Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2019 May 25;3(3):364-371.
doi: 10.1002/rth2.12214. eCollection 2019 Jul.

Evaluation of the predictive value of the bleeding prediction score VTE-BLEED for recurrent venous thromboembolism

Frederikus A Klok  1   2 , Emilie Presles  3 , Cecile Tromeur  4 , Stefano Barco  1 , Stavros V Konstantinides  1 , Olivier Sanchez  5   6   7 , Gilles Pernod  8 , Leela Raj  4 , Philippe Robin  9 , Pierre-Yves Le Roux  9 , Clément Hoffman  10 , Solen Mélac  4 , Laurent Bertoletti  11 , Philippe Girard  12 , Silvy Laporte  3 , Patrick Mismetti  11 , Guy Meyer  5   6   7 , Christophe Leroyer  4 , Francis Couturaud  4 ; PADIS‐PE Investigators
Collaborators, Affiliations

Evaluation of the predictive value of the bleeding prediction score VTE-BLEED for recurrent venous thromboembolism

Frederikus A Klok et al. Res Pract Thromb Haemost. .

Abstract

Introduction: VTE-BLEED is a validated score for identification of patients at increased risk of major bleeding during extended anticoagulation for venous thromboembolism (VTE). It is unknown whether VTE-BLEED high-risk patients also have an increased risk for recurrent VTE, which would limit the potential usefulness of the score.

Methods: This was a post hoc analysis of the randomized, double-blind, placebo-controlled PADIS-PE trial that randomized patients with a first unprovoked pulmonary embolism (PE) initially treated during 6 months to receive an additional 18-month of warfarin vs. placebo. The primary outcome of this analysis was recurrent VTE during 2-year follow-up after anticoagulant discontinuation, that is, after the initial 6-month treatment in the placebo arm and after 24 months of anticoagulation in the active treatment arm. This rate, adjusted for study treatment allocation, was compared between patients in the high- vs. low-risk VTE-BLEED group.

Results: In complete case analysis (n = 308; 82.4% of total population), 89 (28.9%) patients were classified as high risk; 44 VTE events occurred after anticoagulant discontinuation during 668 patient-years. The cumulative incidence of recurrent VTE was 16.4% (95% confidence interval [CI], 10.0%-26.1%; 14 events) and 14.6% (95% CI, 10.4%-20.3%; 30 events) in the high-risk and low-risk VTE-BLEED groups, respectively, for an adjusted hazard ratio of 1.16 (95% CI, 0.62-2.19).

Conclusion: In this study, patients with unprovoked PE classified at high risk of major bleeding by VTE-BLEED did not have a higher incidence of recurrent VTE after cessation of anticoagulant therapy, supporting the potential yield of the score for making management decisions on the optimal duration of anticoagulant therapy.

Keywords: anticoagulation therapy; bleeding; prediction score; recurrence; venous thromboembolism.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Kaplan Meier curve showing estimated cumulative incidence of recurrent deep vein thrombosis and/or pulmonary embolism in the first 2 years after treatment cessation according to the VTE‐BLEED score (high: red curve; low: blue curve). Number of patients left in analysis are indicated in the table
See this image and copyright information in PMC

References

    1. Konstantinides SV, Torbicki A, Agnelli G, Danchin N, Fitzmaurice D, Galie N, et al.; The Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC) . 2014 ESC guidelines on the diagnosis and management of acute pulmonary embolism. Eur Heart J. 2014;35:3033–69. - PubMed
    1. Kearon C, Akl EA, Ornelas J, Blaivas A, Jimenez D, Bounameaux H, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016;149:315–52. - PubMed
    1. Prandoni P, Noventa F, Ghirarduzzi A, Pengo V, Bernardi E, Pesavento R, et al. The risk of recurrent venous thromboembolism after discontinuing anticoagulation in patients with acute proximal deep vein thrombosis or pulmonary embolism. A prospective cohort study in 1,626 patients. Haematologica. 2007;92:199–205. - PubMed
    1. White RH, Murin S, Wun T, Danielsen B. Recurrent venous thromboembolism after surgery‐provoked versus unprovoked thromboembolism. J Thromb Haemost. 2010;8:987–97. - PubMed
    1. Huisman MV, Barco S, Cannegieter SC, Le Gal G, Konstantinides SV, Reitsma PH, et al. Pulmonary embolism. Nat Rev Dis Primers. 2018;4:18028 10.1038/nrdp.2018.28. - DOI - PubMed

LinkOut - more resources