Long-term follow up of initial clinical cases with NF-kappaB decoy oligodeoxynucleotide transfection at the site of coronary stenting.
BACKGROUND
An essential transcription factor for inflammation, nuclear factor-kappa B (NF-kappaB), plays a pivotal role for restenosis after percutaneous coronary intervention (PCI). To evaluate the safety and effectiveness of NF-kappaB 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-kappaB 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-kappaB 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-kappaB decoy ODN transfer after PCI, although further placebo control trials are necessary.
Egashira
Kensuke
K
Department of Cardiovascular Medicine, Kyushu University School of Medicine, Fukuoka, Japan.
Suzuki
Jun-ichi
J
Ito
Hiroshi
H
Aoki
Motokuni
M
Isobe
Mitsuaki
M
Morishita
Ryuichi
R
D000368:Aged; D000369:Aged, 80 and over; D003324:Coronary Artery Disease / Q000000981:diagnostic imaging / Q000601:surgery*; D023903:Coronary Restenosis / Q000517:prevention & control*; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007564:Japan; D008875:Middle Aged; D016328:NF-kappa B / Q000235:genetics*; D009838:Oligodeoxyribonucleotides / Q000008:administration & dosage* / Q000235:genetics; D018709:Statistics, Nonparametric; D015607:Stents / Q000009:adverse effects; D014162:Transfection; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional
D016328:NF-kappa B; D009838:Oligodeoxyribonucleotides