Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction
Fibrinolysis or Primary PCI in ST-Segment Elevation Myocardial Infarction
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DOI：
10.1056/nejmoa1301092
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发表时间：
2013-04-11
影响因子：
158.5
通讯作者：
Van de Werf, Frans
中科院分区：
文献类型：
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作者：
Armstrong, Paul W.;Gershlick, Anthony H.;Van de Werf, Frans
背景目前尚不清楚是否院前纤溶，加上及时的冠状动脉造影，提供了一个类似的临床结果与直接经皮冠状动脉介入治疗（PCI）后早期急性ST段抬高心肌梗死（STEMI）。患者被随机分配接受直接PCI或纤溶治疗，在运送到PCI医院之前，使用推注替奈普酶（年龄≥ 75岁的患者修改为一半剂量）、氯吡格雷和依诺肝素。如果纤溶失败，则进行紧急冠状动脉造影;否则，在随机化后6 - 24小时进行血管造影。主要终点是死亡、休克、充血性心力衰竭或再梗死的复合终点，持续30天。纤溶组为12.4%，943例患者中有135例（14.3%）（纤溶组的相对危险度为0.86; 95%可信区间为0.68 - 1.09; P = 0.21）。纤溶组中36.3%的患者需要紧急血管造影，而其余患者在随机化后中位数17小时接受血管造影。纤溶组的颅内出血发生率高于直接PCI组（1.0% vs. 0.2%，P = 0.04;方案修订后，0.5% vs. 0.3%，P = 0.45）。非颅内出血的发生率在两个groups. CONCLUSIONSSPrehospital纤溶及时冠状动脉造影导致有效的再灌注早期STEMI患者不能接受直接PCI后1小时内首次医疗接触。然而，纤维蛋白溶解与颅内出血的风险略有增加有关。（由Boehringer Ingelheim资助; ClinicalTrials.gov编号，NCT 00623623。）
BACKGROUNDIt is not known whether prehospital fibrinolysis, coupled with timely coronary angiography, provides a clinical outcome similar to that with primary percutaneous coronary intervention (PCI) early after acute ST-segment elevation myocardial infarction (STEMI).METHODSAmong 1892 patients with STEMI who presented within 3 hours after symptom onset and who were unable to undergo primary PCI within 1 hour, patients were randomly assigned to undergo either primary PCI or fibrinolytic therapy with bolus tenecteplase (amended to half dose in patients >= 75 years of age), clopidogrel, and enoxaparin before transport to a PCI-capable hospital. Emergency coronary angiography was performed if fibrinolysis failed; otherwise, angiography was performed 6 to 24 hours after randomization. The primary end point was a composite of death, shock, congestive heart failure, or reinfarction up to 30 days.RESULTSThe primary end point occurred in 116 of 939 patients (12.4%) in the fibrinolysis group and in 135 of 943 patients (14.3%) in the primary PCI group (relative risk in the fibrinolysis group, 0.86; 95% confidence interval, 0.68 to 1.09; P = 0.21). Emergency angiography was required in 36.3% of patients in the fibrinolysis group, whereas the remainder of patients underwent angiography at a median of 17 hours after randomization. More intracranial hemorrhages occurred in the fibrinolysis group than in the primary PCI group (1.0% vs. 0.2%, P = 0.04; after protocol amendment, 0.5% vs. 0.3%, P = 0.45). The rates of nonintracranial bleeding were similar in the two groups.CONCLUSIONSPrehospital fibrinolysis with timely coronary angiography resulted in effective reperfusion in patients with early STEMI who could not undergo primary PCI within 1 hour after the first medical contact. However, fibrinolysis was associated with a slightly increased risk of intracranial bleeding. (Funded by Boehringer Ingelheim; ClinicalTrials.gov number, NCT00623623.)