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WOVEN 试验:Wingspan 一年血管事件和神经结局。

The WOVEN trial: Wingspan One-year Vascular Events and Neurologic Outcomes.

机构信息

Department of Neurosurgery, Cedars-Sinai Medical Center, Los Angeles, California, USA

Department of Neurosurgery, Stroke and Neurovascular Center of Central California, Santa Barbara, California, USA.

出版信息

J Neurointerv Surg. 2021 Apr;13(4):307-310. doi: 10.1136/neurintsurg-2020-016208. Epub 2020 Jun 19.

DOI:10.1136/neurintsurg-2020-016208
PMID:32561658
Abstract

BACKGROUND

Prior studies evaluating the Wingspan stent for treatment of symptomatic intracranial atherosclerotic disease have included patients with a spectrum of both on-label and off-label indications for the stent. The WEAVE trial assessed 152 patients stented with the Wingspan stent strictly by its current on-label indication and found a 2.6% periprocedural stroke and death rate.

OBJECTIVE

This WOVEN study assesses the 1-year follow-up from this cohort.

METHODS

Twelve of the original 24 sites enrolling patients in the WEAVE trial performed follow-up chart review and imaging analysis up to 1 year after stenting. Assessment of delayed stroke and death was made in 129 patients, as well as vascular imaging follow-up to assess for in-stent re-stenosis.

RESULTS

In the 1-year follow-up period, seven patients had a stroke (six minor, one major). Subsequent to the periprocedural period, no deaths were recorded in the cohort. Including the four patients who had periprocedural events in the WEAVE study, there were 11 strokes or deaths of the 129 patients (8.5%) at the 1-year follow-up.

CONCLUSIONS

The WOVEN study provides the 1-year follow-up on a cohort of 129 patients who were stented according to the current on-label use. It provides a more homogeneous patient group for analysis than prior studies, and demonstrates a relatively low 8.5% 1-year stroke and death rate in stented patients.

摘要

背景

先前评估 Wingspan 支架治疗症状性颅内动脉粥样硬化疾病的研究纳入了符合支架适应证谱的患者,包括标签内和标签外适应证。WEAVE 试验评估了严格按照 Wingspan 支架当前适应证标签进行治疗的 152 例患者,发现围手术期卒中发生率和死亡率为 2.6%。

目的

本 WOVEN 研究评估了该队列的 1 年随访结果。

方法

参与 WEAVE 试验的 24 个中心中的 12 个中心对该研究中的患者进行了随访图表审查和影像学分析,随访时间为支架置入后 1 年。对 129 例患者进行了迟发性卒中及死亡评估,并进行血管影像学随访以评估支架内再狭窄。

结果

在 1 年随访期间,7 例患者发生卒中(6 例为小卒中和 1 例为大卒)。在该队列中,在围手术期后没有记录到死亡。包括 WEAVE 研究中围手术期发生事件的 4 例患者,在 129 例患者中有 11 例(8.5%)在 1 年随访时发生卒中或死亡。

结论

WOVEN 研究提供了根据当前适应证标签对 129 例患者进行支架置入后的 1 年随访结果。与先前的研究相比,该研究提供了一个更同质的患者群体进行分析,并显示了相对较低的 1 年支架置入患者卒中发生率和死亡率为 8.5%。

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