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Título
Venographic comparison of subcutaneous low-molecular weight heparin with oral anticoagulant therapy in the long-term treatment of deep venous thrombosis
Autor
Año del Documento
1999
Descripción
Producción Científica
Documento Fuente
Journal of Vascular Surgery, August, vol.30, n.2. p.283-292
Zusammenfassung
Purpose: The primary objective of this study was to evaluate with venography the rate of
thrombus regression after a fixed dose of low–molecular weight heparin (LMWH) per
day for 3 months compared with oral anticoagulant therapy for deep venous thrombosis
(DVT). Secondary endpoints were the comparisons of the efficacy and safety of both
treatments.
Methods: This study was designed as an open randomized clinical study in a university hospital
setting. Of the 165 patients finally enrolled in the study, 85 were assigned LMWH
therapy and 80 were assigned oral anticoagulant therapy. In the group randomized to oral
anticoagulant therapy, the patients first underwent treatment in the hospital with standard
unfractionated heparin and then coumarin for 3 months. Doses were adjusted with
laboratory monitoring to maintain the international normalized ratio between 2.0 and
3.0. Patients in the LMWH group were administered subcutaneous injections of fixed
doses of 40 mg enoxaparin (4000 anti-Xa units) every 12 hours for 7 days, and after discharge
from the hospital, they were administered 40 mg enoxaparin once daily at fixed
doses for 3 months without a laboratory control assay. A quantitative venographic score
(Marder score) was used to assess the extent of the venous thrombosis, with 0 points indicating
no DVT and 40 points indicating total occlusion of all deep veins. The rate of
thrombus reduction was defined as the difference in quantitative venographic scores after
termination of LMWH or coumarin therapy as compared with the scores obtained on the
initial venographic results. The efficacy was defined as the ability to prevent symptomatic
extension or recurrence of venous thromboembolism (documented with venograms or
serial lung scans). The safety was defined as the occurrence of hemorrhages.
Results: After 3 months of treatment, the mean Marder score was significantly decreased
in both groups in comparison with the baseline score, although the effect of therapy was
significantly better after LMWH therapy (49.4% reduction) than after coumarin therapy
(24.5% reduction; P < .001). LMWH therapy and male gender were independently
associated with an enhanced resolution of the thrombus. A lower frequency of symptomatic
recurrent venous thromboembolism was also shown in patients who underwent
treatment with LMWH therapy (9.5%) than with oral anticoagulant therapy (23.7%; P
< .05), although this difference was entirely a result of recurrence of DVT. Bleeding
complications were significantly fewer in the LMWH group than in the coumarin group
(1.1% vs 10%; P < .05). This difference was caused by minor hemorrhages. Coumarin
therapy and cancer were independently associated with an enhanced risk of complications.
Subcutaneous heparin therapy was well tolerated by all patients.
Conclusion: The patients who were allocated to undergo enoxaparin therapy had a significantly
greater improvement in their quantitative venographic score, a significantly
Materias (normalizadas)
Trombosis-Tratamiento
ISSN
0741-5214
Revisión por pares
SI
Idioma
eng
Derechos
openAccess
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