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替格瑞洛与氯吡格雷用于拟行直接经皮冠状动脉介入治疗的 ST 段抬高型急性冠状动脉综合征患者:血小板抑制和患者结局(PLATO)试验亚组分析。

Ticagrelor versus clopidogrel in patients with ST-elevation acute coronary syndromes intended for reperfusion with primary percutaneous coronary intervention: A Platelet Inhibition and Patient Outcomes (PLATO) trial subgroup analysis.

机构信息

INSERM U, Paris, France.

出版信息

Circulation. 2010 Nov 23;122(21):2131-41. doi: 10.1161/CIRCULATIONAHA.109.927582. Epub 2010 Nov 8.

DOI:10.1161/CIRCULATIONAHA.109.927582
PMID:21060072
Abstract

BACKGROUND

Aspirin and clopidogrel are recommended for patients with acute coronary syndromes (ACS) or undergoing coronary stenting. Ticagrelor, a reversible oral P2Y12-receptor antagonist, provides faster, greater, and more consistent platelet inhibition than clopidogrel and may be useful for patients with acute ST-segment elevation (STE) ACS and planned primary percutaneous coronary intervention.

METHODS AND RESULT

Platelet Inhibition and Patient Outcomes (PLATO), a randomized, double-blind trial, compared ticagrelor with clopidogrel for the prevention of vascular events in 18 624 ACS patients. This report concerns the 7544 ACS patients with STE or left bundle-branch block allocated to either ticagrelor 180-mg loading dose followed by 90 mg twice daily or clopidogrel 300-mg loading dose (with provision for 300 mg clopidogrel at percutaneous coronary intervention) followed by 75 mg daily for 6 to 12 months. The reduction of the primary end point (myocardial infarction, stroke, or cardiovascular death) with ticagrelor versus clopidogrel (10.8% versus 9.4%; hazard ratio [HR], 0.87; 95% confidence interval, 0.75 to 1.01; P=0.07) was consistent with the overall PLATO results. There was no interaction between presentation with STE/left bundle-branch block and randomized treatment (interaction P=0.29). Ticagrelor reduced several secondary end points, including myocardial infarction alone (HR, 0.80; P=0.03), total mortality (HR, 0.82; P=0.05), and definite stent thrombosis (HR, 0.66; P=0.03). The risk of stroke, low in both groups, was higher with ticagrelor (1.7% versus 1.0%; HR,1.63; 95% confidence interval, 1.07 to 2.48; P=0.02). Ticagrelor did not affect major bleeding (HR, 0.98; P=0.76).

CONCLUSION

In patients with STE-ACS and planned primary percutaneous coronary intervention, the effects of ticagrelor were consistent with those observed in the overall PLATO trial.

CLINICAL TRIAL REGISTRATION

URL: http://www.ClinicalTrials.gov. Unique identifier: NCT00391872.

摘要

背景

阿司匹林和氯吡格雷推荐用于急性冠脉综合征(ACS)或接受冠状动脉支架置入的患者。替格瑞洛是一种可逆的口服 P2Y12 受体拮抗剂,与氯吡格雷相比,能更快、更完全、更一致地抑制血小板,对于急性 ST 段抬高型(STE)ACS 并计划行直接经皮冠状动脉介入治疗的患者可能有用。

方法和结果

血小板抑制和患者结局(PLATO)是一项随机、双盲试验,比较了替格瑞洛与氯吡格雷预防 18624 例 ACS 患者血管事件的效果。本报告涉及 7544 例 ACS 患者,STE 或左束支传导阻滞,分为替格瑞洛 180mg 负荷剂量后 90mg 每日 2 次或氯吡格雷 300mg 负荷剂量(在直接经皮冠状动脉介入治疗时可给予 300mg 氯吡格雷)后 75mg 每日 1 次,治疗 6 至 12 个月。与氯吡格雷相比,替格瑞洛降低了主要终点(心肌梗死、卒中和心血管死亡)(10.8% 比 9.4%;危险比[HR],0.87;95%置信区间,0.75 至 1.01;P=0.07),这与 PLATO 总体结果一致。STE/左束支传导阻滞与随机治疗之间无交互作用(交互 P=0.29)。替格瑞洛降低了多个次要终点,包括心肌梗死(HR,0.80;P=0.03)、总死亡率(HR,0.82;P=0.05)和明确的支架血栓形成(HR,0.66;P=0.03)。两组的卒中风险均较低,替格瑞洛组更高(1.7%比 1.0%;HR,1.63;95%置信区间,1.07 至 2.48;P=0.02)。替格瑞洛对大出血无影响(HR,0.98;P=0.76)。

结论

在 STE-ACS 并计划行直接经皮冠状动脉介入治疗的患者中,替格瑞洛的效果与 PLATO 总体试验观察到的效果一致。

临床试验注册

网址:http://www.ClinicalTrials.gov。唯一标识符:NCT00391872。

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