Deep vein thrombosis: recurrent venous thromboembolism and post-thrombotic leg were common.

Clinical bottom line (level 1b)

  1. Patients with a first proximal deep vein thrombosis appear to be at high risk for a recurrence, especially if they have non-transient risk factors (30% at 8 years).
  2. Post-thrombotic leg was found to be common (10% of cases), and can be disabling.
  3. Patients with a first DVT and cancer are at an increased risk of dying (NNF = 2 for 5 years) .
Prandoni et al: Annals of Internal Medicine 1996; 125: 1-7
Expires August 2003

The study

Prospective cohort study with objective outcomes, adjusted for confounding factors, not validated in an independent set of patients.

Setting: hospital outpatient clinic, Italy

355 patients (aged range 29 to 83 years; mean 63, 55% male) first deep vein thrombosis, confirmed by venography

Excluded if
  • recurrent venous thromboembolism



    • Factors studied:
  • recurrent VTE, death
  • cancer
  • impaired coagulation inhibition
  • recent surgery
  • recent trauma or fracture
  • cancer


    • All patients were treated with heparin or LMWH; oral anticoagulants were started on day 5-7, and maintained for three months with target INR of 2-3. All patients wore compression stockings.

    Cox proportional regression was performed.

    96% followed for 2 years
    Outcomes studied:
  • recurrent VTE at 3 months
  • recurrent VTE at 1 year
  • recurrent VTE at 2 years
  • recurrent VTE at 5 years
  • recurrent VTE at 8 years
  • death at 1 year
  • death at 2 years
  • death at 5 years
  • death at 8 years
  • post-thrombotic leg at 1 year
  • post-thrombotic leg at 2 years
  • post-thrombotic leg at 5 years
  • severe post-thrombotic leg at 1 year
  • severe post-thrombotic leg at 2 years

    • The evidence

    outcome time to outcome number of patients/total number %
    (95% CI)
    recurrent VTE at 3 months 2 years / 4.9%
    (2.6% to 7.1%)
    recurrent VTE at 1 year 2 years / 8.6%
    (5.6% to 12%)
    recurrent VTE at 2 years 2 years / 18%
    (14% to 22%)
    recurrent VTE at 5 years 2 years / 25%
    (20% to 30%)
    recurrent VTE at 8 years 2 years / 30%
    (24% to 37%)
    death at 1 year 2 years / 17%
    (13% to 21%)
    death at 2 years 2 years / 20%
    (17% to 24%)
    death at 5 years 2 years / 25%
    (20% to 30%)
    death at 8 years 2 years / 30%
    (24% to 37%)
    post-thrombotic leg at 1 year 2 years / 17%
    (15% to 24%)
    post-thrombotic leg at 2 years 2 years / 23%
    (18% to 28%)
    post-thrombotic leg at 5 years 2 years / 28%
    (23% to 33%)
    severe post-thrombotic leg at 1 year 2 years / 2.6%
    (0.8% to 4.4%)
    severe post-thrombotic leg at 2 years 2 years / 9.3%
    (1.8% to 28%)

    prognostic factor for
    recurrent VTE at 5 years     		time to outcome control rate (%) adjusted OR
    (95% CI)    		 NNF+
    (95% CI)
    cancer 5 years 1.72
    (1.31 to 2.25)     		8
    (5 to 19)
    impaired coagulation inhibition 5 years 1.44
    (1.02 to 2.01)     		14
    (7 to 270)
    recent surgery 5 years 0.36
    (0.21 to 0.62)     		-7
    (-13 to -5)
    recent trauma or fracture 5 years 0.51
    (0.32 to 0.87)     		-10
    (7 to 40)

    prognostic factor for
    death at 5 years     		time to outcome control rate (%) adjusted OR
    (95% CI)    		 NNF+
    (95% CI)
    cancer 5 years 8.10
    (3.60 to 18.1)     		2
    (2 to 3)

    • Only 14% of patients had anticoagulation for longer than 3 months
    • Most deaths (98%) were not directly related to the VTE, but the underlying diagnosis (often cancer).

    Citation

    1. Prandoni P, et al: The long-term clinical course of acute deep venous thrombosis. Annals of Internal Medicine 1996; 125: 1-7
    Contributor: Sharon Straus and Chris Ball, August 2000
    Reviewer: Alan Forster

    Clinical Question.
    Patient first DVT
    Intervention or Exposure risk factors
    Outcome recurrence, postphlebitic syndrome, death