Home therapy of venous thrombosis with long-term LMWH versus usual care: patient satisfaction and post-thrombotic syndrome.
OBJECTIVE
Home-LITE compared long-term treatment at home with tinzaparin or usual care in terms of efficacy, safety, patients' treatment satisfaction, incidence of post-thrombotic syndrome, and associated venous leg ulcers.


METHODS
This multicenter, randomized, controlled trial enrolled 480 patients with documented, acute, proximal deep vein thrombosis. Patients received tinzaparin 175 IU/kg subcutaneously once daily for 12 weeks, or tinzaparin for >or=5 days plus oral warfarin, commenced on day 1, international normalized ratio-adjusted, and continued for >or=12 weeks ("usual care"). Patients received 1 in-clinic injection, then home treatment.


RESULTS
The rate of recurrent venous thromboembolism at 12 weeks was 3.3% in both groups (absolute difference 0%; 95% confidence interval -3.2-3.2), and at 1 year was 10.4%/8.3% in the tinzaparin/usual-care groups, respectively (difference 2.1%; 95% confidence interval -3.1-7.3). There were no between-group differences in deaths at 12 weeks or 1 year, or bleeding at 12 weeks. Patients in the tinzaparin group expressed significantly greater treatment satisfaction (P = .0024), particularly regarding freedom from the inconvenience of blood monitoring; were less likely to report signs/symptoms of post-thrombotic syndrome (individual odds ratios 0.66 to 0.91, overall odds ratio 0.77, P = .001); and reported fewer leg ulcers at 12 weeks: 1 (0.5%) versus 8 (4.1%) (P = .02) with usual care.


CONCLUSIONS
Long-term home treatment with tinzaparin or usual care resulted in similar rates of recurrent venous thromboembolism, death, and bleeding. The significantly lower incidence of post-thrombotic syndrome and leg ulcers observed in the tinzaparin group is a potentially important benefit and deserves further study.
Hull
Russell D
RD
University of Calgary, Calgary, AB, Canada. rdhull@ucalgary.ca
Pineo
Graham F
GF
Brant
Rollin
R
Liang
Jane
J
Cook
Roy
R
Solymoss
Susan
S
Poon
Man-Chiu
MC
Raskob
Gary
G
D000284:Administration, Oral; D005260:Female; D005343:Fibrinolytic Agents / Q000008:administration & dosage*; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage*; D006699:Home Care Services; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D054070:Postthrombotic Syndrome / Q000517:prevention & control*; D012008:Recurrence; D000078222:Tinzaparin; D054556:Venous Thromboembolism / Q000517:prevention & control; D020246:Venous Thrombosis / Q000188:drug therapy*; D014859:Warfarin / Q000008:administration & dosage
D005343:Fibrinolytic Agents; D006495:Heparin, Low-Molecular-Weight; D014859:Warfarin; D000078222:Tinzaparin