Derivation and validation of a novel bleeding risk score for elderly patients with venous thromboembolism on extended anticoagulation

Eva Seiler; Andreas Limacher; Marie Méan; Hans-Jürg Beer; Joseph Osterwalder; Beat Frauchiger; Marc Righini; Markus Aschwanden; Christian M. Matter; Martin Banyai; Nils Kucher; Daniel Staub; Bernhard Lämmle; Nicolas Rodondi; Alessandro Squizzato; Drahomir Aujesky

doi:10.1160/TH17-03-0162

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2017; 117(10): 1930-1936
DOI: 10.1160/TH17-03-0162

Stroke, Systemic or Venous Thromboembolism

Schattauer GmbH

Derivation and validation of a novel bleeding risk score for elderly patients with venous thromboembolism on extended anticoagulation

Eva Seiler

¹Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

,

Andreas Limacher

²CTU Bern and Institute of Social and Preventive Medicine, University of Bern, Switzerland

,

Marie Méan

¹Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

³Department of General Internal Medicine, Lausanne University Hospital, Switzerland

,

Hans-Jürg Beer

⁴Department of Internal Medicine, Cantonal Hospital of Baden, Switzerland

,

Joseph Osterwalder

⁵Emergency Department, Cantonal Hospital of St. Gallen, Switzerland

,

Beat Frauchiger

⁶Department of Internal Medicine, Cantonal Hospital of Frauenfeld, Switzerland

,

Marc Righini

⁷Division of Angiology and Hemostasis, Geneva University Hospital, Switzerland

,

Markus Aschwanden

⁸Department of Angiology, Basel University Hospital, Switzerland

,

Christian M. Matter

⁹Cardiovascular Research, Institute of Physiology, Zurich Center for Integrative Human Physiology, University of Zurich, Switzerland

¹⁰Department of Cardiology, University Heart Center, University Hospital Zurich, Switzerland

,

Martin Banyai

¹¹Division of Angiology, Cantonal Hospital of Lucerne, Switzerland

,

Nils Kucher

¹²Division of Angiology, Inselspital, Bern University Hospital, University of Bern, Switzerland

,

Daniel Staub

⁸Department of Angiology, Basel University Hospital, Switzerland

,

Bernhard Lämmle

¹³University Clinic of Hematology and Central Hematology Laboratory, Inselspital, Bern University Hospital, University of Bern, Switzerland

¹⁴Center for Thrombosis and Hemostasis, University Medical Center, Mainz, Germany

,

Nicolas Rodondi

¹Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

¹⁵Institute of Primary Health Care (BIHAM), University of Bern, Switzerland; and

,

Alessandro Squizzato

¹⁶Research Centre on Thromboembolic Disorders and Antithrombotic Therapies, Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy

,

Drahomir Aujesky

¹Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland

› Author Affiliations

Abstract

Summary

Existing clinical scores do not perform well in predicting bleeding in elderly patients with acute venous thromboembolism (VTE). We sought to derive an easy-to-use clinical score to help physicians identify elderly patients with VTE who are at high-risk of bleeding during extended anticoagulation (>3 months). Our derivation sample included 743 patients aged ≥65 years with VTE who were enrolled in a prospective multicenter cohort study. All patients received extended anticoagulation with vitamin K antagonists. We derived our score using competing risk regression, with the time to a first major bleeding up to 36 months of extended anticoagulation as the outcome, and 17 candidate variables as predictors. We used bootstrapping methods for internal validation. Sixty-six (9%) patients suffered major bleeding. The clinical score is based on seven clinical factors (previous bleeding, active cancer, low physical activity, anemia, thrombocytopenia, antiplatelet drugs/NSAIDs, and poor INR control). Overall, 48% of patients were classified as low-risk, 37% as moderate-risk, and 15% as high-risk of bleeding. The rate of major bleeding was 1.4 events in low-risk, 5.0 events in moderate-risk, and 12.2 events per 100 patientyears in high-risk patients. The c-statistic was 0.78 at 3 months and 0.71 at 36 months of extended anticoagulation. Model calibration was excellent (p=0.93). Internal validation showed similar results. This simple clinical score accurately identified elderly patients with VTE who are at high risk of major bleeding and who may not benefit from extended anticoagulation. Further validation of the score is important before its implementation into practice. The study is registered to https://clinicaltrials.gov as NCT00973596.

This work was carried out at the Department of General Internal Medicine in the Bern University Hospital, Switzerland.

Keywords

Anticoagulation - bleeding risk - elderly

Full Text

References

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