Endovascular Therapy for Post-Thrombotic Syndrome - A Randomized Trial.

Endovascular therapy can eliminate chronic venous obstruction and is hypothesized to reduce the severity of post-thrombotic syndrome.

血管内治疗可以消除慢性静脉阻塞，并被假设可以减轻血栓后综合症的严重程度。

Methods

We randomly assigned 225 patients with moderate or severe post-thrombotic syndrome and imaging-confirmed iliac-vein obstruction to receive endovascular therapy (iliac-vein stent placement and enhanced antithrombotic therapy) plus standard post-thrombotic syndrome care or standard post-thrombotic syndrome care alone.

我们随机分配了225名中度或重度血栓后综合症患者，这些患者通过影像学确认存在髂静脉阻塞，以接受血管内治疗（髂静脉支架置入术和加强抗血栓治疗）加上标准的血栓后综合症护理，或仅接受标准的血栓后综合症护理。

The severity of post-thrombotic syndrome at 6 months (the primary outcome) was assessed with the validated Venous Clinical Severity Score (VCSS) tool (scores range from 0 to 30, with higher scores indicating more severe post-thrombotic syndrome) by evaluators who were unaware of the group assignments.

在6个月时，通过不知晓分组情况的评估者使用经过验证的静脉临床严重程度评分（VCSS）工具（评分范围从0到30，分数越高表示血栓后综合症越严重）来评估血栓后综合症的严重程度（主要结果指标）。

Key secondary outcomes included venous disease-specific and overall quality of life.

主要次要结果包括静脉疾病特异性生活质量以及总体生活质量。

Results

At 6 months, the severity of post-thrombotic syndrome was lower in the endovascular-therapy group than in the no-endovascular-therapy group (mean [±SD] VCSS, 8.1±5.1 vs. 10.0±4.9; adjusted difference, -2.0; P = 0.001).

在6个月时，血管内治疗组的血栓后综合征严重程度低于非血管内治疗组（平均值[±标准差]VCSS，8.1±5.1 vs. 10.0±4.9；调整后差异，-2.0；P = 0.001）。

Venous disease-specific quality of life as assessed with the Venous Insufficiency Epidemiological and Economic Study Quality of Life questionnaire was better in the endovascular-therapy group than in the no-endovascular-therapy group at 6 months (adjusted difference, 14.5 points; P<0.001), as was overall quality of life as assessed with the Medical Outcomes Study 36-Item Short-Form Health Status Survey physical component summary score (adjusted difference, 6.1 points; P<0.001); scores on both tools range from 0 to 100.

使用静脉功能不全流行病学和经济学研究生活质量问卷评估的静脉疾病特异性生活质量在内血管治疗组中优于无内血管治疗组，6个月时（调整差异，14.5分；P<0.001），使用医学结果研究36项简短形式健康状况调查的身体成分总结评分评估的整体生活质量也是如此（调整差异，6.1分；P<0.001）；这两种工具的评分范围均为0至100分。

Through 6 months, bleeding was more common in the endovascular-therapy group than in the no-endovascular-therapy group (in 11.6% vs. 3.6% of the patients; P = 0.03).

在6个月的随访期间，内血管治疗组的出血发生率高于无内血管治疗组（分别占患者总数的11.6%和3.6%；P = 0.03）。

Conclusions

Among patients with moderate or severe post-thrombotic syndrome and iliac-vein obstruction, endovascular therapy led to less severe post-thrombotic syndrome and better health-related quality of life than standard care over a 6-month period but with a higher risk of bleeding.

在中度或重度血栓后综合症和髂静脉阻塞的患者中，血管内治疗在6个月的时间内导致的血栓后综合症较轻，健康相关的生活质量比标准治疗更好，但出血风险更高。

(Funded by the National Heart, Lung, and Blood Institute and others; C-TRACT ClinicalTrials.gov number, NCT03250247.).

(由国家心肺血液研究所和其他机构资助; C-TRACT ClinicalTrials.gov编号, NCT03250247.)。