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Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study

Marc Rodger 1 Grégoire Le Gal 2, 3 David Anderson 4 Jeannot Schmidt 5 Gilles Pernod 6 Susan Kahn Marc Righini 7 Patrick Mismetti 8 Clive Kearon 9 Guy Meyer 10, 11, 12, 13 Antoine Elias 14 Tim Ramsay 15 Thomas Ortel 16 Menno Huisman 17 Michael Kovacs,
1 OHRI - Ottawa Hospital Research Institute [Ottawa]
2 GETBO - Groupe d'Etude de la Thrombose de Bretagne Occidentale
3 CIC Brest
4 University of Portsmouth
5 Unité de soins intensifs [Clermont Ferrand]
6 TIMC-IMAG-ThEMAS - Techniques pour l'Evaluation et la Modélisation des Actions de la Santé
TIMC-IMAG - Techniques de l'Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications, Grenoble - UMR 5525
7 MR - Service d'angiologie et d'hémostase
8 GRT (EA 3065) - Groupe de recherche sur la thrombose
9 DM - McMaster - Department of Medicine
10 UPD5 - Université Paris Descartes - Paris 5
11 HEGP - Hôpital Européen Georges Pompidou [APHP]
12 USPC - Université Sorbonne Paris Cité
13 PARCC - UMR-S U970 - Paris-Centre de Recherche Cardiovasculaire
14 IPGP - Institut de Physique du Globe de Paris
15 Clinical Epidemiology Unit
16 DUHS - DURHAM - Duke University Health System
17 LEIDEN - DTH - Department of Thrombosis and Hemostasis
Abstract : OBJECTIVE To prospectively validate the HERDOO2 rule (Hyperpigmentation, Edema, or Redness in either leg; D-dimer level >= 250 mu g/L; Obesity with body mass index >= 30; or Older age, >= 65 years), which states that women with none or one of the criteria can safely discontinue anticoagulants after short term treatment. DESIGN Prospective cohort management study. SETTING 44 secondary or tertiary care centres in seven countries. PARTICIPANTS Of 3155 consecutive eligible participants with a first unprovoked venous thromboembolism (VTE, proximal leg deep vein thrombosis or pulmonary embolism) who completed 5-12 months of short term anticoagulant treatment, 370 declined to participate, leaving 2785 enrolled participants. 2.3% were lost to follow-up. INTERVENTIONS Women with none or one of the HERDOO2 criteria were classified as at low risk of recurrent VTE and discontinued anticoagulants (intervention arm), whereas anticoagulant management for high risk women (>= 2 HERDOO2 criteria) and men was left to the discretion of the clinicians and patients (observation arm). MAIN OUTCOME MEASURE Recurrent symptomatic VTE (independently and blindly adjudicated) over one year of follow-up. RESULTS Of 1213 women, 631 (51.3%) were classified as low risk and 591 discontinued oral anticoagulant treatment. In the primary analysis, 17 low risk women who discontinued anticoagulants developed recurrent VTE during 564 patient years of follow-up (3.0% per patient year, 95% confidence interval 1.8% to 4.8%). In 323 high risk women and men who discontinued anticoagulants, 25 had VTE during 309 patient years of follow-up (8.1%, 5.2% to 11.9%), whereas in 1802 high risk women and men who continued anticoagulants 28 had recurrent VTE during 1758 patient years of follow-up (1.6%, 1.1% to 2.3%). CONCLUSIONS Women with a first unprovoked VTE event and none or one of the HERDOO2 criteria have a low risk of recurrent VTE and can safely discontinue anticoagulants after completing short term treatment.
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https://hal.univ-brest.fr/hal-02050942
Contributor : Ghislaine Calvez Connect in order to contact the contributor
Submitted on : Wednesday, February 27, 2019 - 2:48:39 PM
Last modification on : Tuesday, April 19, 2022 - 10:11:32 AM

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UNIV-BREST | IMAG | CNRS | GETBO | UNIV-ST-ETIENNE | INSU | UPMC | IBSAM | TIMC-IMAG | UGA | TIMC-IMAG-THEMAS | USPC | SORBONNE-UNIVERSITE | UNIV-PARIS7 | UDL | UNIV-PARIS5 | UNIV-PARIS | UP-SANTE | AFRIQ | IPGP | SU-TI

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Marc Rodger, Grégoire Le Gal, David Anderson, Jeannot Schmidt, Gilles Pernod, et al.. Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study. BMJ, BMJ Publishing Group, 2017, 356, pp.j1065. ⟨10.1136/bmj.j1065⟩. ⟨hal-02050942⟩

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