title: Venous thromboembolism risk in ischemic stroke patients receiving extended-duration enoxaparin prophylaxis: results from the EXCLAIM study.
abstract: OBJECTIVE
  The optimal duration of venous thromboembolism prophylaxis in acute stroke patients is unknown. This subanalysis of the Extended Prophylaxis for Venous ThromboEmbolism in Acutely Ill Medical Patients With Prolonged Immobilization (EXCLAIM) study investigated extended-duration thromboprophylaxis with enoxaparin, compared with placebo following standard-duration enoxaparin, in ischemic stroke patients.
  
  
  METHODS
  Acutely ill medical patients with recently reduced mobility received open-label enoxaparin 40 mg for 10±4 days, and they were then randomized to double-blind enoxaparin 40 mg daily or placebo for further 28±4 days. Venous thromboembolism incidence (symptomatic/asymptomatic deep-vein thrombosis, symptomatic/fatal pulmonary embolism) up to day 28 after randomization and major bleeding rates up to 48 h after the last dose of study treatment were reported.
  
  
  RESULTS
  In total, 389 of 5963 (6.5%) randomized patients had ischemic stroke: 198 received extended-duration prophylaxis and 191 placebo. Extended-duration prophylaxis reduced venous thromboembolism incidence versus placebo (2.4% versus 8.0%; absolute risk difference, -5.6%; 95% CI, -10.5% to -0.7%), but it was associated with an increase in major bleeding (1.5% versus 0% in enoxaparin and placebo groups; absolute risk difference, +1.5%; 95% CI, -0.2% to 3.2%).
  
  
  CONCLUSIONS
  Extended-duration thromboprophylaxis with enoxaparin was associated with reduced venous thromboembolism risk and increased major bleeding in the subgroup of patients with ischemic stroke in the EXCLAIM study.
authors.affiliation: Department of Medicine, McMaster University, Hamilton Health Sciences-General Hospital, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada. turpiea@mcmaster.ca
authors.forename: Alexander G G
authors.initials: AG
authors.lastname: Turpie
authors.forename: Russell D
authors.initials: RD
authors.lastname: Hull
authors.forename: Sebastian M
authors.initials: SM
authors.lastname: Schellong
authors.forename: Victor F
authors.initials: VF
authors.lastname: Tapson
authors.forename: Manuel
authors.initials: M
authors.lastname: Monreal
authors.forename: Meyer-Michel
authors.initials: MM
authors.lastname: Samama
authors.forename: Min
authors.initials: M
authors.lastname: Chen
authors.forename: Roger D
authors.initials: RD
authors.lastname: Yusen
mesh_terms: D000368:Aged; D002545:Brain Ischemia / Q000188:drug therapy* / Q000453:epidemiology; D003692:Delayed-Action Preparations / Q000008:administration & dosage; D004311:Double-Blind Method; D017984:Enoxaparin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012307:Risk Factors; D020521:Stroke / Q000188:drug therapy* / Q000453:epidemiology; D054556:Venous Thromboembolism / Q000453:epidemiology / Q000517:prevention & control*
chemical_list: D003692:Delayed-Action Preparations; D017984:Enoxaparin