Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery: the TACTICS trial.

Abstract

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% CI-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).

• Authors: André Y Denault, Ronald G Pearl, Robert E Michler, Vivek Rao, Steven S L Tsui, Rainald Seitelberger, Matt Cromie, Elisabet Lindberg, Andrea M D'Armini
• Journal: Journal of cardiothoracic and vascular anesthesia (J Cardiothorac Vasc Anesth) Vol. 27 Issue 6 Pg. 1212-7 (Dec 2013) ISSN: 1532-8422 [Electronic] United States
• PMID: 23523254 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2013 Elsevier Inc. All rights reserved.

Chemical References

• Pyridines
• Tetrazoles
• Vasodilator Agents
• tezosentan

Topics

• Adult
• Aged
• Aged, 80 and over
• Cardiac Surgical Procedures (methods, mortality)
• Cardiopulmonary Bypass
• Double-Blind Method
• Endpoint Determination
• Female
• Heart Failure (drug therapy, epidemiology)
• Humans
• Hypertension, Pulmonary (complications, drug therapy)
• Infusions, Intravenous
• Male
• Middle Aged
• Pyridines (administration & dosage, therapeutic use)
• Tetrazoles (administration & dosage, therapeutic use)
• Vasodilator Agents (administration & dosage, therapeutic use)
• Ventricular Dysfunction, Right (complications, drug therapy)
• Young Adult