Purpose

To assess the midterm patency and long-term safety of placement of a dedicated venous stent (Vici Venous Stent System) for the treatment of venous lesions of the iliofemoral outflow tract.

Materials and Methods

Patients with unilateral obstructive disease of the iliofemoral veins and a Clinical, Etiological, Anatomical, Pathophysiological class of 3 or higher or a Venous Clinical Severity Score of 2 or greater were enrolled in this prospective, multicenter, single-arm study at 23 sites in the United States and Europe. The patients were followed up for 36 months after the index procedure for the assessment of patency and up to 60 months for the assessment of safety. The clinical outcomes in 11 patients with a stent fracture were assessed.

Results

A total of 200 patients enrolled in 2 cohorts (ie, feasibility cohort, n = 30; pivotal cohort, n = 170) were combined for this analysis. The overall 36-month primary patency rate was 71.7% (86/120), and the 36-month primary patency rate was 96.4% (27/28) for the nonthrombotic group and 64.1% (59/92) for the postthrombotic group. The freedom from major adverse events was 81.2% (53/65) through 60 months. The 60-month Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) was 84.3%. In 9 of the 11 patients who had a stent fracture (1 patient with nonthrombotic etiology and 10 patients with postthrombotic etiology) identified at 12 months, the stents extended into the common femoral vein. The TVR rates and clinical outcomes were similar between patients with and without a stent fracture.

Conclusions

The results of the VIRTUS study demonstrated good midterm patency and long-term safety following the placement of a dedicated venous stent for iliofemoral obstruction.

中文翻译：

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有症状的髂股静脉阻塞专用静脉内镍钛合金支架置入后的中期和长期结果：VIRTUS 研究的三至五年结果

目的

评估放置专用静脉支架（Vici 静脉支架系统）治疗髂股流出道静脉病变的中期通畅性和长期安全性。

材料和方法

患有单侧髂股静脉阻塞性疾病且临床、病因学、解剖学、病理生理学等级为 3 级或更高或静脉临床严重程度评分为 2 或更高的患者被纳入这项前瞻性、多中心、单臂研究，在 23 个地点进行美国和欧洲。在指标程序后对患者进行了 36 个月的随访以评估通畅性和长达 60 个月的安全性评估。对 11 名支架断裂患者的临床结果进行了评估。

结果

共纳入 2 个队列（即可行性队列，n = 30；关键队列，n = 170）的 200 名患者被合并用于该分析。总体 36 个月一期通畅率为 71.7%（86/120），非血栓形成组的 36 个月一期通畅率为 96.4%（27/28），血栓形成后组为 64.1%（59/92）。到 60 个月时，主要不良事件的发生率为 81.2% (53/65)。60 个月时免于靶血管血运重建 (TVR) 的 Kaplan-Meier 估计值为 84.3%。在 12 个月时发现的 11 名支架断裂患者中有 9 名（1 名患者为非血栓性病因，10 名患者为血栓后病因），支架延伸至股总静脉。有和没有支架断裂的患者的 TVR 率和临床结果相似。

结论

VIRTUS 研究的结果表明，在为髂股动脉阻塞放置专用静脉支架后，中期通畅率和长期安全性良好。