Dynamics of vessel wall changes following the implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months
Dynamics of vessel wall changes following the implantation of the Absorb everolimus-eluting bioresorbable vascular scaffold: a multi-imaging modality study at 6, 12, 24 and 36 months
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DOI：
10.4244/eijv9i11a217
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发表时间：
2014-03-01
期刊：
影响因子：
6.2
通讯作者：
Ormiston, John A.
中科院分区：
文献类型：
--
作者：
Serruys, Patrick W.;Onuma, Yoshinobu;Ormiston, John A.
目的：评估在两个连续队列的患者中进行的Absorb生物可吸收依维莫司洗脱血管支架的多模态成像的观察结果，这些患者在6个月和24个月或12个月和36个月时进行了系列研究。在ABSORB多中心单组试验中，45例患者（队列B1）和56名患者（队列B2）接受了连续侵入性成像，特别是定量冠状动脉造影（QCA）、血管内超声（IVUS）、射频背散射（IVUS-VH）和光学相干断层扫描（OCT）。在1年和3年之间，晚期管腔丢失保持不变（6个月：0.19 mm，1年：0.27 mm，2年：0.27 mm，3年：0.29 mm），整个队列B（n=101）在3年时的节段内血管造影再狭窄率为6%。在IVUS上，平均管腔、支架、斑块和血管面积显示扩大达两年。平均管腔和支架面积在两到三年之间保持稳定，而支柱后的斑块显著减少，EEM有适应性限制性重塑的趋势。血管壁的高回声性（生物吸收过程的替代物）从23.1%降至10.4%，致密钙和坏死核心的射频反向散射减少。在3年时，OCT检测到的支柱核心计数显著增加，可能反映了支架的拆除; 98%的支柱被覆盖。在整个队列B（n=101），三年的主要不良心脏事件率为10.0%，没有任何支架thrombosis.Conclusions：目前的调查表明，动态血管壁的变化后，植入的生物可吸收支架，导致在三年内稳定的管腔尺寸，低再狭窄率和低临床主要不良心脏事件率。临床试验注册信息：http://www.clinicaltrials.gov/ct2/show/NCT00856856
Aims: To assess observations with multimodality imaging of the Absorb bioresorbable everolimus-eluting vascular scaffold performed in two consecutive cohorts of patients who were serially investigated either at 6 and 24 months or at 12 and 36 months.Methods and results: In the ABSORB multicentre single-arm trial, 45 patients (cohort B1) and 56 patients (cohort B2) underwent serial invasive imaging, specifically quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), radiofrequency backscattering (IVUS-VH) and optical coherence tomography (OCT). Between one and three years, late luminal loss remained unchanged (6 months: 0.19 mm, 1 year: 0.27 mm, 2 years: 0.27 mm, 3 years: 0.29 mm) and the in-segment angiographic restenosis rate for the entire cohort B (n=101) at three years was 6%. On IVUS, mean lumen, scaffold, plaque and vessel area showed enlargement up to two years. Mean lumen and scaffold area remained stable between two and three years whereas significant reduction in plaque behind the struts occurred with a trend toward adaptive restrictive remodelling of EEM. Hyperechogenicity of the vessel wall, a surrogate of the bioresorption process, decreased from 23.1% to 10.4% with a reduction of radiofrequency backscattering for dense calcium and necrotic core. At three years, the count of strut cores detected on OCT increased significantly, probably reflecting the dismantling of the scaffold; 98% of struts were covered. In the entire cohort B (n=101), the three-year major adverse cardiac event rate was 10.0% without any scaffold thrombosis.Conclusions: The current investigation demonstrated the dynamics of vessel wall changes after implantation of a bioresorbable scaffold, resulting at three years in stable luminal dimensions, a low restenosis rate and a low clinical major adverse cardiac events rate. Clinical Trial Registration Information: http://www.clinicaltrials.gov/ct2/show/NCT00856856