Lewis Basil S, Mehta Shamir R, Fox Keith A A, Halon David A, Zhao Feng, Peters Ron J G, Keltai Matyas, Budaj Andrzej, Yusuf Salim
Lady Davis Carmel Medical Center, Haifa, Israel.
Am Heart J. 2005 Dec;150(6):1177-84. doi: 10.1016/j.ahj.2005.01.044.
The CURE study demonstrated the benefit of clopidogrel in patients with non-ST elevation (NSTE) acute coronary syndromes (ACSs), including those undergoing percutaneous coronary intervention (PCI). It did not report the relation between clopidogrel and timing of PCI or, more specifically, the role of clopidogrel in patients managed with an early interventional strategy, the current preferred treatment option for patients with NSTE ACSs. In the present study, we examined the relation between clopidogrel therapy, timing of PCI, and cardiovascular (CV) events in patients participating in the CURE study.
A total of 12562 patients with NSTE ACSs was randomized in double-blind fashion to clopidogrel or placebo (300 mg loading dose, then 75 mg/d) in addition to aspirin for up to 1 year. We analyzed the data of the 2658 CURE patients undergoing PCI and related the incidence of outcome events (CV death/myocardial infarction [MI]) to timing of PCI after randomization: early (< 48 hours, median 1.0 day, n = 370), intermediate (> or = 48 hours to initial hospital discharge, median 6.8 days, n = 1360), and late (after initial hospital discharge, median 47.6 days, n = 928).
Clopidogrel showed consistent treatment benefit over the 12-month (mean 9 months) follow-up period irrespective of timing of PCI (relative risk [RR] 0.53 for the early group, RR 0.72 for the intermediate group, RR 0.70 for the late group). After adjustment for propensity to undergo PCI, the greatest treatment benefit of clopidogrel was observed in patients undergoing PCI < 48 hours after randomization (RR 0.45, 95% CI 0.21-0.96, P = .038), although with overlap between groups. The lowest absolute event rate (6.7% CV death/MI) was observed in patients treated with clopidogrel and undergoing PCI within 48 hours. There was no increased risk of major bleeding in the early PCI group.
The benefit of therapy with clopidogrel in addition to aspirin in patients presenting with NSTE ACSs was significant irrespective of the timing of PCI. The combination of clopidogrel and an early (< 48 hours) interventional strategy was associated with low absolute event rates for CV death/nonfatal MI.
CURE研究证实了氯吡格雷在非ST段抬高（NSTE）急性冠状动脉综合征（ACS）患者中的益处，包括接受经皮冠状动脉介入治疗（PCI）的患者。该研究未报告氯吡格雷与PCI时机之间的关系，更具体地说，未报告氯吡格雷在采用早期介入策略治疗的患者中的作用，而早期介入策略是目前NSTE ACS患者的首选治疗方案。在本研究中，我们探讨了参与CURE研究的患者中氯吡格雷治疗、PCI时机与心血管（CV）事件之间的关系。
总共12562例NSTE ACS患者被双盲随机分组，除阿司匹林外，分别接受氯吡格雷或安慰剂治疗（负荷剂量300 mg，然后75 mg/d），治疗时间长达1年。我们分析了2658例接受PCI的CURE患者的数据，并将结局事件（CV死亡/心肌梗死[MI]）的发生率与随机分组后PCI的时机相关联：早期（<48小时，中位数1.0天，n = 370）、中期（≥48小时至首次出院，中位数6.8天，n = 1360）和晚期（首次出院后，中位数47.6天，n = 928）。
在12个月（平均9个月）的随访期内，无论PCI时机如何，氯吡格雷均显示出持续的治疗益处（早期组相对危险度[RR]为0.53，中期组RR为0.72，晚期组RR为0.70）。在对接受PCI的倾向进行调整后，在随机分组后<48小时接受PCI的患者中观察到氯吡格雷最大的治疗益处（RR 0.45，95%可信区间0.21 - 0.96，P = 0.038），尽管各组之间存在重叠。在接受氯吡格雷治疗且在48小时内接受PCI的患者中观察到最低的绝对事件发生率（6.7% CV死亡/MI）。早期PCI组的大出血风险没有增加。
对于NSTE ACS患者，除阿司匹林外，氯吡格雷治疗的益处显著，与PCI时机无关。氯吡格雷与早期（<48小时）介入策略的联合应用与CV死亡/非致命性MI的低绝对事件发生率相关。
