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Anticoagulant therapy in deep venous thrombosis. A randomized controlled study
H K Nielsen1, S E Husted, L R Krusell
1University Department of Medicine, County Hospital of Aarhus, Denmark.
Insights
Anticoagulant treatment showed no significant effect on deep venous thrombosis (DVT) progression in mobilized patients. Further large-scale studies are needed to confirm these findings for DVT management.
Area of Science:
- Vascular Medicine
- Thrombosis Research
- Clinical Pharmacology
Background:
- Deep venous thrombosis (DVT) management often involves anticoagulation.
- Early mobilization and compression stockings are standard care for DVT patients.
- The efficacy of anticoagulant (AC) treatment in actively mobilized DVT patients requires further investigation.
Purpose of the Study:
- To compare the safety and efficacy of anticoagulant treatment versus non-anticoagulant treatment in patients with deep venous thrombosis (DVT) and no clinical signs of pulmonary embolism (PE).
- To assess the impact of anticoagulant therapy on DVT progression and pulmonary embolism development in actively mobilized patients.
Main Methods:
- Ninety patients with venographically proven DVT were randomized into AC and non-AC groups.
- Both groups received early mobilization and graduated compression stockings.
- The non-AC group received phenylbutazone, while the AC group received heparin followed by oral anticoagulants.
- Venography, perfusion-ventilation lung scans, and assessment of bleeding complications were performed.
Main Results:
- No significant difference in DVT regression was observed between the AC and non-AC groups for distal or proximal veins.
- Lung scan results showed no significant difference in pulmonary embolism incidence between the groups at 10 and 60 days.
- The incidence of bleeding complications in the AC group was 8.3%; phenylbutazone had no reported side-effects.
Conclusions:
- Anticoagulant treatment did not demonstrate a significant effect on DVT progression in actively mobilized patients using compression stockings compared to non-AC therapy with phenylbutazone.
- The study's small patient population and wide confidence intervals limit definitive conclusions.
- Larger, placebo-controlled studies are necessary to establish the role of AC treatment in early mobilized DVT patients.
Abstract:
Ninety patients with venographically proven deep venous thrombosis(DVT) but without clinical signs of pulmonary embolism(PE) were randomized into two different treatment regimens to compare the safety and efficacy of continuous intravenous heparin and oral anticoagulant(AC) treatment versus non-AC treatment. All patients in the two treatment groups were actively mobilized from the day of admission and wore graduated compressing stockings. In the non-AC-group the patients were treated with phenylbutazone for ten days. Treatment with heparin was maintained for 6 days and oral AC treatment was given from the third day and continued for 3 months. Venography was repeated after 30 days. A perfusion-ventilation lung scan was performed on day 1-2, 10 and 60. In fifty-nine patients a revenography was performed, twenty nine in the AC-group and thirty in the non-AC group. For distal veins regression was found in nine and eight respectively (4.4% in favour of AC, 95% confidence limit 27.5% to -18.7%) and in proximal veins regression was found in five and eight, respectively (10.9% in favour of AC, 95% confidence limit 32.0% to -10.1%). No difference in lung scans was found after 10 days (0.8% in favour of AC, 95% confidence limit 21.5% to -19.9%) or after 60 days (3.3% in favour of non-AC treatment, 95% confidence limit 21.8% to -28.5%). In the AC group the incidence of bleeding complications was 8.3%. No side-effects of phenylbutazone was found. The present controlled clinical study demonstrated no effect of AC-treatment on DVT progression in actively mobilized patients wearing graduated compressing stockings when compared to a non-AC treated group receiving analgetic therapy with phenylbutazone. However, the patient population of the study is relatively small with wide confidence intervals for differences between groups. Before more general recommendations can be made, a large scale placebo-controlled study is needed to evaluate the possible effect of AC-treatment in DVT patients, who can be mobilized from the first day.