Deep vein thrombosis: no clear difference between anticoagulation started at home or in hospital

Clinical bottom line (level 1b-)

  1. Patients with proximal DVT who were anticoagulated at home compared with hospital were not clearly less more likely to have a recurrent DVT or a major bleed.
Boccalon et al: Archives of Internal Medicine 2000; 160 : 1769-1773
Expires November 2003

The study

Unblinded ?concealed randomised trial with intention-to-treat
Setting: 17 acute hospitals and local community, France

201 patients (aged mean 64, 56% male) with a proximal deep vein thrombosis within previous 30 days (confirmed by ultrasound or venogram)

Excluded if
  • thrombus in inferior vena cava or floating thrombus
  • DVT within previous 6 months
  • DVT with objectively documented symptomatic pulmonary embolism
  • contraindication to anticoagulation
  • requiring hospital admission; or home treatment impossible; or lived too far away
  • risk factors for pulmonary embolism or haemorrhagic complications
  • treated with heparin within previous 48 hours
  • aged < 18, > 85

    Control Group: (n = 102, 102 analysed): hospital care for 10 +/- 2 days for initiation of oral anticoagulation followed by home treatment
    Experimental Group: (n = 99, 99 analysed): immediate home treatment under the care of primary care physician and nurse
    All patients received LMWH (nadoparin, enoxaparin, dalteparin), followed by oral anticoagulation for 6 months. Patients wore compression stockings for 6 months.
    81% followed for 6 months
    Outcome notes:
    • recurrent DVT : confirmed by ultrasound or venogram
    • major bleeding : fall in haemoglobin by at least 2 g/dl, or haemorrhage requiring transfusion of 2 units of blood, or putting a major organ or tissue at risk

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    recurrent DVT 6 months 2
    (1.96%)    		 1
    (1.01%)    		 48%
    (-460% to 95%)    		 0.95%
    (-2.38% to 4.29%)    		 110
    (NNT = 23 to infinity;
    NNH = 42 to infinity)
    major bleeding 6 months 2
    (1.96%)    		 2
    (2.02%)    		 -3%
    (-620% to 85%)    		 -0.06%
    (-3.92% to 3.80%)    		 -1700
    (NNT = 26 to infinity;
    NNH = 25 to infinity)

    Comments

    1. The study was too small to exclude important differences in the outcomes between the two groups.
    2. 2 patients died in the hospitalised group - none in the home treatment group.
    3. A cost minimisation analysis (without sensitivity analysis) found that outpatient treatment for the initial 10 day period was on average FF 11000 cheaper.

    Citation

    1. Boccalon H, Elias A, Chale J-J, et al: clinical outcome and cost of hospital vs home treatment of proximal deep vein thrombosis with a low-molecular weight heparin: the vascular Midi-Pyrenees study. Archives of Internal Medicine 2000; 160 : 1769-1773
    Search Terms: from ACP Journal Club other articles noted
    Contributor: Chris Ball, November 2001
    Reviewer:

    Clinical Question.
    Patient
    Intervention or Exposure
    Outcome