使用纵向序列光学相干断层扫描评估新的双疗法内皮祖细胞捕获西罗莫司洗脱组合支架24个月内的早期愈合情况和新生内膜转化以及3年临床结果：EGO组合研究
Evaluation of Early Healing Profile and Neointimal Transformation Over 24 Months Using Longitudinal Sequential Optical Coherence Tomography Assessments and 3-Year Clinical Results of the New Dual-Therapy Endothelial Progenitor Cell Capturing Sirolimus-Eluting Combo Stent: The EGO-Combo Study.
作者信息
Lee Stephen W L, Lam Simon C C, Tam Frankie C C, Chan Kelvin K W, Shea Catherine P, Kong Shun-Ling, Wong Anthony Y T, Yung Arthur, Zhang Lei-Wei, Tse Hung-Fat, Wu Karl K Y, Chan Raymond, Haude Michael, Mehran Roxana, Mintz Gary S, Maehara Akiko
机构信息
From The University of Hong Kong, Queen Mary Hospital, Hospital Authority (S.W.L.L., S.C.C.L., F.C.C.T., K.K.W.C., C.P.S., S.-L.K., A.Y.T.W., A.Y., L.-W.Z., H.-F.T., K.K.Y.W., R.C.), China; Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany (M.H.); The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.); Cardiovascular Research Foundation, New York, NY (R.M., G.S.M., A.M.); and Columbia University Medical Center, New York, NY (R.M., G.S.M., A.M.).
出版信息
Circ Cardiovasc Interv. 2016 Jul;9(7). doi: 10.1161/CIRCINTERVENTIONS.115.003469.
BACKGROUND
Current monotherapy drug-eluting stents are associated with impaired healing, neoatherosclerosis, and late stent thrombosis. The healing profile and neointimal transformation of the first dual-therapy endothelial progenitor cell-capturing sirolimus-eluting stent are unknown.
METHODS AND RESULTS
In this prospective, single-center study, 61 patients treated with the Combo stent had optical coherence tomography at baseline, early follow-up (4 monthly groups in a 1:2:2:1 ratio from 2 to 5 months), 9 months, and 24 months. Optical coherence tomography early strut coverage increased from 77.1% to 92.5% to 92.7% to 94.9% between 2 and 5 months. At 9 months, the major adverse cardiac event rate was 1.64%, and angiographic in-stent late loss was 0.24 mm (0.08-0.40). The 36-month major adverse cardiac event rate was 3.3%. From 9 to 24 months, neointimal regression was confirmed by optical coherence tomography: neointimal thickness (median [first quartile and third quartile]), 0.14 mm (0.08 and 0.21) versus 0.12 mm (0.07 and 0.19), P<0.001; neointimal volume, 29.9 mm(3) (22.1 and 43.2) versus 26.2 mm(3) (19.6 and 35.8), P=0.003; and percent neointimal volume, 17.8% (12.2 and 21.2) versus 15.7% (11.2 and 19.4), P=0.01. No definite or probable late stent thrombosis was recorded.
CONCLUSIONS
With additional endothelial progenitor cell-capturing technology, the Combo stent exhibits a unique late neointimal regression (from 9 to 24 months) that has not been reported in any drug-eluting stents, translating into good 36-month clinical results with minimal restenosis and no late stent thrombosis. This is the first study testing the concept of using a longitudinal sequential optical coherence tomography protocol to continuously document early healing profile and late neointimal transformation, predicting long-term outcomes of a new novel stent platform.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01274234, NCT01756807, and NCT02263313.
背景
目前的单药治疗药物洗脱支架与愈合受损、新生动脉粥样硬化和晚期支架血栓形成有关。首款双重疗法内皮祖细胞捕获西罗莫司洗脱支架的愈合情况和新生内膜转化尚不清楚。
方法与结果
在这项前瞻性单中心研究中，61例接受Combo支架治疗的患者在基线、早期随访（2至5个月，分为4个月度组，比例为1:2:2:1）、9个月和24个月时接受了光学相干断层扫描。在2至5个月之间，光学相干断层扫描显示早期支架小梁覆盖率从77.1%增加到92.5%，再到92.7%，最后到94.9%。在9个月时，主要不良心脏事件发生率为1.64%，血管造影显示支架内晚期管腔丢失为0.24 mm（0.08 - 0.40）。36个月时主要不良心脏事件发生率为3.3%。从9个月到24个月，光学相干断层扫描证实了新生内膜的消退：新生内膜厚度（中位数[第一四分位数和第三四分位数]），0.14 mm（0.08和0.21）对0.12 mm（0.07和0.19），P<0.001；新生内膜体积，29.9 mm³（22.1和43.2）对26.2 mm³（19.6和35.8），P = 0.003；新生内膜体积百分比，17.8%（12.2和21.2）对15.7%（11.2和19.4），P = 0.01。未记录到明确或可能的晚期支架血栓形成。
结论
借助额外的内皮祖细胞捕获技术，Combo支架表现出独特的晚期新生内膜消退（从9个月到24个月），这在任何药物洗脱支架中均未报道，转化为良好的36个月临床结果，再狭窄率最低且无晚期支架血栓形成。这是第一项测试使用纵向序贯光学相干断层扫描方案连续记录早期愈合情况和晚期新生内膜转化以预测新型支架平台长期结果这一概念的研究。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT01274234、NCT01756807和NCT02263313。
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