the First Affiliated Hospital of Nanjing Medical University
National Natural Science Foundation of China (82070367); Natural Science Foundation of Jiangsu Province (BK20210966); Clinical research projects of Jiangsu Province Hospital (303103513BA20)
目的：评估光学相干断层成像（OCT）结合无创功能学检查定量血流分数（QFR）在急性冠脉综合征（ACS）介入诊疗中的指导价值。方法：入选拟行择期经皮冠状动脉介入术（PCI）、并于术中接受OCT检查的ACS患者。若OCT下靶病变的最小管腔面积（MLA）＞2.6mm2且未见斑块破裂或夹层，则予以最佳药物治疗（OMT），设为OCT-OMT组；余ACS患者在OCT指导下行PCI治疗，设为OCT-PCI组。比较两组间OCT测得的相关数据，回顾性使用QFR技术对造影图像质量良好的病变的功能学指标进行分析和验证。收集两组患者术后1年内的不良临床事件，完成数据统计分析。结果：入选120例拟行择期PCI并于术中接受OCT检查的ACS患者，共计146处靶病变。OCT-OMT组47例（39.2%），OCT-PCI组73例（60.8%）。OCT检查结果示：OCT-OMT病变的平均MLA水平显著高于OCT-PCI病变（3.74mm2 vs. 2.41mm2, P<0.0001），同时其平均狭窄程度显著偏低（62.6% vs. 73.6%, P<0.0001）。QFR分析结果示：OCT-OMT病变的平均QFR值显著高于OCT-PCI病变（0.89 vs. 0.75, P<0.0001），OCT-OMT病变“QFR≤0.80”的占比显著低于OCT-PCI病变（7.14% vs. 84.7%, P<0.0001）。术后1年的随访结果示：主要不良心血管事件（死亡、心肌梗死、靶血管重建、因心绞痛再入院）以及大出血事件的总体发生率较低（分别为7.5%和0.8%），且在两组间无统计学差异；而OCT-OMT组小出血事件的发生率显著低于OCT-PCI组（RR: 0.12, P=0.04）。结论：结合QFR分析验证和随访数据，OCT以“MLA＞2.6mm2且未见斑块破裂或夹层”为决策标准指导部分ACS患者行药物治疗安全有效。QFR可为OCT补充功能学证据，两者在评估和指导ACS介入诊疗上有着良好的一致性。
Objective This study was to assess the value of optical coherence tomography (OCT) in guiding the intervention for acute coronary syndrome (ACS) verified by the non-invasive quantitative flow ratio (QFR), functionally. Methods Patients who were intended to undergo percutaneous coronary intervention (PCI) and evaluated by OCT during operation were enrolled. Patients target lesions with a minimum luminal area (MLA) >2.6mm2 by OCT and in whom OCT showed no features of plaque rupture or dissection received optimal medical therapy (OMT) and these patients were assigned to OCT-OMT arm. The other patients received PCI treatment and were assigned to OCT-PCI arm. Data measured by OCT between groups were compared. Functional indexes derived from lesions with high quality images were retrospectively analyzed and validated by QFR. Adverse clinical events between two groups at 1 year follow-up were collected and data statistical analyses were carried out subsequently. Results 120 ACS patients who were intended to undergo PCI and evaluated by OCT during operation with 146 lesions were enrolled. 47 patients (39.2%) were assigned to the OCT-OMT arm, and the other 73 patients (60.8%) were assigned to the OCT-PCI arm. According to OCT analyses, the average MLA of OCT-OMT lesions was significantly higher than that of OCT-PCI lesions (3.74mm2 vs.2.41mm2, P<0.0001), with area stenosis significantly lower (62.57% vs. 73.58%, P<0.0001). According to QFR analyses, the average QFR value of OCT-OMT lesions was significantly higher than that of OCT-PCI lesions (0.89 vs.0.75, P<0.0001); The “QFR≤0.80” rate of OCT-OMT lesions was significantly lower than that of OCT-PCI lesions (7.14% vs. 84.7% P<0.0001). According to 1 year follow-up, the incidence of major adverse cardiac events (death, myocardial infarction, target vessel revascularization and rehospitalization for angina) and major bleeding events were low (7.5% and 0.8%) with no significant difference between two groups. However, the incidence of minor bleeding events in OCT-OMT arm was significantly lower than OCT-PCI arm (RR: 0.12, P=0.04). Conclusion Combination of QFR analyses and follow-up results, OCT is safe and efficient in guiding OMT for patients with acute coronary syndrome with the standard of MLA>2.6mm2 and existing neither plaque rupture nor dissection assessed by OCT. QFR can supply functional evidence additionally. Modest consistency was observed in evaluating and guiding for ACS between QFR and OCT.