title: Rationale and design of the ATTRACT Study: a multicenter randomized trial to evaluate pharmacomechanical catheter-directed thrombolysis for the prevention of postthrombotic syndrome in patients with proximal deep vein thrombosis.
abstract: BACKGROUND
  Current standard therapy for patients with acute proximal deep vein thrombosis (DVT) consists of anticoagulant therapy and graduated elastic compression stockings. Despite use of this strategy, the postthrombotic syndrome (PTS) develops frequently, causes substantial patient disability, and impairs quality of life. Pharmacomechanical catheter-directed thrombolysis (PCDT), which rapidly removes acute venous thrombus, may reduce the frequency of PTS. However, this hypothesis has not been tested in a large multicenter randomized trial.
  
  
  METHODS
  The ATTRACT Study is an ongoing National Institutes of Health-sponsored, Phase III, multicenter, randomized, open-label, assessor-blinded, parallel two-arm, controlled clinical trial. Approximately 692 patients with acute proximal DVT involving the femoral, common femoral, and/or iliac vein are being randomized to receive PCDT + standard therapy versus standard therapy alone. The primary study hypothesis is that PCDT will reduce the proportion of patients who develop PTS within 2 years by one-third, assessed using the Villalta Scale. Secondary outcomes include safety, general and venous disease-specific quality of life, relief of early pain and swelling, and cost-effectiveness.
  
  
  CONCLUSIONS
  ATTRACT will determine if PCDT should be routinely used to prevent PTS in patients with symptomatic proximal DVT above the popliteal vein.
authors.affiliation: Mallinckrodt Institute of Radiology, Washington University School of Medicine, St Louis, MO, USA. vedanthams@mir.wustl.edu
authors.forename: Suresh
authors.initials: S
authors.lastname: Vedantham
authors.forename: Samuel Z
authors.initials: SZ
authors.lastname: Goldhaber
authors.forename: Susan R
authors.initials: SR
authors.lastname: Kahn
authors.forename: Jim
authors.initials: J
authors.lastname: Julian
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Magnuson
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Murphy
authors.forename: David J
authors.initials: DJ
authors.lastname: Cohen
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Comerota
authors.forename: Heather L
authors.initials: HL
authors.lastname: Gornik
authors.forename: Mahmood K
authors.initials: MK
authors.lastname: Razavi
authors.forename: Lawrence
authors.initials: L
authors.lastname: Lewis
authors.forename: Clive
authors.initials: C
authors.lastname: Kearon
mesh_terms: D000925:Anticoagulants / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003362:Cost-Benefit Analysis; D006493:Heparin / Q000627:therapeutic use; D006801:Humans; D057194:Intention to Treat Analysis; D054070:Postthrombotic Syndrome / Q000517:prevention & control*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D015912:Thrombolytic Therapy / Q000191:economics / Q000379:methods*
chemical_list: D000925:Anticoagulants; D006493:Heparin
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