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 language | English (US) |
|---|---|
| Pages (from-to) | 1212-1217 |
| Number of pages | 6 |
| Journal | Journal of Cardiothoracic and Vascular Anesthesia |
| Volume | 27 |
| Issue number | 6 |
| DOIs | |
| State | Published - Dec 2013 |
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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 journal › Article
}
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.
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
UR - http://www.scopus.com/inward/record.url?scp=84888289239&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84888289239&partnerID=8YFLogxK
U2 - 10.1053/j.jvca.2013.01.023
DO - 10.1053/j.jvca.2013.01.023
M3 - Article
C2 - 23523254
AN - SCOPUS:84888289239
VL - 27
SP - 1212
EP - 1217
JO - Journal of Cardiothoracic and Vascular Anesthesia
JF - Journal of Cardiothoracic and Vascular Anesthesia
SN - 1053-0770
IS - 6
ER -