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

Koo, Bon‐Kwon; Kim, Yong-Seok; Park, Kyung Woo; Yang, Han–Mo; Kwon, Dong-A; Chung, Jung Kee; Hahn, Joo‐Yong; Lee, Hae Young; Park, Jin-Shik; Kang, Hyun–Jae; Cho, Young-Seok; Youn, Tae‐Jin; Chung, Woo-Young; Chae, In‐Ho; Choi, Dong‐Ju; Oh, Byung Hee; Park, Young-Bae; Kim, Hyo–Soo

doi:10.1016/s0140-6736(07)61295-1

Cited by 40 publications

(33 citation statements)

References 33 publications

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“…This finding would not be expected if the relative risk were the same regardless of an individual's baseline risk and is consistent with a mechanism of risk that postulates a coxib-induced imbalance between thromboxane and prostacyclin, which would likely be most important under thrombogenic conditions. Because no available compelling data suggest that coxibs increase atherosclerotic burden-and recent evidence showing a reduction in restenosis rates after percutaneous coronary intervention in patients randomized to celecoxib 27 may suggest the opposite-potential imbalances between thromboxane and prostacyclin production would likely be most meaningful in a patient predisposed to pathological thrombus formation. Thus, patients with preexisting atherosclerotic plaque might be most susceptible to the risk imposed by coxibs, and in the presence of a plaque rupture, coxib use might increase the likelihood of sustained thrombosis.…”

Section: Solomon Et Al Trials Of Celecoxib and Cardiovascular Riskmentioning

confidence: 99%

Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials

et al. 2008

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Background-Observational studies and randomized trials have reported increased cardiovascular risk associated with cyclooxygenase-2 inhibitors. Prior placebo-controlled randomized studies had limited ability to assess the relationship of either celecoxib dose or pretreatment cardiovascular status to risk associated with celecoxib. Our aim was to assess the cardiovascular risk associated with celecoxib in 3 dose regimens and to assess the relationship between baseline cardiovascular risk and effect of celecoxib on cardiovascular events. Methods and Results-We performed a patient-level pooled analysis of adjudicated data from 7950 patients in 6 placebo-controlled trials comparing celecoxib with placebo for conditions other than arthritis with a planned follow-up of at least 3 years. Patients were administered celecoxib in 3 dose regimens: 400 mg QD, 200 mg BID, or 400 mg BID.From the pooled data, we calculated a hazard ratio for all dose regimens combined and individual hazard ratios for each dose regimen and examined whether celecoxib-related risk was associated with baseline cardiovascular risk. The primary end point was the combination of cardiovascular death, myocardial infarction, stroke, heart failure, or thromboembolic event. With 16 070 patient-years of follow-up, the hazard ratio for the composite end point combining the tested doses was 1.6 (95% CI, 1.1 to 2.3). The risk, which increased with dose regimen (Pϭ0.0005), was lowest for the 400-mg-QD dose (hazard ratio, 1.1; 95% CI, 0.6 to 2.0), intermediate for the 200-mg-BID dose (hazard ratio, 1.8; 95% CI, 1.1 to 3.1), and highest for the 400-mg-BID dose (hazard ratio, 3.1; 95% CI, 1.5 to 6.1). Patients at highest baseline risk demonstrated disproportionately greater risk of celecoxib-related adverse events (P for interactionϭ0.034). Conclusions-We observed evidence of differential cardiovascular risk as a function of celecoxib dose regimen and baseline cardiovascular risk. By further clarifying the extent of celecoxib-related cardiovascular risk, these findings may help guide treatment decisions for patients who derive clinical benefit from selective cyclooxygenase-2 inhibition.

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Section: Solomon Et Al Trials Of Celecoxib and Cardiovascular Riskmentioning

confidence: 99%

Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials

et al. 2008

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“…Показано отсутствие увеличения сердечно-сосуди-стой смертности у больных воспалительными артритами при приеме НПВП [124, 125] и увеличение риска ИМ по-сле их отмены при РА, снижение частоты развития инт-раоперационного ИМ и рестеноза после реваскуляриза-ции сосудов на фоне приема целекоксиба [126], что дает основание рассматривать НПВП в качестве перспектив-ного средства профилактики атеросклероза при РА [124][125][126][127].…”

Section: противоревматическая терапияunclassified

Arterial hypertension in rheumatoid arthritis

Новикова¹,

Попкова²,

Насонов³

2011

rsp

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“…9 On the basis of these novel findings, we have further demonstrated that adjunctive celecoxib treatment for 6 months after paclitaxel-eluting stent (PES) implantation in patients with complex coronary lesions reduces late luminal loss and need for target lesion revascularization at 6 months in the COREA-TAXUS randomized clinical trial ("Effect of Celecoxib On REstenosis after coronary Angioplasty with a TAXUS stent"). 10 However, caution for COX-2 inhibitors was raised when rofecoxib was voluntarily withdrawn from the market by its manufacturer after the Adenomatous Polyp Prevention On Vioxx study. 11 Since the publication of that study, there has been much controversy and intense debate whether there is an increased risk for adverse cardiovascular events with celecoxib.…”

Section: Clinical Perspective On P 248mentioning

confidence: 99%

“…The detailed descriptions of the study protocol and procedure were previously reported. 10 Men and women were eligible if they were 18 to 75 years old, had angina pectoris or a positive stress test, and had native coronary lesions for which PES (Taxus, Boston Scientific, Mass) implantation was feasible. Complex lesions such as chronic total occlusion, long, calcified, type C, bifurcation, or small artery lesions were included because adjunctive medications to reduce restenosis is really needed for lesions with high restenosis rates.…”

Section: Study Populationmentioning

confidence: 99%

Long-Term Outcome of Adjunctive Celecoxib Treatment After Paclitaxel-Eluting Stent Implantation for the Complex Coronary Lesions

Chung

Yang²,

Park³

et al. 2010

Circ: Cardiovascular Interventions

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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. Methods and 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. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT 00292721.

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

Cited by 40 publications

References 33 publications

Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials

Cardiovascular Risk of Celecoxib in 6 Randomized Placebo-Controlled Trials

Arterial hypertension in rheumatoid arthritis

Long-Term Outcome of Adjunctive Celecoxib Treatment After Paclitaxel-Eluting Stent Implantation for the Complex Coronary Lesions

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