title: A randomized study of the safety and efficacy of fondaparinux versus placebo in the prevention of venous thromboembolism after coronary artery bypass graft surgery.
abstract: Venous thromboembolism (VTE) after coronary artery bypass graft (CABG) surgery may increase the postoperative morbidity and mortality. Therefore, we examined the current postoperative need for prophylactic antithrombotic therapy after CABG surgery.
  
  
  METHODS
  This randomized, placebo-controlled, double-blind study was designed to compare the safety and efficacy of fondaparinux versus placebo in the prevention of VTE after CABG surgery. Between March 2010 and January 2013, 78 patients free from preoperative deep vein thrombosis (DVT) were enrolled, of whom 37 were randomly assigned to placebo and 41 to treatment with fondaparinux. The primary study end point was a composite, up to day 11, of (a) cumulative incidence of all VTE events, defined as symptomatic and asymptomatic DVT, and fatal and nonfatal pulmonary embolisms (efficacy end point), and (b) cumulative incidence of major hemorrhages (safety end point).
  
  
  RESULTS
  A single asymptomatic DVT of a lower extremity was detected by duplex ultrasound at the time of discharge from the hospital in the placebo-treated group, and a single major postoperative hemorrhage occurred in the fondaparinux-treated group.
  
  
  CONCLUSIONS
  The incidence of postprocedural asymptomatic DVT in this sample of patients undergoing CABG surgery was low. The overall incidence of DVT in the control and investigational treatment groups was similar. Our results showed no benefit of prophylactic postoperative fondaparinux in this population. These findings are congruent with other published studies and provide additional support for recent recommendations not to routinely use anticoagulant prophylaxis after cardiac surgery.
authors.affiliation: Ohio Health Heart and Vascular Physicians, Columbus, OH. Electronic address: Raghu.Kolluri@ohiohealth.com.
authors.forename: Raghu
authors.initials: R
authors.lastname: Kolluri
authors.affiliation: Prairie Education and Research Cooperative, Springfield, IL.
authors.forename: Anna L
authors.initials: AL
authors.lastname: Plessa
authors.affiliation: Prairie Education and Research Cooperative, Springfield, IL.
authors.forename: Mark C
authors.initials: MC
authors.lastname: Sanders
authors.affiliation: IU Health Arnett Hospital, Lafayette, IN.
authors.forename: Nishith K
authors.initials: NK
authors.lastname: Singh
authors.affiliation: St John's Hospital, Springfield, IL.
authors.forename: Charles
authors.initials: C
authors.lastname: Lucore
mesh_terms: D000925:Anticoagulants / Q000008:administration & dosage; D001026:Coronary Artery Bypass / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D000077425:Fondaparinux; D006801:Humans; D015994:Incidence; D008297:Male; D008875:Middle Aged; D011134:Polysaccharides / Q000008:administration & dosage*; D011183:Postoperative Complications / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*; D012449:Safety; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000209:etiology / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D011134:Polysaccharides; D000077425:Fondaparinux