Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients With Venous Thromboembolism at Low Risk for Major Bleeding.
Outpatient treatment of acute venous thromboembolism (VTE) requires the selection of patients with a low risk of bleeding during the first few weeks of anticoagulation. The accuracy of four systems, originally derived for predicting bleeding in VTE treated with vitamin K antagonists (VKAs), was assessed in VTE patients treated with rivaroxaban.
All patients treated with rivaroxaban in the multinational EINSTEIN deep vein thrombosis (DVT) and pulmonary embolism (PE) trials were included. Major bleeding was defined as ≥2 g/dL drop in hemoglobin or ≥2-unit blood transfusion, bleeding in critical area, or bleeding contributing to death. The authors examined the incidence of major bleeding in patients with low-risk assignment by the systems of Ruiz-Gimenez et al. (score = 0 to 1), Beyth et al. (score = 0), Kuijer et al. (score = 0), and Landefeld and Goldman. (score = 0). For clinical relevance, the definition of low risk for all scores except Kuijer includes all patients < 65 years with no prior bleeding history and no comorbid conditions (current cancer, renal insufficiency, diabetes mellitus, anemia, prior stroke, or myocardial infarction).
A total of 4,130 patients (1,731 with DVT only, 2,399 with PE with or without DVT) were treated with rivaroxaban for a mean (±SD) duration of 207.6 (±95.9) days. Major bleeding occurred in 1.0% (40 of 4,130; 95% confidence interval [CI] = 0.7% to 1.3%) overall. Rates of major bleeding for low-risk patients during the entire treatment period were similar: Ruiz-Gimenez et al., 12 of 2,622 (0.5%; 95% CI = 0.2% to 0.8%); Beyth et al., nine of 2,249 (0.4%; 95% CI = 0.2% to 0.8%); Kuijer et al., four of 1,186 (0.3%; 95% CI = 0.1% to 0.9%); and Landefeld and Goldman, 11 of 2,407 (0.5%; 95% CI = 0.2% to 0.8%). At 30 days, major bleed rates for low-risk patients were as follows: Ruiz-Gimenez et al., five of 2,622 (0.2%; 95% CI = 0.1% to 0.4%); Beyth et al., five of 2,249 (0.2%; 95% CI = 0.1% to 0.5%); Kuijer et al., three of 1,186 (0.3%; 95% CI = 0.1% to 0.7%); and Landefeld and Goldman, seven of 2,407 (0.3%; 95% CI = 0.1% to 0.6%). No low-risk patient had a fatal bleed.
Four scoring systems that use criteria obtained in routine clinical practice, derived to predict low bleeding risk with VKA treatment for VTE, identified patients with less than a 1% risk of major bleeding during full-course treatment with rivaroxaban.
Kline JA
，Jimenez D
，Courtney DM
，Ianus J
，Cao L
，Lensing AW
，Prins MH
，Wells PS
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Comparison of Bleeding Risk Scores in Elderly Patients Receiving Extended Anticoagulation with Vitamin K Antagonists for Venous Thromboembolism.
In elderly patients with venous thromboembolism (VTE), the decision to extend anticoagulation beyond 3 months must be weighed against the bleeding risk. We compared the predictive performance of 10 clinical bleeding scores (VTE-BLEED, Seiler, Kuijer, Kearon, RIETE, ACCP, OBRI, HEMORR2HAGES, HAS-BLED, ATRIA) in elderly patients receiving extended anticoagulation for VTE.
In a multicenter Swiss cohort study, we analyzed 743 patients aged ≥65 years who received extended treatment with vitamin K antagonists after VTE. The outcomes were the time to a first major and clinically relevant bleeding. For each score, we classified patients into two bleeding risk categories (low/moderate vs. high). We calculated likelihood ratios and the area under the receiver operating characteristic (ROC) curve for each score.
Over a median anticoagulation duration of 10.1 months, 45 patients (6.1%) had a first major and 127 (17.1%) a clinically relevant bleeding. The positive likelihood ratios for predicting major bleeding ranged from 0.69 (OBRI) to 2.56 (Seiler) and from 1.07 (ACCP) to 2.36 (Seiler) for clinically relevant bleeding. The areas under the ROC curves were poor to fair and varied between 0.47 (OBRI) and 0.70 (Seiler) for major and between 0.52 (OBRI) and 0.67 (HEMORR2HAGES) for clinically relevant bleeding.
The predictive performance of most clinical bleeding risk scores does not appear to be sufficiently high to identify elderly patients with VTE who are at high risk of bleeding and who may therefore not be suitable candidates for extended anticoagulation.
Frei AN
，Stalder O
，Limacher A
，Méan M
，Baumgartner C
，Rodondi N
，Aujesky D
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Prediction of major bleeding in patients receiving DOACs for venous thromboembolism: A prospective cohort study.
In the direct oral anticoagulants (DOACs) era, extended anticoagulation is an attractive strategy after venous thromboembolism (VTE). The role of currently available bleeding risk scores for VTE patients treated with DOACs in clinical practice is undefined.
Consecutive patients with VTE were included in a prospective multicenter cohort at the initiation of treatment with DOACs. The role of ATRIA, HAS-BLED, Kuijer, ORBIT, RIETE and VTE-BLEED scores in predicting major bleeding (ISTH definition) while on DOAC treatment was assessed.
Overall, 1034 patients were included and followed for one year or until the end of treatment or the occurrence of major bleeding. During study period, 26 major bleedings occurred in 25 patients (2.8% patient-year). Anemia, bleeding history and creatinine clearance <60 ml/min were significant predictors of major bleedings. The predictive value of bleeding risk scores was modest. In the 12-month study period, ORBIT (HR intermediate-high vs. low risk patients 3.62, 95% CI 1.65-7.94 and c-statistics 0.645, 95% CI 0.523-0.767) and VTE-BLEED (HR high vs. low 16.11, 95% CI 2.18-119.09 and c-statistics 0.674, 95% CI 0.593-0.755) score significantly predicted major bleeding. The lowest incidence of major bleeding (0.3%) was observed in the low-risk category of VTE-BLEED, while the highest (7.1%) in the high-risk category of ORBIT.
In a real-life cohort of patients with VTE treated with DOACs, the predictive value of currently available bleeding risk scores was modest and not statistically different. Whether these scores can be used for decision making on anticoagulation should be assessed in management studies.
Vedovati MC
，Mancuso A
，Pierpaoli L
，Paliani U
，Conti S
，Ascani A
，Galeotti G
，Di Filippo F
，Caponi C
，Agnelli G
，Becattini C
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Prospective, multicenter validation of prediction scores for major bleeding in elderly patients with venous thromboembolism.
The Outpatient Bleeding Risk Index (OBRI) and the Kuijer, RIETE and Kearon scores are clinical prognostic scores for bleeding in patients receiving oral anticoagulants for venous thromboembolism (VTE). We prospectively compared the performance of these scores in elderly patients with VTE.
In a prospective multicenter Swiss cohort study, we studied 663 patients aged ≥ 65 years with acute VTE. The outcome was a first major bleeding at 90 days. We classified patients into three categories of bleeding risk (low, intermediate and high) according to each score and dichotomized patients as high vs. low or intermediate risk. We calculated the area under the receiver-operating characteristic (ROC) curve, positive predictive values and likelihood ratios for each score.
Overall, 28 out of 663 patients (4.2%, 95% confidence interval [CI] 2.8-6.0%) had a first major bleeding within 90 days. According to different scores, the rate of major bleeding varied from 1.9% to 2.1% in low-risk, from 4.2% to 5.0% in intermediate-risk and from 3.1% to 6.6% in high-risk patients. The discriminative power of the scores was poor to moderate, with areas under the ROC curve ranging from 0.49 to 0.60 (P = 0.21). The positive predictive values and positive likelihood ratios were low and varied from 3.1% to 6.6% and from 0.72 to 1.59, respectively.
In elderly patients with VTE, existing bleeding risk scores do not have sufficient accuracy and power to discriminate between patients with VTE who are at a high risk of short-term major bleeding and those who are not.
Scherz N
，Méan M
，Limacher A
，Righini M
，Jaeger K
，Beer HJ
，Frauchiger B
，Osterwalder J
，Kucher N
，Matter CM
，Banyai M
，Angelillo-Scherrer A
，Lämmle B
，Husmann M
，Egloff M
，Aschwanden M
，Bounameaux H
，Cornuz J
，Rodondi N
，Aujesky D
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