Long-term follow up of initial clinical cases with NF-κB decoy oligodeoxynucleotide transfection at the site of coronary stenting

Background: 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. Methods: Seventeen patients who were suffering from angina with organic coronary stenosis were treated with NF-κB decoy ODN after PCI using bare metal stents. Results: 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. Conclusions: These results suggest the clinical usefulness and safety of the NF-κB decoy ODN transfer after PCI, although further placebo control trials are necessary.