Home Therapy of Venous Thrombosis with Long-term LMWH versus Usual Care: Patient Satisfaction and Post-thrombotic Syndrome

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 >= 5 days plus oral warfarin, commenced on day 1, international normalized ratio-adjusted, and continued for >= 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/usualcare 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. (C) 2009 Elsevier Inc. All rights reserved. The American Journal of Medicine (2009) 122, 762-769