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

doi:10.1016/j.amjmed.2008.12.023

The American Journal of Medicine

Volume 122, Issue 8, August 2009, Pages 762-769.e3

https://doi.org/10.1016/j.amjmed.2008.12.023 Get rights and content

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 ≥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/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.

Section snippets

Study Design

The study design, patient eligibility and allocation, treatment regimens, and procedures for surveillance and follow-up are shown in Table 3 (available online).1, 3, 4, 10, 11, 12

Assessment of Outcomes

The primary efficacy outcome measure was the occurrence of objectively documented, symptomatic, recurrent venous thromboembolism at 12 weeks and 1 year. Other efficacy outcomes were: death rates at 12 weeks and 1 year; patients' self-reported treatment satisfaction during the treatment period; symptoms of

Study Population

Of 797 consecutive patients screened for eligibility between April 1997 and November 1998, 480 were randomized to long-term subcutaneous tinzaparin (240 patients) or to initial tinzaparin and long-term warfarin (240 patients). Excluded patients had received anticoagulant therapy for >2 days at time of referral (n = 104) or did not give consent (n = 213). The number of patients lost to follow-up was 0 at 3 months and 3 at 12 months (1 tinzaparin, 2 usual care). The groups were comparable at

Discussion

In Home-LITE, patients with proximal deep vein thrombosis not requiring hospitalization successfully received long-term treatment with tinzaparin or tinzaparin followed by warfarin (“usual care”). Rates of recurrent venous thromboembolism and deaths were similar in the 2 groups at 12 weeks and 1 year, and bleeding rates were similar during the 12-week study period. The patients treated with tinzaparin for 12 weeks expressed significantly greater satisfaction with their treatment, had a lower

Conclusions

Home-LITE is the first reported trial comparing long-term treatment of deep vein thrombosis with either a low-molecular-weight heparin or usual care in patients treated at home from the outset. The results add to the evidence showing similar efficacy and safety for the 2 regimens, and confirm the effectiveness of once-daily tinzaparin. Patients treated with tinzaparin expressed significantly greater satisfaction with their treatment. The occurrence of symptoms of post-thrombotic syndrome and of

Acknowledgement

LEO Pharma A/S Ltd. provided an unrestricted educational grant for the preparation of this article. Editorial assistance was provided by Watermeadow Medical.

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We conducted a systematic review and meta-analysis using PubMed, EMBASE and Cochrane Library for all related studies from inception until March 2020. Two reviewers independently screened studies, extracted data, and appraised the quality of included studies. The primary outcome was overall risk of PTS. The secondary outcomes were risks of each PTS category (mild, moderate, severe) and venous ulcer.
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: Funding: The study was supported by grants from the Medical Research Council (now Canadian Institutes for Health Research) and industry (LEO Pharma A/S Ltd., Ballerup, Denmark). Additional funding was provided by Pharmion and Dupont Pharmaceuticals. LEO Pharma provided the study drug and drug safety monitoring. The industry sponsors did not have any influence on the design or analysis of the study. The protocol was designed by 3 investigators. The Thrombosis Research Unit, University of Calgary, coordinated the study and carried out the data management and administrative duties. Statistical analysis was carried out independently of the industry sponsors by Rollin F. Brant, PhD, Department of Community Health Sciences, University of Calgary, Canada.

: Conflict of Interest: R. Hull has received grants/research support from Bayer Pharmaceuticals Corporation, LEO Pharma Inc., and sanofi-aventis; been a consultant for LEO Pharma, Inc., Pfizer Inc., and GlaxoSmithKline, and sat on advisory boards for Pfizer Inc. and sanofi-aventis. Graham Pineo is a consultant or advisory board member (or both): sanofi-aventis, Pfizer, and steering committee member for sanofi-aventis. Susan Solymoss has received honoraria from Pfizer and LEO-Pharma. Jane Liang, Man-Chiu Poon, Roy Cook, and Rollin Brant have no conflict of interest to declare. Gary Raskob receives consultant income or honoraria (or both) from the following companies: GlaxoSmithKline, Pfizer, and sanofi-aventis.

: Authorship: All authors had access to the data and contributed to/critically reviewed drafts of the manuscript.

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

Abstract

Purpose

Methods

Results

Conclusions

Section snippets

Study Design

Assessment of Outcomes

Study Population

Discussion

Conclusions

Acknowledgement

Chest

Chest

Am J Med

J Thromb Haemost

J Thromb Haemost

Chest

Thromb Res

Lancet

J Vasc Surg

J Vasc Surg

Eur J Vasc Endovasc Surg

Blood

J Vasc Surg

J Clin Epidemiol

Eur J Vasc Endovasc Surg

Chest

Self-managed long-term low-molecular-weight heparin therapy: the balance of benefits and harms

Am J Med

The post-thrombotic syndrome: the forgotten morbidity of deep venous thrombosis

J Thromb Thrombolysis

Below-knee elastic compression stockings to prevent the post-thrombotic syndrome: a randomized, controlled trial

Ann Intern Med

Interventional approaches to acute venous thromboembolism

Semin Respir Crit Care Med

Value of the ventilation/perfusion scan in acute pulmonary embolism. Results of the prospective investigation of pulmonary embolism diagnosis (PIOPED)

JAMA

Modified PIOPED criteria used in clinical practice

J Nucl Med

Measuring Functioning and Well-being: The Medical Outcomes Study Approach

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