C control validating event
C control validating event - local dating profile
Patients were excluded if they were unable or unwilling to provide informed consent; were aged less than 18 years; had already discontinued oral anticoagulant treatment; required ongoing anticoagulation (eg, mechanical heart valves, atrial fibrillation, inferior vena cava filter, or had known high risk thrombophilia before enrolment.
Patients who do not bleed during this time, termed “anticoagulant experienced” patients, are at lower risk of major bleeding with ongoing treatment (1.3% per year).7 Major bleeding is fatal in 11.3% of affected patients.6Guidelines recommend long term anticoagulant treatment in patients with unprovoked VTE with non-high bleeding risks, but this is based on weak evidence (grade 2B)11 owing to closely balanced competing risks and burdens of recurrent VTE and major bleeding.Patients with malignancy arising after diagnosis of index VTE but before enrolment were not eligible for inclusion.Patients with previous episodes of provoked VTE were eligible.The baseline assessment took place 5-12 months after the index VTE event, while patients were still receiving oral anticoagulant treatment.We documented demographic data, causes, and diagnostic or therapeutic management of the index VTE event.We previously derived a clinical decision rule to identify patients at low risk of recurrent VTE who could discontinue anticoagulants.15 The clinical decision rule, HERDOO2, identifies women with one or fewer of the four following criteria as being at low risk of recurrent VTE: Hyperpigmentation, Edema, or Redness in either leg; D-dimer level ≥250 μg/L during treatment with anticoagulants; Obesity with body mass index ≥30; and Older age, ≥65 years (fig 1).15 No subgroup of men could be identified as low risk for recurrent VTE.
Before adopting a clinical decision rule in clinical practice it should be prospectively validated in multiple clinical settings.17 As such, we validated the HERDOO2 clinical decision rule in a multinational prospective cohort management study.
Objective To 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. 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. 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).
Women who met two or more criteria and all men were classified as high risk.
Per protocol, low risk patients were to discontinue anticoagulants (intervention arm), whereas anticoagulant management in high risk patients was left to the discretion of the clinicians and patients (observation arm).
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.