A Comparison of Low-Molecular-Weight Heparin with Unfractionated Heparin for Acute Pulmonary Embolism
Why the study?
Does subcutaneous low-molecular-weight heparin (tinzaparin) reduce recurrent thromboembolism, major bleeding, and death in patients with symptomatic pulmonary embolism compared to intravenous unfractionated heparin?
Population
612 patients with symptomatic pulmonary embolism who did not require thrombolytic therapy or embolectomy
Comparison
Subcutaneous low-molecular-weight heparin given… vs Adjusted-dose, intravenous unfractionated…
Design
RCT, randomly assigned
Follow-up
90 days
Authors
Discussion
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Overview
Subcutaneous tinzaparin is as effective and safe as UFH for acute symptomatic PE; confirms LMWH as a convenient initial alternative.
Key Points
- This research aims to compare the safety and effectiveness of low-molecular-weight heparin with unfractionated heparin in treating acute pulmonary embolism.
- Randomly assigned 612 patients with acute pulmonary embolism to either subcutaneous low-molecular-weight heparin or intravenous unfractionated heparin.
- Oral anticoagulant therapy was initiated between days 1 and 3, continued for at least three months.
- Treatment outcomes were assessed at day 8 and day 90 for recurrent thromboembolism, major bleeding, and death.
- In the first eight days, 2.9% of patients on unfractionated heparin and 3.0% on low-molecular-weight heparin reached at least one end point; absolute difference of 0.1 percentage point.
- By day 90, 7.1% of unfractionated heparin patients and 5.9% of low-molecular-weight heparin patients reached an end point (P=0.54).
- The risk of major bleeding was similar in both groups throughout the study.
Structured PICO
Does subcutaneous low-molecular-weight heparin (tinzaparin) reduce recurrent thromboembolism, major bleeding, and death in patients with symptomatic pulmonary embolism compared to intravenous unfractionated heparin?
P
Population
612 patients with symptomatic pulmonary embolism who did not require thrombolytic therapy or embolectomy
I
Intervention
Subcutaneous low-molecular-weight heparin (tinzaparin) given once daily in a fixed dose, with oral anticoagulant therapy begun between the first and third day and given for at least three months
C
Comparator
Adjusted-dose, intravenous unfractionated heparin, with oral anticoagulant therapy begun between the first and third day and given for at least three months
O
Outcome
Combined end point of recurrent thromboembolism, major bleeding, and death at day 8 and day 90composite
Subcutaneous low-molecular-weight heparin (tinzaparin) is as effective and safe as intravenous unfractionated heparin for the initial treatment of acute symptomatic pulmonary embolism.
Cite This Study
Simonneau et al. (1997) studied this question.