title: The effect of graduated compression stockings on long-term outcomes after stroke: the CLOTS trials 1 and 2.
abstract: OBJECTIVE
  Most randomized controlled trials of venous thromboembolism prophylaxis have focused on reduction of deep vein thrombosis, predominantly asymptomatic deep vein thrombosis, detected on imaging. We aimed to estimate the effects of graduated compression stockings on venous thromboembolism events, survival, and functional status at 6 months after stroke.
  
  
  METHODS
  The CLOTS Trials adopted an international multicentre, parallel group design, with central randomization and a 1:1 treatment allocation. In CLOTS Trial 1, 2518 immobile stroke patients were allocated thigh-length graduated compression stockings or not, and in CLOTS trial 2, 3014 to thigh-length or below-knee graduated compression stockings. We measured vital status, Oxford Handicap Scale, and quality of life (EQ5D-3 L) at 6 months.
  
  
  RESULTS
  We compared survival in patients enrolled in Trials 1 and 2 with a Cox proportional hazards model, including variables included in our minimization algorithm. In both trials, allocation to thigh-length graduated compression stockings was associated with a very slight, but nonsignificant, increased hazard of death in the first 6 months (Trial 1: hazard ratio, 1.087; 95% confidence interval, 0.913-1.295; and Trial 2: hazard ratio, 1.037; 95% confidence interval, 0.892-1.205). There were no statistically significant differences in venous thromboembolism events, Oxford Handicap Scale, or EQ5D-3 L between the treatment groups in CLOTS Trials 1 or 2.
  
  
  CONCLUSIONS
  Although underpowered to detect clinically important effects on long-term outcomes, our results effectively exclude a >10% relative reduction in the hazard of death within 6 months associated with the use of thigh-length stockings. No other long-term benefits were apparent.
authors.affiliation: Division of Clinical Neurosciences, University of Edinburgh, Western General Hospital, Crewe Rd, Edinburgh EH4 2XU, UK. martin.dennis@ed.ac.uk
authors.forename: Martin
authors.initials: M
authors.lastname: Dennis
authors.forename: Peter
authors.initials: P
authors.lastname: Sandercock
authors.forename: John
authors.initials: J
authors.lastname: Reid
authors.forename: Catriona
authors.initials: C
authors.lastname: Graham
authors.forename: Gordon
authors.initials: G
authors.lastname: Murray
authors.forename: Graham
authors.initials: G
authors.lastname: Venables
authors.forename: Anthony
authors.initials: A
authors.lastname: Rudd
authors.forename: Gill
authors.initials: G
authors.lastname: Bowler
mesh_terms: D000368:Aged; D000465:Algorithms; D005260:Female; D006801:Humans; D008297:Male; D016016:Proportional Hazards Models; D011788:Quality of Life; D053828:Stockings, Compression; D020521:Stroke / Q000401:mortality; D000071939:Stroke Rehabilitation; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000150:complications; D020246:Venous Thrombosis / Q000150:complications