Risk assessment tools for bleeding in patients with unprovoked venous thromboembolism: an analysis of the PLATO-VTE study
Noori A.M. Guman 1) 2), Anne-Marie L. Becking 1), Suzanne S. Weijers 3), Noémie Kraaijpoel 1), Frits I. Mulder 1) 2), Marc Carrier 4), Luis Jara-Palomares 5) 6), Marcello Di Nisio 7), Walter Ageno 8), Jan Beyer-Westendorf 9), Frederikus A. Klok 10), Thomas Vanassche 11), Johannes M.M.B. Otten 12), Benilde Cosmi 13), Mike J.L. Peters 14), Marije ten Wolde 15), Aurélien Delluc 4), Veronica Sanchez-Lopez 6) 16), Ettore Porreca 17), Patrick M.M. Bossuyt 18), Victor E.A. Gerdes 1) 19), Harry R. Büller 1), Nick van Es 1), Pieter W. Kamphuisen 1) 2)
1-Department of Vascular Medicine, Amsterdam Cardiovascular Sciences, Amsterdam Univesity Medical Center, University of Amsterdam, Amsterdam, the Netherlands; Amsterdam Cardiovascular Sciences, Pulmonary Hypertension and Thrombosis, Amsterdam, the Netherlands
2-Department of Internal Medicine, Tergooi MC, Hilversum, the Netherlands
3-Department of Central Diagnostic Laboratory, Amsterdam University Medical Center location Vrije Universiteit Amsterdam, Amsterdam, the Netherlands
4-Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, Ontario, Canada
5-Department of Respiratory Diseases, Hospital Universitario Virgen del Rocio, Seville, Spain
6-Centro de Investigación Biomédica en Red de Enfermedades Respiratorias, Instituto de Salud Carlos III, Madrid, Spain
7-Department of Medicine and Ageing Sciences, Gabriele D’Annunzio University, Chieti, Italy
8-Department of Medicine and Surgery, University of Insubria, Varese, Italy
9-Thrombosis Research Unit, Department of Medicine I, Division “Thrombosis & Hemostasis” University Hospital “Carl Gustav Carus” Dresden, Germany
10-Department of Medicine – Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands
11-Department of Cardiovascular Sciences, University Hospitals Leuven, Leuven, Belgium
12-Department of Internal Medicine, Meander Medisch Centrum, Amersfoort, the Netherlands
13-Department of Medical and Surgical Sciences, University of Bologna Istituto di Ricovero e Cura a Carattere Scientifico Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy
14-Department of Internal Medicine, University Medical Center Utrecht, Utrecht, the Netherlands
15-Department of Internal Medicine, Flevo Hospital, Almere, the Netherlands
16-Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocio/Centro de Investigaciones Cientificas/Universidad de Sevilla, Seville, Spain
17-Department of Innovative Technologies in Medicine and Dentistry, School of Medicine and Health Sciences, “G. D’Annunzio” University, Chieti, Italy
18-Department of Epidemiology and Data Science, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands
19-Department of Internal Medicine, Spaarne Hospital, Hoofddorp, the Netherlands
Abstract
Background
Guidelines suggest indefinite anticoagulation after unprovoked venous thromboembolism (VTE) unless the bleeding risk is high, yet there is no consistent guidance on assessing bleeding risk.
Objectives
This study aimed to evaluate the performance of 5 bleeding risk tools (RIETE, VTE-BLEED, CHAP, VTE-PREDICT, and ABC-Bleeding).
Methods
PLATO-VTE, a prospective cohort study, included patients aged ≥40 years with a first unprovoked VTE. Risk estimates were calculated at VTE diagnosis and after 3 months of treatment. Primary outcome was clinically relevant bleeding, as per International Society on Thrombosis and Haemostasis criteria, during 24-month follow-up. Discrimination was assessed by the area under the receiver operating characteristic curve (AUROC). Patients were classified as having a “high risk” and “non–high risk” of bleeding according to predefined thresholds; bleeding risk in both groups was compared by hazard ratios (HRs).
Results
Of 514 patients, 38 (7.4%) had an on-treatment bleeding. AUROCs were 0.58 (95% CI, 0.48-0.68) for ABC-Bleeding, 0.56 (95% CI, 0.46-0.66) for RIETE, 0.53 (95% CI, 0.43-0.64) for CHAP, 0.50 (95% CI, 0.41-0.59) for VTE-BLEED, and 0.50 (95% CI, 0.40-0.60) for VTE-PREDICT. The proportion of high-risk patients ranged from 1.4% with RIETE to 36.9% with VTE-BLEED. The bleeding incidence in the high-risk groups ranged from 0% with RIETE to 13.0% with ABC-Bleeding, and in the non–high-risk groups, it varied from 7.7% with ABC-Bleeding to 9.6% with RIETE. HRs ranged from 0.93 (95% CI, 0.46-1.9) for VTE-BLEED to 1.67 (95% CI, 0.86-3.2) for ABC-Bleeding. Recalibration at 3-month follow-up did not alter the results.
Conclusion
In this cohort, discrimination of currently available bleeding risk tools was poor. These data do not support their use in patients with unprovoked VTE.