Riva Nicoletta, Ageno Walter, Schulman Sam, Beyer-Westendorf Jan, Duce Rita, Malato Alessandra, Santoro Rita, Poli Daniela, Verhamme Peter, Martinelli Ida, Kamphuisen Pieter, Dentali Francesco
Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Department of Clinical and Experimental Medicine, University of Insubria, Varese, Italy.
Lancet Haematol. 2016 Jun;3(6):e267-75. doi: 10.1016/S2352-3026(16)30020-5. Epub 2016 May 11.
Little information is available about the clinical history of patients with incidentally detected splanchnic vein thrombosis and its therapeutic management remains controversial. The aim of this study was to assess the risk factors, therapeutic strategies, and long-term outcomes of incidentally detected splanchnic vein thrombosis.
We analysed data from patients with incidentally detected splanchnic vein thrombosis who were enrolled in an international, multicentre, prospective cohort study of splanchnic vein thrombosis between 2008 and 2012. The study was done at 31 centres in 11 countries (Italy, South Korea, Germany, Canada, Belgium, the Netherlands, Brazil, USA, France, Israel, UK). Information about demographic characteristics, risk factors, and treatment was collected. The study outcomes during the 2-year follow-up were major bleeding (International Society on Thrombosis and Haemostasis definition plus the need for hospital admission), thrombotic events (venous or arterial thromboses), and mortality. The primary analysis period was from the diagnosis of incidentally detected splanchnic vein thrombosis until the first adjudicated clinical outcome or the end of follow-up.
Between May 2, 2008, and Jan 30, 2012, we enrolled 177 patients with incidentally detected splanchnic vein thrombosis (median age 57 years [IQR 49-66], 118 [67%] men, 138 [78%] patients with portal vein thrombosis). The most common underlying diseases were liver cirrhosis (82 [46%] patients) and solid cancer (62 [35%] patients). Anticoagulant treatment was prescribed to 109 (62%) patients. Median duration of anticoagulation was 6 months (IQR 5-12) for patients who received parenteral anticoagulants alone and 24 months (IQR 12-24) for patients treated with vitamin K antagonists. During a median follow-up of 2 years (IQR 1-2), the incidence of major bleeding was 3·3 events (95% CI 1·7-6·3) per 100 patient-years and the incidence of thrombotic events was 8·0 events (95% CI 5·2-12·1) per 100 patient-years. On-treatment incidence was 3·2 events (95% CI 1·2-8·4) per 100 patient-years for major bleeding and 3·9 events (95% CI 1·6-9·5) per 100 patient-years for thrombotic events. In multivariate analysis, anticoagulant treatment as a time-dependent variable reduced the incidence of thrombotic events (hazard ratio 0·85, 95% CI 0·76-0·96) without increasing the risk of major bleeding (p>0·05). In patients with clinically suspected splanchnic vein thrombosis, the incidence of major bleeding was 3·9 events (95% CI 2·6-5·7) per 100 patient-years and the incidence of thrombotic events was 7·0 events (95% CI 5·2-9·3) per 100 patient-years.
Our results show that the prognosis of incidentally detected splanchnic vein thrombosis is similar to that of clinically suspected splanchnic vein thrombosis and suggest that similar treatment strategies should be applied.
Pfizer Canada research grant.
关于偶然发现的内脏静脉血栓形成患者的临床病史，目前所知甚少，其治疗管理仍存在争议。本研究的目的是评估偶然发现的内脏静脉血栓形成的危险因素、治疗策略和长期预后。
我们分析了2008年至2012年间纳入一项国际多中心前瞻性内脏静脉血栓形成队列研究的偶然发现内脏静脉血栓形成患者的数据。该研究在11个国家（意大利、韩国、德国、加拿大、比利时、荷兰、巴西、美国、法国、以色列、英国）的31个中心进行。收集了有关人口统计学特征、危险因素和治疗的信息。2年随访期间的研究结局为大出血（国际血栓与止血学会定义加上需住院治疗）、血栓形成事件（静脉或动脉血栓形成）和死亡率。主要分析期为从偶然发现内脏静脉血栓形成的诊断至首次判定的临床结局或随访结束。
在2008年5月2日至2012年1月30日期间，我们纳入了177例偶然发现内脏静脉血栓形成的患者（中位年龄57岁[四分位间距49 - 66岁]，118例[67%]为男性，138例[78%]为门静脉血栓形成患者）。最常见的基础疾病是肝硬化（82例[46%]患者）和实体癌（62例[35%]患者）。109例（62%）患者接受了抗凝治疗。仅接受胃肠外抗凝剂治疗的患者抗凝中位持续时间为6个月（四分位间距5 - 12个月），接受维生素K拮抗剂治疗的患者为24个月（四分位间距12 - 24个月）。在中位2年（四分位间距1 - 2年）的随访期间，大出血发生率为每100患者年3.3次事件（95%置信区间1.7 - 6.3），血栓形成事件发生率为每100患者年8.0次事件（95%置信区间5.2 - 12.1）。治疗期间大出血发生率为每100患者年3.2次事件（95%置信区间1.2 - 8.4），血栓形成事件发生率为每100患者年3.9次事件（95%置信区间1.6 - 9.5）。在多变量分析中，作为时间依赖性变量的抗凝治疗降低了血栓形成事件的发生率（风险比0.85，95%置信区间0.76 - 0.96），且未增加大出血风险（p>0.05）。在临床疑似内脏静脉血栓形成的患者中，大出血发生率为每100患者年3.9次事件（95%置信区间2.6 - 5.7），血栓形成事件发生率为每100患者年7.0次事件（95%置信区间5.2 - 9.3）。
我们的结果表明，偶然发现的内脏静脉血栓形成的预后与临床疑似内脏静脉血栓形成的预后相似，并建议应采用相似的治疗策略。
辉瑞加拿大研究基金。
