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Intracoronary basic fibroblast growth factor (FGF-2) in patients with severe ischemic heart disease: results of a Phase I open-label dose escalation study

Roger J. Laham, MD^* , Nicholas A. Chronos, MD, Marilyn Pike, MD, PhD, Mark E. Leimbach, MD^||, James E. Udelson, MD^¶, Justin D. Pearlman, MD, PhD^*, Roderic I. Pettigrew, MD^||, M. J. Whitehouse, MD, Carl Yoshizawa, PhD and Michael Simons, MD^*

^* Angiogenesis Research Center, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
Interventional Cardiology Section, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA
Atlanta Cardiology Group, Atlanta, Georgia, USA
Chiron Corporation, Emeryville, California, USA
^|| Division of Cardiology, Emory University, Atlanta, Georgia, USA
^¶ Division of Cardiology, New England Medical Center and Tufts University, Boston, Massachusetts, USA

View larger version (49K): [in a new window]   Figure 1 Quality of life assessment using the Seattle Angina Questionnaire showed significant improvements in all five scales (angina frequency, angina stability, exertional capacity, disease perception, and treatment satisfaction) at days 57 (gray bar) and 180 (checkered bar) as compared to baseline (black bar). Data presented as mean ± SEM. *Denotes statistical significance, p < 0.05.

View larger version (20K): [in a new window]   Figure 2 Exercise treadmill times in patients with matched baseline and follow-up protocols showed minimal improvement at day 29 with more significant improvement at day 57 and day 180. Data presented as mean ± SEM. *Denotes p = 0.023 (for day 29), **denotes p < 0.001 for days 57 and 180.

View larger version (47K): [in a new window]   Figure 3 Regional wall thickening was measured using magnetic resonance imaging. Baseline (black bar) target wall thickening was significantly reduced compared to normal wall thickening and improved at days 29 (white bar), 57 (gray bar) and 180 (checkered bar). Data presented as mean ± SEM. *Denotes statistical significance with p < 0.01.

View larger version (19K): [in a new window]   Figure 4 Magnetic resonance perfusion imaging allowed the determination of the extent of the myocardial area with delayed contrast arrival, which was significantly reduced at days 29 (white bar), 57 (gray bar) and 180 (checkered bar), as compared to baseline (black bar). Data presented as mean ± SEM. *Denotes statistical significance with p < 0.001.