Circulation. 2002;105:788-793
Published online before print January 14, 2002, doi: 10.1161/hc0802.104407
Published online before print January 14, 2002, doi: 10.1161/hc0802.104407
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(Circulation. 2002;105:788.)
© 2002 American Heart Association, Inc.
Clinical Investigation and Reports |
Pharmacological Treatment of Coronary Artery Disease With Recombinant Fibroblast Growth Factor-2
Double-Blind, Randomized, Controlled Clinical Trial
From Dartmouth-Hitchcock Medical Center, Lebanon, NH (M.S.); Duke University Medical Center, Durham, NC (B.H.A.); Beth Israel Deaconess Medical Center, Boston, Mass (R.J.L., E.V.G.); Methodist Hospital, Houston, Tex (N.K.); Hennepin County Medical Center, Minneapolis, Minn (T.H.); University of Massachusetts Memorial Health Care, Worcester, Mass (H.D.); New England Medical Center, Boston, Mass (J.E.U.); Chiron Corporation, Emeryville, Calif (M.P., M.J.W., T.M.); and Atlanta Cardiology Research Institute, Atlanta, Ga (N.A.C.).
Correspondence to Michael Simons, MD, Section of Cardiology, Dartmouth-Hitchcock Medical Center, One Medical Center Dr, Lebanon, NH 03756. E-mail Michael.Simons{at}Dartmouth.edu
Background— Single-bolus intracoronary administration of fibroblast growth factor-2 (FGF2) improved symptoms and myocardial function in a phase I, open-label trial in patients with coronary artery disease. We conducted the FGF Initiating RevaScularization Trial (FIRST) to evaluate further the efficacy and safety of recombinant FGF2 (rFGF2).
Methods and Results— FIRST is a multicenter, randomized, double-blind, placebo-controlled trial of a single intracoronary infusion of rFGF2 at 0, 0.3, 3, or 30 µg/kg (n=337 patients). Efficacy was evaluated at 90 and 180 days by exercise tolerance test, myocardial nuclear perfusion imaging, Seattle Angina Questionnaire, and Short-Form 36 questionnaire. Exercise tolerance was increased at 90 days in all groups and was not significantly different between placebo and FGF-treated groups. rFGF2 reduced angina symptoms as measured by the angina frequency score of the Seattle Angina Questionnaire (overall P=0.035) and the physical component summary scale of the Short-Form 36 (pairwise P=0.033, all FGF groups versus placebo). These differences were more pronounced in highly symptomatic patients (baseline angina frequency score 
40 or Canadian Cardiovascular Society score of III or IV). None of the differences were significant at 180 days because of continued improvement in the placebo group. Adverse events were similar across all groups, except for hypotension, which occurred with higher frequency in the 30-µg/kg rFGF2 group.
Conclusions— A single intracoronary infusion of rFGF2 does not improve exercise tolerance or myocardial perfusion but does show trends toward symptomatic improvement at 90 (but not 180) days.
Key Words: coronary disease • angina • revascularization • angiogenesis • trials
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J. Rutanen, T. T. Rissanen, J. E. Markkanen, M. Gruchala, P. Silvennoinen, A. Kivela, A. Hedman, M. Hedman, T. Heikura, M.-R. Orden, et al. Adenoviral Catheter-Mediated Intramyocardial Gene Transfer Using the Mature Form of Vascular Endothelial Growth Factor-D Induces Transmural Angiogenesis in Porcine Heart Circulation, March 2, 2004; 109(8): 1029 - 1035. [Abstract] [Full Text] [PDF]
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G. C. Hughes, S. S. Biswas, B. Yin, R. E. Coleman, T. R. DeGrado, C. K Landolfo, J. E. Lowe, B. H. Annex, and K. P. Landolfo Therapeutic angiogenesis in chronically ischemic porcine myocardium: comparative effects of bFGF and VEGF Ann. Thorac. Surg., March 1, 2004; 77(3): 812 - 818. [Abstract] [Full Text] [PDF]
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M Fujita and K Tambara Recent insights into human coronary collateral development Heart, March 1, 2004; 90(3): 246 - 250. [Abstract] [Full Text] [PDF]
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P. Schalch, G. F. Rahman, G. Patejunas, R. A. Goldschmidt, J. Carbray, M. A. Retuerto, D. Kim, K. Esser, R. G. Crystal, and T. K. Rosengart Adenoviral-mediated transfer of vascular endothelial growth factor 121 cDNA enhances myocardial perfusion and exercise performance in the nonischemic state J. Thorac. Cardiovasc. Surg., February 1, 2004; 127(2): 535 - 540. [Abstract] [Full Text] [PDF]
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S. L. House, C. Bolte, M. Zhou, T. Doetschman, R. Klevitsky, G. Newman, and J. E. J. Schultz Cardiac-Specific Overexpression of Fibroblast Growth Factor-2 Protects Against Myocardial Dysfunction and Infarction in a Murine Model of Low-Flow Ischemia Circulation, December 23, 2003; 108(25): 3140 - 3148. [Abstract] [Full Text] [PDF]
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C. Seiler The human coronary collateral circulation Heart, November 1, 2003; 89(11): 1352 - 1357. [Full Text] [PDF]
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C. L. Grines, M. W. Watkins, J. J. Mahmarian, A. E. Iskandrian, J. J. Rade, P. Marrott, C. Pratt, N. Kleiman, and for the Angiogenic GENe Therapy (AGENT-2) Study Gr A randomized, double-blind, placebo-controlled trial of Ad5FGF-4 gene therapy and its effect on myocardial perfusion in patients with stable angina J. Am. Coll. Cardiol., October 15, 2003; 42(8): 1339 - 1347. [Abstract] [Full Text] [PDF]
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F. J. Giordano Retrograde coronary perfusion: a superior route to deliver therapeutics to the heart? J. Am. Coll. Cardiol., September 17, 2003; 42(6): 1129 - 1131. [Full Text] [PDF]
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M. Ruel, G. F. Wu, T. A. Khan, P. Voisine, C. Bianchi, J. Li, J. Li, R. J. Laham, and F. W. Sellke Inhibition of the Cardiac Angiogenic Response to Surgical FGF-2 Therapy in a Swine Endothelial Dysfunction Model Circulation, September 9, 2003; 108(90101): II-335 - 340. [Abstract] [Full Text] [PDF]
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V. Chhokar and A. L. Tucker Angiogenesis: Basic Mechanisms and Clinical Applications Seminars in Cardiothoracic and Vascular Anesthesia, September 1, 2003; 7(3): 253 - 280. [Abstract] [PDF]
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Y.-s. Yoon and D. W. Losordo All in the Family: VEGF-B Joins the Ranks of Proangiogenic Cytokines Circ. Res., July 25, 2003; 93(2): 87 - 90. [Full Text] [PDF]
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Y. Sakakibara, K. Tambara, G. Sakaguchi, F. Lu, M. Yamamoto, K. Nishimura, Y. Tabata, and M. Komeda Toward surgical angiogenesis using slow-released basic fibroblast growth factor Eur. J. Cardiothorac. Surg., July 1, 2003; 24(1): 105 - 112. [Abstract] [Full Text] [PDF]
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S. Fuchs, L. F. Satler, R. Kornowski, P. Okubagzi, G. Weisz, R. Baffour, R. Waksman, N. J. Weissman, M. Cerqueira, M. B. Leon, et al. Catheter-based autologous bone marrow myocardial injection in no-option patients with advanced coronary artery disease: A feasibility study J. Am. Coll. Cardiol., May 21, 2003; 41(10): 1721 - 1724. [Abstract] [Full Text] [PDF]
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T. D. Henry, B. H. Annex, G. R. McKendall, M. A. Azrin, J. J. Lopez, F. J. Giordano, P.K. Shah, J. T. Willerson, R. L. Benza, D. S. Berman, et al. The VIVA Trial: Vascular Endothelial Growth Factor in Ischemia for Vascular Angiogenesis Circulation, March 18, 2003; 107(10): 1359 - 1365. [Abstract] [Full Text] [PDF]
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F. W. Sellke and M. Ruel Vascular growth factors and angiogenesis in cardiac surgery Ann. Thorac. Surg., February 1, 2003; 75(2): S685 - 690. [Abstract] [Full Text] [PDF]
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M. Ruel, R. A. Kelly, and F. W. Sellke Therapeutic Angiogenesis, Transmyocardial Laser Revascularization, and Cell Therapy Card. Surg. Adult, January 1, 2003; 2(2003): 715 - 750. [Full Text]
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K. A. Detillieux, F. Sheikh, E. Kardami, and P. A. Cattini Biological activities of fibroblast growth factor-2 in the adult myocardium Cardiovasc Res, January 1, 2003; 57(1): 8 - 19. [Abstract] [Full Text] [PDF]
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D. W. Losordo and A. Kawamoto Biological Revascularization and the Interventional Molecular Cardiologist: Bypass for the Next Generation Circulation, December 10, 2002; 106(24): 3002 - 3005. [Full Text] [PDF]
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C. Heilmann, P. von Samson, K. Schlegel, T. Attmann, B.-U. von Specht, F. Beyersdorf, and G. Lutter Comparison of protein with DNA therapy for chronic myocardial ischemia using fibroblast growth factor-2 Eur. J. Cardiothorac. Surg., December 1, 2002; 22(6): 957 - 964. [Abstract] [Full Text] [PDF]
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H. Kamihata, H. Matsubara, T. Nishiue, S. Fujiyama, K. Amano, O. Iba, T. Imada, and T. Iwasaka Improvement of Collateral Perfusion and Regional Function by Implantation of Peripheral Blood Mononuclear Cells Into Ischemic Hibernating Myocardium Arterioscler Thromb Vasc Biol, November 1, 2002; 22(11): 1804 - 1810. [Abstract] [Full Text] [PDF]
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S. Herzog, H. Sager, E. Khmelevski, A. Deylig, and W. D. Ito Collateral arteries grow from preexisting anastomoses in the rat hindlimb Am J Physiol Heart Circ Physiol, November 1, 2002; 283(5): H2012 - H2020. [Abstract] [Full Text] [PDF]
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M. Ruel, R. J. Laham, J. A. Parker, M. J. Post, J. A. Ware, M. Simons, and F. W. Sellke Long-term effects of surgical angiogenic therapy with fibroblast growth factor 2 protein J. Thorac. Cardiovasc. Surg., July 1, 2002; 124(1): 28 - 34. [Abstract] [Full Text] [PDF]
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