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Clinical outcome of patients with major bleeding after venous thromboembolism - Findings from the RIETE Registry*

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 2008: 100/5 (Nov) pp. 727-954
Pages: 789-796

Clinical outcome of patients with major bleeding after venous thromboembolism - Findings from the RIETE Registry*

José Antonio Nieto 1, Timoteo Camara 1, Elena Gonzalez-Higueras 1, Nuria Ruiz-Gimenez 2, Ricardo Guijarro 3, Pablo Javier Marchena 4, Manuel Monreal 5; for the RIETE Investigators*
1 Servicio de Medicina Interna, Hospital Virgen de la Luz, Cuenca, Spain; 2 Servicio de Medicina Interna, Hospital de la Princesa, Madrid, Spain; 3 Servicio de Medicina Interna, Hospital Carlos Haya de Málaga, Spain; 4 Servicio de Medicina Interna, Hospital de Sant Boi (Barcelona), Spain; 5 Professor of Medicine, Servicio de Medicina Interna, Hospital Universitari Germans Trias i Pujol, Badalona, Spain


venous thromboembolism, outcome, major bleeding, anticoagulant therapy


The natural history of patients with venous thromboembolism (VTE) who develop a major bleeding complication while on anticoagulant therapy is not well known. RIETE is a prospective registry of consecutive patients with symptomatic, objectively confirmed, acute VTE. The clinical characteristics, treatment decisions and outcome of all VTE patients who had major bleeding during the first three months of anticoagulant therapy were retrospectively studied.As of January 2007,17,368 patients were included in RIETE. Of these, 407 (2.3%) had major bleeding during the study period: 144 gastrointestinal, 119 haematoma, 51 intracranial, 43 genitourinary, 50 other. In 286 (69%) patients anticoagulant therapy was discontinued, in 74 (18%) not modified, in 38 (9.1%) a vena cava filter was inserted. During the first 30 days after bleeding, 24 (5.9%) patients re-bled, 20 (4.9%) had recurrentVTE, 133 (33%) died. Of these, 75 died of bleeding, 12 of recurrent pulmonary embolism. Most deaths occurred shortly after the bleeding episode (median:1 day).On multivariate analysis, insertion of a vena cava filter was the only variable independently associated with a lower incidence of fatal bleeding (odds ratio [OR]: 0.10; 95% confidence interval [CI]: 0.01–0.79) and all-cause mortality (OR: 0.21; 95%CI: 0.07–0.63). In conclusion, the occurrence of major bleeding in patients with VTE is outstanding in terms of overall mortality (33% within 30 days), fatal bleeding (18%) or re-bleeding (5.9%). However, these patients also have an increased incidence of recurrent VTE (4.9%) and fatal pulmonary embolism (1.2%).

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