Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial
Leela Raj, Emilie Presles, Raphael Le Mao, Philippe Robin, Olivier Sanchez, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Catherine A Lemarié, Florent Leven, Clément Hoffmann, Benjamin Planquette, Pierre-Yves Le Roux, Pierre-Yves Slaun, Michel Nonent, Philippe Girard, Karine Lacut, Solen Mélac, Marie Guégan, Patrick Mismetti, Silvy Laporte, Guy Meyer, Christophe Leroyer, Cécile Tromeur, Francis Couturaud, PADIS-PE Investigators, Leela Raj, Emilie Presles, Raphael Le Mao, Philippe Robin, Olivier Sanchez, Gilles Pernod, Laurent Bertoletti, Patrick Jego, Catherine A Lemarié, Florent Leven, Clément Hoffmann, Benjamin Planquette, Pierre-Yves Le Roux, Pierre-Yves Slaun, Michel Nonent, Philippe Girard, Karine Lacut, Solen Mélac, Marie Guégan, Patrick Mismetti, Silvy Laporte, Guy Meyer, Christophe Leroyer, Cécile Tromeur, Francis Couturaud, PADIS-PE Investigators
Abstract
Background: We aimed to validate the Men Continue and HERDOO2 (HERDOO2), D-dimer, age, sex, hormonal therapy (DASH), and updated Vienna recurrent venous thromboembolism prediction models in a population composed entirely of first unprovoked pulmonary embolism, and to analyze the impact of the addition of the pulmonary vascular obstruction index (PVOI) on score accuracy.
Methods: Analyses were based on the double-blind, randomized PADIS-PE trial, which included 371 unprovoked pulmonary embolism patients initially treated for 6 months, successively randomized to receive an additional 18 months of warfarin or placebo, and subsequently followed-up for 2 years.
Results: The HERDOO2, DASH, and updated Vienna scores displayed C-statistics of 0.61 (95% CI 0.54-0.68), 0.60 (95% CI 0.53-0.66), and 0.58 (95% CI 0.51-0.66), respectively. Only the HERDOO2 score identified low recurrence risk patients (<3%/year) after anticoagulation was stopped. When added to either of the prediction models, PVOI measured at pulmonary embolism diagnosis, after 6 months of anticoagulation, or both, improved scores' C-statistics between +0.06 and +0.11 points and consistently led to identifying at least 50% of patients who experienced recurrence but in whom the scores would have indicated against extended anticoagulation.
Conclusions: In patients with a first unprovoked pulmonary embolism, the HERDOO2 score is able to identify patients with a low recurrence risk after treatment discontinuation. Addition of PVOI improves accuracy of all scores.
Clinical trials registration: URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.
Keywords: Randomized trial; Recurrent venous thromboembolism; Risk factors; Unprovoked pulmonary embolism.
Copyright © 2020 Elsevier Inc. All rights reserved.
Source: PubMed