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根据经皮冠状动脉介入治疗的时间,替格瑞洛与氯吡格雷在 ST 段抬高型心肌梗死患者中的疗效比较:TRITON-TIMI 38 亚组分析(评估通过优化血小板抑制改善治疗结果的试验:替格瑞洛在心肌梗死中的疗效 38)。

Prasugrel versus clopidogrel in patients with ST-segment elevation myocardial infarction according to timing of percutaneous coronary intervention: a TRITON-TIMI 38 subgroup analysis (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38).

机构信息

Women's College Research Institute and Cardiovascular Division, Department of Medicine, Women's College Hospital, University of Toronto, Toronto, Ontario, Canada.

TIMI Study Group, Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

出版信息

JACC Cardiovasc Interv. 2014 Jun;7(6):604-12. doi: 10.1016/j.jcin.2014.01.160.

Abstract

OBJECTIVES

This study sought to evaluate the efficacy of prasugrel versus clopidogrel in ST-segment elevation myocardial infarction (STEMI) by the timing of percutaneous coronary intervention (PCI).

BACKGROUND

Treatment strategies and outcomes for patients with STEMI may differ when treated with primary compared with secondary PCI.

METHODS

STEMI patients in the TRITON-TIMI 38 (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis In Myocardial Infarction 38) were randomized to prasugrel or clopidogrel on presentation if primary PCI was intended or later during secondary PCI. Primary PCI was defined as within 12 h of symptom onset. The primary endpoint was cardiovascular death, myocardial infarction (MI), or stroke. Because periprocedural MI is difficult to assess in the setting of STEMI, we performed analyses excluding these events.

RESULTS

Reductions in the primary endpoint with prasugrel versus clopidogrel (hazard ratio [HR]: 0.79; 95% confidence interval [CI]: 0.65 to 0.97; p = 0.022) were consistent between primary and secondary PCI patients at 15 months (HR: 0.89; 95% CI: 0.69 to 1.13 vs. HR: 0.65; 95% CI: 0.46 to 0.93; p interaction = 0.15). However, a tendency toward a difference in treatment effect at 30 days (HR: 0.68; 95% CI: 0.54 to 0.87; p = 0.002) was observed between primary and secondary PCI patients (HR: 0.81; 95% CI: 0.60 to 1.09 vs. HR: 0.51; 95% CI: 0.34 to 0.76; p interaction = 0.06). When periprocedural MI was excluded, the efficacy of prasugrel remained consistent among primary and secondary PCI patients at 30 days (HR: 0.53; 95% CI: 0.34 to 0.81 vs. HR: 0.44; 95% CI: 0.22 to 0.88; p interaction = 0.68) and 15 months (HR: 0.76; 95% CI: 0.56 to 1.03 vs. HR: 0.75; 95% CI: 0.46 to 1.21; p interaction = 0.96).

CONCLUSIONS

The efficacy of prasugrel versus clopidogrel was consistent irrespective of the timing of PCI, particularly in preventing nonprocedural events. (Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition with Prasugrel-Thrombolysis in Myocardial Infarction 38; NCT00097591).

摘要

目的

本研究旨在通过经皮冠状动脉介入治疗(PCI)的时间来评估普拉格雷与氯吡格雷在 ST 段抬高型心肌梗死(STEMI)患者中的疗效。

背景

与直接 PCI 相比,采用补救性 PCI 治疗 STEMI 患者时,其治疗策略和结局可能存在差异。

方法

TRITON-TIMI 38(普拉格雷与氯吡格雷在急性心肌梗死溶栓治疗 38 试验中评估改善治疗结果的血小板抑制作用)研究中,如果计划行直接 PCI,则在就诊时将 STEMI 患者随机分为普拉格雷或氯吡格雷组,如果行补救性 PCI,则在直接 PCI 后进行。直接 PCI 定义为症状发作后 12 h 内进行。主要终点为心血管死亡、心肌梗死(MI)或卒中等复合终点。由于在 STEMI 患者中难以评估围手术期 MI,因此我们进行了排除这些事件的分析。

结果

在 15 个月时,与氯吡格雷相比,普拉格雷降低主要终点的疗效(风险比 [HR]:0.79;95%置信区间 [CI]:0.65 至 0.97;p=0.022)在直接和补救性 PCI 患者中一致(HR:0.89;95%CI:0.69 至 1.13 与 HR:0.65;95%CI:0.46 至 0.93;p 交互=0.15)。然而,在 30 天时,观察到直接和补救性 PCI 患者之间治疗效果存在差异的趋势(HR:0.68;95%CI:0.54 至 0.87;p=0.002)(HR:0.81;95%CI:0.60 至 1.09 与 HR:0.51;95%CI:0.34 至 0.76;p 交互=0.06)。当排除围手术期 MI 时,普拉格雷在直接和补救性 PCI 患者中的疗效在 30 天时(HR:0.53;95%CI:0.34 至 0.81 与 HR:0.44;95%CI:0.22 至 0.88;p 交互=0.68)和 15 个月时(HR:0.76;95%CI:0.56 至 1.03 与 HR:0.75;95%CI:0.46 至 1.21;p 交互=0.96)仍保持一致。

结论

普拉格雷与氯吡格雷的疗效在直接和补救性 PCI 时一致,尤其是在预防非手术事件方面。(普拉格雷与氯吡格雷在急性心肌梗死溶栓治疗 38 试验中评估改善治疗结果的血小板抑制作用研究;NCT00097591)

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