Department of Cardiology, Odense University Hospital, Odense, Denmark.
Department of Cardiology, Odense University Hospital, Odense, Denmark.
Cardiovasc Revasc Med. 2022 Jul;40:101-110. doi: 10.1016/j.carrev.2021.12.003. Epub 2021 Dec 15.
The purpose of a bioresorbable scaffold (BRS) is to provide radial support during coronary healing. In this study, coronary artery healing after optical coherence tomography (OCT)- versus angiography-guided magnesium BRS (MBRS) implantation in patients with non-ST-segment-elevation myocardial infarction (NSTEMI) is compared.
75 patients were randomized 1:1 to OCT- or angiography-guided implantation of a MBRS with protocolled pre- and post-dilation. In the OCT-guided group, prespecified criteria indicating additional intervention were (1) scaffold under-expansion, (2) strut malapposition, (3) edge dissection, and (4) residual stenosis at distal or proximal reference segments. The primary endpoint was OCT-derived healing stage at 6 months.
At 6 months, there was no difference in average healing stage between OCT- and angiography-guided intervention (4.6 [interquartile range (IQR): 4.5-4.7] versus 4.5 [IQR: 4.3-4.7]; p = 0.54). The MBRSs were completely resolved in 77.0% [IQR: 68.5-85.5] versus 76.5% [IQR: 67.9-85.5]; (p = 0.97). Minimal lumen area (MLA) was reduced at 6 months in both the OCT- (32.3%; p < 0.01) and the angiography-guided group (21.3%; p < 0.01), however OCT-guided implantation was associated with a greater reduction of total lumen volume (-27.1 ± 32.5 mm versus -5.0 ± 32.9 mm; p < 0.01) and MLA (-2.3 ± 1.6 mm vs. -1.4 ± 1.4 mm; p = 0.02).
In NSTEMI patients, OCT-guidance with protocolled pre- and post-dilation of MBRS implantation showed similar healing pattern at 6 months compared to angiography-guidance alone.
The Coronary Artery Healing Process after Optical Coherence Tomography Guided Percutaneous Coronary Intervention with Magmaris Bioresorbable Scaffold in Patients with Non-ST-Segment-Elevation Myocardial Infarction: (HONEST) trial is registered with ClinicalTrials.gov, NCT03016624.
生物可吸收支架（BRS）的目的是在冠状动脉愈合期间提供径向支撑。在这项研究中，比较了光学相干断层扫描（OCT）指导下与血管造影指导下镁基生物可吸收支架（MBRS）植入治疗非 ST 段抬高型心肌梗死（NSTEMI）患者的冠状动脉愈合情况。
75 例患者按 1:1 随机分为 OCT 或血管造影指导下植入 MBRS，并进行预设的预扩张和后扩张。在 OCT 指导组中，存在以下指定标准时需进行额外干预：（1）支架扩张不足，（2）支架贴壁不良，（3）边缘夹层，（4）远端或近端参考节段存在残余狭窄。主要终点是 6 个月时 OCT 检测到的愈合阶段。
6 个月时，OCT 指导与血管造影指导干预的平均愈合阶段无差异（4.6 [四分位距（IQR）：4.5-4.7] 与 4.5 [IQR：4.3-4.7]；p=0.54）。MBRS 完全降解的比例分别为 77.0% [IQR：68.5-85.5] 和 76.5% [IQR：67.9-85.5]；（p=0.97）。6 个月时 OCT 组（32.3%；p<0.01）和血管造影组（21.3%；p<0.01）的最小管腔面积（MLA）均减小，但 OCT 指导植入与总管腔体积减少（-27.1±32.5mm 与-5.0±32.9mm；p<0.01）和 MLA 减少（-2.3±1.6mm 与-1.4±1.4mm；p=0.02）更相关。
在 NSTEMI 患者中，与单独血管造影指导相比，OCT 指导并采用预设预扩张和后扩张方案植入 MBRS 在 6 个月时显示出相似的愈合模式。
光学相干断层扫描指导下经皮冠状动脉介入治疗非 ST 段抬高型心肌梗死患者应用 Magmaris 生物可吸收支架后冠状动脉愈合过程（HONEST）试验在 ClinicalTrials.gov 注册，NCT03016624。
