Effects of Celecoxib On Restenosis after Coronary Intervention and Evolution of Atherosclerosis (Mini-COREA) Trial: celecoxib, a double-edged sword for patients with angina
Effects of Celecoxib On Restenosis after Coronary Intervention and Evolution of Atherosclerosis (Mini-COREA) Trial: celecoxib, a double-edged sword for patients with angina
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DOI：
10.1093/eurheartj/ehs001
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发表时间：
2012-11-01
影响因子：
39.3
通讯作者：
Kim, Hyo-Soo
中科院分区：
文献类型：
--
作者：
Kang, Hyun-Jae;Oh, Il-Young;Kim, Hyo-Soo
在先前的COREA-TAXUS试验中，连续使用塞来昔布6个月可减少靶病变血运重建（TLR），而不会增加血栓形成风险。我们的目的是确认3个月塞来昔布在接受药物洗脱支架（DES）植入的患者在较大的前瞻性，随机trial.Methods和结果患者（n = 909）治疗的天然冠状动脉病变随机分为四组：对照组或塞来昔布组分层支架：紫杉醇洗脱支架（PES）或佐他莫司洗脱支架（ZES）。塞来昔布组术后给予塞来昔布200 mg，每日2次，连用3个月。主要终点是6个月时的支架内晚期丢失（LL）。塞来昔布组的支架内LL显著低于对照组（0.64 +/- 0.54 vs. 0.55 +/- 0.47 mm，P = 0.02）。塞来昔布组的LL降低趋势在ZES和PES亚组中得以维持，尽管未达到统计学显著性。塞来昔布组中临床驱动的TLR有降低的趋势（5.7 vs. 3.2，对数秩P = 0.09），但两组之间的不良心脏事件发生率无差异（心源性死亡、非致死性心肌梗死和TLR的复合终点; 8.6 vs. 7.7，对数秩P = 0.84）。非致死性心肌梗死和心源性死亡发生率塞来昔布组为1.6例，对照组为0.2例（log-rank P = 0.03）。然而，这项研究可能会引起对塞来昔布增加血栓形成风险的担忧，即使是在接受双重抗血小板治疗的患者中。
Aims In the previous COREA-TAXUS trial, a 6-month adjunctive use of celecoxib reduced target-lesion revascularization (TLR) without increased thrombotic risk. We aimed to confirm the effects of 3-month celecoxib in patients receiving drug-eluting stent (DES) implantation in the larger prospective, randomized trial.Methods and results Patients (n = 909) treated for native coronary lesions were randomized into four groups: the control or the celecoxib group with stratification by stents: paclitaxel-eluting stent (PES) or zotarolimus-eluting stent (ZES). In the celecoxib group, 200 mg of celecoxib was given twice daily for 3 months after the procedure. The primary endpoint was in-stent late loss (LL) at 6 months. In-stent LL was significantly lower in the celecoxib group than the control group (0.64 +/- 0.54 vs. 0.55 +/- 0.47 mm, P = 0.02). The trend of LL reduction in the celecoxib group was maintained in the ZES and PES subgroups, although it did not reach statistical significance. There was a trend towards the reduced clinically driven TLR in the celecoxib group (5.7 vs. 3.2, log-rank P = 0.09), but adverse cardiac events rate did not differ between the two groups (composite of cardiac death, non-fatal myocardial infarction, and TLR; 8.6 vs. 7.7, log-rank P = 0.84). Non-fatal myocardial infarction and cardiac death occurred in 1.6 of the patients in the celecoxib group when compared with 0.2 in the control group (log-rank P = 0.03).Conclusion Three-month adjunctive celecoxib would be useful to reduce LL of DES. However, this study may raise the concern about increased thrombotic risk with celecoxib even in patients receiving dual anti-platelet therapy.