在患有外周动脉疾病的患者中使用沃拉帕克萨:TRA2{degrees}P-TIMI 50的结果
Marc P Bonaca1, Benjamin M Scirica, Mark A Creager
1TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis St, Boston, MA 02115, USA. mbonaca@partners.org
Circulation
|March 19, 2013
概括
沃拉帕克萨在外周动脉疾病患者中没有降低主要心血管事件,但降低了下肢缺血和再血管化率. 这种好处伴随着出血风险的增加.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学是指药理学的学科.
背景情况:
- 蛋白酶激活受体-1 (PAR-1) 是血小板和血管系统上的血栓的关键受体.
- 患有外周动脉疾病 (PAD) 的患者面临动脉血事件和四肢缺血的风险.
研究的目的:
- 评估vorapaxar在患有稳定动脉样硬化血管疾病的患者的疗效和安全性,特别是PAD队列中的患者.
- 评估vorapaxar对心血管事件,四肢缺血症和PAD患者的复血管化的影响.
主要方法:
- 评估SCH 530348在预防动脉样硬化患者心脏病发作和中风方面的影响的试验 (TRA2°P-TIMI 50) 是一项随机,双盲,安慰剂控制的试验.
- 包括3787名患有外周动脉疾病的患者,其定义是指 claudication 和 ankle-brachial index <0.85 或之前的再血管化.
- 主要疗效终点:心血管死亡,心肌梗塞或中风. 安全终点:胃出血.
主要成果:
- 在PAD队列中,Vorapaxar没有显著降低主要终点 (心血管死亡,心脏病发作,中风) (11.3%对11.9%,P=0.53).
- 对于急性四肢缺血 (2.3%对3.9%,P=0.006) 和外周动脉复血管化 (18.4%对22.2%,P=0.017) 的住院治疗率显著降低,与vorapaxar.com一起观察到.
- 报告指出,在冠状动脉封闭 (GUSTO) 发生出血时,全球使用链球激酶和t-PA的风险增加 (7.4%对4.5%,P=0.001).
结论:
- 在患有外周动脉疾病的患者中,Vorapaxar没有改善主要心血管结果.
- 沃拉帕沙在减少急性四肢缺血和需要外周再血管化的过程中显示出显著的益处.
- 肢体血管事件中PAR-1抗的治疗优势与出血风险增加有关.
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