Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban‐treated Patients With Venous Thromboembolism at Low Risk for Major Bleeding

Abstract

ObjectivesOutpatient 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.MethodsAll 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).ResultsA 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.ConclusionsFour 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.

In Well-Selected Patients With a Femoral Deep Vein Thrombosis Central Venous Imaging May Identify Additional Iliocaval Disease

“…12,13 In efforts to improve the sensitivity and specificity for the diagnosis of DVT, multiple scoring methodologies have been developed such as the Well's score, and these take into account clinical as well as historical variables. 14,15 Ultimately, VDU represents the most sensitive and specific modality for the diagnosis of DVT in the lower extremities. 2 The performance of venous duplex has been standardized by various accrediting bodies.…”

Study protocol for a multicentre implementation trial of monotherapy anticoagulation to expedite home treatment of patients diagnosed with venous thromboembolism in the emergency department

“…Bleeding events will be further characterised as major bleeding or clinically relevant non-major bleeding, using published criteria, further defined in the guidance document and using previously established criteria according to guidelines published by ISTH. 1 31 …”

“…For example, the 30-day incidence of major bleeding was <1.0% in both the AMPLIFY and EINSTEIN trials, and for patients with low risk of bleeding, the rate can be expected to be about 0.5% with upper limit 95% CI <1.00. 1 Additionally, in 2015, the 90-day incidence of the composite rate for VTE recurrence and major bleeding reported in systematic reviews and meta analyses of outcomes of low-risk patients with VTE diagnosed in the ED and treated at home with VKAs was 18/785 (2.2%, 95% CI 1.4% to 3.6%). 2 den Exter et al randomised 275 patients who were Hestia negative to be treated with VKAs at home; 90-day follow-up identified three patients with recurrent VTE and three with major bleeding (6/275, 2.2%).…”

Bleeding Risk Assessment in Patients with Venous Thromboembolism

“…31 A variety of studies already validated the score and found decent discriminative ability between the 3 bleeding risk categories, but poor to moderate predictive value. 50,53,55,56 Risk Assessment for Extended Anticoagulation Treatment…”