Thromb Haemost 2008; 100(05): 789-796
DOI: 10.1160/TH08-06-0390
Blood Coagulation, Fibrinolysis and Cellular Haemostasis
Schattauer GmbH

Clinical outcome of patients with major bleeding after venous thromboembolism

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

Publication History

Received 19 June 2008

Accepted after minor revision 12 August 2008

Publication Date:
15 December 2017 (online)

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Summary

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 recurrent VTE, 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%).

* A full list of RIETE investigators is given in the appendix.