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Comparison of low-molecular-weight heparin and warfarin for the secondary prevention of venous
thromboembolism in patients with cancer
Reported by: Meyer G et al. Arch Intern Med. 2002;162:1729-1735.
Outcome Measures
Figure 1. Recurrent VTE or major hemorrhage during the 3-month
Table 2. Major bleeding during the 3-month treatment period with
The primary end point was the composite of treatment failure, treatment period in 138 patients with cancer and VTE treated with warfarin (n = 75) or enoxaparin (n = 71) in 146 patients with cancer Background: Warfarin use in patients with cancer for the prophylaxis
defined as symptomatic and objectively confirmed recurrent VTE warfarin and enoxaparin. P=.04 by the log-rank test.
of venous thromboembolism (VTE) is associated with significant risk
and/or major bleeding within the 3 month treatment period for recurrence and bleeding. Low-molecular-weight heparins (LMWH)
may reduce the rate of complications. This study was conducted to
Secondary end points included 3- and-6-month mortality, evolution Site of Bleeding
Last INR or
examine whether fixed-dose, subcutaneous enoxaparin was superior
of underlying cancer at 6 months, major and minor bleeding, Bleeding
to oral warfarin for secondary prophylaxis of VTE in patients with
heparin-induced thrombocytopenia, and recurrent thromboembolism cancer and VTE.
Methods: A total of 146 patients with VTE and cancer received open-
IU/mL (Date)
label subcutaneous enoxaparin sodium (1.5 mg/kg/d) or warfarin for
Warfarin group
3 months. The primary outcome measure was the composite of major
bleeding or recurrent VTE at 3 months.

A total of 146 patients were included in the study Results: Among the 71 patients who received warfarin, 15 (21.1%)
Of these, 75 and 71 were randomized to receive warfarin experienced one major outcome event compared with 7 (10.5%) who
experienced 1 major outcome event in the enoxaparin group (P=.09).
Baseline characteristics of patients are shown in Table 1 Death due to bleeding was more frequent with warfarin (6 deaths)
compared with enoxaparin (0 deaths). Overall, there were 17 deaths
(22.7%) in the warfarin group and 8 deaths in the LMWH group
Table 1. Baseline Characteristics
(11.3%). No differences were seen in the rate of progression of cancer
or cancer-related death.
During the 3-month treatment period, 17 of the 75 warfarin patients Conclusions: Warfarin was associated with a high bleeding rate in
(22.7%) and 8 of the 71 (11.3%) enoxaparin patients died (Figure 2) patients with VTE and cancer. Long-term LMWH may be safer and as
effective as warfarin in treating VTE in patients with cancer.
VTE, No. (%)
Figure 2. Overall mortality during the 3-month treatment period in 146
Enoxaparin group
cancer patients with VTE treated with warfarin or enoxaparin. P=.07 by INTRODUCTION
Patients with cancer and VTE have a 3-fold lower survival rate than Risk Factors, No. (%)
At the time of this study, patients with cancer were often treated with Underlying risks include recurrent VTE and bleeding A recent meta-analysis showed initial treatment with LMWH caused a 40% reduction in mortality rate among patients with cancer compared with patients who received initial treatment with Six Month Follow-up
Previous studies have suggested that LMWH can be safely At the end of the 3-month treatment period, 121 patients were alive and were followed for an additional 3 months This open-label, randomized trial was conducted to compare the A total of 29 (38.7%) and 22 (31.0%) patients in the warfarin and efficacy of a fixed dose of LMWH administered subcutaneously with enoxaparin groups died during the 6-month follow-up oral-dose warfarin in patients with cancer and VTE for secondary Cancer progressed in 27 (36.0%) and 24 (33.8%) patients during CONCLUSIONS
During the 3-month treatment period, 15 (21.1%) and 7 (10.5%) Warfarin was associated with a high bleeding rate in patients with Patients ≥18 years with cancer and DVT, pulmonary embolism (PE), patients in the warfarin and enoxaparin groups, respectively, A total of 12 (16.0%) and 5 (7.0%) patients receiving warfarin and experienced major hemorrhage or recurrent VTE (P=.09) enoxaparin, respectively, experienced major hemorrhage (Table 2) The LMWH enoxaparin was as effective as warfarin and was When time to event for the primary outcome was analyzed, No patients in the enoxaparin group and 6 patients (8.0%) in the associated with a substantially lower bleeding rate Treatments
enoxaparin was more effective than warfarin (P=.04; Figure 1) Patients received a subcutaneous dose of enoxaparin (1.5 mg/kg/d) A total of 21 (29.6%) and 13 (19.4%) patients who received warfarin or enoxaparin and warfarin (6 to 10 mg orally) for 3 months and enoxaparin treatment experienced major hemorrhage, recurrent (adjusted to achieve an INR between 2.0 and 3.0) Patients who were randomized to oral anticoagulation received enoxaparin until the INR reached ≥2.0 on 2 consecutive measurements measured 24 hours apart after at ≥4 days of For educational purposes only. These were not prepared or reviewed by the primary author.


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