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

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
min 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
and 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).