TY - JOUR
T1 - Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery
T2 - The TACTICS trial
AU - Denault, André Y.
AU - Pearl, Ronald G.
AU - Michler, Robert E.
AU - Rao, Vivek
AU - Tsui, Steven S.L.
AU - Seitelberger, Rainald
AU - Cromie, Matt
AU - Lindberg, Elisabet
AU - D'Armini, Andrea M.
N1 - Funding Information:
The authors wish to acknowledge all other investigators who took part in this study. Austria: Ralf Geiger, Innsbruck. Canada: Jean S. Bussières, Quebec; John C Mullen, Edmonton; John Murkin, Ontario. Czech Republic: Jan Pirk, Prague. France: Pierre Coriat, Paris. Germany: Roland Hetzer, Berlin; Peter P. Kleine, Frankfurt; Klaus Matschke, Dresden. India: Krishna Lanka, Hyderabad; Ravindra Singh Rathor, Bangalore. Israel: Bitran Dani, Jerusalem. Italy: Mauro Rinaldi, Turin. Poland: Stanislaw Wos, Katowice. Serbia: Sinisa Gradinac, Belgrade. Slovakia: Villiam Fischer, Bratislava. Sweden: Sven-Erik Rickstein, Goteborg. UK: Peter Braidley, Sheffield. USA: Christopher F. Sulzer, Durham, NC; Irving L. Kron, Charlottesville, VA; Michael A. E. Ramsey, Dallas, TX; Ervant Nishanian, New York, NY; Jean-Pierre Yared, Cleveland OH; Alfred C Nicolosi, Milwaukee, WI, and Anna Nozza, Montreal Heart Institute Coordinating Center. The authors also would like to acknowledge the support of Elements Communications Ltd., UK, who provided medical writing assistance, funded by Actelion Pharmaceuticals Ltd.
Funding Information:
This trial was funded by Actelion Pharmaceuticals Ltd., Switzerland.
PY - 2013/12
Y1 - 2013/12
N2 - 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).
AB - 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).
KW - cardiopulmonary bypass
KW - endothelin receptor antagonist
KW - left-sided heart disease
KW - pulmonary hypertension
KW - right ventricular failure
KW - tezosentan
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U2 - 10.1053/j.jvca.2013.01.023
DO - 10.1053/j.jvca.2013.01.023
M3 - Article
C2 - 23523254
AN - SCOPUS:84888289239
SN - 1053-0770
VL - 27
SP - 1212
EP - 1217
JO - Journal of Cardiothoracic and Vascular Anesthesia
JF - Journal of Cardiothoracic and Vascular Anesthesia
IS - 6
ER -