RESUMO
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%).
Assuntos
Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Embolia Pulmonar/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Doença Aguda , Idoso , Idoso de 80 Anos ou mais , Argentina/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Hemorragia/mortalidade , Humanos , Israel/epidemiologia , Masculino , Pessoa de Meia-Idade , Razão de Chances , Embolia Pulmonar/etiologia , Embolia Pulmonar/mortalidade , Recidiva , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores de Tempo , Resultado do Tratamento , Filtros de Veia Cava , Tromboembolia Venosa/complicações , Tromboembolia Venosa/mortalidadeRESUMO
A score that can accurately determine the risk of major bleeding during anticoagulant therapy may help to make decisions on anticoagulant use. RIETE is an ongoing registry of consecutive patients with acute venous thromboembolism (VTE). We composed a score to predict the risk for major bleeding within three months of anticoagulant therapy. Of 19,274 patients enrolled, 13,057 (67%) were randomly assigned to the derivation sample, 6,572 to the validation sample. In the derivation sample 314 (2.4%) patients bled (fatal bleeding, 105). On multivariate analysis, age >75 years, recent bleeding, cancer, creatinine levels >1.2 mg/dl, anemia, or pulmonary embolism at baseline were independently associated with an increased risk for major bleeding. A score was composed assigning 2 points to recent bleeding, 1.5 to abnormal creatinine levels or anemia, 1 point to the remaining variables. In the derivation sample 2,654 (20%) patients scored 0 points (low risk); 9,645 (74%) 1-4 points (intermediate); 758 (5.8%) >4 points (high risk). The incidences of major bleeding were: 0.3% (95% confidence interval [CI]: 0.1-0.6), 2.6% (95% CI: 2.3-2.9), and 7.3% (95% CI: 5.6-9.3), respectively. The likelihood ratio test was: 0.14 (95% CI: 0.07-0.27) for patients at low risk;2.96 (95% CI: 2.18-4.02) for those at high risk. In the validation sample the incidence of major bleeding was: 0.1%, 2.8%, and 6.2%, respectively. In conclusion, a risk score based on six variables documented at entry can identify VTE patients at low, intermediate, or high risk for major bleeding during the first three months of therapy.