Abstract 3042: Two-Year Follow Up of Initial Clinical Cases With an NF-kB Decoy Transfection at the Site of the Coronary Stenting
Background- Nuclear factor-kappa B (NF-kB) plays a pivotal role for restenosis after percutaneous coronary intervention (PCI). To evaluate the safety and effectiveness of an NF-kB decoy for preventing restenosis, we started clinical trials.
Methods and Results- Sixteen patients (14 males/ 2 females), who were suffering from angina pectoris with organic coronary stenosis, received NF-kB decoy (1mg 6 cases, 2mg 6 cases, and 4 mg 4 cases) transfection after PCI using bare metal stents. Although the average coronary stenosis was 90.0 +/− 7.2 % measured by coronary angiogram before the stent implantation, the stenosis improved to 2.0 +/− 6.3 % after the intervention and transfection. Serum MCP-1 levels were significantly suppressed in the NF-kB decoy treated group (230 +/− 124 pg/mL) compared to those in the non-treated group (376 +/− 86 pg/mL, p<0.05) on day 3 after the PCI. We used a standard anti-platelet treatment (ticlopidine) after the PCI, clopidogrel was not used in any cases. Six months after the PCI, significant restenosis (more than 75% stenosis at the stent site) was found in only 1 of the 16 patients, and the average restenosis rate measured using coronary angiogram was 38.0 +/− 21.7 %. No in-stent thrombosis was found without the clopidogrel treatment and no significant systemic adverse effect occurred in any of the patients over this 2-year observation period.
Conclusion- These results suggest the clinical usefulness and safety of the NF-kB decoy transfection after PCI.