Abstract：
BACKGROUND: The effects of the glycoprotein IIb/IIIa receptor inhibitor tirofiban in patients with acute ischemic stroke but who have no evidence of complete occlusion of large or medium-sized vessels have not been extensively studied.
METHODS: In a multicenter trial in China, we enrolled patients with ischemic stroke without occlusion of large or medium-sized vessels and with a National Institutes of Health Stroke Scale score of 5 or more and at least one moderately to severely weak limb. Eligible patients had any of four clinical presentations: ineligible for thrombolysis or thrombectomy and within 24 hours after the patient was last known to be well; progression of stroke symptoms 24 to 96 hours after onset; early neurologic deterioration after thrombolysis; or thrombolysis with no improvement at 4 to 24 hours. Patients were assigned to receive intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus intravenous placebo) for 2 days; all patients then received oral aspirin until day 90. The primary efficacy end point was an excellent outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. Secondary end points included functional independence at 90 days and a quality-of-life score. The primary safety end points were death and symptomatic intracranial hemorrhage.
RESULTS: A total of 606 patients were assigned to the tirofiban group and 571 to the aspirin group. Most patients had small infarctions that were presumed to be atherosclerotic. The percentage of patients with a score of 0 or 1 on the modified Rankin scale at 90 days was 29.1% with tirofiban and 22.2% with aspirin (adjusted risk ratio, 1.26; 95% confidence interval, 1.04 to 1.53, P = 0.02). Results for secondary end points were generally not consistent with the results of the primary analysis. Mortality was similar in the two groups. The incidence of symptomatic intracranial hemorrhage was 1.0% in the tirofiban group and 0% in the aspirin group.
CONCLUSIONS: In this trial involving heterogeneous groups of patients with stroke of recent onset or progression of stroke symptoms and nonoccluded large and medium-sized cerebral vessels, intravenous tirofiban was associated with a greater likelihood of an excellent outcome than low-dose aspirin. Incidences of intracranial hemorrhages were low but slightly higher with tirofiban. (Funded by the National Natural Science Foundation of China; RESCUE BT2 Chinese Clinical Trial Registry number, ChiCTR2000029502.).
METHODS: In a multicenter trial in China, we enrolled patients with ischemic stroke without occlusion of large or medium-sized vessels and with a National Institutes of Health Stroke Scale score of 5 or more and at least one moderately to severely weak limb. Eligible patients had any of four clinical presentations: ineligible for thrombolysis or thrombectomy and within 24 hours after the patient was last known to be well; progression of stroke symptoms 24 to 96 hours after onset; early neurologic deterioration after thrombolysis; or thrombolysis with no improvement at 4 to 24 hours. Patients were assigned to receive intravenous tirofiban (plus oral placebo) or oral aspirin (100 mg per day, plus intravenous placebo) for 2 days; all patients then received oral aspirin until day 90. The primary efficacy end point was an excellent outcome, defined as a score of 0 or 1 on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. Secondary end points included functional independence at 90 days and a quality-of-life score. The primary safety end points were death and symptomatic intracranial hemorrhage.
RESULTS: A total of 606 patients were assigned to the tirofiban group and 571 to the aspirin group. Most patients had small infarctions that were presumed to be atherosclerotic. The percentage of patients with a score of 0 or 1 on the modified Rankin scale at 90 days was 29.1% with tirofiban and 22.2% with aspirin (adjusted risk ratio, 1.26; 95% confidence interval, 1.04 to 1.53, P = 0.02). Results for secondary end points were generally not consistent with the results of the primary analysis. Mortality was similar in the two groups. The incidence of symptomatic intracranial hemorrhage was 1.0% in the tirofiban group and 0% in the aspirin group.
CONCLUSIONS: In this trial involving heterogeneous groups of patients with stroke of recent onset or progression of stroke symptoms and nonoccluded large and medium-sized cerebral vessels, intravenous tirofiban was associated with a greater likelihood of an excellent outcome than low-dose aspirin. Incidences of intracranial hemorrhages were low but slightly higher with tirofiban. (Funded by the National Natural Science Foundation of China; RESCUE BT2 Chinese Clinical Trial Registry number, ChiCTR2000029502.).
摘要：
背景：糖蛋白IIb/IIIa受体抑制剂替罗非班对急性缺血性卒中但没有大血管或中等血管完全闭塞证据的患者的作用尚未得到广泛研究。
方法：在中国的一项多中心试验中，我们纳入了无大型或中型血管闭塞且美国国立卫生研究院卒中量表评分≥5分的缺血性卒中患者和至少1例中度至重度弱肢.符合条件的患者有以下四种临床表现中的任何一种：不符合溶栓或血栓切除术的条件，并且在患者最后一次已知病情良好后24小时内；发作后24至96小时中风症状进展；溶栓后早期神经系统恶化；或溶栓在4至24小时无改善。患者被分配接受静脉注射替罗非班（加口服安慰剂）或口服阿司匹林（每天100毫克，加静脉注射安慰剂）2天；然后所有患者都接受口服阿司匹林，直到第90天。主要疗效终点是极好的结局，定义为修改后的Rankin量表上的0或1分(范围，0[无症状]至6[死亡])在90天。次要终点包括90天的功能独立性和生活质量评分。主要安全终点为死亡和症状性颅内出血。
结果：共有606例患者被分配到替罗非班组，571例患者被分配到阿司匹林组。大多数患者有小梗塞，推测为动脉粥样硬化。90天时在改良的Rankin量表上评分为0或1分的患者百分比为29.1％使用替罗非班和22.2％使用阿司匹林（调整后的风险比，1.26；95%置信区间，1.04至1.53，P=0.02）。次要终点的结果通常与主要分析的结果不一致。两组的死亡率相似。替罗非班组症状性颅内出血发生率为1.0%,阿司匹林组为0%。
结论：在这项试验中，研究对象包括近期发作或进展的卒中症状和未阻塞的大、中型脑血管的异质性卒中患者组，与小剂量阿司匹林相比,静脉注射替罗非班具有更高的良好结局可能性.替罗非班的颅内出血发生率低，但略高。（由国家自然科学基金资助；RESCUEBT2中国临床试验登记号，ChiCTR2000029502。).
方法：在中国的一项多中心试验中，我们纳入了无大型或中型血管闭塞且美国国立卫生研究院卒中量表评分≥5分的缺血性卒中患者和至少1例中度至重度弱肢.符合条件的患者有以下四种临床表现中的任何一种：不符合溶栓或血栓切除术的条件，并且在患者最后一次已知病情良好后24小时内；发作后24至96小时中风症状进展；溶栓后早期神经系统恶化；或溶栓在4至24小时无改善。患者被分配接受静脉注射替罗非班（加口服安慰剂）或口服阿司匹林（每天100毫克，加静脉注射安慰剂）2天；然后所有患者都接受口服阿司匹林，直到第90天。主要疗效终点是极好的结局，定义为修改后的Rankin量表上的0或1分(范围，0[无症状]至6[死亡])在90天。次要终点包括90天的功能独立性和生活质量评分。主要安全终点为死亡和症状性颅内出血。
结果：共有606例患者被分配到替罗非班组，571例患者被分配到阿司匹林组。大多数患者有小梗塞，推测为动脉粥样硬化。90天时在改良的Rankin量表上评分为0或1分的患者百分比为29.1％使用替罗非班和22.2％使用阿司匹林（调整后的风险比，1.26；95%置信区间，1.04至1.53，P=0.02）。次要终点的结果通常与主要分析的结果不一致。两组的死亡率相似。替罗非班组症状性颅内出血发生率为1.0%,阿司匹林组为0%。
结论：在这项试验中，研究对象包括近期发作或进展的卒中症状和未阻塞的大、中型脑血管的异质性卒中患者组，与小剂量阿司匹林相比,静脉注射替罗非班具有更高的良好结局可能性.替罗非班的颅内出血发生率低，但略高。（由国家自然科学基金资助；RESCUEBT2中国临床试验登记号，ChiCTR2000029502。).
