NEJM：靶向抑制血小板以澄清急性冠脉综合征的更佳药物治疗方案

　　背景  对于无ST段抬高并且未进行血运重建的不稳定型心绞痛或心肌梗死患者，强化血小板抑制的效果尚未被描述。

　　方法  在这项双盲、随机试验中，在主要分析（包括7243例年龄＜75岁且接受阿司匹林治疗的患者）中，我们评估了普拉格雷（10 mg/d）和氯吡格雷（75 mg/d）治疗长达30个月的效果比较。在次要分析（包括2083 例年龄≥75 岁的患者）中，我们评估了普拉格雷5 mg 和氯吡格雷75 mg的效果比较。

　　结果  中位随访17个月时，在年龄＜75岁的患者中，普拉格雷组13.9%的患者和氯吡格雷组16.0%的患者发生因心血管原因、心肌梗死或卒中所致死亡的主要终点[普拉格雷组风险比0.91，95%可信区间（CI）0.79~1.05，P＝0.21]。我们在总人群中观察到相似结果。在年龄＜75岁的患者中，多种复发性缺血性事件（主要终点的所有成分）的预先设定分析显示普拉格雷的危险较低（风险比0.85，95%CI 0.72~1.00，P＝0.04）。在所有年龄组中，两组重度出血和颅内出血的发生率相似。组间非出血性严重不良事件的发生频率差异不显著，但氯吡格雷组心力衰竭的发生频率较高。

　　结论  在无ST 段抬高的不稳定型心绞痛或心肌梗死患者中，与氯吡格雷相比，普拉格雷未显著降低主要终点的发生频率，并且我们观察到（两组）出血危险相似。

Prasugrel versus Clopidogrel for Acute Coronary Syndromes without Revascularization

BACKGROUND

The effect of intensified platelet inhibition for patients with unstable angina or myocardial infarction without ST-segment elevation who do not undergo revascularization has not been delineated.

METHODS

In this double-blind, randomized trial, in a primary analysis involving 7243 patients under the age of 75 years receiving aspirin, we evaluated up to 30 months of treatment with prasugrel (10 mg daily) versus clopidogrel (75 mg daily). In a secondary analysis involving 2083 patients 75 years of age or older, we evaluated 5 mg of prasugrel versus 75 mg of clopidogrel.

RESULTS

At a median follow-up of 17 months, the primary end point of death from cardiovascular causes, myocardial infarction, or stroke among patients under the age of 75 years occurred in 13.9% of the prasugrel group and 16.0% of the clopidogrel group (hazard ratio in the prasugrel group, 0.91; 95% confidence interval [CI], 0.79 to 1.05; P=0.21). Similar results were observed in the overall population. The prespecified analysis of multiple recurrent ischemic events (all components of the primary end point) suggested a lower risk for prasugrel among patients under the age of 75 years (hazard ratio, 0.85; 95% CI, 0.72 to 1.00; P=0.04). Rates of severe and intracranial bleeding were similar in the two groups in all age groups. There was no significant between-group difference in the frequency of nonhemorrhagic serious adverse events, except for a higher frequency of heart failure in the clopidogrel group.

CONCLUSIONS

Among patients with unstable angina or myocardial infarction without ST-segment elevation, prasugrel did not significantly reduce the frequency of the primary end point, as compared with clopidogrel, and similar risks of bleeding were observed. (Funded by Eli Lilly and Daiichi Sankyo; TRILOGY ACS ClinicalTrials.gov number, NCT00699998.)