Table 3. Phase 2 VEGF Trials.
Henry et al. (45) VIVA | Hedman et al. (47) KAT | Kastrup et al. (46) Euroinject One | |
---|---|---|---|
Patients | Stable angina, “no-option” CAD | Stable CAD undergoing PCI | Severe, stable angina; “no-option” CAD |
Therapy | Recombinant human VEGF | Ad or PL VEGF | Plasmid VEGF |
Duration of follow-up | 60 days, 120 days | 6 months | 3 months |
Primary end point | Δ ETT at 60 days | Minimal lumen diameter, % stenosis | Δ Myocardial perfusion |
Secondary end points | Δ ETT, angina, and myocardial perfusion at day 120 |
Myocardial perfusion, exercise tolerance, incidence of new cardiac events, revascularization, functional class |
Safety, wall motion, LVEF, angina |
Treatment groups | High-dose (n = 59) Low-dose (n = 56) Placebo (n = 63) |
Adv (n = 37) PL (n = 28) Placebo (n = 38) |
VEGF-A165 (n = 40) Placebo (n = 40) |
Dosage | High-dose: 50 ng/kg per min IC for 20 min† Low-dose: 17 ng/kg per min IC for 20 min† |
Adv: 2 × 1010 PFU IC PL: 2,000 μg IC |
VEGF-A165: 0.5 mg |
Findings | ↓ in angina class at day 120 in high-dose group compared with placebo*; no benefit in ΔETT |
↑ in perfusion at 6 months compared with baseline in Ad group*; no differences among groups |
Improved regional wall motion in VEGF group compared with placebo* |
p ≤ 0.05.
Followed by 4-h infusions on days 3, 6, and 9.
Adv = adenovirus vector; IC = intracoronary; PCI = percutaneous coronary intervention; PFU = plaque-forming unit; PL = plasmid liposome; VEGF = vascular endothelial growth factor; other abbreviations as in Table 2.