Deep vein thrombosis: patients on LMWH could probably be sent home safely.

Clinical bottom line (level 1b-)

  1. In patients with acute proximal deep vein thrombosis, low molecular weight heparin administered primarily at home was probably as effective and safe as unfractionated heparin administered in the hospital.
Koopman et al: New England Journal of Medicine 1996; 334 (11): 682-687
Expires May 2003

The study

Unblinded concealed randomised trial with intention-to-treat
Setting: hospitals in Europe, Australia and New Zealand

400 patients (aged mean 61 years, 51% male) acute proximal deep vein thrombosis (confirmed by venography or duplex ultrasonography)

Excluded if
  • DVT in previous two years
  • pulmonary embolism
  • previous treatment with heparin for >24 hours
  • geographic inaccessibility
  • life expectancy <6 months
  • overt post-thrombotic syndrome
  • <18 years old
  • pregnant


    • Control Group: (n = 198, 198 analysed): heparin iv bolus of 5000 units followed by a continuous infusion of 1250 IU per hour, in the hospital. Infusion was adjusted to maintain activated partial thromboplastin time at 1.5 to 2.0 times the normal value
    Experimental Group: (n = 202, 202 analysed): nadroparin-calcium subcutaneously twice daily with dose adjusted for the patient's weight, administered at home. No laboratory monitoring was done in this group.
    All patients received oral anticoagulant treatment initiated on the first day and continued for a total of three months
    100% followed for 24 weeks

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    symptomatic recurrent thromboembolism 90 days 17
    (8.59%)    		 14
    (6.93%)    		 19%
    (-59% to 59%)    		 1.66%
    (-3.59% to 6.90%)    		 60
    (NNT = 14 to infinity;
    NNH = 28 to infinity)
    major bleed 90 days 4
    (2.02%)    		 1
    (0.50%)    		 75%
    (-120% to 97%)    		 1.66%
    (-0.66% to 3.71%)    		 66
    (NNT = 27 to infinity;
    NNH = 151 to infinity)

    Outcome Control Group
    (SD)    		 Experimental Group
    (SD)    		 Mean Difference
    (95% CI)
    length of hospital stay (days) 8.1
    ()     		2.7
    ()     		5.4
    ( to )

    Comments

    1. 75% of the patients assigned to LMWH were never hospitalised or were discharged early in the trial.
    2. The decision to treat in an ambulatory setting depends on the ability to provide injections in the community, severity of the VTE event, co-morbid conditions, and risk of bleeding.
    3. Approximately two thirds of patients with acute proximal DVT were excluded; 40% unable to receive outpatient treatment with LMWH because of associated coexisting conditions, ie. treatment will only be successful in patients who were healthy before the DVT.
    4. No difference in quality of life scores for heparin or LMWH.

    Citation

    1. Koopman MM, et al: Treatment of venous thrombosis with intravenous unfractionated heparin administered in the hospital as compared with subcutaneous low-molecular-weight heparin administered at home. New England Journal of Medicine 1996; 334 (11): 682-687
    Contributor: Chris Ball and Clare Wotton, May 2000
    Reviewer: Alan Forster

    Clinical Question.
    Patient acute proximal DVT
    Intervention or Exposure heparin in the hospital
    Comparison enoxaparin at home
    Outcome recurrent thromboembolism