Comparison of low-molecular-weight heparin, administered primarily at home, with unfractionated heparin, administered in hospital, and subcutaneous heparin, administered at home for deep-vein thrombosis
G. Belcaro et al., Comparison of low-molecular-weight heparin, administered primarily at home, with unfractionated heparin, administered in hospital, and subcutaneous heparin, administered at home for deep-vein thrombosis, ANGIOLOGY, 50(10), 1999, pp. 781-787
In this study, 294 patients with acute proximal DVT (deep venous thrombosis
) were randomly assigned to receive intravenous standard heparin in the hos
pital (98 patients) or low-molecular-weight heparin (LMWH) (nadroparin 0.1
mL [equivalent to 100 AXa IU] per kg of body weight subcutaneously twice da
ily) administered primarily at home (outpatients) or alternatively in hospi
tal (97 patients) or subcutaneous calcium heparin (SCHep) (99 patients, 0.5
mL bid) administered directly at home. The study design allowed outpatient
s taking LMWH heparin to go home immediately and hospitalized patients taki
ng LMWH to be discharged early. Patients treated with standard heparin or L
MWH received the oral anticoagulant starting on the second day, and heparin
was discontinued when the therapeutic range (INR 2-3) had been reached. An
ticoagulant treatment was maintained for 3 months. Patients treated with SC
Hep were injected twice daily for 3 months without oral anticoagulants. Pat
ients were evaluated for inclusion and follow-up with color duplex scanning
. Venography was not used. In case of suspected pulmonary embolism (PE) a v
entilatory-perfusional lung scan was performed. Endpoints of the study were
recurrent or extension of DVT, bleeding, the number of days spent in hospi
tal, and costs of treatments. Of the 325 patients included, 294 completed t
he study. Dropouts totaled 31 (10.5%); six of the 325 included patients (1.
8%) died from the related, neoplastic illness. Recurrence or extension of D
VT was observed in 6.1% of patients in the LMWH group, in 6.2% in the stand
ard heparin group, and in 7.1% in the SCHep group. Most recurrences (11/17)
were in the first month in all groups. Bleedings were all minor, mostly du
ring hospital stay. Hospital stay in patients treated with LMWH was 1.2 +/-
1.4 days in comparison with 5.4 +/- 1.2 in those treated with standard hep
arin. There was no hospital stay in the SCHep group. Average treatment cost
s in 3 months in the standard heparin group (US $2,760) were considered to
be 100%; in comparison costs in the LMWH group was 28% of the standard hepa
rin and 8% in the SCHep group. This study indicated that LMWH and SCHep can
be used safely and effectively to treat patients with proximal DVT at home
at a lower cost.