Low Molecular Weight Heparin versus Acenocoumarol in the Secondary Prophylaxis of Deep Vein Thrombosis

1999 ◽  
Vol 81 (01) ◽  
pp. 26-31 ◽  
Author(s):  
H. Bielska-Falda ◽  
W. Noszczyk ◽  
M. Bielawiec ◽  
W. Witkiewicz ◽  
S. Filipecki ◽  
...  

SummaryThe aim of this study was to determine the efficacy and safety of subcutaneous weight-adjusted dose low molecular weight heparin (LMWH) compared with oral anticoagulant (OA) in the prevention of recurrent venous thromboembolism. In a prospective multicenter trial, 202 patients with symptomatic proximal deep vein thrombosis (DVT) were included. As soon as the diagnosis of DVT was confirmed by phlebography, 101 were randomly assigned to receive LMWH (nadroparin) for secondary prophylaxis and 101 to receive OA (acenocoumarol). Patients in both groups were initially treated with nadroparin in a dose of 85 anti-Xa IU/kg s.c. every 12 h. Secondary prophylaxis with either nadroparin, 85 anti-Xa IU/kg s.c. once daily, or acenocoumarol was continued for at least 3 months. Three patients in the LMWH group and 6 in the OA group were excluded from analysis for various reasons. During the one-year combined secondary prophylaxis and surveillance period, 7 of of the 98 evaluable patients (7.1%) in the LMWH group and 9 of the 95 evaluable patients (9.5%) in the OA group had a documented recurrence of venous thromboembolism (Fisher ’s exact test, p = 0.61). Of these, 2 patients who received LMWH and 7 patients on acenocoumarol had recurrences in the 3-month period of secondary prophylaxis. Four patients (4.1%) in the LMWH group developed bleeding complications during this study period, as compared with 7 (7.4%) in the OA group (Fisher’s exact test, p = 0.37). There were two major bleedings, one in the LMWH group and one in the OA group. Eleven patients died, 5 (5.1%) in the LMWH group and 6 (6.3%) in the OA group. It is concluded that nadroparin in a dose of 85 anti-Xa IU/kg s.c. once daily provides an effective and safe alternative to oral anticoagulants in the secondary prophylaxis of DVT.

1998 ◽  
Vol 79 (05) ◽  
pp. 897-901 ◽  
Author(s):  
Bernard A. Charbonnier ◽  
Jean-Noël Fiessinger ◽  
J. D. Banga ◽  
Ernst Wenzel ◽  
Pascal d’Azemar ◽  
...  

SummaryBackground: Clinical trials have been performed to compare with standard heparin a once or a twice daily regimen of low-molecular-weight heparin but no direct comparison has been done between these two low-molecular-weight heparin regimens in terms of efficacy and safety with a long-term clinical evaluation.Methods: Patients with proximal deep vein thrombosis, confirmed by venography were randomly assigned to either nadroparin (10,250 AXa IU/ml) twice daily or nadroparin (20,500 AXa IU/ml) once daily for at least 5 days. Regimens were adjusted to bodyweight. Oral anticoagulants were started on day 1 or 2 and continued for 3 months. Patients were followed up for 3 months. The composite outcome of venous thromboembolism and death possibly related to pulmonary embolism was the primary measure of efficacy. Major bleeding was the principal measure of safety. The study was designed to show equivalence between the two regimens.Results: Recurrent thromboembolic events or death possibly related to pulmonary embolism were reported in 13 patients in the once daily group (4.1%) and in 24 patients of the twice daily group (7.2%): (absolute difference 3.1% in favor of the once daily regimen; 95% confidence interval -6.6%, +0.5%). Major bleeding episodes during nadroparin treatment occurred in 4 (1.3%) and 4 patients (1.2%) in the once and twice daily groups, respectively.Conclusions: A nadroparin regimen of one injection per day is at least as effective and safe as the same total daily dose divided over two injections for the treatment of acute deep vein thrombosis.


1987 ◽  

The efficacy and safety of a low molecular weight heparin (Kabi 2165) in preventing postoperative deep vein thrombosis (D.V.T.), was assessed in a double blind randomly allocated multicenter trial. 385 patients were included and analysed on a intention to treat basis. Kabi 2165 was given S.C. 24 hourly in 2 500 anti-factor Xa units and compared with standard low dose calcium heparin 5 000 i.u. S.C. 12 hourly in patients undergoing major abdominal or gynaecological surgery. The first dose was administered two hours before operation in both groups. The relevant characteristics of the patients in the two treatment groups were similar. The two groups were well matched for risk factors which could predispose to D.V.T.DVT was detected by the radioactive fibrinogen test. Venography was performed whenever a positive scan developed in a patient. Six (3,1 96) of 195 patients receiving Kabi 2165 and seven (3,7 96) of 190 patients in the standard heparin group developed D.V.T. No pulmonary embolism we re detected during the prophylactic regimens. There was no significant difference between the two groups in terms of blood loss during surgery, postoperative drainage, blood transfusion, wound haematoma. Mean hemoglobin levels and mean hematocrit values preoperatively and postoperatively (day 1 and 6) were :There were no statistically significant differences in both groups. No thrombocytopenia was reported in this study. The antifactor Xa activity was significantly higher in the Kabi 2165 group.In conclusion, Kabi 2165 once daily is as effective and safe as standard heparin twice daily in preventing postoperative D.V.T. in general surgery.


2019 ◽  
Vol 25 ◽  
pp. 107602961989041
Author(s):  
Chu Chen ◽  
Qing Tang ◽  
Wenjuan Zhang ◽  
Huijun Yuan ◽  
Ying Huai ◽  
...  

At present, there is no consistent understanding of the effect of traditional Chinese medicine (TCM) prescription in the prevention of the deep vein thrombosis (DVT), though TCM has been widely used in China. To evaluate the efficacy of TCM prescription combined with low-molecular-weight heparin (LMWH) for preventing DVT after major orthopedics surgery. All the retrieved articles were evaluated using specific inclusion and exclusion criteria. Then, data were extracted and evaluated for inclusion in a randomized controlled trial. In this study, variables included relative risk (RR), mean difference (MD), and their corresponding 95% confidence intervals (95% CIs). Overall, 16 articles were included with 1538 patients, 768 in the combination group (combination of TCM prescription and LMWH) and 770 in the LMWH group. The results indicated that in the combination group, the incidence of DVT (RR: 0.34, 95% CI: 0.23-0.50, P < .00001) and d-dimer levels (standardized mean difference: −1.19, 95% CI: −1.80 to −0.58, P = .0001) was significantly lower than that in the LMWH group. Furthermore, the combination treatment obviously decreased the concentration of fibrinogen (MD: −1.19, 95% CI: −2.13 to −0.25, P = .01). The combination of TCM prescription and LMWH could significantly reduce the incidence of DVT, suggesting that it may be a more effective prophylaxis measure for DVT after major orthopedics surgery.


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