三个月与十二个月的双重抗血小板治疗后,托洛利斯排泄支架:优化随机试验
Fausto Feres1, Ricardo A Costa1, Alexandre Abizaid1
1Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil.
JAMA
|November 2, 2013
概括
对于接受托利斯排泄支架的患者来说,三个月的双重抗血小板治疗与十二个月一样安全和有效. 这种双重抗血小板治疗 (DAPT) 的较短持续时间可以降低风险,而不会增加支架血栓形成.
科学领域:
- 心脏病学 心脏病学
- 干预心脏病学 干预心脏病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 目前的指导方针建议在药物释放支架植入后至少进行12个月的双重抗血小板治疗 (DAPT).
- 最佳的DAPT持续时间因特定的药物释放支架类型而异,需要进一步研究.
研究的目的:
- 为了比较3个月 (短期) 与12个月 (长期) DAPT的临床非劣质性,在接受采用zotarolimus排泄支架的皮肤穿透冠状动脉干预 (PCI) 的患者中.
主要方法:
- 该OPTIMIZE试验是一项1:1随机化,开放标签,主动控制的非劣等性研究,涉及巴西33个地点的319名患者.
- 患者在PCI后3个月或12个月接受阿司匹林和克洛皮多格雷尔,并使用托利斯排泄的支架.
- 主要终点是净不良临床和大脑事件 (NACCE),次要终点包括主要不良心脏事件 (MACE) 和支架血栓形成.
主要成果:
- NACCE发生在短期DAPT组的6.0%和长期DAPT组的5.8%中,表明非劣势性 (P=.002).
- 一年的MACE率为短期的8.3%,长期的DAPT为7.4% (HR,1.12;95% CI,0.87-1.45).
- 从91天到360天的组之间没有观察到NACCE,MACE或支架血栓形成的显著差异.
结论:
- 三个月的DAPT与NACCE的12个月相比,在用托利斯排泄支架治疗的患者中没有劣势.
- 较短的DAPT持续时间并没有显著增加支架血栓形成或其他不良事件的风险.
- 这些发现支持在特定患者群体和特定支架类型中更短的DAPT持续时间.
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