Rodger Marc A, Le Gal Gregoire, Anderson David R, Schmidt Jeannot, Pernod Gilles, Kahn Susan R, Righini Marc, Mismetti Patrick, Kearon Clive, Meyer Guy, Elias Antoine, Ramsay Tim, Ortel Thomas L, Huisman Menno V, Kovacs Michael J
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.
BMJ. 2017 Mar 17;356:j1065. doi: 10.1136/bmj.j1065.
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. Prospective cohort management study. 44 secondary or tertiary care centres in seven countries. 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. 2.3% were lost to follow-up. 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). Recurrent symptomatic VTE (independently and blindly adjudicated) over one year of follow-up. Of 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%). Women 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. clinicaltrials.gov NCT00967304.
为前瞻性验证HERDOO2规则（双腿出现色素沉着、水肿或发红；D - 二聚体水平≥250μg/L；体重指数≥30的肥胖；或年龄≥65岁），该规则表明无该标准或仅有一项标准的女性在短期治疗后可安全停用抗凝剂。前瞻性队列管理研究。七个国家的44个二级或三级护理中心。在3155名连续入选的首次发生不明原因静脉血栓栓塞（VTE，近端腿部深静脉血栓形成或肺栓塞）且完成5 - 12个月短期抗凝治疗的合格参与者中，370人拒绝参与，剩余2785名入选参与者。2.3%失访。无HERDOO2标准或仅有一项标准的女性被归类为复发性VTE低风险并停用抗凝剂（干预组），而高风险女性（≥2项HERDOO2标准）和男性的抗凝管理由临床医生和患者自行决定（观察组）。随访一年的复发性症状性VTE（独立且盲法判定）。在1213名女性中，631名（51.3%）被归类为低风险，591名停用口服抗凝治疗。在初步分析中，564患者年的随访期间，17名停用抗凝剂的低风险女性发生复发性VTE（每年3.0%，95%置信区间1.8%至4.8%）。在323名停用抗凝剂的高风险女性和男性中，309患者年的随访期间有25人发生VTE（8.1%，5.2%至11.9%），而在1802名继续抗凝的高风险女性和男性中，1758患者年的随访期间有28人发生复发性VTE（1.6%，1.1%至2.3%）。首次发生不明原因VTE事件且无HERDOO2标准或仅有一项标准的女性复发性VTE风险低，完成短期治疗后可安全停用抗凝剂。clinicaltrials.gov NCT00967304
