Risk assessment tools for bleeding in patients with unprovoked venous thromboembolism: an analysis of the PLATO-VTE study
Guman, Noori A.M.; Becking, Anne Marie L.; Weijers, Suzanne S.; Kraaijpoel, Noémie; Mulder, Frits I.; Carrier, Marc; Jara-Palomares, Luis; Di Nisio, Marcello; Ageno, Walter; Beyer-Westendorf, Jan; Klok, Frederikus A.; Vanassche, Thomas; Otten, Johannes M.M.B.; Cosmi, Benilde; Peters, Mike J.L.; Wolde, Marije ten; Delluc, Aurélien; Sanchez-Lopez, Veronica; Porreca, Ettore; Bossuyt, Patrick M.M.; Gerdes, Victor E.A.; Büller, Harry R.; van Es, Nick; Kamphuisen, Pieter W.
(2024) Journal of Thrombosis and Haemostasis, volume 22, issue 9, pp. 2470 - 2481
(Article)
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
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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.
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Keywords: anticoagulants, hemorrhage, hemostasis, risk assessment, venous thromboembolism, Hematology
ISSN: 1538-7933
Publisher: Wiley-Blackwell
Note: Publisher Copyright: © 2024
(Peer reviewed)