在 ISAR-Absorb MI 试验中，生物可吸收支架与传统依维莫司洗脱支架植入 6 个月后的光学相干断层扫描组织覆盖和特征。

Optical coherence tomography tissue coverage and characterization at six months after implantation of bioresorbable scaffolds versus conventional everolimus eluting stents in the ISAR-Absorb MI trial.

机构信息

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Cardiovascular Research Institute Dublin, Mater Private Network, Dublin, Ireland.

出版信息

Int J Cardiovasc Imaging. 2021 Oct;37(10):2815-2826. doi: 10.1007/s10554-021-02251-x. Epub 2021 Aug 21.

PURPOSE

Data regarding vessel healing by optical coherence tomography (OCT) after everolimus-eluting bioresorbable scaffolds (BRS) or everolimus-eluting metallic stent (EES) implantation in acute myocardial infarction (AMI) patients is scarce. We compared OCT findings after BRS or EES implantation in patients with AMI enrolled in a randomized trial.

METHODS

In ISAR-Absorb MI, AMI patients were randomized to BRS or EES implantation, with 6-8 month angiographic follow-up. This analysis includes patients who underwent OCT during surveillance angiography. Tissue characterization was done using grey-scale signal intensity analysis. The association between OCT findings and target lesion failure (TLF) at 2 years was investigated.

RESULTS

OCT was analyzed in 103 patients (2237 frames, 19,827 struts) at a median of 216 days post-implantation. Of these, 70 were treated with BRS versus 32 with EES. Pre-(92.8 vs. 68.7%, p = 0.002) and post-dilation (51.4 vs. 12.5%, p < 0.001) were more common in BRS as compared to EES. Strut coverage was higher in BRS vs. EES (97.5% vs. 90.9%, p < 0.001). Mean neointimal thickness was comparable in both groups [85.5 (61.9, 124.1) vs. 69.5 (32.7, 127.5) µm, respectively, p = 0.20]. Mature neointimal regions were numerically more common in BRS (43.0% vs. 24.6%; p = 0.35); this difference was statistically significant in ST-elevation myocardial infarction patients (40.9% vs. 21.1%, p = 0.03). At two-years, 8 (7.8%) patients experienced TLF. Mean neointimal area [0.61 (0.21, 1.33) vs. 0.41 (0.11, 0.75) mm, p = 0.03] and mean neointimal coverage [106.1 (65.2, 214.8) vs. 80.5 (53.5, 122.1) µm, p < 0.01] were higher, with comparable tissue maturity, in lesions with versus without TLF.

CONCLUSIONS

In selected patients who underwent OCT surveillance 6-8 months after coronary intervention for AMI with differing implantation characteristics depending on the device type used, vessel healing was more advanced in BRS compared with EES, particularly in the STEMI subgroup.

目的

光学相干断层扫描（OCT）在急性心肌梗死（AMI）患者中评估依维莫司洗脱生物可吸收支架（BRS）或依维莫司洗脱金属支架（EES）血管愈合的数据很少。我们比较了在随机试验中 AMI 患者中植入 BRS 或 EES 后的 OCT 发现。

方法

在 ISAR-Absorb MI 中，AMI 患者被随机分配至 BRS 或 EES 植入，6-8 个月行血管造影随访。此分析包括在监测血管造影期间接受 OCT 的患者。使用灰阶信号强度分析进行组织特征描述。研究 OCT 发现与 2 年时的靶病变失败（TLF）之间的关系。

结果

在植入后中位时间 216 天，对 103 例患者（2237 帧，19827 个支架）进行了 OCT 分析。其中 70 例接受 BRS 治疗，32 例接受 EES 治疗。BRS 组较 EES 组更常行预扩张（92.8% vs. 68.7%，p=0.002）和后扩张（51.4% vs. 12.5%，p<0.001）。BRS 组的支架覆盖率高于 EES 组（97.5% vs. 90.9%，p<0.001）。两组的平均新生内膜厚度相似[分别为 85.5（61.9，124.1）和 69.5（32.7，127.5）µm，p=0.20]。BRS 组的成熟新生内膜区域更为常见（43.0% vs. 24.6%，p=0.35）；在 ST 段抬高型心肌梗死患者中，这一差异具有统计学意义（40.9% vs. 21.1%，p=0.03）。两年时，8（7.8%）例患者发生 TLF。TLF 患者的平均新生内膜面积[0.61（0.21，1.33）比 0.41（0.11，0.75）mm，p=0.03]和平均新生内膜覆盖率[106.1（65.2，214.8）比 80.5（53.5，122.1）µm，p<0.01]更高，组织成熟度相似。