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Effects of Celecoxib On Restenosis after Coronary Intervention and Evolution of Atherosclerosis : An interim analysis of Mini-COREA multicenter randomized controlled trial.
서울대학교병원 순환기내과¹ , 분당서울대학교병원 순환기내과² , 광주보훈병원 심장내과³ ,고려대학교 구로병원 순환기내과⁴ , 건양대학교병원 심장내과5
강현재¹, 오일영¹ ,서정원² , 박경우¹ ,이해영¹ , 조영석² , 연태진² , 구본권¹ , 강원유³, 김원³, 나승운⁴ ,배장호5 ,채인호² ,최동주² ,김효수¹ , 오병희¹ ,박영배¹
BACKGROUND: Previous COREA-TAXUS trial have shown that the adjunctive use of celecoxib, inhibitor of cyclo-oxygenase 2 and akt, for 6 months is safe and can reduce the need for revascularization of the target lesion. We aimed to test whether 3-month use of celecoxib has similar effects in paclitaxel-eluting stent (PES) and zotarolimus-eluting stent (ZES). METHODS: In a randomized five-centre trial, we enrolled 930 patients who had angina pectoris or a positive stress test and who had native coronary artery lesions for which implantation of drug-eluting stents was feasible. Patients were randomized into PES or ZES group, and then assigned to celecoxib or control group respectively (PES: 270 vs. 284, ZES: 190 vs. 186). In celecoxib group 200mg of celecoxib was given twice daily for 3 months after the revascularization procedure. The primary endpoint was late luminal loss on quantitative coronary angiography at 6 months after the intervention. Secondary endpoints were occurrence of major adverse cardiac event (MACE: cardiac death, non-fatal myocardial infarction, and revascularization of the target lesion). Analysis was done on a modified intention-to-treat basis. Results: This is a ongoing trial and we expect complete data will be presented at meeting. The inclusion criteria cover most of the real world tough cases (B2/C lesion:70%, total occlusion:9%, bifurcation:22%). Baseline demographic and angiographic characteristics were similar between groups. After completion of 71% angiographic follow-up, mean in-stent late luminal loss was significantly lower in the celecoxib group than in the control group (control vs. celecoxib: 0.65±0.54mm vs. 0.54±0.44mm , p=0.01). Benefits of celecoxib treatment were observed in both PES group (control 0.59±0.53mm vs. celecoxib 0.48±0.41mm, p=0.05) and ZES group (control 0.74±0.53mm vs. celecoxib 0.61±0.47mm, p=0.09) with borderline statistical significance. After completion of 85% clinical follow-up, celecoxib treatment showed a trend of less occurrence of MACE compared to the control, which was not statistically significant (Control vs. celecoxib: 8.6% vs. 7.6%, Relative risk[95% confidence interval]: 0.94[0.74-1.18], p=0.61). Conclusion: Adjunctive use of celecoxib for 3 months would be useful to improve the efficacy of DES in the real world patients with tough lesions and high late loss even after DES implantation


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