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

Trial comparing Low-molecular-weight Heparin With 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 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.

1. Two daily subcutaneous injections of fragmin as compared with intravenous standard heparin in the treatment of deep venous thrombosis. (1990)

• Patient enrollment: 119 patients
• Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
• Result: Repeat phlebography after 5-7 days showed improvement in 34/45 patients (76%) in the Fragmin group and in 30/49 patients (61%) in the SH group and progress in 2/45 (4%) and 3/49 (6%), respectively. The mean Marder scores decreased from 18.7 +/- 12.1 to 15.7 +/- 12.7 in the Fragmin group and from 16.9 +/- 12.0 to 14.4 +/- 11.8 in the SH group (ns). Two patients in the SH group and none in the Fragmin group had major bleedings. After 22 +/- 7 months follow up 6 rethromboses had occurred in the SH group and 4 in the Fragmin group. Postthrombotic signs and symptoms were similar in both groups.
• Conclusion: Two daily sc Fragmin doses seem as effective and safe as continuous SH in the treatment of DVT of the leg.

2. A randomised trial of subcutaneous low molecular weight heparin (CY 216) compared with intravenous unfractionated heparin in the treatment of deep vein thrombosis. (1991)

• Patient enrollment: 166 patients
• Purpose: To compare subcutaneous low molecular weight heparin with intravenous unfractionated heparin in the treatment of deep vein thrombosis .
• Result: Both "therapeutic efficacy" and "intention to-treat" analyses showed that subcutaneous CY 216 in fixed doses based only on body weight was more effective on the Arnesen and Marder phlebographic scores than continuous i.v. standard heparin with daily dose adjustment according to results of coagulation tests. There was no increase in the risks of pulmonary embolism, haemorrhage or clot extension.