Key result
Fraxiparine at 400 anti-Xa units/kg was as effective as unfractionated heparin for improving pulmonary vascular obstruction at day 8, whereas higher doses caused major bleeding.
Why the study?
Does subcutaneous low-molecular-weight heparin improve pulmonary vascular obstruction compared to intravenous unfractionated heparin in patients with submassive pulmonary embolism?
RCT (n=101)
randomized
Does subcutaneous low-molecular-weight heparin improve pulmonary vascular obstruction compared to intravenous unfractionated heparin in patients with submassive pulmonary embolism?
Subcutaneous low-molecular-weight heparin at 400 anti-Xa units/kg is as effective and safe as intravenous unfractionated heparin for submassive pulmonary embolism, while higher doses cause unacceptable bleeding.
Answers are grounded in this paper and cite their sources.
Supports fixed-dose subcutaneous LMWH as convenient alternative to UFH in submassive PE; reinforces LMWH role in acute VTE.
BACKGROUND: We compared the efficacy and safety of different dosages of a low-molecular-weight heparin, CY 216 D (Fraxiparine), in the treatment of submassive pulmonary embolism with unfractionated heparin in a prospective, randomized, dose-finding study. METHODS AND RESULTS: The primary outcome was the evolution of pulmonary vascular obstruction. We enrolled 101 patients. Four patient groups were formed: standard heparin by continuous intravenous infusion (group 1) and Fraxiparine subcutaneously 400, 600, and 900 anti-Xa Institute Choay units/kg, respectively (groups 2, 3, and 4). Inclusions were stopped prematurely in groups 3 and 4 because of the incidence of major bleedings. At day 8, the improvement of the pulmonary vascular obstruction and the major bleedings were similar in groups 1 and 2. CONCLUSIONS: The Fraxiparine dosage of 400 anti-Xa Institute Choay units/kg is as effective and safe as unfractionated heparin in the treatment of submassive pulmonary embolism.
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Théry et al. (1992) conducted an RCT in submassive pulmonary embolism (n=101). Fraxiparine (CY 216 D) vs. continuous intravenous unfractionated heparin was evaluated on evolution of pulmonary vascular obstruction. Fraxiparine at 400 anti-Xa units/kg was as effective as unfractionated heparin for improving pulmonary vascular obstruction at day 8, whereas higher doses caused major bleeding.
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