title: One versus two years of elastic compression stockings for prevention of post-thrombotic syndrome (OCTAVIA study): randomised controlled trial.
abstract: OBJECTIVE
  To study whether stopping elastic compression stockings (ECS) after 12 months is non-inferior to continuing them for 24 months after proximal deep venous thrombosis.
  
  
  METHODS
  Multicentre single blind non-inferiority randomised controlled trial.
  
  
  METHODS
  Outpatient clinics in eight teaching hospitals in the Netherlands, including one university medical centre.
  
  
  METHODS
  Patients compliant with compression therapy for 12 months after symptomatic, ultrasound proven proximal deep venous thrombosis of the leg.
  
  
  METHODS
  Continuation or cessation of ECS 12 months after deep venous thrombosis.
  
  
  METHODS
  The primary outcome was the incidence of post-thrombotic syndrome 24 months after diagnosis of deep venous thrombosis, as assessed by the standardised Villalta scale in an intention to treat analysis. The predefined non-inferiority margin was 10%. The main secondary outcome was quality of life (VEINES-QOL/Sym).
  
  
  RESULTS
  518 patients compliant with ECS and free of post-thrombotic syndrome were randomised one year after diagnosis of deep venous thrombosis to stop or continue ECS therapy for another year. In the stop-ECS group, 51 of 256 patients developed post-thrombotic syndrome, with an incidence of 19.9% (95% confidence interval 16% to 24%). In the continue-ECS group, 34 of 262 patients developed post-thrombotic syndrome (incidence 13.0%, 9.9% to 17%), of whom 85% used ECS six or seven days a week during the study period, for an absolute difference of 6.9% (95% confidence interval upper limit 12.3%). Because the upper limit of the 95% confidence interval exceeds the predefined margin of 10%, non-inferiority was not reached. The number needed to treat to prevent one case of post-thrombotic syndrome by continuing ECS was 14 (95% confidence interval lower limit 8). Quality of life did not differ between the two groups.
  
  
  CONCLUSIONS
  Stopping ECS after one year in compliant patients with proximal deep venous thrombosis seemed not to be non-inferior to continuing ECS therapy for two years in this non-inferiority trial.
  
  
  BACKGROUND
  Netherlands Trial Register NTR1442.
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Hospital, Utrecht, Netherlands Department of Internal Medicine, University Medical Center, Utrecht, Netherlands Department of Vascular Medicine, University Medical Center, 3508 GA Utrecht, Netherlands.
authors.forename: G C
authors.initials: GC
authors.lastname: Mol
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Hospital, Utrecht, Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: van de Ree
authors.affiliation: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands.
authors.forename: F A
authors.initials: FA
authors.lastname: Klok
authors.affiliation: Department of Dermatology, Diakonessenhuis Hospital, Utrecht, Netherlands.
authors.forename: M J A M
authors.initials: MJ
authors.lastname: Tegelberg
authors.affiliation: Department of Radiology, Diakonessenhuis Hospital, Utrecht, Netherlands.
authors.forename: F B M
authors.initials: FB
authors.lastname: Sanders
authors.affiliation: Department of Dermatology, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Koppen
authors.affiliation: Department of Hematology, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: O
authors.initials: O
authors.lastname: de Weerdt
authors.affiliation: Department of Internal Medicine, Groene Hart Hospital, Gouda, Netherlands.
authors.forename: T
authors.initials: T
authors.lastname: Koster
authors.affiliation: Department of Internal Medicine, Rijnstate Hospital, Arnhem, Netherlands.
authors.forename: M M C
authors.initials: MM
authors.lastname: Hovens
authors.affiliation: Department of Internal Medicine, University Medical Center, Utrecht, Netherlands.
authors.forename: H A H
authors.initials: HA
authors.lastname: Kaasjager
authors.affiliation: Department of Hematology, Reinier de Graaf Group, Delft, Netherlands.
authors.forename: R E
authors.initials: RE
authors.lastname: Brouwer
authors.affiliation: Department of Hematology, Reinier de Graaf Group, Delft, Netherlands.
authors.forename: E
authors.initials: E
authors.lastname: Kragten
authors.affiliation: Department of Internal Medicine, Gelre Hospitals, Apeldoorn, Netherlands.
authors.forename: C G
authors.initials: CG
authors.lastname: Schaar
authors.affiliation: Department of Vascular Medicine, University Medical Center, 3508 GA Utrecht, Netherlands.
authors.forename: W
authors.initials: W
authors.lastname: Spiering
authors.affiliation: Department of Dermatology, Gelderse Vallei Hospital, Ede, Netherlands.
authors.forename: W P
authors.initials: WP
authors.lastname: Arnold
authors.affiliation: Department of Hematology, St Antonius Hospital, Nieuwegein, Netherlands.
authors.forename: D H
authors.initials: DH
authors.lastname: Biesma
authors.affiliation: Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands m.v.huisman@lumc.nl.
authors.forename: M V
authors.initials: MV
authors.lastname: Huisman
mesh_terms: D000328:Adult; D000368:Aged; D000072700:Conservative Treatment / Q000295:instrumentation / Q000379:methods; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D054070:Postthrombotic Syndrome / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D053828:Stockings, Compression; D055512:Tertiary Prevention / Q000295:instrumentation / Q000379:methods; D013997:Time Factors; D014463:Ultrasonography / Q000379:methods; D014680:Veins / Q000000981:diagnostic imaging / Q000503:physiopathology; D020246:Venous Thrombosis / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy