血流储备分数指导下介入策略的改变对于患者的影响

The Impacts of Changes in PCI Strategy under the Guidance of FFR on Patient Prognosis

摘要: 背景：冠状动脉粥样硬化性心脏病(Coronary heart disease, CHD)是指向心脏提供血液的动脉，即冠状动脉发生粥样硬化引起管腔狭窄或闭塞，继而导致心肌缺血、缺氧或坏死，继而造成不同程度的胸痛、胸闷、憋气等不适，严重者可危及生命的一系列疾病。对于冠心病的诊断，冠脉造影术(Coronary angiography, CAG)一直被视作“金标准”，但在冠状动脉临界病变及一些功能性缺血病变中，CAG用于判断冠脉病变远端的心肌是否存在灌注不足是存在缺陷的。冠状动脉血流储备分数(fractional flow reserve, FFR)是评估冠状动脉血流的功能学和生理学指标，定义为存在狭窄病变情况下该冠状动脉提供给心肌的最大血流量与理论上无狭窄情况下心肌所能获得最大血流量的比值。多项研究也证明FFR对临界病变具有准确的诊断作用，它可以帮助我们从功能学和生理学的角度来判断冠状动脉病变是否造成心肌缺血。在实际的手术过程中，术者在进行冠脉造影后制定的介入手术策略，在FFR指导后常可改变，目测的非缺血性病变可能接受了PCI，而血管造影上识别出的缺血性病变可能采取了保守治疗的策略。目的：探讨FFR指导下PCI策略的改变对于患者的预后是否存在正向的影响，以及FFR对于介入医师决策的影响力，证实FFR在临床上是否有更大的应用价值。方法：分析2016年9月至2021年6月期间就诊于我院心脏中心心内科并行CAG检查显示冠脉动脉至少一支为中度狭窄病变(50%~90%)的冠心病患者共600例，其中观察组为联合FFR指导实行PCI治疗的患者，共300名，对照组为仅冠脉造影指导制定治疗策略的患者，共300名，600名患者出院后均将所有患者的冠脉造影结果收集后，由我中心3名有经验的心脏介入医师回顾性阅片，结合患者病史、症状、年龄指定治疗策略，通过查阅手术记录回顾当时行FFR检查后的治疗策略，统计改变治疗策略的人数(观察组A)与未改变治疗策略的人数(观察组B)，随访所有患者术后6~12个月的情况，随访方式包括电话随访、门诊随访、住院随访等，有42例患者失访，最终有558例患者纳入本研究，其中对照组272人，观察组286人，观察患者基线资料、冠脉造影及PCI资料及心血管不良事件(Major adverse cardiovascular event, MACE) (包括心源性死亡、心肌梗死、再次血运重建、心绞痛发作)在对照组及观察组之间及观察组A和B之间的差异。结果：各组患者在一般临床资料比较中显示，包括年龄、性别、吸烟、高血压、糖尿病、高脂血症、左室射血分数、心梗示、PCI史、病变血管狭窄程度、病变血管数等因素之间的差异无统计学意义(p > 0.05)。两组病人手术时间比较差异无统计学意义(p > 0.05)；观察组置入支架数、造影剂使用量均低于对照组(p < 0.05)，住院时间较对照组明显缩短(p < 0.05)，观察组不良心血管事件发生率低于对照组(p < 0.05)，观察组A共121 (42.3%)人，观察组B共165 (57.7%)人，观察组A与观察组B的不良心血管事件发生率无明显差异(p > 0.05)。结论：对于存在冠脉临界病变的患者，进行冠脉造影联合FFR检测可减少支架置入数量、造影剂使用量，缩短住院时间，且降低不良心血管事件发生率。FFR对于术者PCI策略的决定有着显著影响力，且策略的改变对于患者预后无明显影响。故对于冠脉临界病变的患者，FFR检测具有较高的应用价值。

Abstract: Background: Coronary heart disease (CHD) is a series of diseases that point to the artery that pro-vides blood to the heart, that is, coronary artery atherosclerosis causes lumen stenosis or occlusion, which leads to myocardial ischemia, hypoxia or necrosis, and then leads to varying degrees of chest pain, chest tightness, suffocation and other discomfort. In severe cases, it can be life-threatening. For the diagnosis of coronary heart disease, coronary angiography (CAG) has always been regarded as the “gold standard”, but in critical coronary artery lesions and some functional ischemic lesions, CAG is defective in judging whether there is insufficient perfusion in the myocardium at the distal end of coronary artery lesions. Fractional flow reserve (FFR) is a functional and physiological index to evaluate coronary blood flow. It is defined as the ratio of the maximum blood flow provided by the coronary artery to the maximum blood flow that can be obtained by the myocardium without stenosis. Many studies have also proved that FFR can accurately diagnose critical lesions. It can help us judge whether coronary artery lesions cause myocardial ischemia from the perspective of function and physiology. In the actual procedure process, the intervention strategy formulated by the operator after coronary angiography can often be changed under the guidance of FFR. The visual non ischemic lesions may receive PCI, while the ischemic lesions not identified on angiography may adopt the strategy of conservative treatment. Objective: To explore whether the changes of PCI strategy under the guidance of FFR has a positive impact on the prognosis of patients and the influence of FFR on the decision-making of interventional physicians, and to confirm whether FFR has greater clinical application value. Methods: A total of 600 patients with coronary heart disease with at least one coronary artery with moderate stenosis (50%~90%) were analyzed in the Department of Cardiology of the heart center of our hospital from September 2016 to June 2021. Among them, 300 patients in the experimental group were treated with PCI under the guidance of FFR, and 300 patients in the CAG group were treated with treatment strategies under the guidance of coronary angiography only. After 600 patients were discharged from the hospital, the coronary angiography results of all the patients were collected, and 3 experienced cardiac interventional cardiologists in our center reviewed the films, designated the treatment strategy in combination with the patient’s medical history, symptoms and age, and reviewed the treatment strategy after FFR examination by consulting the procedure records. The number of patients who changed the treatment strategy (FFR group A) and the number of patients who did not change the treatment strategy (FFR group B) were counted. All the patients were followed up for 6 months to 1 year after procedure. The follow-up methods included telephone follow-up, outpatient follow-up and inpatient follow-up. Forty-two patients lost the follow-up. Finally, 558 patients were included in the study, including 272 in the CAG group and 286 in the FFR group. The baseline data of patients were observed differences in coronary angiography and PCI data and major adverse cardiovascular event (MACE) (including cardiac death, myocardial infarction, revascularization and angina pectoris attack) between the CAG group and the FFR group and between FFR groups A and B. Results: The clinical data of patients with hypertension, smoking and diabetes were compared between groups, smoking, hypertension, diabetes, hyperlipidemia, left ventricular ejection fraction, myocardial infarction, PCI history, degree of stenosis of diseased vessels, number of diseased vessels and other factors. There was no significant difference between them (p > 0.05). There was no significant difference in procedure times between the two groups (p > 0.05); the number of stents and the amount of contrast medium used in FFR group were lower than those in the CAG group (p < 0.05); the length of hospital stay was significantly shorter than that in the CAG group (p < 0.05), and the incidence of adverse cardiovascular events in the FFR group was lower than that in the CAG group (p < 0.05). There were 121 (42.3%) in FFR group A and 165 (57.7%) in FFR group B, There was no significant difference in the incidence of adverse cardiovascular events between FFR group A and FFR group B (p > 0.05). Conclusion: For patients with critical coronary lesions, coronary angiography combined with FFR can reduce the number of stents, the use of contrast agents, shorten the length of hospital stay, and reduce the incidence of adverse cardiovascular events. FFR has a significant impact on the decision of PCI strategy, and the change of strategy has no significant impact on the prognosis of patients. Therefore, FFR detection has high application value for patients with coronary critical lesions.