O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada (F.K.).
School of Epidemiology and Public Health, University of Ottawa, Ottawa, Ontario, Canada (D.C.).
Ann Intern Med. 2023 Jul;176(7):949-960. doi: 10.7326/M22-3559. Epub 2023 Jun 27.
Clinical practice guidelines recommend indefinite anticoagulation for a first unprovoked venous thromboembolism (VTE).
To estimate the benefit-harm tradeoffs of indefinite anticoagulation in patients with a first unprovoked VTE.
Markov modeling study.
Systematic reviews and meta-analyses for the long-term risks and case-fatality rates of recurrent VTE and major bleeding. Published literature for costs, quality of life, and other clinical events.
Patients with a first unprovoked VTE who have completed 3 to 6 months of initial anticoagulant treatment.
Lifetime.
Canadian health care public payer.
Indefinite anticoagulation with direct oral anticoagulants.
Recurrent VTE events, major bleeding events, costs in 2022 Canadian dollars (CAD), and quality-adjusted life-years (QALYs).
RESULTS OF BASE-CASE ANALYSIS: When compared with discontinuing anticoagulation after initial treatment in a hypothetical cohort of 1000 patients aged 55 years, indefinite anticoagulation prevented 368 recurrent VTE events, which included 14 fatal pulmonary emboli, but induced an additional 114 major bleeding events, which included 30 intracranial hemorrhages and 11 deaths from bleeding. Indefinite anticoagulation cost CAD $16 014 more per person and did not increase QALYs (-0.075 per person).
Model results were most sensitive to the case-fatality rate of major bleeding and the annual risk for major bleeding during extended anticoagulation.
The model assumed that risks for recurrent VTE and major bleeding measured in clinical trials at 1 year remained constant during extended anticoagulation.
Clinicians should use shared decision making to incorporate individual patient preferences and values when considering treatment duration for unprovoked VTE.
Canadian Institutes of Health Research.
临床实践指南建议对首次无诱因静脉血栓栓塞症（VTE）患者进行无限期抗凝治疗。
评估对首次无诱因 VTE 患者进行无限期抗凝治疗的获益-危害权衡。
Markov 模型研究。
用于评估复发性 VTE 和大出血的长期风险和病死率的系统评价和荟萃分析。用于评估成本、生活质量和其他临床事件的已发表文献。
已完成 3 至 6 个月初始抗凝治疗的首次无诱因 VTE 患者。
终生。
加拿大医疗保健公共支付方。
使用直接口服抗凝剂进行无限期抗凝。
复发性 VTE 事件、大出血事件、2022 年加拿大元（CAD）成本和质量调整生命年（QALY）。
与初始治疗后停止抗凝治疗相比，无限期抗凝在一个年龄为 55 岁的 1000 名患者的假设队列中预防了 368 例复发性 VTE 事件，其中包括 14 例致命性肺栓塞，但导致额外的 114 例大出血事件，其中包括 30 例颅内出血和 11 例出血性死亡。无限期抗凝的人均成本增加了 16014 加元（每人增加 16014 加元），并且不会增加 QALYs（每人减少 0.075）。
模型结果对大出血病死率和延长抗凝期间大出血的年风险最为敏感。
该模型假设临床试验中在 1 年内测量的复发性 VTE 和大出血风险在延长抗凝期间保持不变。
临床医生应使用共同决策，在考虑无诱因 VTE 的治疗持续时间时，将患者个体的偏好和价值观纳入其中。
加拿大卫生研究院。
