International Circulation: Could you please give an introduction to the results of CURRENT OASIS 7?

《国际循环》：您能否介绍一下CURRENT OASIS 7研究的结果？

Professor Mehta: CURRENT OASIS 7 was a trial of 25，000 patients with ACS (UA/NSTEMI and STEMI)， assessing the optimal dose of aspirin and clopidogrel.  All patients had to have coronary angiography with an intention for PCI， and 70% of the cohort received a PCI. There were 2 randomizations: the first was to double dose clopidogrel (600 mg loading dose followed by 150 mg daily for one week then 75 mg daily) versus the standard dose (300 mg loading dose followed by 75 mg daily). Those that did not have a PCI generally had normal coronary arteries/non-significant CAD (about 50% of this group) or they had their study drug stopped because of coronary artery bypass graft (CABG) surgery (about 25%).  The primary outcome of the trial (CV death， myocardial infarction (MI)， or stroke) showed a significant reduction in events with double dose clopidogrel for 7 days， compared with the standard dose regimen. In those who did not receive PCI， there was no significant difference between the groups and overall (combining PCI and no PCI patients) there was no significant difference). The benefits in PCI patients were achieved without an increase in TIMI major bleeding although there was a modest increase in CURRENT defined major bleeding driven mostly by a slightly higher need for blood transfusion in the double dose group.  There was a small increase in the need for blood transfusion between the two groups.  Importantly， there was a 40% reduction in definite stent thrombosis in favor of the double dose of clopidogrel compared with the standard dose.  With regard to the aspirin dose comparison， there was no difference between the high-dose and low-dose aspirin groups， for efficacy or for safety.  The overall conclusions of the study are that for patients who are undergoing PCI， a double dose of clopidogrel given for one week， followed by the standard dose of 75mg daily will lower CV death， MI， and stroke， as well as have a large reduction in stent thrombosis.  Secondly， for those patients who do not undergo PCI， the standard dose regimen of clopidogrel is sufficient.  Finally， these benefits were achieved without any increase in TIMI major bleeding， no increase in fatal bleeding， and no increase in intracranial hemorrhage.

S R Mehta教授：CURRENT OASIS 7研究共纳入25 000例急性冠脉综合征（ACS）患者，包括不稳定性心绞痛（UA）/非ST段抬高型心肌梗死（NSTEMI）和ST段抬高型心肌梗死（STEMI）患者，研究对阿司匹林和氯吡格雷的最佳剂量进行了评估。所有欲行经皮冠状动脉介入（PCI）治疗的患者均进行冠状动脉造影，本研究队列中70%的患者接受了PCI治疗。共进行了2次随机化分组，第1次分为氯吡格雷双倍剂量（600 mg负荷剂量后150 mg/d持续1周，而后为75 mg/d）组 vs. 标准剂量（300 mg负荷剂量，继而75 mg/d维持）组。那些未行PCI的患者通常冠状动脉正常或为轻度冠心病（约占该组的50%），或者因行冠状动脉旁路移植术（CABG）而停用研究药物（约25%）。该研究主要终点（心血管[CV]死亡、心肌梗死[MI]或卒中）结果显示，与标准剂量给药组相比，氯吡格雷双倍剂量7天组事件发生率显著降低。在未接受PCI的患者中，组间和整体（PCI患者加未行PCI的患者）无显著差异 。PCI患者获益且TIMI主要出血事件未增加，但CURRENT定义的主要出血略有增加，这主要源于双倍剂量组输血需要稍有升高。这两组间输血需要略增加。重要的是，与标准剂量组相比，氯吡格雷双倍剂量组确诊的支架血栓形成减少了40%。而阿司匹林的剂量对比结果显示，大剂量和小剂量阿司匹林组间无论是有效性还是安全性均无差异。该研究的总体结论为：第一，对行PCI的患者，氯吡格雷双倍剂量1周继以标准剂量75 mg/d将降低CV死亡、MI和卒中，同时大大降低支架血栓的发生率；其次，对那些未行PCI的患者，标准剂量给药方案已经足够；最后，这些获益是在未增加TIMI主要出血、未增加致死性出血和未增加颅内出血的情况下取得的。