Hoyt Taylor, Feldman Marc D, Okutucu Sercan, Lendel Vasili, Marmagkiolis Konstantinos, McIntosh Victoria, Ates Ismail, Kose Gulcan, Mego David, Paixao Andre, Iliescu Cezar, Park Jongwan, Shaar Mohammad, Avci Recep, McElroy Austin, Dijkstra Jouke, Milner Thomas E, Cilingiroglu Mehmet
University of Texas Health, 7703 Floyd Curl Dr., San Antonio US-TX 78229, United States of America.
Memorial Ankara Hospital, Balgat Mah., Mevlana Blv., & 1422. Sok. No: 4, 06520 Ankara, Turkey.
Cardiovasc Revasc Med. 2020 Jan;21(1):101-107. doi: 10.1016/j.carrev.2019.07.009. Epub 2019 Jul 8.
Zilver PTX nitinol self-expanding drug-eluting stent with paclitaxel coating is effective for treatment of superficial femoral artery (SFA) disease. However, as with any stent, it induces a measure of vascular inflammatory response. The current clinical trial (NCT02734836) aimed to assess vascular patency, remodeling, and inflammatory markers with intravascular optical coherence tomography (OCT) in patients with SFA disease treated with Zilver PTX stents.
Serial OCT examinations were performed in 13 patients at baseline and 12-month follow-up. Variables evaluated included neointimal area, luminal narrowing, thrombus area, stent expansion as well as measures of inflammation including, peri-strut low-intensity area (PLIA), macrophage arc, neovascularization, stent strut apposition and coverage.
Percentage of malapposed struts decreased from 10.3 ± 7.9% post-intervention to 1.1 ± 2.2% at 12-month follow-up, but one patient showed late-acquired stent malapposition (LASM). The percent of uncovered struts at follow-up was 3.0 ± 4.5%. Average expansion of stent cross-sectional area from baseline to follow-up was 35 ± 19%. The average neointimal area was 7.8 ± 3.8 mm. Maximal luminal narrowing was 61.1 ± 25.0%, and average luminal narrowing was 35.4 ± 18.2%. Average peri-strut low-intensity area (PLIA) per strut was 0.017 ± 0.018 mm. Average number of neovessels per mm of stent was 0.138 ± 0.181. Average macrophage angle per frame at follow-up was 7 ± 11°. Average thrombus area at follow-up was 0.0093 ± 0.0184 mm.
At 12-month follow-up, OCT analysis of Zilver PTX stent shows outward remodeling and minimal neointimal growth, but evidence of inflammation including PLIA, neovessels, thrombus and macrophages.
Thirteen patients with PAD had paclitaxel-coated stents implanted in their SFAs and were then imaged with OCT at baseline and 12-month follow-up. OCT proxy metrics of inflammation were quantified.
带有紫杉醇涂层的Zilver PTX镍钛诺自膨胀药物洗脱支架对治疗股浅动脉（SFA）疾病有效。然而，与任何支架一样，它会引发一定程度的血管炎症反应。当前的临床试验（NCT02734836）旨在通过血管内光学相干断层扫描（OCT）评估接受Zilver PTX支架治疗的SFA疾病患者的血管通畅情况、重塑情况及炎症标志物。
对13例患者在基线期和12个月随访时进行了系列OCT检查。评估的变量包括新生内膜面积、管腔狭窄、血栓面积、支架扩张情况以及炎症指标，包括支架周围低强度区域（PLIA）、巨噬细胞弧、新生血管形成、支架支柱贴壁情况及覆盖情况。
贴壁不良支柱的百分比从干预后10.3±7.9%降至12个月随访时的1.1±2.2%，但有1例患者出现迟发性支架贴壁不良（LASM）。随访时未覆盖支柱的百分比为3.0±4.5%。从基线到随访，支架横截面积的平均扩张率为35±19%。平均新生内膜面积为7.8±3.8mm²。最大管腔狭窄为61.1±25.0%，平均管腔狭窄为35.4±18.2%。每个支柱的平均支架周围低强度区域（PLIA）为0.017±0.018mm²。每毫米支架的平均新生血管数量为0.138±0.181。随访时每帧的平均巨噬细胞角度为7±11°。随访时的平均血栓面积为0.0093±0.0184mm²。
在12个月随访时，对Zilver PTX支架的OCT分析显示向外重塑且新生内膜生长 minimal，但存在包括PLIA、新生血管、血栓和巨噬细胞在内的炎症证据。
13例外周动脉疾病患者在其股浅动脉植入了紫杉醇涂层支架，然后在基线期和12个月随访时用OCT成像。对炎症的OCT替代指标进行了量化。
