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

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

Research output: Contribution to journalArticle

26 Citations (Scopus)

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).

Original languageEnglish (US)
Pages (from-to)1212-1217
Number of pages6
JournalJournal of Cardiothoracic and Vascular Anesthesia
Volume27
Issue number6
DOIs
StatePublished - Dec 2013

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Pulmonary Hypertension
Thoracic Surgery
Placebos
Cardiopulmonary Bypass
Incidence
Patient Rights
Risk Reduction Behavior
Randomized Controlled Trials
Mortality
tezosentan
Therapeutics

Keywords

  • cardiopulmonary bypass
  • endothelin receptor antagonist
  • left-sided heart disease
  • pulmonary hypertension
  • right ventricular failure
  • tezosentan

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine
  • Anesthesiology and Pain Medicine

Cite this

Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery : The TACTICS trial. / Denault, André Y.; Pearl, Ronald G.; Michler, Robert E.; Rao, Vivek; Tsui, Steven S L; Seitelberger, Rainald; Cromie, Matt; Lindberg, Elisabet; D'Armini, Andrea M.

In: Journal of Cardiothoracic and Vascular Anesthesia, Vol. 27, No. 6, 12.2013, p. 1212-1217.

Research output: Contribution to journalArticle

Denault, André Y. ; Pearl, Ronald G. ; Michler, Robert E. ; Rao, Vivek ; Tsui, Steven S L ; Seitelberger, Rainald ; Cromie, Matt ; Lindberg, Elisabet ; D'Armini, Andrea M. / Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery : The TACTICS trial. In: Journal of Cardiothoracic and Vascular Anesthesia. 2013 ; Vol. 27, No. 6. pp. 1212-1217.
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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).",
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AU - Rao, Vivek

AU - Tsui, Steven S L

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