Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism
Fibrinolysis for Patients with Intermediate-Risk Pulmonary Embolism
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DOI：
10.1056/nejmoa1302097
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发表时间：
2014-04-10
影响因子：
158.5
通讯作者：
Konstantinides, Stavros V.
中科院分区：
文献类型：
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作者：
Meyer, Guy;Vicaut, Eric;Konstantinides, Stavros V.
背景纤溶治疗在中危肺栓塞患者中的作用存在争议。方法在一项随机双盲试验中，我们在血压正常的中危肺栓塞患者中比较了替奈普酶加肝素与安慰剂加肝素。符合条件的患者在超声心动图或计算机断层扫描中患有右心室功能障碍，以及心肌肌钙蛋白 I 或肌钙蛋白 T 检测呈阳性表明存在心肌损伤。主要结局是随机分组后 7 天内死亡或血流动力学失代偿（或虚脱）。主要安全性结局是随机分组后7天内的严重颅外出血和缺血性或出血性卒中。结果在接受随机分组的1006名患者中，1005名纳入意向治疗分析。替奈普酶组 506 例患者中有 13 例（2.6%）发生死亡或血流动力学失代偿，而安慰剂组 499 例患者中有 28 例（5.6%）发生死亡或血流动力学失代偿（比值比，0.44；95% 置信区间，0.23 至 0.87；P=0.02）。从随机分组到第 7 天，替奈普酶组共有 6 名患者（1.2%）死亡，安慰剂组共有 9 名患者（1.8%）死亡（P=0.42）。替奈普酶组有 32 名患者（6.3%）发生颅外出血，安慰剂组有 6 名患者（1.2%）发生颅外出血（P
BackgroundThe role of fibrinolytic therapy in patients with intermediate-risk pulmonary embolism is controversial.MethodsIn a randomized, double-blind trial, we compared tenecteplase plus heparin with placebo plus heparin in normotensive patients with intermediate-risk pulmonary embolism. Eligible patients had right ventricular dysfunction on echocardiography or computed tomography, as well as myocardial injury as indicated by a positive test for cardiac troponin I or troponin T. The primary outcome was death or hemodynamic decompensation (or collapse) within 7 days after randomization. The main safety outcomes were major extracranial bleeding and ischemic or hemorrhagic stroke within 7 days after randomization.ResultsOf 1006 patients who underwent randomization, 1005 were included in the intention-to-treat analysis. Death or hemodynamic decompensation occurred in 13 of 506 patients (2.6%) in the tenecteplase group as compared with 28 of 499 (5.6%) in the placebo group (odds ratio, 0.44; 95% confidence interval, 0.23 to 0.87; P=0.02). Between randomization and day 7, a total of 6 patients (1.2%) in the tenecteplase group and 9 (1.8%) in the placebo group died (P=0.42). Extracranial bleeding occurred in 32 patients (6.3%) in the tenecteplase group and 6 patients (1.2%) in the placebo group (P