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 -