Venous thromboembolism: prophylaxis: total hip replacement: hirudin was more effective than heparin.

Clinical bottom line (level 1b)

  1. In patients undergoing first total hip replacement, hirudin was more effective at preventing deep vein thrombosis (NNT = 6 at 44 days) and pulmonary embolism (NNT = 44 at 44 days) , than heparin.
  2. The effect on thrombocytopenia was unclear.
Eriksson et al: Journal of Bone and Joint Surgery 1997; 79 (3): 326-333
Expires May 2003

The study

Double-blinded concealed randomised trial without intention-to-treat
Setting: 11 centres, Scandinavia

445 patients (aged mean 68 years, 58% female) undergoing first total hip replacement

Excluded if
  • <18 years old
  • <50 kg in weight
  • child bearing potential
  • bleeding disorder
  • major surgery in last three months
  • cerebrovascular accident in last six months
  • renal impairment
  • on aspirin or anticoagulant
  • uncontrolled hypertension
  • known allergy to hirudin, heparin or contrast media


    • Control Group: (n = 220, 177 analysed): heparin subcutaneously 5000 units tds pre-operatively to 8-11 days post-operatively
    Experimental Group: (n = 225, 174 analysed): desirudin (recombinant hirudin) 15 mg subcutaneously bd pre-operatively to 8-11 days post-operatively

    100% followed for 44 days
    Outcome notes:
    • deep venous thrombosis : bilateral venograms at 8-11 days post-op- assessed by two independent observers
    • pulmonary embolism : diagnosed by angiogram or high probability v/q scan

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    deep venous thrombosis 44 days 41
    (23%)    		 13
    (7.5%)    		 68%
    (42% to 82%)    		 15.7%
    (8.35% to 23.0%)    		 6
    (4 to 12)
    pulmonary embolism 44 days 4
    (2.3%)    		 0
    (0%)    		 100%
    (% to %)    		 2.26%
    (0.07% to 4.45%)    		 44
    (22 to 1400)
    thrombocytopenia 44 days 2
    (1.1%)    		 0
    (0%)    		 100%
    (% to %)    		 1.13%
    (-0.43% to 2.69%)    		 89
    (NNT = 37 to infinity;
    NNH = 234 to infinity)

    Comments

    1. Patients were randomised in groups of six.
    2. Patients were not analysed if they did not have a adequate bilateral venogram (n=94).

    Citation

    1. Eriksson BI, Ekman S, Lindbratt S, et al: Prevention of thromboembolism with use of recombinant hirudin. Journal of Bone and Joint Surgery 1997; 79 (3): 326-333
    Contributor: Chris Ball and Clare Wotton, May 2000
    Reviewer:

    Clinical Question.
    Patient total hip replacement
    Intervention or Exposure desirudin
    Comparison heparin
    Outcome DVT or PE