Deep vein thrombosis: danaparoid was not clearly better than heparin.

Clinical bottom line (level 1b-)

  1. In patients with deep venous thrombosis or pulmonary embolism, danaparoid was not clearly as effective as unfractionated heparin in preventing recurrences.
de Valk et al: Annals of Internal Medicine 1995; 123 (1): 1-9
Expires May 2003

The study

Unblinded concealed randomised trial without intention-to-treat
Setting: three university hospitals, The Netherlands

188 patients (aged range 18 to 95 years; mean 55, 55% female) deep vein thrombosis of the leg (diagnosed by venogram or ultrasound scan) or pulmonary embolism (diagnosed by V/Q scan)

Excluded if
  • <18 years old
  • intracranial bleed within two months
  • resuscitated by external chest compression within 48 hours
  • heparin allergy
  • pregnant
  • on coumarin derivative
  • on aspirin, NSAIDs, dextran or fibrinolytics
  • >7 days duration of DVT/PE


    • Control Group: (n = 60, 60 analysed): unfractionated heparin 2500 units bolus iv, then 30,000 units per 24 hours, adjusted so a aPTT 2.5 to 3.5
    Experimental Group: (n = 128, 128 analysed): danaparoid 1250 units or 2000 units bolus iv and 1250 units or 2000 units subcutaneously twice daily

    100% followed for 2 months

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    recurrent venous thromboembolism 5 days 20
    (33.3%)    		 27
    (21.1%)    		 37%
    (-3% to 61%)    		 12.2%
    (-1.63% to 26.1%)    		 8
    (NNT = 4 to infinity;
    NNH = 62 to infinity)
    major bleed 5 days 1
    (1.67%)    		 1
    (0.78%)    		 53%
    (-640% to 97%)    		 0.89%
    (-2.70% to 4.47%)    		 113
    (NNT = 22 to infinity;
    NNH = 37 to infinity)
    death 2 months 3
    (5.00%)    		 0
    (0%)    		 inf%
    (53% to infinite%)    		 5.00%
    (-0.51% to 10.5%)    		 20
    (NNT = 10 to infinity;
    NNH = 194 to infinity)

    Comments

    1. The trial is too small to show any clear difference between the two treatments.
    2. Danaparoid is thought to cause less thrombocytopenia than heparin (based on animal studies).

    Citation

    1. de Valk HW, Banga JD, Westar JWJ, et al: Comparing subcutaneous danaparoid with intravenous unfractionated heparin for the treatment of venous thromboembolism: a randomised controlled trial. Annals of Internal Medicine 1995; 123 (1): 1-9
    Contributor: Chris Ball and Clare Wotton, May 2000
    Reviewer:

    Clinical Question.
    Patient DVT or PE
    Intervention or Exposure danaparoid
    Comparison unfractionated heparin
    Outcome recurrent VTE