Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical Revascularization for non-ST-elevation acute coronary syndrome - The Clopidogrel in Unstable Angina to prevent Recurrent Ischemic Events (CURE) trial
Benefits and risks of the combination of clopidogrel and aspirin in patients undergoing surgical Revascularization for non-ST-elevation acute coronary syndrome - The Clopidogrel in Unstable Angina to prevent Recurrent Ischemic Events (CURE) trial
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DOI：
10.1161/01.cir.0000140675.85342.1b
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发表时间：
2004-09-01
期刊：
影响因子：
37.8
通讯作者：
Yusuf, S
中科院分区：
文献类型：
--
作者：
Fox, KAA;Mehta, SR;Yusuf, S
背景-抗血小板治疗和抗凝血酶治疗已被证明可以降低急性冠脉综合征患者的心脏事件风险，但所有有效的治疗方法也会增加出血风险。方法和结果-在氯吡格雷用于不稳定型心绞痛预防复发性缺血事件（CURE）试验中，12562例患者被随机分为氯吡格雷组或安慰剂组，主要转归为心血管（CV）死亡、心肌梗死（MI）或卒中。接受经皮冠状动脉介入治疗（PCI）的患者[氯吡格雷组为9.6%，安慰剂组为13.2%;相对风险（RR）为0.72; 95%CI为0.57 - 0.90]，冠状动脉旁路移植术（CABG）的患者（氯吡格雷组14.5%，安慰剂组16.2%; RR，0.89; 95%CI，0.71 - 1.11）和仅药物治疗（氯吡格雷组8.1%，安慰剂组10.0%; RR，0.80; 95%CI，0.69 - 0.92;分层间相互作用检验，0.53）。对于首次住院期间的CABG（安慰剂组530例，氯吡格雷组485例），CABG前CV死亡、MI或卒中的频率安慰剂组为4.7%，氯吡格雷组为2.9%（RR，0.56; 95% CI，0.29 - 1.08）。在整个研究中，大出血发生率超过1%，但危及生命的出血没有显著增加。在接受CABG的患者中，氯吡格雷组和安慰剂组的危及生命的出血发生率分别为5.6%和4.2（RR，1.30; 95% CI，0.91 ~ 1.95;结论：早期和长期氯吡格雷治疗的益处与风险（无CV死亡、MI、卒中或危及生命的出血）在接受血运重建（CABG或PCI）的患者和整个研究人群中相似。总体而言，入院时开始使用氯吡格雷的益处似乎超过风险，即使在初次住院期间进行CABG的患者中也是如此。
Background-Antiplatelet therapy and antithrombin therapy have been demonstrated to reduce the risk of cardiac events in patients presenting with acute coronary syndrome, yet all effective therapies also increase the risk of bleeding.Methods and Results-In the Clopidogrel in Unstable angina to prevent Recurrent ischemic Events ( CURE) trial, 12 562 patients were randomized to clopidogrel or placebo in addition to aspirin, and the primary outcome was cardiovascular ( CV) death, myocardial infarction (MI), or stroke. The benefits were consistent among those undergoing percutaneous coronary intervention (PCI) [9.6% for clopidogrel, 13.2% for placebo; relative risk (RR), 0.72; 95% CI, 0.57 to 0.90], coronary artery bypass grafting (CABG) surgery (14.5% for clopidogrel 16.2% for placebo; RR, 0.89; 95% CI, 0.71 to 1.11), and medical therapy only (8.1% for clopidogrel, 10.0% for placebo; RR, 0.80; 95% CI, 0.69 to 0.92; test for interaction among strata, 0.53). For CABG during the initial hospitalization ( 530 for placebo, 485 for clopidogrel), the frequency of CV death, MI or stroke before CABG was 4.7% for placebo and 2.9% for clopidogrel (RR, 0.56; 95% CI, 0.29 to 1.08). For the entire study, there was a 1% excess of major bleeding but no significant excess of life-threatening bleeding. Among patients undergoing CABG, the rates of life-threatening bleeding were 5.6% for clopidogrel and 4.2% for placebo (RR, 1.30; 95% CI, 0.91 to 1.95; both nonsignificant).Conclusions-The benefits versus risks of early and long-term clopidogrel therapy ( freedom from CV death, MI, stroke, or life-threatening bleeding) are similar in those undergoing revascularization ( CABG or PCI) and in the study population as a whole. Overall, the benefits of starting clopidogrel on admission appear to outweigh the risks, even among those who proceed to CABG during the initial hospitalization.