Home therapy of venous thrombosis with long-term LMWH versus usual care: patient satisfaction and post-thrombotic syndrome.

Abstract

PURPOSE:

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.

• Authors: Russell D Hull, Graham F Pineo, Rollin Brant, Jane Liang, Roy Cook, Susan Solymoss, Man-Chiu Poon, Gary Raskob, LITE Trial Investigators
• Journal: The American journal of medicine (Am J Med) Vol. 122 Issue 8 Pg. 762-769.e3 (Aug 2009) ISSN: 1555-7162 [Electronic] United States
• PMID: 19635277 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Heparin, Low-Molecular-Weight
• Warfarin
• Tinzaparin

Topics

• Administration, Oral
• Female
• Fibrinolytic Agents (administration & dosage)
• Heparin, Low-Molecular-Weight (administration & dosage)
• Home Care Services
• Humans
• Injections, Subcutaneous
• Male
• Middle Aged
• Patient Satisfaction
• Postthrombotic Syndrome (prevention & control)
• Recurrence
• Tinzaparin
• Venous Thromboembolism (prevention & control)
• Venous Thrombosis (drug therapy)
• Warfarin (administration & dosage)