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Prepublished online as a Blood First Edition Paper on July 12, 2002; DOI 10.1182/blood-2002-01-0108.
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Blood, 15 November 2002, Vol. 100, No. 10, pp. 3484-3488
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Recurrent venous thromboembolism and bleeding complications
during anticoagulant treatment in patients with cancer and venous
thrombosis
Paolo Prandoni,
Anthonie W. A. Lensing,
Andrea Piccioli,
Enrico Bernardi,
Paolo Simioni,
Bruno Girolami,
Antonio Marchiori,
Paola Sabbion,
Martin H. Prins,
Franco Noventa, and
Antonio Girolami
From the Department of Medical and Surgical Sciences,
Second Chair of Internal Medicine, and the Department of Clinical and
Experimental Medicine, Clinical Epidemiology Group, Fifth Chair of
Internal Medicine, University Hospital of Padua, Italy;
and Center for Vascular Medicine and the Department of Clinical
Epidemiology, Academic Medical Center, University of Amsterdam, The
Netherlands.
A small proportion of patients with deep vein thrombosis develop
recurrent venous thromboembolic complications or bleeding during
anticoagulant treatment. These complications may occur more frequently
if these patients have concomitant cancer. This prospective follow-up
study sought to determine whether in thrombosis patients those with
cancer have a higher risk for recurrent venous thromboembolism or
bleeding during anticoagulant treatment than those without cancer. Of
the 842 included patients, 181 had known cancer at entry. The 12-month
cumulative incidence of recurrent thromboembolism in cancer patients
was 20.7% (95% CI, 15.6%-25.8%) versus 6.8% (95% CI, 3.9%-
9.7%) in patients without cancer, for a hazard ratio of 3.2 (95% CI,
1.9-5.4) The 12-month cumulative incidence of major bleeding was 12.4%
(95% CI, 6.5%-18.2%) in patients with cancer and 4.9% (95% CI,
2.5%-7.4%) in patients without cancer, for a hazard ratio of 2.2 (95% CI, 1.2-4.1). Recurrence and bleeding were both related to cancer
severity and occurred predominantly during the first month of
anticoagulant therapy but could not be explained by sub- or
overanticoagulation. Cancer patients with venous thrombosis are more
likely to develop recurrent thromboembolic complications and major
bleeding during anticoagulant treatment than those without malignancy.
These risks correlate with the extent of cancer. Possibilities for
improvement using the current paradigms of anticoagulation seem limited
and new treatment strategies should be developed.

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