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.
J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
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.
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.
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.
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.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01751906 (ABSORB III); NCT01844284 (ABSORB Japan).
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。
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。
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。
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。
网址：http://www.clinicaltrials.gov。唯一标识符：NCT01751906（ABSORB III）；NCT01844284（ABSORB 日本）。
