Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study

• Published in: The Lancet (British edition) 2007-08, Vol.370 (9587), p.567-574
• Main Authors: Koo, Bon-Kwon, MD, Kim, Yong-Seok, MD, Park, Kyung-Woo, MD, Yang, Han-Mo, MD, Kwon, Dong-A, MD, Chung, Jin-Wook, MD, Hahn, Joo-Yong, MD, Lee, Hae-Young, MD, Park, Jin-Shik, MD, Kang, Hyun-Jae, MD, Cho, Young-Seok, MD, Youn, Tae-Jin, MD, Chung, Woo-Young, MD, Chae, In-Ho, MD, Choi, Dong-Ju, MD, Oh, Byung-Hee, MD, Park, Young-Bae, MD, Kim, Hyo-Soo, Dr
• Format: Article
• Language: English
• Subjects: Aged; Angina pectoris; Angioplasty; Angioplasty, Balloon, Coronary; Antineoplastic Agents, Phytogenic - administration & dosage; Apoptosis; Blood clots; Celecoxib; Coronary Restenosis - pathology; Coronary Restenosis - prevention & control; Cyclooxygenase Inhibitors - administration & dosage; Cyclooxygenase Inhibitors - adverse effects; Cyclooxygenase Inhibitors - therapeutic use; Data analysis; Disease-Free Survival; Drug therapy; Drug Therapy, Combination; Female; Heart attacks; Heart failure; Hospitals; Humans; Internal Medicine; Kaplan-Meier Estimate; Lesions; Male; Medical imaging; Middle Aged; Myocardial infarction; Paclitaxel - administration & dosage; Prospective Studies; Pyrazoles - administration & dosage; Pyrazoles - adverse effects; Pyrazoles - therapeutic use; Stents; Stents - adverse effects; Studies; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Veins & arteries
• ISSN: 0140-6736; 1474-547X
• DOI: 10.1016/S0140-6736(07)61295-1

Summary Background In-vitro and animal experiments have shown that the cyclo-oxygenase 2 inhibitor celecoxib can reduce formation of neointima within stents. We aimed to test whether celecoxib has similar effects in a clinical setting. Methods In a randomised two-centre trial, we enrolled 274 patients who had angina pectoris or a positive stress test and who had native coronary artery lesions for which implantation of paclitaxel-eluting stents was feasible. All patients were given aspirin (100 mg daily) and clopidogrel (75 mg daily). 136 patients were randomly assigned to receive celecoxib (400 mg before the intervention, and 200 mg twice daily for 6 months after the procedure). The primary endpoint was late luminal loss on quantitative coronary angiography at 6 months after the intervention. Secondary endpoints were cardiac death, non-fatal myocardial infarction, and revascularisation of the target lesion. Analysis was done on a modified intention-to-treat basis. This study is registered with ClinicalTrials.gov , number NCT00292721. Findings At 6 months, mean in-stent late luminal loss was lower in the celecoxib group (0·49 mm, SD 0·47) than in the control group (0·75 mm, 0·60) (absolute difference 0·26 mm; 95% CI 0·12–0·40). Frequency of secondary outcomes at 6 months was also lower in the celecoxib group, mainly because of a reduced need for revascularisation of the target lesion. Interpretation These data suggest that the adjunctive use of celecoxib for 6 months after stent implantation in patients with coronary artery disease is safe and can reduce the need for revascularisation of the target lesion.