Optical coherence tomography-guided stent optimization for complex coronary lesions: the OCCUPI trial.

Methods

From the OCCUPI randomized trial investigating the impact of OCT guidance compared to angiography guidance in complex lesions, patients who underwent OCT-guided PCI with post-stenting OCT evaluations were enrolled and classified into two groups based on whether they met the OCCUPI-OCT criteria: OCT Optimization vs OCT Sub-Optimization.

在OCCUPI随机试验中，研究了OCT引导与血管造影引导在复杂病变中的影响，纳入了接受OCT引导PCI并进行术后OCT评估的患者，并根据是否满足OCCUPI-OCT标准将患者分为两组：OCT优化组与OCT次优化组。

The primary endpoint was the cumulative incidenceof cardiac death, myocardial infarction, stent thrombosis, or ischemia-driven target vessel revascularization during one year in the as-treated population.

主要终点是一年内在按治疗方案处理的人群中，心脏死亡、心肌梗死、支架血栓形成或缺血驱动的目标血管再血管化的累积发生率。

Results

Among the 773 patients who underwent OCT-guided PCI, 549 (71.0%) met the optimization criteria (OCT Optimization), whereas 224 did not (OCT Sub-Optimization).

在773名接受OCT引导的PCI治疗的患者中，有549名（71.0%）符合优化标准（OCT优化），而224名不符合（OCT次优化）。

On multivariable analysis, long lesions and small-vessel disease were significant independent predictors of OCT Sub-Optimization.

在多变量分析中，长病变和小血管病变是OCT次优效果的重要独立预测因素。

The occurrence of the primary endpoint was significantly lower in the OCT Optimization (2.9%) than in the OCT Sub-Optimization [9.4%, hazard ratio(HR): 0.30, 95% confidence interval(CI): 0.16-0.58, P < .001] or angiography guidance [7.5%, HR: 0.38, 95% CI: 0.22-0.66, P < .001].

主要终点事件的发生率在OCT优化组（2.9%）显著低于OCT次优效果组[9.4%，风险比（HR）：0.30，95%置信区间（CI）：0.16-0.58，P < .001]或血管造影引导组[7.5%，HR：0.38，95% CI：0.22-0.66，P < .001]。

Each acceptable component of OCCUPI-OCT criteria assessing stent expansion (minimal stent area, ≥80% mean reference lumen or ≥100% distal reference lumen areas; > 4.5 mm2), apposition (malapposed distance, <400 μm), and absence of major edge dissection, was significantly associated with favourable outcomes (all P < .001).

OCCUPI-OCT标准评估支架扩张的每个可接受组成部分（最小支架面积≥80%平均参考腔面积或≥100%远端参考腔面积；>4.5 mm2）、贴壁（未贴合距离<400 μm）以及无重大边缘撕裂，均与有利结果显著相关（所有P<.001）。

Conclusions

The current study identifies long lesions or small-vessel disease as the determinants of stent optimization following OCT guidance, with the achievement of stent optimization significantly associated with improved clinical outcomes.

当前研究确定长病变或小血管疾病为OCT引导下支架优化的决定因素，实现支架优化与改善临床结果显著相关。

Stent expansion, apposition, and edge dissection, the three key components of the OCCUPI-OCT criteria, were highly predictive of favourable clinical outcomes.

支架扩张、贴壁和边缘撕裂，OCCUPI-OCT标准的三个关键组成部分，对临床结果有很高的预测性。