title: Tezosentan and right ventricular failure in patients with pulmonary hypertension undergoing cardiac surgery: the TACTICS trial.
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.
  
  
  METHODS
  Multicenter, double-blind, randomized, placebo-controlled trial.
  
  
  METHODS
  Thirty-one cardiac surgical centers in 14 countries.
  
  
  METHODS
  Two hundred seventy-four patients with pulmonary hypertension aged ≥ 18 years scheduled to undergo cardiac surgery.
  
  
  METHODS
  Intravenous tezosentan (5 mg/h) during surgery and up to 24 hours afterwards (1 mg/h), or matched placebo.
  
  
  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]).
  
  
  CONCLUSIONS
  A reduction in RV failure with tezosentan was not observed in this study.(Current Controlled Trials, identifier NCT00458276).
authors.affiliation: Department of Anesthesiology, Montreal Heart Institute and Université de Montréal, Montreal, Canada. Electronic address: andre.denault@umontreal.ca.
authors.forename: André Y
authors.initials: AY
authors.lastname: Denault
authors.forename: Ronald G
authors.initials: RG
authors.lastname: Pearl
authors.forename: Robert E
authors.initials: RE
authors.lastname: Michler
authors.forename: Vivek
authors.initials: V
authors.lastname: Rao
authors.forename: Steven S L
authors.initials: SS
authors.lastname: Tsui
authors.forename: Rainald
authors.initials: R
authors.lastname: Seitelberger
authors.forename: Matt
authors.initials: M
authors.lastname: Cromie
authors.forename: Elisabet
authors.initials: E
authors.lastname: Lindberg
authors.forename: Andrea M
authors.initials: AM
authors.lastname: D'Armini
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006348:Cardiac Surgical Procedures / Q000379:methods* / Q000401:mortality; D002315:Cardiopulmonary Bypass; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D006333:Heart Failure / Q000188:drug therapy / Q000453:epidemiology; D006801:Humans; D006976:Hypertension, Pulmonary / Q000150:complications / Q000188:drug therapy*; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011725:Pyridines / Q000008:administration & dosage / Q000627:therapeutic use*; D013777:Tetrazoles / Q000008:administration & dosage / Q000627:therapeutic use*; D014665:Vasodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018497:Ventricular Dysfunction, Right / Q000150:complications / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D011725:Pyridines; D013777:Tetrazoles; D014665:Vasodilator Agents; C120582:tezosentan
keywords: cardiopulmonary bypass; endothelin receptor antagonist; left-sided heart disease; pulmonary hypertension; right ventricular failure; tezosentan