Deep vein thrombosis: route of thrombolysis had no clear effect on thrombolysis or bleeding risk.

Clinical bottom line (level 1b-)

  1. In patients with DVT, tPA caused bleeding in around one in four patients
  2. tPA given locally was not clearly more effective than tPA given systemically.
Schweider et al: Thrombosis and Haemostasis 1995; 74 (5): 1240-1243
Expires May 2003

The study

Unblinded concealed quasi-randomised trial with intention-to-treat
Setting: forty hospitals, Germany

151 patients (aged range 18 to 65 years; mean 46, 53% male) deep vein thrombosis diagnosed by venography

Excluded if
  • symptoms for >14 dyas
  • previous DVT in same leg
  • GI/GU bleed within previous four weeks
  • acute pancreatitis
  • surgery <10 days age
  • intramuscular injection <7 days ago
  • hypertensive or diabetic retinopathy
  • stroke or neurosurgery within 8 months
  • Cr>350 mg/dl
  • AST>100 or PT <50%
  • pregnant or lactating
  • clotting disorder


    • Control Group: (n = 79, 69 analysed): 20 mg recombinant tissue plasminogen activator over 4 hours for four to seven days via dorsalis pedis vein (local)
    Experimental Group: (n = 72, 68 analysed): 20 mg rt-PA over 4 hours for four to seven days via anticubital vein (systemic)

    91% followed for 7 days
    Outcome notes:
    • major bleed : cerebral or retroperitoneal bleed or frank haematuria

    The evidence

    Outcome Time to outcome CEREERRRR
    (95% CI)    		ARR
    (95% CI)    		NNT
    (95% CI)
    thrombolysis >50% 7 days 18
    (26%)    		 21
    (31%)    		 -18%
    (-102% to 31%)    		 -4.80%
    (-19.9% to 10.3%)    		 -21
    (NNT = 10 to infinity;
    NNH = 5 to infinity)
    major bleed 7 days 10
    (14%)    		 6
    (8.8%)    		 39%
    (-58% to 77%)    		 5.67%
    (-5.03% to 16.4%)    		 18
    (NNT = 6 to infinity;
    NNH = 20 to infinity)

    Comments

    1. Risk of major bleeding is greatly increased over heparin alone, with no clear benefits.
    2. The study is too small to clearly demonstrate any benefit between the two therapies.
    3. Uncertaintiies remain about the value of tPA in venous thromboembolic disease

    Citation

    1. Schweider G, Grimm W, Siemens HJ, et al: Intermittent regional treatment with rt-PA is not superior to systemic thrombolysis in deep vein thrombosis: a German multicenter trial. Thrombosis and Haemostasis 1995; 74 (5): 1240-1243
    Contributor: Chris Ball and Clare Wotton, May 2000
    Reviewer: Alex Gallus

    Clinical Question.
    Patient DVT
    Intervention or Exposure local tPA
    Comparison systemic tPA
    Outcome thrombolysis