Validating the HERDOO2 rule to guide treatment duration for women with unprovoked venous thrombosis: multinational prospective cohort management study.
ObjectiveTo prospectively validate the HERDOO2 rule (Hyperpigmentation, Edema, or Redness in either leg; D-dimer level ≥250 μg/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.DesignProspective cohort management study.Setting44 secondary or tertiary care centres in seven countries.ParticipantsOf 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.InterventionsWomen 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 measureRecurrent symptomatic VTE (independently and blindly adjudicated) over one year of follow-up.ResultsOf 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%).ConclusionsWomen 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.Trial registrationclinicaltrials.gov NCT00967304.
Thrombosis Program, Division of Hematology, Ottawa Blood Disease Center, Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8L6, Canada mrodger@ohri.ca.|Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.|School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, ON, Canada.
Marc A
MA
Rodger
Thrombosis Program, Division of Hematology, Ottawa Blood Disease Center, Department of Medicine, Faculty of Medicine, University of Ottawa, Ottawa, ON, K1H 8L6, Canada.|Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.|School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, ON, Canada.|EA 3878, INSERM CIC 1412, Université de Brest, Brest, France.
Gregoire
G
Le Gal
Faculty of Medicine, Dalhousie University, Halifax, NS, Canada.
David R
DR
Anderson
Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont, France.
Jeannot
J
Schmidt
Centre Hospitalier Universitaire de Grenoble, Grenoble, France.
Gilles
G
Pernod
Jewish General Hospital, McGill University, Montreal, QC, Canada.
Susan R
SR
Kahn
Division of Angiology and Hemostasis, Geneva University Hospital, Geneva, Switzerland.
Marc
M
Righini
Centre Hospitalier Universitaire de Saint Etienne Bellevue, Saint Etienne, France.
Patrick
P
Mismetti
Department of Medicine and Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, ON, Canada.
Clive
C
Kearon
Respiratory Department, Hopital Europeen Georges-Pompidou, APHP, Université Paris Descartes Sorbonne, Paris Cité: INSERM UMRS 970, Paris, and INNOVTE, Saint-Etienne, France.
Guy
G
Meyer
Centre Hospitalier Intercommunal de Toulon, Toulon, France.
Antoine
A
Elias
Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, ON, Canada.|School of Epidemiology, Public Health and Preventative Medicine, University of Ottawa, Ottawa, ON, Canada.
Tim
T
Ramsay
Department of Medicine, Duke University Medical Center, Durham, NC, USA.
Thomas L
TL
Ortel
Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, Netherlands.
Menno V
MV
Huisman
London Health Sciences Centre, Western University, London, ON, Canada.
Michael J
MJ
Kovacs
D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D000066491:Clinical Decision-Making; D003661:Decision Support Techniques; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D012307:Risk Factors; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000175:diagnosis* / Q000188:drug therapy*
D000925:Anticoagulants