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使用三维光学相干断层成像术对生物可吸收血管支架封闭的分支血管进行 5 年的连续评估:来自 ABSORB 队列 B 试验的观察结果(生物可吸收依维莫司洗脱冠状动脉支架系统治疗初发原生冠状动脉病变患者的临床评估)。

Serial 5-Year Evaluation of Side Branches Jailed by Bioresorbable Vascular Scaffolds Using 3-Dimensional Optical Coherence Tomography: Insights From the ABSORB Cohort B Trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions).

机构信息

From the Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (Y.O., S.N., R.-J.v.G.); Cardialysis, Rotterdam, the Netherlands (Y.O.); Academic Medical Center, University of Amsterdam, the Netherlands (M.J.G., T.A., Y.S., J.J.W., R.J.d.W.); National Heart Centre Singapore (N.F., J.N.); National University of Singapore (J.N.); Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine, Yamaguchi-Ube, Japan (T.O.); Catharina Ziekenhuis, Eindhoven, the Netherlands (J.K.); Skejby Sygehus, Aarhus, Denmark (E.C.); The Cardiovascular Research Centre, St. Vincents Hospital, Fitzroy, Australia (R.W.); Cardiology Department, Christchurch Hospital, New Zealand (D.M.); Division of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands (P.S.); Division of Cardiology Swiss Cardiovascular Center, Bern, Switzerland (S.W.); Auckland City Hospital, New Zealand (J.A.O.); and International Center for Circulatory Health NHLI, Imperial College London, United Kingdom (P.W.S.).

出版信息

Circ Cardiovasc Interv. 2017 Sep;10(9). doi: 10.1161/CIRCINTERVENTIONS.116.004393.

Abstract

BACKGROUND

The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts.

METHODS AND RESULTS

We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm (baseline) to 0.68 mm (first follow-up visit at 6 months or 1 year) and 0.63 mm (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm (=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time.

CONCLUSIONS

This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients.

CLINICAL TRIAL REGISTRATION

URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

摘要

背景

Absorb 生物可吸收血管支架(雅培血管,圣克拉拉,CA)的支柱封锁侧支开口的长期命运尚不清楚。因此,我们连续(术后和 6 个月、1 年、2 年、3 年和 5 年)评估被监禁的 Absorb 生物可吸收血管支架支柱的外观和命运。

方法和结果

我们使用一种新的、经过验证的切割平面分析方法,对 ABSORB 试验 B 队列(生物可吸收依维莫司洗脱冠状动脉支架系统在治疗原发性冠状动脉病变患者中的临床评估)进行了 3 年的光学相干断层扫描分析。我们纳入了 29 例共 85 个侧支开口的患者。在可进行真正连续评估的 12 个开口中,7 个显示出初始开口面积无支架减少的模式,随后在 5 年随访结束时,无支架的开口面积增加。在以时间为固定变量,无支架开口面积为因变量的重复测量分析中,我们发现无支架开口面积从 0.75mm(基线)到 0.68mm(6 个月或 1 年首次随访)和 0.63mm(2 或 3 年第二次随访)呈数值下降。然而,从第二次随访到 5 年随访,从 0.63mm 到 0.89mm(=0.001)有统计学显著增加。覆盖开口的支架将开口分成多个隔室,这些隔室的数量随时间减少。

结论

本研究表明,在大多数情况下,无支架开口面积最初减少。然而,随着支架完全生物吸收,在大多数患者中,2 至 3 年和 5 年后,无支架开口面积增加。

临床试验注册

网址:http://www.clinicaltrials.gov。唯一标识符:NCT00856856。

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