Evaluation of Venous Thromboembolism Recurrence Scores in an Unprovoked Pulmonary Embolism Population: A Post-hoc Analysis of the PADIS-PE trial.

Adult Age Factors Aged Anticoagulants / therapeutic use Duration of Therapy Female Fibrin Fibrinogen Degradation Products / metabolism Humans Male Middle Aged Proportional Hazards Models Pulmonary Embolism / diagnostic imaging Randomized Controlled Trials as Topic Recurrence Risk Assessment Sex Factors Venous Thromboembolism / epidemiology Venous Thrombosis / epidemiology Ventilation-Perfusion Scan Warfarin / therapeutic use

Randomized trial Recurrent venous thromboembolism Risk factors Unprovoked pulmonary embolism

Journal

The American journal of medicine

ISSN: 1555-7162

Titre abrégé: Am J Med

Pays: United States

ID NLM: 0267200

Informations de publication

Date de publication:
08 2020

Historique:

received: 07 09 2019

revised: 01 02 2020

accepted: 13 03 2020

pubmed: 26 4 2020

medline: 22 9 2020

entrez: 26 4 2020

Statut: ppublish

Résumé

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. 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. 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. 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. URL: http://www.controlled-trials.com. Unique identifier: NCT00740883.

Sections du résumé

BACKGROUND

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.

Identifiants

DOI: 10.1016/j.amjmed.2020.03.040 PMID: 32333853

pubmed: 32333853

pii: S0002-9343(20)30346-6

doi: 10.1016/j.amjmed.2020.03.040

pii:

doi:

Substances chimiques

Anticoagulants 0

Fibrin Fibrinogen Degradation Products 0

fibrin fragment D 0

Warfarin 5Q7ZVV76EI

Banques de données

ClinicalTrials.gov

['NCT00740883']

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

Pagination

e406-e421