Tezosentan and Right Ventricular Failure in Patients With Pulmonary Hypertension Undergoing Cardiac Surgery: The TACTICS Trial

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• 作者：Andr茅 Y. Denault ; Ronald G. Pearl ; Robert E. Michler ; Vivek Rao ; Steven S.L. Tsui ; Rainald Seitelberger ; Matt Cromie ; Elisabet Lindberg ; Andrea M. D鈥橝rmini
• 关键词：tezosentan ; endothelin receptor antagonist ; pulmonary hypertension ; left-sided heart disease ; cardiopulmonary bypass ; right ventricular failure
• 刊名：Journal of Cardiothoracic and Vascular Anesthesia
• 出版年：December, 2013
• 年：2013
• 卷：27
• 期：6
• 页码：1212-1217
• 全文大小：258 K

文摘

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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鈮?8聽years scheduled to undergo cardiac surgery.

Intervention

Intravenous tezosentan (5聽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% CI鈭?.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).