Tezosentan and Right Ventricular Failure in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: The TACTICS Trial
Tezosentan and Right Ventricular Failure in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: The TACTICS Trial
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DOI：
10.1053/j.jvca.2013.01.023
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发表时间：
2013-12-01
影响因子：
2.8
通讯作者：
D'Armini, Andrea M.
中科院分区：
文献类型：
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作者：
Denault, Andre Y.;Pearl, Ronald G.;D'Armini, Andrea M.
目的：评价替佐生在降低既往肺动脉高压患者右室功能衰竭发生率和相关死亡率方面的作用。研究的主要终点是在体外循环结束后30分钟评估脱机期间右室衰竭患者的比例。设计：多中心、双盲、随机、安慰剂对照试验。设置：14个国家的31个心脏外科中心。参与者：274名年龄为18岁的肺动脉高压患者计划接受心脏手术。干预：术中和术后24小时内静脉注射替佐生(5 mg/h)(1 mg/h)，或匹配的安慰剂。测量和主要结果：133名患者接受替佐生，141名接受安慰剂。发生右室功能衰竭30例(10.9%)，其中37%死亡。两组右室功能衰竭的发生率无差异(相对风险降低：0.07[95%CI-0.83，0.53；P=0.8278]。结论：本研究未观察到替唑生坦能减少右室功能衰竭。(C)2013 Elsevier Inc.保留所有权利。
Objective: To evaluate the efficacy of tezosentan in reducing the incidence of right ventricular (RV) failure and associated mortality in patients with pre-existing pulmonary hypertension. The primary endpoint was the proportion of patients with RV failure during weaning from cardiopulmonary bypass (CPB), assessed 30 minutes after the end of CPB.Design: Multicenter, double-blind, randomized, placebo-controlled trial.Setting: Thirty-one cardiac surgical centers in 14 countries.Participants: Two hundred seventy-four patients with pulmonary hypertension aged >= 18 years scheduled to undergo cardiac surgery.Intervention: Intravenous tezosentan (5 mg/h) during surgery and up to 24 hours afterwards (1 mg/h), or matched placebo.Measurements and Main Results: One-hundred thirty-three patients received tezosentan and 141 placebo. RV failure occurred in 30 patients (10.9%), 37% of whom died. There was no difference in the incidence of RV failure between the two treatment groups (relative risk reduction: 0.07 [95% Cl -0.83, 0.53; P = 0.8278]).Conclusion: A reduction in RV failure with tezosentan was not observed in this study.(Current Controlled Trials, identifier NCT00458276). (C) 2013 Elsevier Inc. All rights reserved.