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

Abstract

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. setting 44 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.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 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 registratiOn clinicaltrials.gov NCT00967304.

Deep vein thrombosis

“…Patients with a proximal DVT and a persistent risk factor or high risk of DVT recurrence might be offered lifelong anticoagulation 43. Scoring systems such as the DASH prediction score and HERD002 score (in women) help predict recurrence after an unprovoked VTE event 4344. These might be used for risk stratification of patients to guide duration of anticoagulation.…”

A randomised controlled trial of extended anticoagulation treatment versus standard treatment for the prevention of recurrent venous thromboembolism (VTE) and post‐thrombotic syndrome in patients being treated for a first episode of unprovoked VTE (the ExACT study)

“…It is possible that a lower D-dimer cutoff threshold could be more informative for patients on anticoagulation. The HERDOO2 rule has been prospectively validated using a lower cutoff (250 mcg/l) and a different D-dimer assay (VIDAS) (Rodger et al, 2017). However, other investigators have not used this cutoff (e.g.…”

Six months versus two years of oral anticoagulation after a first episode of unprovoked deep-vein thrombosis. The PADIS-DVT randomized clinical trial

“…Our results suggest that patients such as ours require continued treatment. Whether direct oral anticoagulants, at full or low dose, 10–12 could constitute an effective and safe alternative to warfarin or could be tailored according to patients’ risk factors (including elevated D-dimer levels), 27 will need further investigation.…”