Safety of Tirofiban in Acute Ischemic Stroke The SaTIS Trial
Safety of Tirofiban in Acute Ischemic Stroke The SaTIS Trial
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DOI：
10.1161/strokeaha.110.599662
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发表时间：
2011-09-01
期刊：
影响因子：
8.3
通讯作者：
Fiebach, Jochen B.
中科院分区：
文献类型：
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作者：
Siebler, Mario;Hennerici, Michael G.;Fiebach, Jochen B.
背景和目的替罗非班是一种高选择性、快速起效的非肽类血小板受体糖蛋白IIb/IIIa拮抗剂，半衰期短。糖蛋白IIb/IIIa拮抗剂在大型临床试验中被证明可有效治疗急性冠状动脉综合征。在缺血性卒中患者中的安全性和有效性尚不确定。这是解决在安全性替罗非班在急性缺血性中风（萨蒂斯）trial. Methods二百六十例急性缺血性中风患者随机安慰剂对照，前瞻性，开放标签治疗，盲法结果阅读多中心试验。国立卫生研究院卒中量表评分在4 - 18之间的受试者在症状发作后3 - 22小时内静脉注射替罗非班或安慰剂，持续48小时。主要终点是入选后2 - 7天随访CT扫描测量的脑出血率。次要终点为1周内的临床疗效（国立卫生研究院卒中量表，改良兰金量表）和5个月后结果：两组间脑出血性转化（I/II）和脑实质出血（I/II）的发生率无差异（替罗非班36/120;安慰剂33/124：OR，1.18; 95%CI，0.66 - 2.06）。接受替罗非班治疗的患者5个月后的死亡率显著降低（3/130 [2.3%] vs 11/126 [8.7%]; OR，4.05; 95%CI，1.1 - 14.9）。1周后和5 months. Conclusions，我们的结论是，替罗非班可能是安全的急性中度缺血性中风，即使在一个大的时间窗口内症状发作后，管理，并可能挽救生命的后期结果后，神经/功能的结果没有差异。
Background and Purpose-Tirofiban is a highly selective, fast-acting nonpeptide glycoprotein IIb/IIIa platelet receptor antagonist with a short half-life time. Glycoprotein IIb/IIIa antagonists are effective for the treatment of acute coronary syndromes proven in large clinical trials. Safety and efficacy in patients with ischemic stroke are uncertain. This was addressed in the Safety of Tirofiban in acute Ischemic Stroke (SaTIS) trial.Methods-Two hundred sixty patients with acute ischemic stroke were randomized in a placebo-controlled, prospective, open-label treatment, blinded outcome reading multicenter trial. Subjects with a National Institutes of Health Stroke Scale between 4 and 18 received intravenously either tirofiban or placebo within 3 to 22 hours after symptom onset for 48 hours. The primary end point was the rate of cerebral bleeding as measured in follow-up CT scans 2 to 7 days after inclusion. The secondary end point was clinical efficacy within 1 week (National Institutes of Health Stroke Scale, modified Rankin Scale) and after 5 months (Barthel Index, modified Rankin Scale).Results-The rate of cerebral hemorrhagic transformation (I/II) and parenchymal hemorrhage (I/II) did not differ between both groups (tirofiban 36 of 120; placebo 33 of 124: OR, 1.18; 95% CI, 0.66 to 2.06). Mortality after 5 months was significantly lower in patients treated with tirofiban (3 of 130 [2.3%] versus 11 of 126 [8.7%]; OR, 4.05; 95% CI, 1.1 to 14.9). No difference in neurological/functional outcome was found after 1 week and after 5 months.Conclusions-We conclude that tirofiban might be safe in acute moderate ischemic stroke even when administered within a large time window after symptom onset and might save lives in the late outcome.