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替格瑞洛与氯吡格雷治疗急性冠脉综合征患者的支架血栓形成:来自前瞻性、随机 PLATO 试验的分析。

Stent thrombosis with ticagrelor versus clopidogrel in patients with acute coronary syndromes: an analysis from the prospective, randomized PLATO trial.

机构信息

INSERM-Unité 698, Hôpital Bichat, 46 Rue Henri Huchard, Paris, France.

出版信息

Circulation. 2013 Sep 3;128(10):1055-65. doi: 10.1161/CIRCULATIONAHA.113.002589. Epub 2013 Jul 30.

Abstract

BACKGROUND

We aimed to describe the effects of ticagrelor versus clopidogrel on stent thrombosis in the Platelet Inhibition and Patient Outcomes (PLATO) trial.

METHODS AND RESULTS

Of 18 624 patients hospitalized for acute coronary syndromes, 11 289 (61%) had at least 1 intracoronary stent. Ticagrelor reduced stent thrombosis compared with clopidogrel across all definitions: definite, 1.37% (n=71) versus 1.93% (n=105; hazard ratio [HR], 0.67; 95% confidence interval [CI], 0.50-0.90; P=0.0091); definite or probable, 2.21% (n=118) versus 2.87% (n=157; HR, 0.75; 95% CI, 0.59-0.95; P=0.017); and definite, probable, and possible, 2.94% (n=154) versus 3.77 (n=201; HR, 0.77; 95% CI, 0.62-0.95). The reduction in definite stent thrombosis was consistent regardless of acute coronary syndrome type, presence of diabetes mellitus, stent type (drug-eluting or bare metal stent), CYP2C19 genetic status, loading dose of aspirin, dose of clopidogrel before randomization, and use of glycoprotein IIb/IIIa inhibitors at randomization. The reduction in stent thrombosis with ticagrelor was numerically greater for late (>30 days; HR, 0.48; 95% CI, 0.24-0.96) and subacute (4 hours-30 days; HR, 0.60; 95% CI, 0.39-0.93) compared with acute (<24 hours; HR, 0.94; 95% CI, 0.43-2.05) stent thrombosis or for patients compliant to therapy (ie, taking blinded study treatment ≥80% of the time) compared with less compliant patients. Randomization to ticagrelor was a strong independent inverse predictor of definite stent thrombosis (HR, 0.65; 95% CI, 0.48-0.88).

CONCLUSION

Ticagrelor compared with clopidogrel reduces the incidence of stent thrombosis in patients with acute coronary syndromes, with consistent benefit across a broad range of patient, stent, and treatment characteristics.

摘要

背景

我们旨在描述血小板抑制和患者结局(PLATO)试验中替格瑞洛与氯吡格雷对支架血栓形成的影响。

方法和结果

在因急性冠状动脉综合征住院的 18624 例患者中,有 11289 例(61%)至少有 1 个冠状动脉内支架。与氯吡格雷相比,替格瑞洛降低了所有定义的支架血栓形成:明确的支架血栓形成,替格瑞洛组为 1.37%(n=71),氯吡格雷组为 1.93%(n=105;风险比[HR],0.67;95%置信区间[CI],0.50-0.90;P=0.0091);明确或可能的支架血栓形成,替格瑞洛组为 2.21%(n=118),氯吡格雷组为 2.87%(n=157;HR,0.75;95%CI,0.59-0.95;P=0.017);明确、可能和很可能的支架血栓形成,替格瑞洛组为 2.94%(n=154),氯吡格雷组为 3.77%(n=201;HR,0.77;95%CI,0.62-0.95)。无论急性冠状动脉综合征类型、是否合并糖尿病、支架类型(药物洗脱支架或金属裸支架)、CYP2C19 遗传状态、阿司匹林负荷剂量、随机分组前氯吡格雷剂量以及随机分组时是否使用糖蛋白 IIb/IIIa 抑制剂,替格瑞洛降低明确支架血栓形成的效果均一致。替格瑞洛治疗组迟发(>30 天;HR,0.48;95%CI,0.24-0.96)和亚急性(4 小时-30 天;HR,0.60;95%CI,0.39-0.93)支架血栓形成的风险低于氯吡格雷组,而替格瑞洛治疗组急性(<24 小时;HR,0.94;95%CI,0.43-2.05)支架血栓形成的风险与氯吡格雷组相似。与不依从治疗的患者(即,接受盲法研究治疗的时间<80%)相比,替格瑞洛组依从治疗的患者(即,接受盲法研究治疗的时间≥80%)发生明确支架血栓形成的风险更低。替格瑞洛随机分组是明确支架血栓形成的一个强有力的独立负向预测因子(HR,0.65;95%CI,0.48-0.88)。

结论

与氯吡格雷相比,替格瑞洛可降低急性冠状动脉综合征患者支架血栓形成的发生率,在广泛的患者、支架和治疗特征中具有一致的获益。

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