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Direct intramyocardial plasmid vascular endothelial growth factor-A₁₆₅ gene therapy in patients with stable severe angina pectoris

A randomized double-blind placebo-controlled study: The Euroinject One trial

Jens Kastrup, MD^_*, Erik Jørgensen, MD^_*, Andreas Rück, MD, Kristina Tägil, MD, Dietmar Glogar, MD, Witold Ruzyllo, MD^||, Hans Erik Bøtker, MD^¶, Dariusz Dudek, MD^#, Viktor Drvota, MD, Birger Hesse, MD^_**, Leif Thuesen, MD^¶, Pontus Blomberg, PhD, Mariann Gyöngyösi, MD, Christer Sylvén, MD, FACC^,_* the Euroinject One Group

^_* 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

View larger version (28K): [in a new window]   Figure 1 Computer-based quantitative analysis of myocardial perfusion. Fraction (%) of total segments (460) at polar map rest and stress single-photon emission computed tomography with severe (normalized tracer uptake 50%; upper panel) and moderate perfusion defects (normalized tracer uptake between 51% and 70%; lower panel) at baseline and at follow-up in placebo (empty bars) and vascular endothelial growth factor-treated groups (filled bars). No differences between the groups were observed. Values are given as mean ± SEM.

View larger version (58K): [in a new window]   Figure 2 (Upper panel) Mean voltage and local linear shortening values of the injected area at baseline and at the three-month follow-up. No changes were observed in voltage values. Significantly better local linear shortening (LLS) in the injected area in the vascular endothelial growh factor group (filled bars) versus the placebo group (empty bars) at the three-month follow-up was noted. Values are given as mean ± SEM. (Bottom panel) NOGA mapping from a 56-year-old patient with chronic occlusion of the left circumflex coronary artery. The patient received intramyocardial injection of plasmid encoding vascular endothelial growh factor-A165. Baseline registrations with injection points are shown in the small figure in the upper left corner of the NOGA map. The larger figures show three-month follow-up registrations. No change was observed in the voltage map, whereas improved local linear shortening was observed in the injection area.

View larger version (15K): [in a new window]   Figure 3 Segmental ventricular function of the injected area expressed as standard deviations (SD)/cord as assessed from digitized left ventriculography. Significantly better local wall motion was recorded in the vascular endothelial growth factor group (filled bars) versus the placebo group (empty bars) at the three-month follow-up. Values are given as mean ± SEM.