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撤回:急性心肌梗死的直接血管成形术与静脉溶栓治疗对比

WITHDRAWN: Primary angioplasty versus intravenous thrombolysis for acute myocardial infarction.

作者信息

Cucherat M, Bonnefoy E, Tremeau G

机构信息

Cardiovascular Hospital, Dept of Clinical Pharmacology, 162, Av. Lacassagne, Lyon, France, 69003.

出版信息

Cochrane Database Syst Rev. 2007 Jul 18;2003(3):CD001560. doi: 10.1002/14651858.CD001560.pub2.

Abstract

BACKGROUND

Intravenous thrombolytic therapy is the standard care for patients with acute myocardial infarction, based upon its widespread availability and ability to reduce patient mortality well demonstrated in randomised trials. Despite its proven efficacy, thrombolytic therapy has limitations. Many patients are ineligible for treatment with thrombolytics. Of those given thrombolytic therapy, 10 to 15 percent have persistent occlusion or reocclusion of the infarct-related artery. Consequently, primary angioplasty (primary PTCA) has been advocated as a better treatment of myocardial infarction.

OBJECTIVES

To determine whether primary coronary angioplasty is superior to thrombolytic therapy for the treatment of patients with acute myocardial infarction.

SEARCH STRATEGY

Electronic search of The Cochrane Library (1998; Issue 2). MEDLINE (to January 1998); references from reviews, trials and previously published meta-analyses; and experts. Date of most recent searches January 1998.

SELECTION CRITERIA

All unconfounded, randomised controlled trials comparing primary angioplasty against intravenous thrombolysis in patients with acute myocardial infarction

DATA COLLECTION AND ANALYSIS

At least two independent reviewers abstracted data on morbidity and mortality and trial characteristics. The following outcomes were assessed: total mortality at the end of the study, reinfarction, stroke of any type, composite endpoint of death and reinfarction, recurrent ischemia, severe bleeding and coronary artery bypass grafting.

MAIN RESULTS

Ten trials including 2573 subjects were identified. Compared to thrombolytic therapy, primary angioplasty was associated with a significant reduction in short-term mortality at the end of the studies (relative reduction in risk RRR = 32% 95%CI = 5%;50%). Similar reductions were observed for the rate of reinfarction (RRR = 52%, 95%CI = 30%;67%), recurrent ischemia (RRR = 54%; 95%CI = 39%,66%) and for the combined criteria death or reinfarction (RRR = 46%; 95%CI=30%;58%). The frequency of strokes of any cause was significantly decreased by 66% (95%CI=28%;84%). No significant difference was observed for the incidence of major bleeding (relative risk RR =1.18, 95%CI = 0.73;1.90) but the confidence interval was large. The superiority of the primary angioplasty over thrombolysis in terms of the composite endpoint (mortality and reinfarction) was less with accelerated t-PA (RR=0.70, 95%CI=0.51;0.97) than with streptokinase (RR=0.30, 95%CI=0.17;0.53). The biggest and most recent trial, Gusto 2B (GUSTO-2B 97), which involved general as well as highly specialised centres, obtained less favorable results.

AUTHORS' CONCLUSIONS: This meta-analysis suggests that angioplasty provides a short-term clinical advantage over thrombolysis which may not be sustained. Primary angioplasty when available promptly at experienced centres, may be considered the preferred strategy for myocardial reperfusion. In most situations, however, optimal thrombolytic therapy should still be regarded as an excellent reperfusion strategy.

摘要

背景

静脉溶栓治疗是急性心肌梗死患者的标准治疗方法,这是基于其广泛的可及性以及在随机试验中充分证明的降低患者死亡率的能力。尽管溶栓治疗已被证实有效,但仍存在局限性。许多患者不符合溶栓治疗的条件。在接受溶栓治疗的患者中,10%至15%的患者梗死相关动脉持续闭塞或再闭塞。因此,直接血管成形术(直接经皮冠状动脉腔内血管成形术)已被提倡作为治疗心肌梗死的更好方法。

目的

确定直接冠状动脉血管成形术在治疗急性心肌梗死患者方面是否优于溶栓治疗。

检索策略

对Cochrane图书馆(1998年第2期)进行电子检索。检索MEDLINE(至1998年1月);检索综述、试验及先前发表的荟萃分析中的参考文献;并咨询专家。最近一次检索日期为1998年1月。

选择标准

所有比较直接血管成形术与静脉溶栓治疗急性心肌梗死患者的无混杂因素的随机对照试验。

数据收集与分析

至少两名独立的审阅者提取有关发病率、死亡率及试验特征的数据。评估以下结局:研究结束时的总死亡率、再梗死、任何类型的中风、死亡和再梗死的复合终点、复发性缺血、严重出血及冠状动脉搭桥术。

主要结果

共确定了10项试验,涉及2573名受试者。与溶栓治疗相比,直接血管成形术与研究结束时短期死亡率的显著降低相关(风险相对降低RRR = 32%,95%可信区间CI = 5%;50%)。再梗死率(RRR = 52%,95%CI = 30%;67%)、复发性缺血(RRR = 54%;95%CI = 39%,66%)以及死亡或再梗死的综合标准(RRR = 46%;95%CI = 30%;58%)也有类似程度的降低。任何原因导致的中风发生率显著降低了66%(95%CI = 28%;84%)。大出血发生率未观察到显著差异(相对危险度RR = 1.18,95%CI = 0.73;1.90),但可信区间较宽。与链激酶相比,加速组织型纤溶酶原激活剂(t-PA)在复合终点(死亡率和再梗死)方面,直接血管成形术优于溶栓治疗的优势较小(RR = 0.70,95%CI = 0.51;0.97),而链激酶组为(RR = 0.30,95%CI = 0.17;0.53)。规模最大且最新的试验Gusto 2B(GUSTO - 2B 97),该试验涉及综合及高度专业化中心,结果不太理想。

作者结论

该荟萃分析表明,血管成形术在短期内比溶栓治疗具有临床优势,但这种优势可能无法持续。在有经验的中心能够及时进行直接血管成形术时,可将其视为心肌再灌注的首选策略。然而,在大多数情况下,最佳溶栓治疗仍应被视为一种出色的再灌注策略。

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