Department of Cardiology, Angiology and Intensive Care Medicine, Deutsches Herzzentrum Charité, Charité-Universitätsmedizin Berlin, Berlin, Germany.
Berlin Institute of Health, Berlin, Germany.
Eur Heart J. 2024 Nov 14;45(43):4630-4643. doi: 10.1093/eurheartj/ehae521.
Observational registries have suggested that optical coherence tomography (OCT) imaging-derived parameters may predict adverse events after drug-eluting stent (DES) implantation. The present analysis sought to determine the OCT predictors of clinical outcomes from the large-scale ILUMIEN IV trial.
ILUMIEN IV was a prospective, single-blind trial of 2487 patients with diabetes or high-risk lesions randomized to OCT-guided versus angiography-guided DES implantation. All patients underwent final OCT imaging (blinded in the angiography-guided arm). From more than 20 candidates, the independent OCT predictors of 2-year target lesion failure (TLF; the primary endpoint), cardiac death or target-vessel myocardial infarction (TV-MI), ischaemia-driven target lesion revascularization (ID-TLR), and stent thrombosis were analysed by multivariable Cox proportional hazard regression in single treated lesions.
A total of 2128 patients had a single treated lesion with core laboratory-analysed final OCT. The 2-year Kaplan-Meier rates of TLF, cardiac death or TV-MI, ID-TLR, and stent thrombosis were 6.3% (n = 130), 3.3% (n = 68), 4.3% (n = 87), and 0.9% (n = 18), respectively. The independent predictors of 2-year TLF were a smaller minimal stent area (per 1 mm2 increase: hazard ratio 0.76, 95% confidence interval 0.68-0.89, P < .0001) and proximal edge dissection (hazard ratio 1.77, 95% confidence interval 1.20-2.62, P = .004). The independent predictors of cardiac death or TV-MI were smaller minimal stent area and longer stent length; of ID-TLR were smaller intra-stent flow area and proximal edge dissection; and of stent thrombosis was smaller minimal stent expansion.
In the ILUMIEN IV trial, the most important OCT-derived post-DES predictors of both safety and effectiveness outcomes were parameters related to stent area, expansion and flow, proximal edge dissection, and stent length.
观察性注册研究表明，光学相干断层扫描（OCT）成像衍生的参数可能预测药物洗脱支架（DES）植入后的不良事件。本分析旨在确定来自大规模 ILUMIEN IV 试验的 OCT 预测临床结局的指标。
ILUMIEN IV 是一项前瞻性、单盲试验，共纳入 2487 例糖尿病或高危病变患者，随机分为 OCT 指导与血管造影指导的 DES 植入组。所有患者均接受最终 OCT 成像（血管造影指导组盲法）。从 20 多个候选参数中，通过多变量 Cox 比例风险回归分析，在单支病变中分析了 2 年靶病变失败（TLF；主要终点）、心脏死亡或靶血管心肌梗死（TV-MI）、缺血驱动的靶病变血运重建（ID-TLR）和支架血栓形成的独立 OCT 预测因素。
共 2128 例患者的单支病变进行了核心实验室分析的最终 OCT。2 年Kaplan-Meier 发生率为 TLF、心脏死亡或 TV-MI、ID-TLR 和支架血栓形成分别为 6.3%（n=130）、3.3%（n=68）、4.3%（n=87）和 0.9%（n=18）。2 年 TLF 的独立预测因素为最小支架面积较小（每增加 1mm2：风险比 0.76，95%置信区间 0.68-0.89，P<0.0001）和近端边缘夹层（风险比 1.77，95%置信区间 1.20-2.62，P=0.004）。心脏死亡或 TV-MI 的独立预测因素为最小支架面积和支架长度较长；ID-TLR 的独立预测因素为支架内血流面积较小和近端边缘夹层；支架血栓形成的独立预测因素为最小支架扩张。
在 ILUMIEN IV 试验中，DES 后最重要的与安全性和有效性结果相关的 OCT 衍生预测因素是与支架面积、扩张和血流、近端边缘夹层和支架长度相关的参数。
