Long-term results after the glycoprotein IIb/IIIa inhibitor abciximab in unstable angina - One-year survival in the GUSTO IV-ACS (global use of strategies to open occluded coronary arteries IV - Acute coronary syndrome) trial
Long-term results after the glycoprotein IIb/IIIa inhibitor abciximab in unstable angina - One-year survival in the GUSTO IV-ACS (global use of strategies to open occluded coronary arteries IV - Acute coronary syndrome) trial
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DOI：
10.1161/01.cir.0000046487.06811.5e
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发表时间：
2003-01-28
期刊：
影响因子：
37.8
通讯作者：
Simoons, ML
中科院分区：
文献类型：
--
作者：
Ottervanger, JP;Armstrong, P;Simoons, ML
背景-本研究旨在调查糖蛋白IIb/IIIa抑制剂阿昔单抗在急性冠状动脉综合征无ST段抬高的患者中的长期效果，这些患者未接受冠状动脉intervention.Methods和Results-A共7800例急性冠状动脉综合征无ST段抬高的患者，记录为心肌肌钙蛋白升高或一过性或持续性ST段压低。他们被随机分配到阿昔单抗推注和24小时输注，阿昔单抗推注和48小时输注，或匹配安慰剂。总体1年死亡率为8.3%（649例患者）。安慰剂组的一年死亡率为7.8%，阿昔单抗输注24小时组为8.2%，48小时组为9.0%。与安慰剂相比，24小时输注阿昔单抗的风险比为1.1（95% CI 0.86至1.29），48小时输注的风险比为1.2（95% CI 0.95至1.41）。在研究的每个亚组中均观察到阿昔单抗缺乏获益。肌钙蛋白阴性或C反应蛋白升高的患者在接受阿昔单抗治疗48小时后的死亡率高于安慰剂：肌钙蛋白阴性者为8.5% vs 5.8%（P=0.02），16.3%对12.1%的C-反应蛋白升高的患者（P=0.04）。结论：与安慰剂相比，阿昔单抗对急性冠状动脉综合征伴ST段压低和/或ST段抬高的患者1年生存率无任何益处。或肌钙蛋白升高的患者，未计划进行早期冠状动脉血运重建。在亚组患者中，特别是心肌肌钙蛋白低或C反应蛋白升高的患者，阿昔单抗与死亡率增加相关。
Background-This study was designed to investigate long-term effects of the glycoprotein IIb/IIIa inhibitor abciximab in patients with acute coronary syndrome without ST elevation who were not scheduled for coronary intervention.Methods and Results-A total of 7800 patients were included with an acute coronary syndrome without ST elevation, documented by either elevated cardiac troponin or transient or persistent ST-segment depression. They were randomized to abciximab bolus and 24-hour infusion, abciximab bolus and 48-hour infusion, or matching placebo. The overall 1-year mortality rate was 8.3% (649 patients). One-year mortality was 7.8% in the placebo group and 8.2% in the 24-hour and 9.0% in the 48-hour abciximab infusion group. Compared with placebo, the hazard ratio for the 24-hour infusion of abciximab was 1.1 (95% CI 0.86 to 1.29), and for the 48-hour infusion, it was 1.2 (95% CI 0.95 to 1.41). The lack of benefit of abciximab was observed in every subgroup studied. Patients with negative troponin or elevated C-reactive protein had a higher mortality rate after treatment with abciximab for 48 hours than with placebo: 8.5% versus 5.8% in those with negative troponin (P=0.02), 16.3% versus 12.1% in those with elevated C-reactive protein (P=0.04).Conclusions-Compared with placebo, abciximab did not provide any survival benefit at I year in patients admitted with an acute coronary syndrome with ST depression and/or elevated troponin who were not scheduled to undergo early coronary revascularization. In subgroups of patients, in particular those with low cardiac troponin or elevated C-reactive protein, abciximab was associated with excess mortality.