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J Thromb Haemost. 2015 Jun;13(6):1028-35. doi: 10.1111/jth.12923. Epub 2015 May 10.

Treatment of venous thromboembolism in cancer patients with dalteparin for up to 12 months: the DALTECAN Study.

Author information

1
University of Rochester Medical Center, Rochester, NY, USA.
2
Georgetown University Hospital, Washington, DC, USA.
3
Brigham and Women's Hospital, Boston, MA, USA.
4
London Health Sciences Centre, London, Ontario, Canada.
5
Hospital Universitari Germans Trias i Pujol, Carretera de Canyet, Barcelona, Spain.
6
Leiden University Medical Center, Leiden, the Netherlands.
7
University Hospital, Uppsala, Sweden.
8
Hamilton Health Sciences, McMaster University, Hamilton, ON, Canada.
9
Duke University Medical Center, Durham, NC, USA.
10
Medical University of Vienna, Wien, Austria.
11
Barts and The London Queen Mary's School of Medicine and Dentistry, London, UK.

Abstract

BACKGROUND:

Treatment of venous thromboembolism (VTE) in patients with cancer has a high rate of recurrence and bleeding complications. Guidelines recommend low-molecular-weight heparin (LMWH) for at least 3-6 months and possibly indefinitely for patients with active malignancy. There are, however, few data supporting treatment with LMWH beyond 6 months. The primary aim of the DALTECAN study (NCT00942968) was to determine the safety of dalteparin between 6 and 12 months in cancer-associated VTE.

METHODS:

Patients with active cancer and newly diagnosed VTE were enrolled in a prospective, multicenter study and received subcutaneous dalteparin for 12 months. The rates of bleeding and recurrent VTE were evaluated at months 1, 2-6 and 7-12.

FINDINGS:

Of 334 patients enrolled, 185 and 109 completed 6 and 12 months of therapy; 49.1% had deep vein thrombosis (DVT); 38.9% had pulmonary embolism (PE); and 12.0% had both on presentation. The overall frequency of major bleeding was 10.2% (34/334). Major bleeding occurred in 3.6% (12/334) in the first month, and 1.1% (14/1237) and 0.7% (8/1086) per patient-month during months 2-6 and 7-12, respectively. Recurrent VTE occurred in 11.1% (37/334); the incidence rate was 5.7% (19/334) for month 1, 3.4% (10/296) during months 2-6, and 4.1% (8/194) during months 7-12. One hundred and sixteen patients died, four due to recurrent VTE and two due to bleeding.

CONCLUSION:

Major bleeding was less frequent during dalteparin therapy beyond 6 months. The risk of developing major bleeding complications or VTE recurrence was greatest in the first month of therapy and lower over the subsequent 11 months.

KEYWORDS:

cancer; dalteparin; deep vein thrombosis; low-molecular-weight heparin; pulmonary embolism; venous thromboembolism

Comment in

PMID:
25827941
DOI:
10.1111/jth.12923
[Indexed for MEDLINE]
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