Background:We investigated whether optical coherence tomography (OCT) guidance would reduce nonoptimal bioresorbable vascular scaffold (BVS) deployment.Methods:This was a randomized controlled trial. Patients who required percutaneous coronary intervention for ischemic heart disease were recruited from 2 centers in Korea. The enrolled patients were randomly assigned to receive either OCT-guided BVS (Absorb; Abbott Vascular) implantation or angiography-guided BVS implantation using an optimized technique. The primary outcome was nonoptimal deployment, which was a composite outcome of the following parameters assessed by OCT: a minimal scaffold area <5 mm², residual area stenosis >20%, incomplete apposition of the scaffold struts >5%, major edge dissection, or scaffold disruption. The secondary outcome was a procedural complication defined by the occurrence of no reflow, coronary perforation, or flow-limiting dissection.Results:Between September 2016 and January 2018, 88 patients (90 lesions) were assigned to OCT guidance, while 88 patients (89 lesions) were assigned to angiography guidance. The recruitment was prematurely terminated in March 2018 because the manufacturer stopped supplying BVS. Postprocedural OCT data were available for 88 lesions with OCT guidance and for 88 lesions with angiography guidance. There was nonoptimal BVS deployment postprocedurally in 35.2% of patients in the OCT-guidance group and in 38.6% in the angiography-guidance group (absolute difference, −3.7% [95% CI, −19.0% to 11.6%]; P=0.64). There were no procedural complications in either group.Conclusions:OCT-guided BVS implantation did not reduce the incidence of nonoptimal deployment compared to that of angiography-guided BVS implantation (using optimized techniques).Clinical Trial Registration:URL: https://www.clinicaltrials.gov. Unique identifier: NCT02894697.

中文翻译：

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冠状动脉生物可吸收血管支架植入术的光学相干断层扫描：随机对照试验。

背景：我们研究了光学相干断层扫描（OCT）指导是否会减少非最佳生物可吸收血管支架（BVS）的部署。方法：这是一项随机对照试验。从韩国的两个中心招募了需要经皮冠状动脉介入治疗缺血性心脏病的患者。入选患者被随机分配接受使用优化技术的OCT引导BVS（Absorb； Abbott血管）植入术或血管造影术BVS植入术。主要结果是非最佳部署，这是OCT评估的以下参数的综合结果：最小支架面积<5 mm ²，残余面积狭窄> 20％，支架撑杆的不完全并置> 5％，大边缘剥离或支架破裂。次要结果为手术并发症，其定义为未发生再流，冠状动脉穿孔或血流受限夹层。结果：2016年9月至2018年1月，将88例患者（90个病变）分配给OCT指导，而88例患者（89个）病变）分配到血管造影指导。由于制造商停止供应BVS，招募于2018年3月提前终止。在OCT指导下，有88个病变，在血管造影术指导下，有88个病变的手术后OCT数据可用。OCT指导组中35.2％的患者进行了术后最佳BVS部署，而血管造影术指导组中38.6％的患者进行了术后最佳BVS部署（绝对差异为-3.7％[95％CI，P = 0.64）。两组均无手术并发症。结论：OCT引导的BVS植入与血管造影术引导的BVS植入（使用优化技术）相比没有降低非最佳部署的发生率。临床试验注册：URL：https：// www。 .clinicaltrials.gov。唯一标识符：NCT02894697。