
¶ Department of Cardiology, Skejby Sygehus, Aarhus, Denmark
Department of Cardiology, University of Vienna, Vienna, Austria
|| Institute of Cardiology, Warsaw, Poland
# Institute of Cardiology, Krakow, Poland
Department of Clinical Physiology, Malmö, Sweden
Department of Cardiology and Gene Therapy Center, Karolinska University Hospital at Huddinge, Karolinska Institutet, Stockholm, Sweden
Manuscript received August 5, 2004; accepted December 6, 2004.
* Reprint requests and correspondence: Dr. Christer Sylvén, Department of Cardiology, M52, Karolinska University Hospital, SE-141 86 Stockholm, Sweden (Email: Christer.Sylven{at}medhs.ki.se).
OBJECTIVES: In the Euroinject One phase II randomized double-blind trial, therapeutic angiogenesis of percutaneous intramyocardial plasmid gene transfer of vascular endothelial growth factor (phVEGF-A165) on myocardial perfusion, left ventricular function, and clinical symptoms was assessed.
BACKGROUND: Evidence for safety and treatment efficacy have been presented in phase I therapeutic angiogenesis trials.
METHODS: Eighty "no-option" patients with severe stable ischemic heart disease, Canadian Cardiovascular Society functional class 3 to 4, were assigned randomly to receive, via the NOGA-MyoStar system (Cordis Corp., Miami Lakes, Florida), either 0.5 mg of phVEGF-A165 (n = 40) or placebo plasmid (n = 40) in the myocardial region showing stress-induced myocardial perfusion defects on 99mTc sestamibi/tetrofosmin single-photon emission computed tomography.
RESULTS: No differences among the groups were recorded at baseline with respect to clinical, perfusion, and wall motion characteristics. After three months, myocardial stress perfusion defects did not differ significantly between the VEGF gene transfer and placebo groups (38 ± 3% and 44 ± 2%, respectively). Similarly, semiquantitative analysis of the change in perfusion in the treated region of interest did not differ significantly between the two groups. Compared with placebo, VEGF gene transfer improved the local wall motion disturbances, assessed both by NOGA (p = 0.04) and contrast ventriculography (p = 0.03). Canadian Cardiovascular Society functional class classification of angina pectoris improved significantly in both groups but without difference between the groups. No phVEGF-A165-related adverse events were observed; however, NOGA procedure-related adverse events occurred in five patients.
CONCLUSIONS: The VEGF gene transfer did not significantly improve stress-induced myocardial perfusion abnormalities compared with placebo; however, improved regional wall motion, as assessed both by NOGA and by ventriculography, may indicate a favorable anti-ischemic effect. This result should encourage more studies within the field. Transient VEGF overexpression seems to be safe.
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