title: Effect of aspirin and warfarin therapy in stroke patients with valvular strands.
abstract: BACKGROUND
  Valvular strands are associated with ischemic stroke. The recurrent rate of adverse events in stroke patients with valvular strands has not been defined and, importantly, there are no randomized studies to evaluate efficacy of antithrombotic therapies in these patients.
  
  
  METHODS
  Patent Foramen Ovale in Cryptogenic Stroke Study (PICSS) enrolled 630 stroke patients, of whom 312 (49.5%) were randomized to warfarin and 318 (50.5%) were randomized to aspirin; 265 patients experienced cryptogenic stroke and 365 experienced stroke with known subtypes. Endpoints were recurrent ischemic stroke or death from any cause. All transesophageal echocardiography studies were blindly, centrally analyzed and all endpoints were blindly adjudicated.
  
  
  RESULTS
  Overall, of 619 studies analyzed, valvular strands were present in 39.4% of the patients (244/619), 5.8% (36/619) on the aortic valve and 27.8% (172/619) on the mitral valve, and 5.8% (36/619) on both valves. In an intention-to-treat analysis, there was no significant difference in the time to primary endpoints between patients with and without strands in the overall population (P=0.82; hazard ratio: 1.05; 95% CI: 0.70 to 1.57; 2-year event rates: 16.4% versus 15.5%). Among the patients with strands, there was no significant difference in the time to primary endpoints between those treated with warfarin or aspirin (P=0.21; hazard ratio: 0.67; 95% CI: 0.36 to 1.26; 2-year event rates: 13.5% versus 19.6%).
  
  
  CONCLUSIONS
  While on medical therapy, valvular strands do not significantly increase recurrent adverse event rates in patients with ischemic stroke. Furthermore, the study does not provide evidence to support an advantage of warfarin or aspirin for this purpose.
authors.affiliation: Department of Medicine, Columbia University, College of Physicians and Surgeons, 630 West 168th Street, New York, NY 10032, USA. sh23@columbia.edu
authors.forename: Shunichi
authors.initials: S
authors.lastname: Homma
authors.forename: Marco R
authors.initials: MR
authors.lastname: Di Tullio
authors.forename: Robert R
authors.initials: RR
authors.lastname: Sciacca
authors.forename: Ralph L
authors.initials: RL
authors.lastname: Sacco
authors.forename: J P
authors.initials: JP
authors.lastname: Mohr
mesh_terms: D000328:Adult; D000368:Aged; D001021:Aortic Valve / Q000000981:diagnostic imaging*; D001241:Aspirin / Q000627:therapeutic use*; D017548:Echocardiography, Transesophageal; D023381:Endpoint Determination; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000000981:diagnostic imaging*; D012008:Recurrence; D020521:Stroke / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000453:epidemiology; D014859:Warfarin / Q000627:therapeutic use*
chemical_list: D005343:Fibrinolytic Agents; D014859:Warfarin; D001241:Aspirin