Abstract
BackgroundWe aimed to validate and to refine current recurrent venous thromboembolism (VTE) risk classification.
MethodsWe performed apost hocanalysis of a multicentre cohort including 1881 patients with a first symptomatic VTE prospectively followed after anticoagulation discontinuation. The primary objective was to validate the International Society of Thrombosis and Haemostasis (ISTH) risk classification in predicting recurrence risk. The secondary objective was to evaluate a refined ISTH classification based on the recurrence risk estimate for each individual risk factor.
ResultsDuring a 4.8-year median follow-up after anticoagulation discontinuation, symptomatic recurrent VTE occurred in 230 patients (12.2%). Based on the ISTH classification, patients with unprovoked VTE or VTE with minor or major persistent risk factors had a 2-fold increased recurrence risk compared with those with VTE and major transient risk factors. Recurrence risk was not increased in patients with minor transient factors (hazard ratio (HR) 1.31, 95% CI 0.84–2.06). Individual risk factors analysis identified hormone-related VTE (pregnancy: HR 0.26, 95% CI 0.08–0.82; oestrogens: HR 0.25, 95% CI 0.14–0.47) and amyotrophic lateral sclerosis (HR 5.84, 95% CI 1.82–18.70). After reclassification of these factors as major transient for the former and major persistent for the latter, the modified ISTH classification allowed us to accurately discriminate between patients at low risk of recurrence (i.e.with major transient risk factors) and those at high risk of recurrence (i.e.without major transient risk factors).
ConclusionsAmong patients who stopped anticoagulation after a first VTE, a refined ISTH classification based on recurrence risk intensity of individual factors allowed discrimination between patients at low recurrence risk, including hormonal exposure in women, and patients at high recurrence risk.
Abstract
Refined ISTH classification based on recurrence risk intensity of individual factors discriminates between low and high riskof recurrent VTEhttps://bit.ly/3rwEEhP
Footnotes
Author contributions: R. Le Mao had full access to all of the data in the study, and takes responsibility for the integrity of the data and the accuracy of the data analysis. Study concept and design: R. Le Mao, C. Orione, K. Lacut, F. Couturaud, C. Tromeur and C. Leroyer. Acquisition of data: M. Guegan. Statistical analysis: C. Orione and F. Couturaud. Analysis and interpretation of data: all authors. Drafting of the manuscript: R. Le Mao, F. Couturaud, C. Tromeur and C. Leroyer. Critical revision of the manuscript for important intellectual content: all authors. Final approval of the manuscript: all authors. Obtaining funding: F. Couturaud. Administrative, technical or material support: F. Couturaud, K. Lacut and C. Leroyer. Study supervision: F. Couturaud.
Conflict of interest: D. Jimenez has served as an advisor or consultant for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Leo Pharma, Pfizer, ROVI and Sanofi; served as a speaker or a member of a speakers’ bureau for Bayer HealthCare Pharmaceuticals, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi Sankyo, Leo Pharma, ROVI and Sanofi; received grants for clinical research from Daiichi Sankyo, Sanofi and ROVI. E. Le Moigne reports having received research grants from Leo Pharma. C. Leroyer reports having received research grant support from Pfizer and fees for board memberships or symposia from Bayer and AstraZeneca and having received travel support from Bayer, Daiichi Sankyo, Leo Pharma, Intermune and Actelion. K. Lacut reports having received personal fees from Bayer Health Care, Bristol-Myers Squibb and Boehringer Ingelheim. F. Couturaud reports having received research grant support from Pfizer and fees for board memberships or symposia from Bayer, Bristol-Myers Squibb/Pfizer and AstraZeneca, and having received travel support from Bayer, Bristol-Myers Squibb/Pfizer, Boehringer Ingelheim, Leo Pharma and Actelion. The remaining authors declare no conflict of interest related to this research.
Support statement: The study was supported by grants from the “Programme Hospitalier de Recherche Clinique” (French Dept of Health) and the sponsor was the University Hospital of Brest. The funding source was not involved in designing or conducting the study, collecting, managing, analysing or interpreting the data, preparing, reviewing or approving the manuscript, or deciding to submit this for publication. Funding information for this article has been deposited with theCrossref Funder Registry.
- ReceivedJuly 10, 2021.
- AcceptedJanuary 30, 2022.
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