Background

Magnesium-based bioresorbable Magmaris stents are rapidly resorbed. Few randomized studies have evaluated the efficacy of such stents in patients with acute coronary syndrome.

Aim

To investigate late lumen loss as assessed via quantitative coronary angiography (QCA) and optical coherence tomography (OCT) in patients with acute coronary syndrome treated with Magmaris stents or permanent, everolimus-eluting metallic Xience stents.

Methods and Results

This PRAGUE-22 study was a two-centre, investigator-initiated, randomized study. Fifty patients were randomized based on the inclusion criteria for acute coronary syndrome and the anatomical suitability to receive Magmaris or Xience stents. The patient characteristics did not differ between the Magmaris group (n = 25) and Xience group (n = 25). The mean ages were 57.0 ± 10.5 vs. 55.5 ± 9.2 years (p = 0.541) and the total implanted stent length was 24.6 ± 10.7 mm vs. 27.6 ± 11.1 mm (p = 0.368), respectively. Four clinical events occurred in the Magmaris group and one in the Xience group during 12 months of follow-up. The extent of late lumen loss (assessed via QCA) at 12 months was greater in the Magmaris group than in the Xience group (0.54 ± 0.70 vs. 0.11 ± 0.37 mm; p = 0.029). The late lumen loss diameter (measured via OCT) in the Magmaris group was also significantly larger than that in the Xience group (0.59 ± 0.37 vs. 0.22 ± 0.20 mm; p = 0.01).

Conclusion

Implantation of a magnesium-based bioresorbable stent in patients with acute coronary syndrome is associated with a greater extent of late lumen loss at the 12-month follow-up compared with implantation of a permanent, everolimus-eluting metallic stent.

Trial Registration: ISRCTN89434356

中文翻译：

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可生物吸收的镁基西罗莫司洗脱支架与永久性依维莫司洗脱金属支架治疗急性冠状动脉综合征患者的比较：PRAGUE-22 研究

 背景

镁基生物可吸收 Magmaris 支架可快速吸收。很少有随机研究评估此类支架对急性冠状动脉综合征患者的疗效。

 目的

目的 通过定量冠状动脉造影 (QCA) 和光学相干断层扫描 (OCT) 评估接受 Magmaris 支架或永久性依维莫司洗脱金属 Xience 支架治疗的急性冠状动脉综合征患者的晚期管腔丢失情况。

 方法和结果

这项 PRAGUE-22 研究是一项由研究者发起的双中心随机研究。根据急性冠状动脉综合征的纳入标准以及接受 Magmaris 或 Xience 支架的解剖学适合性，对 50 名患者进行随机分组。 Magmaris 组 ( n = 25) 和 Xience 组 ( n = 25) 之间的患者特征没有差异。平均年龄分别为 57.0 ± 10.5 岁和 55.5 ± 9.2 岁 ( p = 0.541)，植入支架总长度分别为 24.6 ± 10.7 mm 和 27.6 ± 11.1 mm ( p = 0.368)。在 12 个月的随访期间，Magmaris 组发生了 4 起临床事件，Xience 组发生了 1 起临床事件。 12 个月时 Magmaris 组的晚期管腔损失程度（通过 QCA 评估）大于 Xience 组（0.54 ± 0.70 对比 0.11 ± 0.37 mm； p = 0.029）。 Magmaris 组的晚期管腔损失直径（通过 OCT 测量）也显着大于 Xience 组（0.59 ± 0.37 vs. 0.22 ± 0.20 mm； p = 0.01）。

 结论

与植入永久性依维莫司洗脱金属支架相比，在急性冠状动脉综合征患者中植入镁基生物可吸收支架在 12 个月的随访中会导致更大程度的晚期管腔丢失。

试用注册： ISRCTN89434356