on March 10, 2003
Circulation. 2003
Published online before print March 10, 2003, doi: 10.1161/01.CIR.0000061911.47710.8A
Published online before print March 10, 2003, doi: 10.1161/01.CIR.0000061911.47710.8A
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Submitted on July 24, 2002
From the Divisions of Cardiology at Hennepin County Medical Center and University of Minnesota, Minneapolis (T.D.H.); Duke University Medical Center and Durham Veterans Affair Medical Center, Durham, NC (B.H.A.); Rhode Island Hospital, Brown Medical School, Providence (G.R.M.); University of Connecticut Medical Center, Farmington (M.A.A.); University of Iowa, Iowa City (J.J.L.); University of California, San Diego Medical Center (F.J.G.); Cedars-Sinai Medical Center, Los Angeles, Calif (P.K.S., D.S.B.); University of Texas, Houston (J.T.W.); University of Alabama, Birmingham (R.L.B.); TIMI Data Coordinating Center, Boston, Mass (C.M.G.); and Genentech, Inc, South San Francisco, Calif (A.B., A.C.R., J.F., E.R.M.). * To whom correspondence should be addressed. E-mail: henry003{at}tc.umn.edu.
Background--Recombinant human vascular endothelial growth factor protein (rhVEGF) stimulates angiogenesis in animal models and was well tolerated in Phase I clinical trials. VIVA (Vascular endothelial growth factor in Ischemia for Vascular Angiogenesis) is a double-blind, placebo-controlled trial designed to evaluate the safety and efficacy of intracoronary and intravenous infusions of rhVEGF. Methods and Results--A total of 178 patients with stable exertional angina, unsuitable for standard revascularization, were randomized to receive placebo, low-dose rhVEGF (17 ng · kg-1 · min-1), or high-dose rhVEGF (50 ng · kg-1 · min-1) by intracoronary infusion on day 0, followed by intravenous infusions on days 3, 6, and 9. Exercise treadmill tests, angina class, and quality of life assessments were performed at baseline, day 60, and day 120. Myocardial perfusion imaging was performed at baseline and day 60. At day 60, the change in exercise treadmill test (ETT) time from baseline was not different between groups (placebo, +48 seconds; low dose, +30 seconds; high dose, +30 seconds). Angina class and quality of life were significantly improved within each group, with no difference between groups. By day 120, placebo-treated patients demonstrated reduced benefit in all three measures, with no significant difference compared with low-dose rhVEGF. In contrast, high-dose rhVEGF resulted in significant improvement in angina class (P=0.05) and nonsignificant trends in ETT time (P=0.15) and angina frequency (P=0.09) as compared with placebo. Conclusions--rhVEGF seems to be safe and well tolerated. rhVEGF offered no improvement beyond placebo in all measurements by day 60. By day 120, high-dose rhVEGF resulted in significant improvement in angina and favorable trends in ETT time and angina frequency.
Revised on November 13, 2002
Accepted on December 4, 2002
The VIVA Trial. Vascular Endothelial Growth Factor in Ischemia for Vascular Angiogenesis
Timothy D. Henry MD*,
Key words: angiogenesis • growth substances • ischemia • angina • heart disease
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J. Yoshida, K. Ohmori, H. Takeuchi, K. Shinomiya, T. Namba, I. Kondo, H. Kiyomoto, and M. Kohno Treatment of Ischemic Limbs Based on Local Recruitment of Vascular Endothelial Growth Factor-Producing Inflammatory Cells With Ultrasonic Microbubble Destruction J. Am. Coll. Cardiol., September 6, 2005; 46(5): 899 - 905. [Abstract] [Full Text] [PDF]
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Y. Tsutsumi and D. W. Losordo Double Face of VEGF Circulation, August 30, 2005; 112(9): 1248 - 1250. [Full Text] [PDF]
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P. Leppanen, S. Koota, I. Kholova, J. Koponen, C. Fieber, U. Eriksson, K. Alitalo, and S. Yla-Herttuala Gene Transfers of Vascular Endothelial Growth Factor-A, Vascular Endothelial Growth Factor-B, Vascular Endothelial Growth Factor-C, and Vascular Endothelial Growth Factor-D Have No Effects on Atherosclerosis in Hypercholesterolemic Low-Density Lipoprotein-Receptor/Apolipoprotein B48-Deficient Mice Circulation, August 30, 2005; 112(9): 1347 - 1352. [Abstract] [Full Text] [PDF]
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D. Hou, E. A.-S. Youssef, T. J. Brinton, P. Zhang, P. Rogers, E. T. Price, A. C. Yeung, B. H. Johnstone, P. G. Yock, and K. L. March Radiolabeled Cell Distribution After Intramyocardial, Intracoronary, and Interstitial Retrograde Coronary Venous Delivery: Implications for Current Clinical Trials Circulation, August 30, 2005; 112(9_suppl): I-150 - I-156. [Abstract] [Full Text] [PDF]
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P. Voisine, J. Li, C. Bianchi, T. A. Khan, M. Ruel, S.-H. Xu, J. Feng, A. Rosinberg, T. Malik, Y. Nakai, et al. Effects of L-Arginine on Fibroblast Growth Factor 2-Induced Angiogenesis in a Model of Endothelial Dysfunction Circulation, August 30, 2005; 112(9_suppl): I-202 - I-207. [Abstract] [Full Text] [PDF]
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A. Heinl-Green, P. W. Radke, F. M. Munkonge, O. Frass, J. Zhu, K. Vincent, D. M. Geddes, and E. W.F.W. Alton The efficacy of a 'master switch gene' HIF-1{alpha} in a porcine model of chronic myocardial ischaemia Eur. Heart J., July 1, 2005; 26(13): 1327 - 1332. [Abstract] [Full Text] [PDF]
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G. A. Krombach, J. G. Pfeffer, S. Kinzel, M. Katoh, R. W. Gunther, and A. Buecker MR-guided Percutaneous Intramyocardial Injection with an MR-compatible Catheter: Feasibility and Changes in T1 Values after Injection of Extracellular Contrast Medium in Pigs Radiology, May 1, 2005; 235(2): 487 - 494. [Abstract] [Full Text] [PDF]
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M. Simons Angiogenesis: Where Do We Stand Now? Circulation, March 29, 2005; 111(12): 1556 - 1566. [Full Text] [PDF]
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Y. Cao, A. Hong, H. Schulten, and M. J. Post Update on therapeutic neovascularization Cardiovasc Res, February 15, 2005; 65(3): 639 - 648. [Abstract] [Full Text] [PDF]
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B. H. Annex and M. Simons Growth factor-induced therapeutic angiogenesis in the heart: protein therapy Cardiovasc Res, February 15, 2005; 65(3): 649 - 655. [Abstract] [Full Text] [PDF]
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J. E. Markkanen, T. T. Rissanen, A. Kivela, and S. Yla-Herttuala Growth factor-induced therapeutic angiogenesis and arteriogenesis in the heart-gene therapy Cardiovasc Res, February 15, 2005; 65(3): 656 - 664. [Abstract] [Full Text] [PDF]
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J. A. Rodriguez, B. Nespereira, M. Perez-Ilzarbe, E. Eguinoa, and J. A. Paramo Vitamins C and E prevent endothelial VEGF and VEGFR-2 overexpression induced by porcine hypercholesterolemic LDL Cardiovasc Res, February 15, 2005; 65(3): 665 - 673. [Abstract] [Full Text] [PDF]
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Q. Dai, J. Huang, B. Klitzman, C. Dong, P. J. Goldschmidt-Clermont, K. L. March, J. Rokovich, B. Johnstone, E. J. Rebar, S. K. Spratt, et al. Engineered Zinc Finger-Activating Vascular Endothelial Growth Factor Transcription Factor Plasmid DNA Induces Therapeutic Angiogenesis in Rabbits With Hindlimb Ischemia Circulation, October 19, 2004; 110(16): 2467 - 2475. [Abstract] [Full Text] [PDF]
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K. Ohtani, K. Egashira, K.-i. Hiasa, Q. Zhao, S. Kitamoto, M. Ishibashi, M. Usui, S. Inoue, Y. Yonemitsu, K. Sueishi, et al. Blockade of Vascular Endothelial Growth Factor Suppresses Experimental Restenosis After Intraluminal Injury by Inhibiting Recruitment of Monocyte Lineage Cells Circulation, October 19, 2004; 110(16): 2444 - 2452. [Abstract] [Full Text] [PDF]
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J. Jacobi, B. Y.Y. Tam, G. Wu, J. Hoffman, J. P. Cooke, and C. J. Kuo Adenoviral Gene Transfer With Soluble Vascular Endothelial Growth Factor Receptors Impairs Angiogenesis and Perfusion in a Murine Model of Hindlimb Ischemia Circulation, October 19, 2004; 110(16): 2424 - 2429. [Abstract] [Full Text] [PDF]
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M. Heil and W. Schaper Influence of Mechanical, Cellular, and Molecular Factors on Collateral Artery Growth (Arteriogenesis) Circ. Res., September 3, 2004; 95(5): 449 - 458. [Abstract] [Full Text] [PDF]
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B. Sivakumar, L. E. Harry, and E. M. Paleolog Modulating Angiogenesis: More vs Less JAMA, August 25, 2004; 292(8): 972 - 977. [Abstract] [Full Text] [PDF]
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Y. F. Zhou, E. Stabile, J. Walker, M. Shou, R. Baffour, Z. Yu, D. Rott, G. D. Yancopoulos, J. S. Rudge, and S. E. Epstein Effects of gene delivery on collateral development in chronic hypoperfusion: Diverse effects of angiopoietin-1 versus vascular endothelial growth factor J. Am. Coll. Cardiol., August 18, 2004; 44(4): 897 - 903. [Abstract] [Full Text] [PDF]
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