急性髂股腘静脉血栓形成患者接受导管内溶栓与标准治疗的长期疗效比较（CaVenT 研究）：一项随机对照试验。
Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial.
机构信息
Department of Haematology, Oslo University Hospital, Oslo, Norway.
出版信息
Lancet. 2012 Jan 7;379(9810):31-8. doi: 10.1016/S0140-6736(11)61753-4. Epub 2011 Dec 13.
BACKGROUND
Conventional anticoagulant treatment for acute deep vein thrombosis (DVT) effectively prevents thrombus extension and recurrence, but does not dissolve the clot, and many patients develop post-thrombotic syndrome (PTS). We aimed to examine whether additional treatment with catheter-directed thrombolysis (CDT) using alteplase reduced development of PTS.
METHODS
Participants in this open-label, randomised controlled trial were recruited from 20 hospitals in the Norwegian southeastern health region. Patients aged 18-75 years with a first-time iliofemoral DVT were included within 21 days from symptom onset. Patients were randomly assigned (1:1) by picking lowest number of sealed envelopes to conventional treatment alone or additional CDT. Randomisation was stratified for involvement of the pelvic veins with blocks of six. We assessed two co-primary outcomes: frequency of PTS as assessed by Villalta score at 24 months, and iliofemoral patency after 6 months. Analyses were by intention to treat. This trial is registered at ClinicalTrials.gov, NCT00251771.
FINDINGS
209 patients were randomly assigned to treatment groups (108 control, 101 CDT). At completion of 24 months' follow-up, data for clinical status were available for 189 patients (90%; 99 control, 90 CDT). At 24 months, 37 (41·1%, 95% CI 31·5-51·4) patients allocated additional CDT presented with PTS compared with 55 (55·6%, 95% CI 45·7-65·0) in the control group (p=0·047). The difference in PTS corresponds to an absolute risk reduction of 14·4% (95% CI 0·2-27·9), and the number needed to treat was 7 (95% CI 4-502). Iliofemoral patency after 6 months was reported in 58 patients (65·9%, 95% CI 55·5-75·0) on CDT versus 45 (47·4%, 37·6-57·3) on control (p=0·012). 20 bleeding complications related to CDT included three major and five clinically relevant bleeds.
INTERPRETATION
Additional CDT should be considered in patients with a high proximal DVT and low risk of bleeding.
FUNDING
South-Eastern Norway Regional Health Authority; Research Council of Norway; University of Oslo; Oslo University Hospital.
背景
急性深静脉血栓形成（DVT）的常规抗凝治疗可有效预防血栓延伸和复发，但不能溶解血栓，许多患者会发生血栓后综合征（PTS）。我们旨在研究使用阿替普酶的导管定向溶栓（CDT）治疗是否会减少 PTS 的发生。
方法
这项开放标签、随机对照试验的参与者来自挪威东南部卫生区的 20 家医院。纳入的患者为首次出现髂股静脉 DVT 且发病后 21 天内的 18-75 岁患者。患者按照密封信封的最低编号进行 1:1 随机分组，分别接受单纯常规治疗或额外的 CDT。根据盆腔静脉受累情况，按 6 个区块进行分层随机分组。我们评估了两个主要结局：24 个月时Villalta 评分评估的 PTS 发生率，以及 6 个月时髂股静脉通畅率。分析采用意向治疗。这项试验在 ClinicalTrials.gov 注册，编号为 NCT00251771。
结果
209 名患者被随机分配至治疗组（108 名对照组，101 名 CDT 组）。在完成 24 个月的随访时，189 名患者（90%；99 名对照组，90 名 CDT 组）提供了临床状态数据。24 个月时，与对照组（55 例[55.6%，95%CI 45.7-65.0]）相比，55 例（41.1%，95%CI 31.5-51.4）接受额外 CDT 治疗的患者发生 PTS（p=0.047）。PTS 的差异相当于绝对风险降低 14.4%（95%CI 0.2-27.9），需要治疗的人数为 7（95%CI 4-502）。6 个月时，101 例接受 CDT 治疗的患者中有 58 例（65.9%，95%CI 55.5-75.0）出现髂股静脉通畅，而对照组 45 例（47.4%，37.6-57.3）出现髂股静脉通畅（p=0.012）。20 例与 CDT 相关的出血并发症包括 3 例大出血和 5 例临床相关出血。
结论
对于近端 DVT 高且出血风险低的患者，应考虑额外的 CDT。
经费
挪威东南部地区卫生局；挪威研究理事会；奥斯陆大学；奥斯陆大学医院。
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