我国复杂冠心病治疗方式选择的合理性及其对预后的影响

发布时间：2018-06-25 21:04

本文选题：我国 + 复杂　；参考：《北京协和医学院》2016年博士论文

【摘要】：冠心病三支病变和左主干病变的自然预后差。血运重建治疗(CABG或PCI)是其主要治疗方式。既往研究显示,欧美国家存在血运重建技术使用过度和使用不足的问题。我国冠心病发病率逐年增加,PCI和CABG迅速普及,但两者的手术量之比为12～15：1,远高于发达国家水平(3：1)。我国目前尚无公认的血运重建指南和合理性评价标准,专科医生培养体系有待健全,目前医务工作的报偿仍以医疗服务规模而非医疗质量为依据,因此我们有必要评价目前临床事件中复杂冠心病治疗策略选择的合理性。中国复杂冠心病医疗结果评价研究(China PEACE-3VD)是由我国24家同时具备CABG和PCI治疗能力的教学医院联合开展的前瞻性观察性研究,共入选了超过4000例接受择期冠脉造影被诊断为复杂冠心病(三支病变或左主干病变)的患者。我们利用国际指南评价该队列患者治疗策略的合理性,分析治疗合理性与临床预后的相关性,并探究治疗策略选择过程中的不合理环节,为将来的临床路径优化提供依据。主要的的研究结果如下：第一部分：复杂冠心病治疗的合理性评价目的：利用一项在我国进行的前瞻性观察性研究队列评价冠心病三支病变和/或左主干病变治疗策略的合理性。方法：我们在24家单位连续入选了超过4000例在该中心接受择期冠脉造影并被诊断为冠心病三支和/或左主干病变的患者,并利用2014年版欧洲心脏病协会/欧洲心胸外科医师协会发布的冠心病血运重建指南评价治疗合理性。结果：单中心和多中心队列中接受合理治疗的患者占比分别为68%和57.3%,各单位(23%-74.5%)、同一单位的各个病房(50%-78%)和冠脉造影医生(48%-82%)间治疗策略合理性差异显著。患者的手术危险性(SinoSCORE、慢性肾功能不全、年龄)和解剖病变复杂程度(SYNTAX评分、左主干病变)是治疗策略合理性的独立危险因素,治疗策略合理性与单位、科室或医师的接诊量无关(单位间Pearson相关系数0.278,p=0.222；医师Pearson相关系数0.216,科室Pearson相关系数0.455,p0.05)。结论：我国复杂冠心病治疗策略的合理性有待提高,单位间差异显著,提示较大的质量改善空间。第二部分：复杂冠心病治疗合理性对预后的影响目的：我们发现复杂冠心病患者中大约40%接受了与指南指征不符的治疗,合理性欠佳。本研究旨在进一步评价治疗合理性对患者临床预后的影响,以验证指南对我国患者的适用性。方法：我们通过随访获得前述队列患者的重要临床事件发生情况。我们利用COX回归模型、倾向性积分匹配COX回归模型来比较不同指征分层下各类治疗策略与患者预后的相关性。结果：共有3213例患者(保守治疗485例,CABG治疗1104例,PCI治疗1199例)纳入本次分析。COX回归模型分析发现,保守治疗的MACCE发生率(14% vs 5.9%, HR=2.004, p0.001)、全因死亡/心梗/脑卒中的发生率(8.9% vs 3.1%, HR=1.918, p=0001)明显高于血运重建组。我们根据患者的PCI治疗指征将实际接受血运重建的患者分成A组(符合CABG的Ⅰ类及PCI的Ⅰ类或Ⅱa类指征,1624例)和B组(符合CABG的Ⅰ类及PCI的Ⅲ类指征,1104例)。A组CABG的MACCE发生率(2.6% vs 5.7%, HR=2.563, p=0.008)明显低于PCI组,死亡/心梗/脑卒中的发生率无统计学差异(1.4%vs 2.6%,HR=2.009,p=0.159)。B组CABG的MACCE发生率(3.8% vs 10%, HR=2.532, p=0.002)和死亡/心梗/脑卒中的发生率(2.5% vs 5.6%, HR=1.997)都明显低于PCI,其中死亡/心梗/脑卒中的发生率在两种治疗策略间出现了接近统计学意义的差异。采用倾向性积分匹配的方法获得的结果与未匹配的COX模型结果类似。结论：对于指南推荐血运重建的患者,仅接受保守治疗的预后不佳。接受不合理的血运重建治疗也将影响患者预后。欧洲血运重建指南评价的治疗合理性与患者预后具有明显的相关性。第三部分：复杂冠心病治疗方式选择过程的合理性评价目的：复杂冠心病的治疗策略选择过程常需要内外科医师、患者和家属参与。本研究旨在探讨治疗策略选择过程中各个关键环节的合理性及其对预后的影响。方法：我们通过病案回顾确认患者接受ad hoc PCI(造影后直接PCI)、外科会诊,以及拒绝医师治疗建议的比例,并利用COX回归模型、倾向性积分匹配COX回归模型评价这些关键环节与患者临床预后的关系。结果：3213例患者被纳入本次分析,ad hoc PCI使用率、外科会诊率和患者拒绝的比例分别为49%,36.3%和16.6%。与接受分期血运重建治疗相比,ad hocPCI患者治疗合理性降低(57.9%vs 87.7%,p0.01),MACCE发生率(8.6% vs 4.9%, HR=0.543, p=0.002)更高。与获得外科会诊的患者相比,无外科会诊的患者治疗策略合理性降低(56.6%vs 77.8%,p0.01),预后不佳(7.7%vs 6.3%,p=0.017)。与依从医师建议的患者相比,拒绝医师建议的患者实际接受治疗的合理性不佳(19.6%vs 74.2%,p0.01),影响预后(MACCE:12.2% vs 6.2%, HR=0.579, p0.001)。结论：我国复杂冠心病患者的外科会诊率低,ad hoc PCI使用率偏高,尚有一部分患者拒绝医师的治疗策略建议,三个关键指标都影响治疗策略的合理性和临床预后。第四部分：中国冠心病血运重建适宜使用标准的验证目的：中国冠心病血运重建适宜标准(中国AUC)已经发布,我们利用单中心队列数据比较该标准与欧洲指南对合理性评价的一致性。方法：我们根据中国AUC制定合理性评价方法,利用该方法评价本研究单中心队列患者的治疗合理性。我们通过比较两种合理性评价方法评价治疗策略合理性的一致程度来验证中国AUC的适用性。结果：利用中国AUC建立评价标准,发现本研究单中心队列中有65%接受合理的治疗,该比例与欧洲指南类似。中国AUC可以区分各病房(50%-73.6%)和冠脉造影医生(47.6%-81.8%)间治疗策略合理性差异。该标准与欧洲指南的合理性评价一致性为96.4%。结论：根据中国AUC建立的评价标准与欧洲指南具有较好的一致性,可以用于评价复杂冠心病治疗的合理性及其单位间差异。
[Abstract]:The natural prognosis of three branches of coronary heart disease and left main artery disease is poor. Blood revascularization (CABG or PCI) is the main treatment method. Previous studies have shown that there is a problem of excessive use and insufficient use of blood transport reconstruction in European and American countries. The incidence of coronary heart disease in China is increasing year by year, and PCI and CABG are rapidly popularized, but the ratio of the amount of operation is 12 15:1, far higher than the level of developed countries (3:1). There is no recognized guidelines for blood transportation and the standard of rational evaluation in China. The training system of specialist doctors remains to be improved. At present medical service is still based on the scale of medical service rather than medical quality. Therefore, it is necessary for us to evaluate the treatment of complex coronary heart disease in the current clinical events. The rationality of the choice of therapeutic strategies. The Chinese complex coronary heart disease medical results evaluation study (China PEACE-3VD) is a prospective observational study conducted jointly by 24 Chinese teaching hospitals with the ability to treat CABG and PCI. More than 4000 patients with selective coronary angiography were diagnosed with complex coronary artery disease (three or left main coronary arteries). We use the international guidelines to evaluate the rationality of the patients' treatment strategy in this cohort, analyze the correlation between the rationality of the treatment and the clinical prognosis, and explore the irrational links in the course of the treatment strategy selection, and provide the basis for the optimization of the future clinical pathway. The main results are as follows: complex coronary heart disease Objective: To evaluate the reasonableness of a prospective observational cohort of three coronary lesions and / or left main coronary artery disease in China. Methods: more than 4000 patients received selective coronary angiography and diagnosed as three coronary artery disease and / or coronary artery disease in 24 units. The patients with left main disease were treated with the guidelines of the 2014 edition of the European Heart Association / European Cardiology surgeon Association for coronary artery revascularization. Results: 68% and 57.3% of patients received reasonable treatment in single center and multicenter cohort, each unit (23%-74.5%), each unit of the same unit (50% There were significant differences in the rationality of treatment strategies between -78%) and coronary angiography (48%-82%). Surgical risk (SinoSCORE, chronic renal insufficiency, age) and the complexity of anatomical lesions (SYNTAX score, left main disease) were independent risk factors for the rationality of the treatment strategy, the rational and unit of the treatment strategy, the number of departments or doctors' visits. It was not related (Pearson correlation coefficient 0.278, p=0.222; physician Pearson correlation coefficient 0.216, Pearson correlation coefficient 0.455, P0.05). Conclusion: the rationality of the treatment strategy of complex coronary heart disease in our country needs to be improved, the difference between units is significant and the greater quality is improved. The second part: the rationality of the treatment of complex coronary heart disease is the prognosis. Objective: we have found that about 40% of patients with complex coronary heart disease have been treated with incompatible treatment with guidelines. The purpose of this study is to further evaluate the effect of treatment rationality on the patient's clinical prognosis in order to verify the applicability of the guide to the patients in our country. We used the COX regression model and the tendency integral matching COX regression model to compare the correlation between the different treatment strategies under different indications and the patients' prognosis. Results: 3213 patients (485 cases of conservative treatment, 1104 cases with CABG, 1199 cases with PCI) were included in the analysis of the.COX regression model. The incidence of MACCE (14% vs 5.9%, HR=2.004, p0.001), the incidence of all causes of death / myocardial infarction / stroke (8.9% vs 3.1%, HR=1.918, p=0001) was significantly higher than that in the revascularization group. We divided the patients who actually received the revascularization according to the PCI treatment indications of the patients into the A group (class I and PCI of CABG and PCI, 1624 or class II indications, 1624 The incidence of MACCE (2.6% vs 5.7%, HR=2.563, p=0.008) in group.A was significantly lower than that of the PCI group in group B and group B (class I and PCI). There was no significant difference in the incidence of death / myocardial infarction / stroke (1.4%vs 2.6%, HR=2.009, 10%) and death / myocardial infarction. The incidence of stroke (2.5% vs 5.6%, HR=1.997) was significantly lower than that of PCI, and the incidence of death / myocardial infarction / stroke occurred close to statistical difference between the two treatments. The results obtained by the tendency integral matching method were similar to those of the unmatched COX model. Patients received poor prognosis only with conservative treatment. Receiving irrational revascularization will also affect the patient's prognosis. The rationality of the European guidelines for revascularization has a significant correlation with the prognosis of the patients. The third part: the objective of rational evaluation of the selection process of complex coronary heart disease: the treatment of complex coronary heart disease The strategy selection process often requires the participation of internal and external physicians, patients and family members. The purpose of this study is to explore the rationality of each key link in the process of treatment strategy selection and its impact on the prognosis. Methods: We reviewed the patient's acceptance of ad hoc PCI (direct PCI after contrast), surgical consultation, and the rejection of the physician's advice. The COX regression model and the tendency integral matching COX regression model were used to evaluate the relationship between these key links and the patient's clinical prognosis. Results: 3213 patients were included in this analysis, the rate of ad hoc PCI use, the rate of surgical consultation and the rejection rate of patients were 49%, 36.3% and 16.6%. were compared with the reconstructive therapy for ad hocPCI. The patient's treatment reasonableness decreased (57.9%vs 87.7%, P0.01), the incidence of MACCE (8.6% vs 4.9%, HR=0.543, p=0.002) was higher. Compared with the patients who received surgical consultation, the treatment strategy of patients without surgical consultation was lower (56.6%vs 77.8%, P0.01), and the prognosis was poor (7.7%vs 6.3%, p=0.017). The reasonableness of the patient's treatment was not reasonable (19.6%vs 74.2%, P0.01), affecting the prognosis (MACCE:12.2% vs 6.2%, HR=0.579, p0.001). Conclusion: the surgical consultation rate of the patients with complex coronary heart disease is low, the ad hoc PCI use rate is high, there are some patients who refuse the doctor's treatment strategy advice, and the three key indexes all affect the treatment strategy. The fourth part: the fourth part: China's coronary artery revascularization suitable standard test objective: the Chinese coronary artery revascularization suitable standard (China AUC) has been published, we use the single center queue data to compare the consistency between the standard and the European guide to the rationality evaluation. Methods: we are based on the Chinese AUC system. This method is used to evaluate the rationality of the treatment of the patients in the single center of this study. We compare the consistency of the two rational evaluation methods to verify the applicability of the Chinese AUC. Results: the evaluation criteria of Chinese AUC are established, and there are 65% connections in the single center queue of this study. The ratio is similar to the European guide. China's AUC can distinguish the differences in the rationality of the treatment strategy between the wards (50%-73.6%) and the coronary angiography (47.6%-81.8%). The consistency of the standard with the European guide is 96.4%. conclusion: the evaluation standards built according to China's AUC are in good agreement with the European guide. It can be used to evaluate the rationality of the treatment of complex coronary heart disease and its differences among units.
【学位授予单位】：北京协和医学院
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R541.4

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