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D-dimer was measured using VIDAS D-dimer reagent on the VIDAS Instrument (bio Mérieux, Marcy L’Etoile, France).We then applied the HERDOO2 clinical decision rule.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%).In women, body mass index was calculated and both legs were examined for hyperpigmentation, oedema, or redness.D-Dimer samples were drawn during anticoagulant treatment at the baseline assessment (at any time if the patient was using vitamin K antagonists or at the time of peak anticoagulant effect for the other oral anticoagulants (dabigatran 4-8 hours, apixaban 2-6 hours, rivaroxaban 2-6 hours, and edoxaban 2-6 hours)).We conducted a prospective multinational cohort management study of patients with a first unprovoked VTE event who were included after 5-12 months of anticoagulant treatment.
Index VTE had to have been managed for 5-12 months with an appropriate anticoagulant treatment, including initial treatment with either unfractionated heparin, low molecular weight heparin, rivaroxaban, or apixaban, followed by 5-12 months of oral anticoagulant treatment with vitamin K antagonists (target international normalised ratio 2-3), dabigatran, rivaroxaban, apixaban, or edoxaban.
Consecutive unselected patients at 44 secondary and tertiary care centres in seven countries (see supplementary appendix) were asked to participate if they had a first episode of major, symptomatic, objectively proved unprovoked VTE 5-12 months before enrolment (referred to as the index VTE).
Index VTE was defined as unprovoked, in line with other studies,181920 in the absence of the following major VTE provoking factors: leg fracture or lower extremity plaster cast, immobilisation for more than three days, major surgery in the three months before the index VTE event, and no diagnosis of a malignancy in the past five years (with the exception of localised skin malignancy).
Participants were then followed for one year for recurrent VTE and major bleeding.
All patients provided written informed consent before participation.
Baseline imaging was conducted to assist in the diagnosis of subsequent suspected recurrent VTE in patients who discontinued anticoagulants.