Predictive variables for major bleeding events in patients presenting with documented acute venous thromboembolism. Findings from the RIETE Registry
Nuria Ruíz-Giménez1, Carmen Suárez1, Rocío González2, José Antonio Nieto3, José Antonio Todolí4, Ángel Luis Samperiz5, Manuel Monreal6, and the RIETE Investigators*
1Servicio de Medicina Interna, Hospital de la Princesa, Madrid, Spain; 2Fundación de Investigación Biomédica, Hospital de la Princesa, Madrid, Spain; 3Servicio de Medicina Interna, Hospital Virgen de la Luz, Cuenca, Spain; 4Servicio de Medicina Interna, Hospital Universitario La Fe, Valencia, Spain; 5Servicio de Medicina Interna, Hospital Reina Sofia de Tudela, Navarra, Spain; 6Servicio de Medicina Interna, Hospital Germans Trias i Pujol, Badalona, Spain
Prediction, bleeding complications, venous thromboembolism
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 identifyVTE patients at low, intermediate, or high risk for major bleeding during the first three months of therapy.