Départementde Médecine Interne et Pneumologie, CHU de Brest, Université de Bretagne Occidentale, EA 3878, CIC INSERM 1412, F-CRIN INNOVTE, Brest
Département de Médecine Vasculaire, CHU de Grenoble, Université de Grenoble 1, F-CRIN INNOVTE, Grenoble.
Haematologica. 2019 Jul;104(7):1493-1501. doi: 10.3324/haematol.2018.210971. Epub 2019 Jan 3.
The optimal duration of anticoagulation after a first episode of unprovoked deep-vein thrombosis is uncertain. We aimed to assess the benefits and risks of an additional 18 months of treatment with warfarin placebo, after an initial 6 months of anticoagulation for a first unprovoked proximal deep-vein thrombosis. We conducted a multicenter, randomized, double-blind, controlled trial comparing an additional 18 months of warfarin with placebo in patients with a unprovoked proximal deep-vein thrombosis initially treated for 6 months (treatment period: 18 months; follow up after treatment period: 24 months). The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at 18 months. Secondary outcomes were the composite at 42 months, as well as each component of the composite, and death unrelated to pulmonary embolism or major bleeding, at 18 and 42 months. All outcomes were centrally adjudicated. A total of 104 patients, enrolled between July 2007 and October 2013 were analyzed on an intention-to-treat basis; no patient was lost to follow-up. During the 18-month treatment period, the primary outcome occurred in none of the 50 patients in the warfarin group and in 16 out of 54 patients (cumulative risk, 29.6%) in the placebo group (hazard ratio, 0.03; 95% confidence interval: 0.01 to 0.09; <0.001). During the entire 42-month study period, the composite outcome occurred in 14 patients (cumulative risk, 36.8%) in the warfarin group and 17 patients (cumulative risk, 31.5%) in the placebo group (hazard ratio, 0.72; 95% confidence interval: 0.35-1.46). In conclusion, after a first unprovoked proximal deep-vein thrombosis initially treated for 6 months, an additional 18 months of warfarin therapy reduced the composite of recurrent venous thrombosis and major bleeding compared to placebo. However, this benefit was not maintained after stopping anticoagulation. .
首次无诱因深静脉血栓形成后抗凝的最佳持续时间尚不确定。我们旨在评估在初次无诱因近端深静脉血栓形成初始抗凝 6 个月后，用华法林加安慰剂治疗 18 个月与安慰剂相比的益处和风险。我们进行了一项多中心、随机、双盲、对照试验，比较了在初次接受 6 个月治疗的无诱因近端深静脉血栓形成患者中，加用华法林与安慰剂治疗 18 个月（治疗期：18 个月；治疗期后随访：24 个月）。主要结局是 18 个月时复发性静脉血栓栓塞或大出血的复合结局。次要结局是 42 个月时的复合结局，以及 18 个月和 42 个月时的复合结局各个组成部分，以及与肺栓塞或大出血无关的死亡。所有结局均由中心裁决。2007 年 7 月至 2013 年 10 月间共纳入 104 例患者进行意向治疗分析；无患者失访。在 18 个月的治疗期间，华法林组的 50 例患者中无一例出现主要结局，安慰剂组的 54 例患者中有 16 例（累积风险，29.6%）（风险比，0.03；95%置信区间：0.01 至 0.09；<0.001）。在整个 42 个月的研究期间，华法林组的 14 例患者（累积风险，36.8%）和安慰剂组的 17 例患者（累积风险，31.5%）出现复合结局（风险比，0.72；95%置信区间：0.35 至 1.46）。综上，在初次无诱因近端深静脉血栓形成初始治疗 6 个月后，与安慰剂相比，华法林治疗 18 个月可降低复发性静脉血栓形成和大出血的复合结局。然而，在停止抗凝后，这种益处并未持续。
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