Background:The pathomechanisms underlying restenosis of the bioabsorbable sirolimus-eluting metallic scaffold (Magmaris) remain unknown. Using serial optical coherence tomography, we investigated causes of restenosis, including the contribution of late scaffold recoil versus neointimal hyperplasia.Methods:Patients enrolled in BIOSOLVE-II undergoing serial angiography and optical coherence tomography (post-intervention and follow-up: 6 months and/or 1 year) were analyzed. Patients were divided into 2 groups according to angiographic in-scaffold late lumen loss (LLL) <0.5 or ≥0.5 mm. End points were late absolute scaffold recoil and neointimal hyperplasia area as assessed by optical coherence tomography.Results:Serial data were available for analysis from 70 patients (LLL <0.5 mm: n=41; LLL ≥0.5 mm: n=29). Patient and lesion characteristics were comparable, and there was no significant difference in mean and minimal scaffold area between groups at post-intervention. Late absolute scaffold recoil was less among patients with LLL <0.5 mm (0.53±0.68 mm²) compared with those with LLL ≥0.5 mm (1.48±1.20 mm²; P<0.001). Neointimal hyperplasia area was smaller among patients with LLL <0.5 mm at follow-up (1.47±0.33 mm²) compared with patients with LLL ≥0.5 mm (1.68±0.34 mm²; P=0.013). In a matched-frame analysis (post-intervention and follow-up), late absolute scaffold recoil varied according to the underlying plaque type (lipid: 0.63±1.23 mm²; calcified: 0.81±1.44 mm²; and fibrous: 1.20±1.52 mm²; P <0.001), while there was no difference with regards to neointimal hyperplasia area (P=0.132).Conclusions:In addition to neointimal hyperplasia, late scaffold recoil contributed significantly to LLL of sirolimus-eluting absorbable metal scaffolds. The extent of late scaffold recoil was dependent on the underlying plaque morphology and was the highest among fibrotic lesions.Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT01960504.

中文翻译：

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药物洗脱可吸收金属支架再狭窄的机理

背景：可生物吸收的西罗莫司洗脱金属支架（Magmaris）再狭窄的病理机制仍然未知。使用串行光学相干层析成像技术，我们调查了再狭窄的原因，包括晚期支架后坐力对新内膜增生的影响。方法：入组BIOSOLVE-II的患者接受了连续血管造影和光学相干层析成像（干预后及随访：6个月和/或1年）进行了分析。根据血管造影支架内晚期管腔丢失（LLL）<0.5或≥0.5mm将患者分为两组。通过光学相干断层扫描评估终点为晚期绝对支架后坐力和新内膜增生区域。结果：可从70例患者中分析序列数据（LLL <0.5 mm：n = 41； LLL≥0.5mm：n = 29）。病人和病变特征可比，干预后各组之间的平均和最小支架面积没有显着差异。LLL <0.5 mm（0.53±0.68 mm）的患者中晚期绝对支架后坐力较少²）与LLL≥0.5mm（1.48±1.20 mm ² ; P <0.001）的情况相比。与LLL≥0.5mm的患者（1.68±0.34mm ²；P＝ 0.013）相比，LLL ＜0.5mm的患者在随访中（1.47±0.33mm ²）新内膜增生面积较小。在匹配框架分析（干预后和随访）中，晚期绝对支架后坐力根据基础斑块类型（脂质：0.63±1.23 mm ²；钙化：0.81±1.44 mm ²；纤维状：1.20±1.52）而变化mm ² ; P <0.001），而新内膜增生面积无差异（P= 0.132）。结论：除了新内膜增生外，晚期支架后坐力显着促进了西罗莫司洗脱的可吸收金属支架的LLL。晚期脚手架后坐力的程度取决于潜在的斑块形态，在纤维化病变中最高。注册：URL：https://www.clinicaltrials.gov。唯一标识符：NCT01960504。