Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial
Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial
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DOI：
10.1016/s2352-3026(15)00248-3
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发表时间：
2016-02-01
影响因子：
24.7
通讯作者：
Sandset, Per Morten
中科院分区：
文献类型：
--
作者：
Haig, Ylva;Enden, Tone;Sandset, Per Morten
血栓后综合征是急性近端深静脉血栓形成（DVT）后的常见并发症，与生活质量降低和巨大的费用负担相关。在CaVenT研究的2年结果中，与常规治疗相比，额外的导管定向溶栓将血栓后综合征的风险降低了14%，但不影响生活质量。在这项研究中，我们报告的结果，在5年的后续行动，旨在评估结果是否血栓后综合征和生活质量的stabilis.Methods之间的2006年1月3日，2009年12月22日，我们招募了18-75岁的患者，首次高近端下肢DVT从20家医院在挪威东南部健康区。使用密封信封，将参与者随机（1：1）分配至标准治疗（压缩袜和抗凝剂）（对照组）或标准治疗加自症状发作后21天内使用阿替普酶进行的导管定向溶栓。本分析中预先规定的结局为使用Villalta评分评估的5年血栓形成后综合征和使用EQ-5D和疾病特异性VEINES-QOL/Sym评估的5年生活质量评分。研究结果在5年随访时（最后日期为2014年10月14日），176例患者（最初随机分配的209例患者中的84%）的数据可用，其中87例最初分配到导管溶栓组，89例最初分配到对照组。ClinicalTrials.gov 37例（43%; 95% CI 33-53）分配至导管定向溶栓组的患者发生血栓后综合征，而63例（71%; 95% CI 61-79）分配至对照组（p= 15或存在溃疡）。两个评估量表的生活质量评分在治疗组之间没有差异。解释额外的导管直接溶栓导致了持续的和增加的临床效益，在随访长达5年，支持使用额外的导管直接溶栓治疗广泛的近端DVT患者。然而，分配到这种治疗并没有导致更好的生活质量。最佳的血管内溶栓方法需要进一步研究。
Background Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted.Methods Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18-75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00251771.Findings At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)-87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33-53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61-79) allocated to the control group (p= 15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups.Interpretation Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation.