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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).

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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%).Hence, the clinical question of who should continue taking anticoagulants indefinitely and who can safely discontinue them after short term treatment for unprovoked VTE remains a high research priority.910 To answer this important question, the long term risks and burdens of recurrent VTE must be balanced against the long term risks and burdens of oral anticoagulant treatment, especially major bleeding.The International Society on Thrombosis and Haemostasis suggests that it is safe to discontinue anticoagulants if the risk of recurrent VTE is less than 5% at one year after discontinuing treatment.12 To date, no clinical decision rules 131415 designed to achieve these standards have been prospectively validated.Index VTE associated with minor or weak risk factors such as travel, exogenous oestrogen, minor immobilisation, or minor surgery was considered unprovoked as it is unclear if the risk of recurrence in “weakly provoked” VTE is low enough to discontinue anticoagulants.12 Objective confirmation of index major VTE comprised either deep vein thrombosis demonstrated with a non-compressible segment in the popliteal vein or more proximal leg veins on compression venous ultrasonography and/or pulmonary embolism demonstrated on a high probability perfusion scan21 or a segmental or more proximal pulmonary artery filling defect on computed tomography (CT) pulmonary angiography.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.