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镁与聚左旋乳酸生物可吸收支架:机械性能的体内光学相干断层扫描比较

Magnesium versus poly-L-lactic acid bioresorbable scaffolds: in vivo optical coherence tomography comparison of mechanical performance.

作者信息

Abellás-Sequeiros Rosa A, Ocaranza-Sanchez Raymundo, Galvaõ-Braga Carlos, Marques Jorge, Gonzalez-Juanatey Carlos

机构信息

Programa de Doctorado de la Universidad de Santiago de Compostela, Santiago de Compostela, Spain.

Unidad de Cardiología Intervencionista, Hospital Universitario Lucus Augusti, Lugo, Spain.

出版信息

Arch Cardiol Mex. 2020;90(1):8-15. doi: 10.24875/ACM.19000127.

Abstract

BACKGROUND

Different mechanical properties have been suggested for metallic bioresorbable vascular scaffolds (BVS) in comparison to polymeric BVS. We aim to evaluate the acute mechanical performance of Magmaris scaffold in comparison to Absorb.

MATERIALS AND METHODS

Two groups of 10 coronary lesions treated with Magmaris and Absorb 1.1 (20584 vs. 21016 struts) were compared. In all cases, optical coherence tomographic (OCT) images were acquired after scaffold deployment. Baseline clinical, angiographic, and procedural characteristics were compared, including OCT evaluations.

RESULTS

No baseline clinical or angiographic significant differences were found between groups. The most common indication for revascularization was effort angina (60% vs. 70% p = 0.45) with no ST-elevation myocardial infarction (MI) cases. Main target artery was left anterior descending, with a mean vessel diameter of 3.46 ± 0.23 in Absorb and 3.52 ± 0.19mm in Magmaris groups (p = 0.56). All cases underwent pre- and post-dilatation with a procedural success rate of 100%. OCT analyses showed larger scaffold and vessel diameters in Magmaris group: 3.11 ± 0.38 mm versus 3.07 ± 0.36 mm, p = 0.03 and 4.12 ± 0.51 mm versus 4.04 ± 0.46 mm, p = 0.04. Despite the application of slightly higher postdilatation pressures to Magmaris devices (18.01 ± 2.15 vs. 17.20 ± 3.80 atm, p = 0.05), significantly lower percentages of disrupted and malapposed struts were identified within Magmaris scaffolds (0.15% vs. 0.27%, p = 0.03 and 1.06% vs. 1.46% p = 0.01). No cardiac death, target vessel-related MI, or clinically driven target lesion revascularization was reported in a 30-day follow-up.

CONCLUSION

Mechanical properties of Magmaris scaffold allow achieving larger vessel and scaffold diameters in a safe manner, with lower rates of malapposition and scaffold disruption.

摘要

背景

与聚合物生物可吸收血管支架(BVS)相比,金属生物可吸收血管支架具有不同的机械性能。我们旨在评估Magmaris支架与Absorb支架相比的急性机械性能。

材料与方法

比较两组分别用Magmaris和Absorb 1.1治疗的10例冠状动脉病变(20584个与21016个支架小梁)。在所有病例中,支架植入后获取光学相干断层扫描(OCT)图像。比较基线临床、血管造影和手术特征,包括OCT评估。

结果

两组之间未发现基线临床或血管造影的显著差异。血运重建最常见的指征是劳力性心绞痛(60%对70%,p = 0.45),无ST段抬高型心肌梗死(MI)病例。主要靶血管为左前降支,Absorb组平均血管直径为3.46±0.23,Magmaris组为3.52±0.19mm(p = 0.56)。所有病例均进行了预扩张和后扩张,手术成功率为100%。OCT分析显示Magmaris组的支架和血管直径更大:分别为3.11±0.38mm对3.07±0.36mm,p = 0.03;4.12±0.51mm对4.04±0.46mm,p = 0.04。尽管对Magmaris装置应用了略高的后扩张压力(18.01±2.15对17.20±3.80大气压,p = 0.05),但在Magmaris支架内发现的支架小梁断裂和贴壁不良的百分比显著更低(0.15%对0.27%,p = 0.03;1.06%对1.46%,p = 0.01)。30天随访中未报告心脏死亡、靶血管相关MI或临床驱动的靶病变血运重建。

结论

Magmaris支架的机械性能能够以安全的方式实现更大的血管和支架直径,同时减少贴壁不良和支架断裂的发生率。

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