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)
