Deep vein thrombosis landmark trials in treatment

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor-In-Chief: Ujjwal Rastogi, MBBS [2]; Kashish Goel,M.D.

Landmark Clinical Trials

Trials comparing Low-molecular-weight Heparin With subcutaneous unfractionated Heparin

1. Compare subcutaneous LMWH with unfractionated heparin for treatment of VTE

• Methods: A total of 720 patients (including those with PE and recurrent VTE) were randomly assigned to subcutaneous LMWH or fixed-dose subcutaneous unfractionated heparin.
• Results: Subcutaneous LMWH and unfractionated heparin groups had similar incidence of recurrent thromboembolic events (4.2% and 3.9%), mortality (3.3% and 3.3%) and major bleeding (0.8% and 1.1%) during 3-months of follow-up.
• Conclusions: Subcutaneous LMWH is as effective and safe as unfractionated heparin for treatment of VTE.

2. Fixed-Dose Heparin (FIDO) trial

• Objective: Compare subcutaneous unfractionated heparin with LMWH for treatment of VTE
• Methods: Randomized, open-label, adjudicator-blinded, noninferiority trial of 708 patients with VTE, who were randomized to unfractionated heparin at an initial dose of 333 U/kg, followed by a fixed dose of 250 U/kg every 12 hours and LMWH at a fixed dose of 100 U/kg every 12 hours. Both treatments were given as outpatients.
• Results: The are of recurrent VTE (3.8% and 3.4%) and major bleeding (1.1% and 1.4%) was almost similar in the UFH and LMWH groups, respectively.
• Conclusions: Fixed dose subcutaneous UFH is as effective and safe as LMWH for treatment of VTE in an outpatient setting.

3. Polish multi center trial

• Methods: A total of 149 patients with DVT were randomly assigned to subcutaneous LMWH or subcutaneous UFH foe 10 days.
• Results: One symptomatic nonfatal PE, two rethromboses and one major leading was noted in the UFH group, compared to none in LMWH group.
• Conculusions: Subcutaneous fixed-dose LMWH is as effective and safe as subcutaneous UFH in treatment of DVT.

Trials comparing Low-molecular-weight Heparin With intravenous unfractionated Heparin

1. Cochrane meta-analysis

• Objective: To compare the effectiveness of LMWH with UFH for VTE treatment.
• Methods: A cochrane collaboration meta-analysis of randomized controlled trials comparing the fixed dose subcutaneous LMWH with adjusted dose intravenous or subcutaneous UFH for treatment of VTE was performed.
• Results: A total of 23 studies were included in the meta-analysis. Thrombotic complications (3.6% vs. 5.3%; OR, 0.70, 95% CI 0.57-0.85), major hemorrhages (1.1% vs. 1.9%; OR, 0.58, 95% CI 0.40-0.83) and mortality (4.3% vs. 5.8%; OR, 0.77, 95% CI 0.63-0.93) was significantly lower in subjects treated with LMWH compared with UFH.
• Conclusions: Subcutaneous LMWH signficantly reduced the incidence of thrombotic complications, major bleeding and mortality in patients with acute VTE. It is more effective and safer than UFH for the initial treatment of VTE.

2. Objective: Compare the effectiveness of two daily subcutaneous injections of [LMWH]] with intravenous UFH in the treatment of deep venous thrombosis. (1990)

• Methods: A total of 119 patients with acute DVT were randomized to either subcutaneous [[LMWH][ or intravenous UFH.
• Results: Repeat imaging after 5-7 days showed similar improvement in thrombosis in both groups (76% vs. 61%), whereas 2 patients in UFH group suffered a major bleed compared to 4 patients in LMWH group. After 22 months of mean follow-up, 6 re-thromboses occurred in the UFH group compared with 4 in the LMWH group. Postthrombotic signs and symptoms were similar in both groups.
• Conclusion: Subcutaneous LMWH is as effective and safe as continuous intravenous UFH in the treatment of DVT of the leg.