An essential transcription factor for inflammation, nuclear factor-kappa B (NF-κB), plays a pivotal role for restenosis after percutaneous coronary intervention (PCI). To evaluate the safety and effectiveness of NF-κB decoy oligodeoxynucleotides (ODN) to prevent restenosis, we initiated an open-label phase I/IIa clinical trial.
Seventeen patients who were suffering from angina with organic coronary stenosis were treated with NF-κB decoy ODN after PCI using bare metal stents.
Although the average coronary stenosis was 90.8 ± 7.0% before the stent implantation, the stenosis improved to 1.4 ± 5.9% after the intervention. Serum MCP-1 levels were significantly suppressed in NF-κB decoy ODN treated patients compared to those in non-treated patients on day 3 after the PCI. Ticlopidine treatment was employed, since clopidogrel was not launched in Japan. Six months after the PCI and decoy ODN transfection, significant restenosis was found in only 1 of the 17 patients, and the average restenosis rate was 39.6 ± 22.3%. No in-stent thrombosis was found and no significant systemic adverse effect occurred in any of the patients in this observation period.
These results suggest the clinical usefulness and safety of the NF-κB decoy ODN transfer after PCI, although further placebo control trials are necessary. Copyright © 2008 John Wiley & Sons, Ltd.