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

Jeffrey Kline, David Jimenez, D. Mark Courtney, Juliana Ianus, Lynn Cao, Anthonie W A Lensing, Martin H. Prins, Philip S. Wells

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Objectives 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. Methods 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). Results 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. Conclusions 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.

Original languageEnglish (US)
Pages (from-to)144-150
Number of pages7
JournalAcademic Emergency Medicine
Volume23
Issue number2
DOIs
StatePublished - Feb 1 2016

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Venous Thromboembolism
Hemorrhage
Confidence Intervals
Venous Thrombosis
Vitamin K
Pulmonary Embolism
Rivaroxaban
Therapeutics
Blood Transfusion
Patient Selection
Renal Insufficiency
Anemia
Diabetes Mellitus
Hemoglobins
Outpatients
Stroke
Myocardial Infarction

ASJC Scopus subject areas

  • Emergency Medicine

Cite this

Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients with Venous Thromboembolism at Low Risk for Major Bleeding. / Kline, Jeffrey; Jimenez, David; Courtney, D. Mark; Ianus, Juliana; Cao, Lynn; Lensing, Anthonie W A; Prins, Martin H.; Wells, Philip S.

In: Academic Emergency Medicine, Vol. 23, No. 2, 01.02.2016, p. 144-150.

Research output: Contribution to journalArticle

Kline, Jeffrey ; Jimenez, David ; Courtney, D. Mark ; Ianus, Juliana ; Cao, Lynn ; Lensing, Anthonie W A ; Prins, Martin H. ; Wells, Philip S. / Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients with Venous Thromboembolism at Low Risk for Major Bleeding. In: Academic Emergency Medicine. 2016 ; Vol. 23, No. 2. pp. 144-150.
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title = "Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients with Venous Thromboembolism at Low Risk for Major Bleeding",
abstract = "Objectives 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. Methods 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). Results 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. Conclusions 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.",
author = "Jeffrey Kline and David Jimenez and Courtney, {D. Mark} and Juliana Ianus and Lynn Cao and Lensing, {Anthonie W A} and Prins, {Martin H.} and Wells, {Philip S.}",
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TY - JOUR

T1 - Comparison of Four Bleeding Risk Scores to Identify Rivaroxaban-treated Patients with Venous Thromboembolism at Low Risk for Major Bleeding

AU - Kline, Jeffrey

AU - Jimenez, David

AU - Courtney, D. Mark

AU - Ianus, Juliana

AU - Cao, Lynn

AU - Lensing, Anthonie W A

AU - Prins, Martin H.

AU - Wells, Philip S.

PY - 2016/2/1

Y1 - 2016/2/1

N2 - Objectives 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. Methods 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). Results 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. Conclusions 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.

AB - Objectives 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. Methods 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). Results 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. Conclusions 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.

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