The VIVA trial: XXXX in @entity63 for @entity455 .

@entity1 @entity455 @entity63 @entity7 @entity951
BACKGROUND: Recombinant @entity1 @entity7 protein (rhVEGF) stimulates angiogenesis in animal models and was well tolerated in Phase I clinical trials. VIVA ( @entity7 in @entity63 for @entity455 ) 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 @entity1 with stable exertional @entity951 , unsuitable for standard revascularization, were randomized to receive placebo, low-dose rhVEGF (17 ng x kg(-1) x min(-1)), or high-dose rhVEGF (50 ng x kg(-1) x min(-1)) by intracoronary infusion on day 0, followed by intravenous infusions on days 3, 6, and 9. Exercise treadmill tests, @entity951 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 @entity1 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 @entity951 class (P=0.05) and nonsignificant trends in ETT time (P=0.15) and @entity951 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 @entity951 and favorable trends in ETT time and @entity951 frequency.
