急性心肌梗死患者采用血小板糖蛋白IIb/IIIa抑制剂联合小剂量溶栓治疗与传统溶栓治疗的1年死亡率比较：GUSTO V随机试验

Mortality at 1 year with combination platelet glycoprotein IIb/IIIa inhibition and reduced-dose fibrinolytic therapy vs conventional fibrinolytic therapy for acute myocardial infarction: GUSTO V randomized trial.

作者信息

Lincoff A Michael, Califf Robert M, Van de Werf Frans, Willerson James T, White Harvey D, Armstrong Paul W, Guetta Victor, Gibler W Brian, Hochman Judith S, Bode Christoph, Vahanian Alec, Steg P Gabriel, Ardissino Diego, Savonitto Stefano, Bar Frits, Sadowski Zygmunt, Betriu Amadeo, Booth Joan E, Wolski Kathy, Waller Michael, Topol Eric J

机构信息

Department of Cardiovascular Medicine, Cleveland Clinic Foundation, 9500 Euclid Ave, Cleveland, OH 44195, USA.

出版信息

JAMA. 2002 Nov 6;288(17):2130-5. doi: 10.1001/jama.288.17.2130.

DOI:10.1001/jama.288.17.2130

PMID:12413372

Abstract

CONTEXT

Among patients with acute myocardial infarction, combination reperfusion therapy with a platelet glycoprotein IIb/IIIa receptor inhibitor (abciximab) and a half dose of a plasminogen activator (reteplase) did not significantly reduce mortality at 30 days compared with a full dose of reteplase. Rates of nonfatal ischemic complications were significantly diminished.

OBJECTIVE

To determine if the beneficial effects of abciximab and reteplase (combination therapy) on early nonfatal complications would translate into a reduction in the risk of death by 1 year.

DESIGN, SETTING, AND PATIENTS: One-year follow-up of a randomized controlled trial (Global Use of Strategies To Open Coronary Arteries [GUSTO] V). Of 16 588 patients who had been treated in 820 community and referral hospitals in 20 countries between July 1999 and February 2001, mortality data were available for 16 453 (99.2%).

INTERVENTION

Patients were randomly assigned to receive (intravenously) a standard dose of reteplase (two 10-U boluses, 30 minutes apart) or the combination of a standard dose of abciximab (0.25 mg/kg bolus, 0.125 microg/kg per minute infusion [maximum 10 micro g/min for 12 hours]) and a half dose of reteplase (two 5-U boluses, 30 minutes apart).

MAIN OUTCOME MEASURE

One-year all-cause mortality rates.

RESULTS

All-cause mortality at 1 year occurred in 692 (8.38%) of 8260 patients in the reteplase group and 698 (8.38%) of the 8328 patients in the combination therapy group (hazard ratio [HR], 1.00; 95% confidence interval [CI], 0.90-1.11; P>.99). Reinfarction within the first 7 days occurred in 3.5% of patients in the reteplase group and 2.3% of patients in the combination therapy group, and was significantly associated with 1-year mortality (22.6% in patients with reinfarction vs 8.0% in patients without reinfarction; HR, 3.08; 95% CI, 2.53-3.75; P<.001). However, treatment assignment did not significantly influence time of mortality regardless of reinfarction status.

CONCLUSION

Combination therapy (abciximab and reteplase) did not reduce mortality over 1 year compared with fibrinolytic therapy with reteplase alone.

摘要

背景

在急性心肌梗死患者中，与全剂量的瑞替普酶相比，血小板糖蛋白IIb/IIIa受体抑制剂（阿昔单抗）与半剂量的纤溶酶原激活剂（瑞替普酶）联合再灌注治疗在30天时并未显著降低死亡率。非致命性缺血并发症的发生率显著降低。

目的

确定阿昔单抗和瑞替普酶（联合治疗）对早期非致命性并发症的有益作用是否会转化为1年内死亡风险的降低。

设计、地点和患者：一项随机对照试验（全球应用冠状动脉开通策略[GUSTO]V）的1年随访。1999年7月至2001年2月期间，在20个国家的820家社区医院和转诊医院接受治疗的16588例患者中，有16453例（99.2%）可获得死亡率数据。

干预措施

患者被随机分配接受（静脉注射）标准剂量的瑞替普酶（两次10单位推注，间隔30分钟）或标准剂量的阿昔单抗（0.25mg/kg推注，0.125μg/kg每分钟输注[最大10μg/min，持续12小时]）与半剂量瑞替普酶（两次5单位推注，间隔30分钟）的联合治疗。

主要观察指标

1年全因死亡率。

结果

瑞替普酶组8260例患者中有692例（8.38%）在1年时发生全因死亡，联合治疗组8328例患者中有698例（8.38%）发生全因死亡（风险比[HR]，1.00；95%置信区间[CI]，0.90 - 1.11；P>.99）。瑞替普酶组3.5%的患者在最初7天内发生再梗死，联合治疗组2.3%的患者发生再梗死，且再梗死与1年死亡率显著相关（再梗死患者中为22.6%，无再梗死患者中为8.0%；HR，3.08；95%CI，2.53 - 3.75；P<.001）。然而，无论再梗死状态如何，治疗分配对死亡时间均无显著影响。