From the CVPath Institute, Inc, Gaithersburg, MD (F.O., E.P., K.S., K.Y., E.L., F.D.K., R.V.); Abbott Vascular, Santa Clara, CA (L.E.L.P., J.P.L., Q.W., M.K., J.W., R.J.P.); and American Preclinical Services, Minneapolis, MN (M.F.).
Circ Cardiovasc Interv. 2014 Jun;7(3):330-42. doi: 10.1161/CIRCINTERVENTIONS.113.000990. Epub 2014 Jun 3.
The Absorb everolimus-eluting bioresorbable vascular scaffold (Absorb) has shown promising clinical results; however, only limited preclinical data have been published. We sought to investigate detailed pathological responses to the Absorb versus XIENCE V (XV) in a porcine coronary model with duration of implant extending from 1 to 42 months.
A total of 335 devices (263 Absorb and 72 XV) were implanted in 2 or 3 main coronary arteries of 136 nonatherosclerotic swine and examined by light microscopy, scanning electron microscopy, pharmacokinetics, and gel permeation chromatography analyses at various time points. Vascular responses to Absorb and XV were largely comparable at all time points, with struts being sequestered within the neointima. Inflammation was mild to moderate (with absence of inflammation at 1 month) for both devices, although the scores were greater in Absorb at 6 to 36 months. Percent area stenosis was significantly greater in Absorb than XV at all time points except at 3 months. The extent of fibrin deposition was similar between Absorb and XV, which peaked at 1 month and decreased rapidly thereafter. Histomorphometry showed expansile remodeling of Absorb-implanted arteries starting after 12 months, and lumen area was significantly greater in Absorb than XV at 36 and 42 months. These changes correlated with dismantling of Absorb seen after 12 months. Gel permeation chromatography analysis confirmed that degradation of Absorb was complete by 36 months.
Absorb demonstrates comparable long-term safety to XV in porcine coronary arteries with mild to moderate inflammation. Although Absorb was associated with greater percent stenosis relative to XV, expansile remodeling was observed after 12 months in Absorb with significantly greater lumen area at ≥ 36 months. Resorption is considered complete at 36 months.
Absorb 依维莫司洗脱生物可吸收血管支架（Absorb）已显示出良好的临床效果；然而，仅有有限的临床前数据发表。我们试图在猪冠状动脉模型中研究 Absorb 与 XIENCE V（XV）的详细病理学反应，植入时间从 1 个月延长至 42 个月。
共在 136 只非动脉粥样硬化猪的 2 或 3 条主要冠状动脉中植入了 335 个器械（263 个 Absorb 和 72 个 XV），并在不同时间点通过光镜、扫描电镜、药代动力学和凝胶渗透色谱分析进行检查。在所有时间点，Absorb 和 XV 的血管反应基本相似，支架被隔离在新生内膜内。两种器械的炎症均为轻度至中度（1 个月时无炎症），但在 6 至 36 个月时 Absorb 的评分更高。除了 3 个月，Absorb 的百分比狭窄程度显著大于 XV。Absorb 和 XV 的纤维蛋白沉积程度相似，在 1 个月时达到峰值，随后迅速下降。组织形态计量学显示 Absorb 植入动脉在 12 个月后开始扩张性重塑，36 个月和 42 个月时 Absorb 的管腔面积显著大于 XV。这些变化与 12 个月后 Absorb 的解体有关。凝胶渗透色谱分析证实 Absorb 的降解在 36 个月时完全。
Absorb 在猪冠状动脉中显示出与 XV 相当的长期安全性，炎症程度为轻度至中度。尽管与 XV 相比，Absorb 与更大的百分比狭窄相关，但在 Absorb 中在 12 个月后观察到扩张性重塑，在≥36 个月时管腔面积显著增大。在 36 个月时，吸收被认为是完全的。
