Citation
Fuchs, Shmuel, et al. "A Randomized, Double-blind, Placebo-controlled, Multicenter, Pilot Study of the Safety and Feasibility of Catheter-based Intramyocardial Injection of AdVEGF121 in Patients With Refractory Advanced Coronary Artery Disease." Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, vol. 68, no. 3, 2006, pp. 372-8.
Fuchs S, Dib N, Cohen BM, et al. A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease. Catheter Cardiovasc Interv. 2006;68(3):372-8.
Fuchs, S., Dib, N., Cohen, B. M., Okubagzi, P., Diethrich, E. B., Campbell, A., Macko, J., Kessler, P. D., Rasmussen, H. S., Epstein, S. E., & Kornowski, R. (2006). A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease. Catheterization and Cardiovascular Interventions : Official Journal of the Society for Cardiac Angiography & Interventions, 68(3), 372-8.
Fuchs S, et al. A Randomized, Double-blind, Placebo-controlled, Multicenter, Pilot Study of the Safety and Feasibility of Catheter-based Intramyocardial Injection of AdVEGF121 in Patients With Refractory Advanced Coronary Artery Disease. Catheter Cardiovasc Interv. 2006;68(3):372-8. PubMed PMID: 16892433.
TY - JOUR
T1 - A randomized, double-blind, placebo-controlled, multicenter, pilot study of the safety and feasibility of catheter-based intramyocardial injection of AdVEGF121 in patients with refractory advanced coronary artery disease.
AU - Fuchs,Shmuel,
AU - Dib,Nabil,
AU - Cohen,Barry M,
AU - Okubagzi,Petros,
AU - Diethrich,Edward B,
AU - Campbell,Ann,
AU - Macko,Jennifer,
AU - Kessler,Paul D,
AU - Rasmussen,Henrik S,
AU - Epstein,Stephen E,
AU - Kornowski,Ran,
PY - 2006/8/8/pubmed
PY - 2007/6/15/medline
PY - 2006/8/8/entrez
SP - 372
EP - 8
JF - Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions
JO - Catheter Cardiovasc Interv
VL - 68
IS - 3
N2 - BACKGROUND: The experience with direct myocardial injection of adenovirus encoding angiogenic growth factor is limited to invasive surgical approach. Accordingly, we sought to evaluate, for the first time, in a randomized, double-blind, placebo-controlled, phase I pilot study the safety and feasibility of percutaneous catheter-based intramyocardial delivery of a replication-deficient adenovector encoding the 121-amino-acid isoform of vascular endothelial growth factor (AdVEGF121). METHODS: Ten "no-option" patients with severe coronary artery disease were randomized (2:1) to receive AdVEGF121 (4 x 10(10) pu) or placebo as fifteen 100 microL, evenly distributed, endomyocardial injections using a nonflouroscopic, 3-dimensional mapping and injection (NOGA) catheter-based system. RESULTS: Injection procedure was successfully completed in all cases and was associated with no major adverse events. AdVEGF121 was considered potentially associated with a single serious adverse event of transient moderate fever. Elevated postprocedure CK and CK-MB fraction levels were recorded in two placebo-treated and three AdVEGF121-treated patients; all CK measured values were <1.5 times upper limit of normal. All adenoviral cultures (urine and throat swab) were negative 24-hr after dosing, and no significant changes in serial plasma VEGF levels were noted over time. At 12 months follow-up, no cancers, proliferative retinal changes, or significant abnormalities in hepatic, renal or hematological indices were observed. CONCLUSIONS: Percutaneous, catheter-based AdVEGF121 intramyocardial injection is a practical, feasible, and potentially safe approach for intramyocardial gene transfer. A larger randomized, phase II efficacy study is warranted.
SN - 1522-1946
UR - https://www.unboundmedicine.com/medline/citation/16892433/A_randomized_double_blind_placebo_controlled_multicenter_pilot_study_of_the_safety_and_feasibility_of_catheter_based_intramyocardial_injection_of_AdVEGF121_in_patients_with_refractory_advanced_coronary_artery_disease_
L2 - https://doi.org/10.1002/ccd.20859
DB - PRIME
DP - Unbound Medicine
ER -