[TCT2008]ASSIST试验: PCI与依替巴肽联合使用在STEMI中不能改善其成果
发布于:2008-10-17 09:53
要点:
GP IIb/IIIa抑制剂与出血的增加有关
(医心评论:朱婧 译 陆卫 校)
Key Points:
By TCT Daily Staff
STEMI patients receiving heparin plus eptifibatide prior to primary PCI do not have improved outcomes compared with patients who receive heparin alone, according to results of the ASSIST trial. Patients were pretreated with a 600-mg loading dose of clopidogrel before receiving the study treatment.
Michel Le May, MD, director of the coronary care unit research group at the University of Ottawa Heart Institute, reported no difference between patients receiving heparin plus eptifibatide and controls for the 30-day endpoints of death (3.5% vs. 2.0%; P=.54), reinfarction (1.5% vs. 0.5%; P=-.62) or recurrent ischemia (3.0% vs. 3.5%; P=.76).
At six months, there still was no difference between the eptifibatide group and the control group for death (4.5% vs. 2.0%; P=.54), recurrent MI (2.0% vs. 1.0%; P=.62), or recurrent severe ischemia (4.5% vs. 4.6%; P=.97).
Le May also reported an increase in the composite of TIMI major or minor bleeding in the eptifibatide group compared with the control group (see Figure).
Researchers from the University of Ottawa Health Institute enrolled 400 patients into the open-label study and randomized them to either PCI with heparin plus eptifibatide (n=201) or PCI with heparin alone (n=199).
"In patients with acute STEMI pretreated with high-dose clopidogrel, as compared with PCI with heparin alone, PCI with eptifibatide initiated before catheterization does not improve clinical outcomes and is associated with more bleeding," Le May concluded.
In the discussant portion of the presentation, Julinda Mehilli, MD, associate professor of medicine at Technische Universität Munich in Germany, highlighted some strengths of the ASSIST trial, such as the high success rate of primary PCI in restoring TIMI 3 flow and the rapid symptom onset to hospital admission times achieved by the ASSIST researchers.
Weaknesses, however, included the study’s open-label design, small sample size and increased hospital admission to PCI interval.
"In the ASSIST trial, we had 22% major or minor bleeding rates against 14% in the control arm," Mehilli said. "We know that after bleeding, mortality is increased not only in the short-term, but also in the long-term."
Mehilli concluded that the ASSIST results did not support the use of eptifibatide for use in primary PCI.
Disclosure:
(source:www.tctmd.com)
根据ASSIST试验结果得知,在PCI前STEMI病人接受肝磷脂加依替巴肽治疗比单独接受肝磷脂治疗的效果没有改善。在此研究开始之前,我们用600-mg起始剂量的氯吡格雷对患者进行预处理。
Michel Le May说,接受肝磷脂加依替巴肽治疗组和对照组相比,30天的死亡率(3.5% vs. 2.0%; P=0.54)、在感染率(1.5% vs. 0.5%; P=-0.62)或再发生局部缺血率(3.0% vs. 3.5%; P=0.76)没有差异。在6个月时,死亡率(4.5% vs. 2.0%; P=0.54)、再发MI率(2.0% vs. 1.0%; P=0.62)或再发生严重局部缺血率(4.5% vs. 4.6%; P=0.97)两者之间仍无差异。依替巴肽组和对照组相比, TIMI出血事件增加。
研究者们选取400名患者进行标签公开研究,并将他们随机的分在肝磷脂加依替巴肽治疗组(n=201)和单独接受肝磷脂的治疗组(n=199)。
Le May总结道:“高剂量氯吡格雷预处理的急性STEMI病人和单独用肝磷脂处理的相比,临床效果并不显著,而且与更多的出血有关”。
在讨论部分Julinda Mehilli提出了本试验的两大亮点,在TIMI血流达到3级的时候首次PCI的成功率高,并且从病人出现症状到接受入院治疗的时间短。缺点包括开放标签的设计、小的模板量和PCI期间医院住院病人增加。
Mehilli说:“在ASSIST试验中,依替巴肽组和对照组的出血率分别为22%和14%,我们知道发生出血事件后,不仅短期的死亡率会增加,长期的也会增加。ASSIST试验得出的结论是在初期的PCI中不应该使用依替巴肽。”
来源: 医心网



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