This Article Abstract Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Grines, C. L. Search for Related Content PubMed PubMed Citation Articles by Grines, C. L.

A randomized, double-blind, placebo-controlled trial of Ad5FGF-4 gene therapy and its effect on myocardial perfusion in patients with stable angina

Cindy L. Grines, MD, FACC^*,*, Matthew W. Watkins, MD, FACC, John J. Mahmarian, MD, FACC, Ami E. Iskandrian, MD, FACC, Jeffrey J. Rade, MD, FACC^||, Pran Marrott, MRCP, MSc^¶, Craig Pratt, MD, FACC, Neal Kleiman, MD, FACC for the Angiogenic GENe Therapy (AGENT-2) Study Group

^* Department of Medicine, Section of Cardiology, William Beaumont Hospital, Royal Oak, Michigan, USA
Department of Medicine, University of Vermont, Burlington, Vermont, USA
Department of Medicine, Section of Cardiology, The Methodist Hospital, Baylor College of Medicine, Houston, Texas, USA
Department of Medicine/Section of Cardiology, The University of Alabama at Birmingham, Birmingham, Alabama, USA
^|| John Hopkins, Baltimore, Maryland, USA
^¶ Berlex Laboratories, Montville, New Jersey, USA

View larger version (104K): [in a new window]   Figure 1 Representative stress only short-axis (SA) (upper three panels) and vertical long-axis (VLA) (lower three panels) tomographic images of a patient before therapy (baseline) and at week 4 and week 8. The corresponding quantitative polar maps are shown on the right. The adenosine-induced ischemic anterior perfusion defect improves dramatically from baseline to week 4 and 8 as reflected by a reduction in perfusion defect size (PDS) from 26% to 17% to 6%. The ischemic (green) area of the polar map resolves, whereas the scarred region (black) remains unchanged over the eight-week period.

View larger version (15K): [in a new window]   Figure 2 Absolute improvement in perfusion defect size at eight weeks post-treatment: Ad5FGF-4 reduced the total and reversible perfusion defect size (RPDS) by 4.6% and 4.2%, respectively (p < 0.001). In the placebo group, the reductions were only 2.4% (p = 0.14) and 1.6% (p = 0.32), respectively. However, the difference between Ad5FGF-4 and placebo was not significantly different. White bars = Ad5FGF-4; black bars = placebo.

View larger version (15K): [in a new window]   Figure 3 Change in myocardial perfusion at eight weeks: a greater percentage improvement (compared with baseline) in both reversible and total perfusion defect size was seen in the Ad5FGF-4 group compared with the placebo group. Moreover, a greater number of Ad5FGF-4 patients had a clinically relevant improvement in perfusion (>5% improvement), and significantly fewer Ad5FGF-4 patients had clinically relevant worsening (4% increase in defect size) of perfusion (6% vs. 35%, p = 0.01). White bars = Ad5FGF-4; black bars = placebo.

View larger version (10K): [in a new window]   Figure 4 Symptomatic improvements at eight weeks post-treatment: a greater percentage of Ad5FGF-4 patients (compared with placebo) had symptomatic improvement, with 30% of patients having no angina and 43% of patients using no nitroglycerin (NTG) at eight weeks; however, these differences were not significant. White bars = Ad5FGF-4; black bars = placebo.