Objective

The aim of this trial was to compare the efficacy of closed-cell stents with Casper stents during carotid angioplasty stenting (CAS).

Methods

This was a randomized superiority trial in which 88 patients were enrolled. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS under distal embolic protection devices (EPD). The secondary end points included stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Ischemic brain lesions were assessed by a diffusion-weighted magnetic resonance image (DW-MRI). Neurological outcomes were evaluated by means of the National Institutes of Health scale score (NIHSS) and the modified Rankin scale (mRS).

Results

Compared with closed-cell stents (n = 47), Casper stents (n = 41), resulted in no significant reduction in the incidence (44.7% versus 39%, P = 0.592), number (1.3 ± 1.8 versus 0.9 ± 1.5, p = 0.444), and size (3.9 ± 5.8 mm versus 2.8 ± 4.1 mm, p = 0.353) of new ischemic brain lesions. The global rate of stroke/TIA/MI was (2/88, 2.3%). Two TIA occurred during the hospitalization period, one in each group (1/41, 2.4% vs 1/47, 2.1%). One patient of the Casper group had an asymptomatic in-stent thrombosis. One patient of the control group had a MI (1/47, 2.1%) after discharge.

Conclusion

The Casper stents did not show superiority in the rate of incidence, number and size of new silent ischemic brain lesions detect by DW-MRI when compared to close cell stents during CAS under distal EPD.

中文翻译：

---

Casper 与封闭细胞支架：颈动脉支架随机试验。

客观的

该试验的目的是比较闭孔支架与 Casper 支架在颈动脉血管成形术支架 (CAS) 中的疗效。

方法

这是一项随机优势试验，其中招募了 88 名患者。主要终点是远端栓塞保护装置 (EPD) 下 CAS 后新发缺血性脑病变的发生率、数量和大小。次要终点包括中风、短暂性脑缺血发作 (TIA) 和心肌梗塞 (MI)。通过弥散加权磁共振图像 (DW-MRI) 评估缺血性脑损伤。神经学结果通过美国国立卫生研究院量表评分 (NIHSS) 和改良的 Rankin 量表 (mRS) 进行评估。

结果

与闭孔支架 ( n  = 47) 相比，Casper 支架 ( n  = 41) 的发生率（44.7% vs 39%，P  = 0.592）、数量（1.3 ± 1.8 vs 0.9 ± 1.5，p  = 0.444)，以及 新缺血性脑损伤的大小（3.9 ± 5.8 mm 与 2.8 ± 4.1 mm，p = 0.353）。中风/TIA/MI 的全球发生率为 (2/88, 2.3%)。住院期间发生 2 次 TIA，每组 1 次（1/41，2.4% vs 1/47，2.1%）。Casper 组的一名患者有无症状的支架内血栓形成。对照组的一名患者出院后出现心肌梗死 (1/47, 2.1%)。

结论

与远端 EPD 下 CAS 期间的闭合细胞支架相比，Casper 支架在 DW-MRI 检测到的新的无症状缺血性脑病变的发生率、数量和大小方面没有表现出优势。