血管内超声预测 ABSORB 生物可吸收支架植入术后长期结局：ABSORB III 与 ABSORB Japan 试验的汇总分析。
Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials.
机构信息
Division of Cardiovascular Medicine, Stanford Cardiovascular Institute, Stanford University School of Medicine, Stanford, CA, United States.
Beth Israel Deaconess Medical Center, Boston, MA, United States.
出版信息
J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
BACKGROUND
The long-term prognostic impact of IVUS findings following Absorb BVS implantation remains uncertain. This study aimed to identify the IVUS predictors of long-term clinical outcomes following ABSORB bioresorbable vascular scaffold (BVS) implantation from the pooled IVUS substudy cohorts of the ABSORB III and Japan trials.
METHODS
A total of 298 lesions in 286 patients were enrolled with 2:1 randomization to ABSORB BVS vs. cobalt-chromium everolimus-eluting stents. This sub-analysis included 168 lesions of 160 patients in the Absorb arm whose post-procedural quantitative IVUS were available. The primary endpoint of this analysis was device-oriented composite endpoint (DOCE) of target lesion failure, including cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. The median follow-up duration was 4.9 [3.1-5.0] years.
RESULTS
During follow-up, DOCE occurred in 10.1% of lesions treated with Absorb BVS. Among several post-procedural IVUS indices associated with DOCE, non-uniform device expansion (defined as uniformity index = minimum / maximum device area) (hazard ratio 0.47 per 0.1 increase [95%CI 0.28 to 0.77]; p = 0.003) and residual reference plaque burden (hazard ratio 4.01 per 10% increase [95%CI 1.50 to 10.77]; p = 0.006) were identified as independent predictors of DOCE by Cox multivariable analysis.
CONCLUSIONS
Nonuniform device expansion and substantial untreated residual plaque in reference segments were associated with long-term adverse events following BVS implantation. Baseline imaging to identify the appropriate device landing zone and procedural imaging to achieve uniform device expansion if possible (e.g. through post-dilatation) may improve clinical outcomes of BVS implantation.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).
背景
在 Absorb BVS 植入术后，血管内超声（IVUS）检查结果对长期预后的影响尚不确定。本研究旨在通过 ABSORB III 和日本试验的 IVUS 子研究队列，确定 Absorb 生物可吸收血管支架（BVS）植入术后 IVUS 预测长期临床结局的指标。
方法
共有 286 例患者的 298 个病变按 2:1 比例随机分为 Absorb BVS 组和钴铬依维莫司洗脱支架组。该亚分析包括 Absorb 组 168 个病变的 160 例患者，这些患者术后均进行了定量 IVUS 检查。本分析的主要终点是基于器械的复合终点（DOCE），包括心脏性死亡、靶血管相关心肌梗死或缺血驱动的靶病变血运重建。中位随访时间为 4.9[3.1-5.0]年。
结果
在随访期间，接受 Absorb BVS 治疗的病变中 DOCE 发生率为 10.1%。在与 DOCE 相关的多个术后 IVUS 指标中，非均匀器械扩张（定义为均匀指数=最小/最大器械面积）（风险比每增加 0.1 为 0.47[95%CI 0.28 至 0.77]；p=0.003）和残余参考斑块负荷（风险比每增加 10%为 4.01[95%CI 1.50 至 10.77]；p=0.006）被 Cox 多变量分析确定为 DOCE 的独立预测因素。
结论
非均匀器械扩张和参考节段内大量未治疗的残余斑块与 BVS 植入后长期不良事件相关。通过基线影像学识别合适的器械着陆区，并尽可能通过后扩张实现均匀的器械扩张（例如），可能会改善 BVS 植入的临床结局。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT01751906（ABSORB III）；NCT01844284（ABSORB 日本）。
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