Deep vein thrombosis: no clear difference between nadroparin and acenocoumarol long-term

Clinical bottom line (level 1b)

  1. Patients with a DVT who took nadroparin long-term compared with acenocourmal were not clearly more likely to have a recurrent DVT, bleed or die.
Lopez-Beret et al: Journal of Vascular Surgery 2001; 33 : 77-90
Expires November 2003

The study

Double-blinded ?concealed randomised trial with intention-to-treat
Setting:

158 patients (aged 18 to 92; mean 66, 56% female) symptomatic lower-limb DVT (confirmed on ultrasound scan)

Excluded if
  • received full doses of anticoagulation
  • surgery within previous 5 days
  • aged < 18
  • pregnant
  • previous episodes of DVT in the same limb
  • past complication due to heparin or acenocoumarol

    Control Group: (n = 77, 77 analysed): acenocoumarol adjusted so INR 2.0 to 3.0; LMWH continued for 2 days after INR within therapeutic range
    Experimental Group: (n = 81, 81 analysed): nadroparin 0.1 ml/10 kg
    Patients received 3 days of 0.1 ml/10kg nadroparin twice daily before randomisation.
    94% followed for 12 months

    The evidence

    Outcome Time to outcome CER EER RRR
    (95% CI)    		 ARR
    (95% CI)    		 NN T
    (95% CI)
    confirmed recurrent DVT 12 months 7
    (9.09%)    		 2
    (2.47%)    		 73%
    (-27% to 94%)    		 6.62%
    (-0.63% to 13.9%)    		 15
    (NNT = 7 to infinity;
    NNH = 160 to infinity)
    death 12 months 9
    (11.7%)    		 6
    (7.41%)    		 37%
    (-70% to 76%)    		 4.28%
    (-4.89% to 13.5%)    		 23
    (NNT = 7 to infinity;
    NNH = 20 to infinity)
    12 months 4
    (5.19%)    		 4
    (4.94%)    		 5%
    (-270% to 75%)    		 0.26%
    (-6.59% to 7.10%)    		 390
    (NNT = 14 to infinity;
    NNH = 15 to infinity)

    Comments

    1. The study is too small to exclude an important clinical difference between the two groups.

    Citation

    1. Lopez-Beret P, Orgaz A, Fontcuberta J, et al: low molecular weight heparin versus oral anticoagulants in the long-term treatment of deep venous thrombosis. Journal of Vascular Surgery 2001; 33 : 77-90
    Search Terms: from ACP Journal Club other articles noted
    Contributor: Chris Ball, November 2001
    Reviewer:

    Clinical Question.
    Patient deep vein thrombosis
    Intervention or Exposure nadroparin long-term
    Comparison acenocoumarol long-term
    Outcome recurrent DVT, death, bleeding
    		•