Long-term outcome of adjunctive celecoxib treatment after paclitaxel-eluting stent implantation for the complex coronary lesions: two-year clinical follow-up of COREA-TAXUS trial.
BACKGROUND
In the COREA-TAXUS trial ("Effect of Celecoxib On REstenosis after coronary Angioplasty with a TAXUS stent"), celecoxib reduced late luminal loss and adverse cardiac events at follow-up around 6 months. The objective of this study was to assess the long-term outcome of short-term adjunctive celecoxib treatment after paclitaxel-eluting stent implantation.


RESULTS
This is a 2-year clinical follow-up of the COREA-TAXUS trial, an open-label randomized controlled study. A total 274 patients were randomized to receive or not receive celecoxib (400 mg before the intervention and 200 mg twice daily for 6 months after the procedure), and 271 underwent successful paclitaxel-eluting stent implantation. All patients were given aspirin (100 mg daily indefinitely) and clopidogrel (75 mg daily for at least 6 months). Among the 271 patients, 267 (98.5%) completed the 2-year clinical follow-up. From the previous follow-up to 2 years, there was no difference in the rate of adverse cardiac events between the celecoxib and control groups (1.6% versus 4.3%, P=0.27). Thus, at 2 years, the rate of adverse cardiac events was consistently lower in the celecoxib group (6.9% versus 19.7%, P=0.002). A significant reduction in need for target lesion revascularization was observed (6.2% versus 18.2%, P=0.003). The efficacy benefit in the celecoxib group was not undermined by an increased risk for cardiac death or myocardial infarction at 2 years (1.5% versus 1.4%).


CONCLUSIONS
Six-month adjunctive celecoxib treatment after paclitaxel-eluting stent implantation was associated with durable long-term efficacy up to 2 years. However, the inconclusive evidence for the long-term safety of this treatment warrants caution.


BACKGROUND
URL: http://www.clinicaltrials.gov. Unique identifier: NCT 00292721.
Chung
Jin-Wook
JW
Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
Yang
Han-Mo
HM
Park
Kyung-Woo
KW
Lee
Hae-Young
HY
Park
Jin-Shik
JS
Kang
Hyun-Jae
HJ
Cho
Young-Seok
YS
Youn
Tae-Jin
TJ
Koo
Bon-Kwon
BK
Chae
In-Ho
IH
Choi
Dong-Ju
DJ
Oh
Byung-Hee
BH
Park
Young-Bae
YB
Kim
Hyo-Soo
HS
D000368:Aged; D000068579:Celecoxib; D017024:Chemotherapy, Adjuvant; D003251:Constriction, Pathologic / Q000209:etiology* / Q000517:prevention & control; D003331:Coronary Vessels / Q000187:drug effects* / Q000473:pathology; D052246:Cyclooxygenase 2 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D054855:Drug-Eluting Stents / Q000706:statistics & numerical data; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D019919:Prosthesis Implantation; D011720:Pyrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D013449:Sulfonamides / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib; D017239:Paclitaxel