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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 Sep; 68(3):372-8.CC

Abstract

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.

Authors+Show Affiliations

Cardiology Department, Rabin Medical Center, Petach-Tikva, Israel. shmuelf@clalit.org.ilNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase I
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

16892433

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.
* Article titles in AMA citation format should be in sentence-case
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 -