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NVAF合并ACS患者PCI术后抗栓治疗策略的研究

发布时间:2018-08-23 20:45
【摘要】:背景与目的:房颤伴有急性冠脉综合征患者需要联合抗凝药物和抗血小板药物进行抗栓治疗,但联合用药在减少血栓事件风险的同时又增加了出血风险,自2013年以来,ACC/AHA与ESC对房颤伴有ACS患者的抗栓策略进行了多次更新,但中国并无明确的指南指导这类患者如何用药,本文旨在回顾性分析北京市房颤合并急性冠脉综合征患者支架置入术后抗栓策略的现状以及不同治疗方案的安全性与有效性。第一部分高龄房颤合并急性冠脉综合征患者支架置入术后抗栓策略现状研究方法:通过随机抽样的方法,在北京市的三级甲等医院中选取35家医院,由于其中部分医院的数据库不完整及涉密问题,最终系统回顾性调查了包括海军总医院在内的北京市12家医院心内科从2010年1月1日至2015年1月1日收治入院的房颤伴ACS并接受PCI治疗的患者,纳入标准是出院诊断中有房颤,当次入院行PCI,年龄大于75岁;排除标准是:风湿性心脏病、瓣膜病、外周支架、妊娠、恶性肿瘤。按照治疗方案分为三联用药组(阿司匹林+氯吡格雷+华法林)、双联用药组(阿司匹林+替格瑞洛、阿司匹林+氯吡格雷、氯吡格雷+华法林、西洛他唑+氯吡格雷)和单一抗血小板治疗(氯吡格雷)组,比较三联用药组与双联用药组患者的不良心脑血管(MACCEs)事件(包括全因死亡、非致死性心肌梗死、支架血栓、再次血运重建、卒中)及出血事件发生率的差异。结果:本研究共纳入470例患者,平均年龄为78.70±3.32岁;其中男性291例,占61.91%,女性179例,占38.09%;男性多于女性,比例为1.63:1。470例患者中三联用药组共17例,占3.62%,平均用药时间5.41±3.59月最短使用时间为1个月,最长使用时间为12个月,双联治疗组共450例,占95.74%,平均用药时间为12.15±2.44月,最短使用时间为1个月,最长使用时间为24个月;单一抗血小板治疗组共3例,占0.64%。MACCEs在三联组发生6(35.29%)例,双联治疗组发生128(28.44%)例,单一抗血小板治疗组发生0((0%)例,全因死亡三联组3(17.65%)例,双联治疗组80(17.78%)例,单一抗血小板治疗组0(0%)例;卒中在三联组发生3(17.65%)例,双联治疗组31(15.69%)例,单一抗血小板治疗组0(0%)例,三联组患者中有3例发生了消化道出血事件,占17.65%,双联治疗组患者中有33例发生了出血事件,占7.33%,单一抗血小板治疗组0例发生消化道出血,占0%。三组用药的MACCE事件发生率(P=0.5890.05)、死亡率(P=0.7660.05)、卒中(P=0.2930.05)、消化道出血(P=0.3380.05)的发生率并无统计学差异,HAS-BLED评分大于等于3分的出血高危患者组,129例患者全部使用双联治疗,而在HAS-BLED小于等于2分的出血低危的患者中,17例(5.03%)患者使用了三联治疗。采用Log-rank检验三联组与双联用药组的生存曲线是否有差异,总的MACCEs(Log-rank P=0.310.05)以及死亡事件(Log-rank P=0.860.05)双抗组与三联组的生存曲线并无差异(P0.05),而三联组的消化道出血的发生率高于双联疗组(Log-rank P=0.010.05).结论:1.在年龄大于75岁的患者中,三联治疗的比例过低,在出血高危患者中无一例使用三联治疗,在出血低危患者中,三联的使用率也仅有5.03%;2.双联治疗仍是目前北京各大医院的主要治疗策略;3.三联用药组与双联用药组相比,MACCEs发生率及死亡率无差异,但是三联用药的消化道出血的发生率较双联用药组高。第二部分PPI使用对NVAF合并ACS患者PCI术后预后的回顾性分析方法:通过随机抽样的方法,在北京市的三级甲等医院中选取35家医院,由于其中部分医院的数据库不完整及涉密问题,最终系统回顾性调查了包括海军总医院在内的北京市12家医院心内科从2010年1月1日至2015年1月1日收治入院的房颤伴ACS并接受PCI治疗的患者,符合标准的患者最终共纳入1967人。按照治疗方案分为PPI组和未使用PPI组,PPI包括奥美拉唑、雷贝拉唑、泮托拉唑、埃索美拉唑和兰索拉唑;比较两组之间的消化道出血事件以及终点事件(MACCEs)(包括全因死亡、非致死性心肌梗死、支架血栓、再次血运重建和卒中)发生率的差异。计量资料以均数±标准差(x±s)表示,组间比较采用独立样本的t检验;计数资料以百分数来表示,组间比较采用χ2检验。采用Kaplan-Meier生存曲线来分析事件的发生率,采用Log-rank法进行检验,所有数据P0.05认为是有显著性统计学差异。结果:1967例患者中,PPI组共488例,占24.8%,平均年龄为66.33±9.75岁;未使用PPI组有患者1479例,占75.2%,平均年龄66.79±9.72岁;平均随访时间为3.48± 1.02年。PPI组和未使用PPI组的患者消化道出血事件分别发生31例(6.35%)和99例(6.69%),两组的消化道出血发生风险无显著性统计学差异(P=0.810.05)。将患者以HAS-BLED评分分层分析后,在出血风险高危的患者中,PPI组和未使用PPI组的患者消化道出血事件分别发生2例(1.96%)和25例(9.09%),两组的消化道出血风险不同(P=0.0240.05),使用PPI可降低出血高危组患者的出血风险;在出血低危患者组,使用了 PPI的患者消化道出血发生了 29例(7.25%),未使用PPI患者组消化道出血发生了 74例(6.22%),两组相比,消化道出血的发生并无显著性的统计学差异(P=0.4980.05)。在使用了氯吡格雷组的患者中,分为PPI组和未使用PPI组,观察两组MACCEs的发生率及卒中的发生率,MACCEs在使用了 PPI组的患者中发生了 79例(16.63%),未使用PPI的患者中发生297例(20.65%)(P=0.1140.05);缺血性卒中在使用了 PPI的患者中发生了 13例(2.74%),未使用PPI的患者中发生了 69例(4.80%)(P=0.0640.05)。缺血性卒中和MACCEs的发生风险在两组之间并无差异。结论:1.本研究结果表明,质子泵抑制剂的使用可减少出血高危组房颤合并急性冠脉综合征且置入支架的患者的消化道出血事件的发生率2.本研究结果显示,质子泵抑制剂的使用不会增加使用氯吡格雷患者的缺血性卒中风险及MACCEs风险,所以PPI的使用不影响氯吡格雷的抗栓效果。
[Abstract]:BACKGROUND AND OBJECTIVE: Patients with atrial fibrillation complicated with acute coronary syndrome need antithrombotic therapy combined with anticoagulants and antiplatelet drugs, but combination therapy reduces the risk of thrombotic events and increases the risk of bleeding. Since 2013, ACC/AHA and ESC have updated their antithrombotic strategies for patients with atrial fibrillation complicated with ACS. In the absence of clear guidelines on how these patients should be treated, this article aims to retrospectively analyze the status of antithrombotic strategies and the safety and efficacy of different treatment options in patients with atrial fibrillation and acute coronary syndrome after stenting in Beijing. Part I: Antithrombotic strategies in elderly patients with atrial fibrillation and acute coronary syndrome after stenting Current Situation Research Methods: By random sampling, 35 hospitals were selected from the third-class first-class hospitals in Beijing. Due to the incomplete database and secret-related problems of some hospitals, a retrospective survey was conducted to investigate the admission of 12 hospitals in Beijing, including the Navy General Hospital, from January 1, 2010 to January 1, 2015. Patients with atrial fibrillation accompanied by ACS and receiving PCI were included in the criteria for discharged diagnosis of atrial fibrillation and then admitted to the hospital for PCI, aged over 75; excluded criteria were: rheumatic heart disease, valvular disease, peripheral stent, pregnancy, malignant tumor. According to the treatment scheme, patients were divided into triple drug group (aspirin + clopidogrel + warfarin), double drug group (aspirin). The adverse cardiac and cerebrovascular events (including all-cause mortality, non-fatal myocardial infarction, stent thrombosis, revascularization) were compared between the triple-drug group and the double-drug group. Results: A total of 470 patients with an average age of 78.70 (+ 3.32 years) were enrolled in the study, including 291 males (61.91%) and 179 females (38.09%) and 17 males (3.62%) were more than females (1.63:1.470) in the triple drug group, with an average duration of 5.41 (+ 3.59) months. The longest use time was 12 months, 450 cases (95.74%) in the double-therapy group, the average time was 12.15 (+ 2.44 months), the shortest use time was 1 month and the longest use time was 24 months; 3 cases (0.64%) in the single-antiplatelet therapy group, MACCEs occurred in the triple-therapy group, 128 cases (28.44%) in the double-therapy group and mono-antiplatelet therapy group. There were 0 ((0%) cases in the plate treatment group, 3 (17.65%) cases in the all-cause-death triad, 80 (17.78%) cases in the double-group, 0 (0%) cases in the single-antiplatelet treatment group, 3 (17.65%) cases in the triple-group, 31 (15.69%) cases in the double-group, 0 (0%) cases in the single-antiplatelet treatment group, and 3 (17.65%) cases in the triple-group with gastrointestinal bleeding. There were 33 cases of hemorrhage in the combined treatment group (7.33%) and 0 cases of gastrointestinal hemorrhage in the single antiplatelet treatment group (0%). The incidence of MACE events (P = 0.5890.05), mortality (P = 0.7660.05), stroke (P = 0.2930.05) and gastrointestinal hemorrhage (P = 0.3380.05) were not significantly different among the three groups. In the 3-point high-risk group, 129 patients were treated with dual therapy, while 17 (5.03%) patients with low-risk of hemorrhage whose HAS-BLED score was less than or equal to 2 were treated with triple therapy. Log-rank was used to test whether there was a difference in survival curve between the triple group and the double-point group, total MACCEs (Log-rank P=0.310.05) and mortality events (Log-r). There was no significant difference in the survival curve between the two groups (P The use rate of triple therapy was only 5.03%. 2. Double therapy is still the main treatment strategy in major hospitals in Beijing. 3. The incidence and mortality of MACCEs in triple therapy group were no different from that in double therapy group, but the incidence of digestive tract bleeding in triple therapy group was higher than that in double therapy group. Retrospective analysis of post-prognosis: Thirty-five hospitals in Beijing were selected by random sampling. Due to the incomplete database and secret-related problems in some hospitals, a systematic retrospective survey was conducted in the Department of Cardiology of 12 hospitals in Beijing, including the Navy General Hospital, from January 1, 2010 to January 1, 2015. Patients with atrial fibrillation (AF) admitted daily with ACS and receiving PCI were eventually enrolled in 1967. Patients were divided into PPI group and non-PPI group according to treatment regimen. PPI included omeprazole, rabeprazole, pantoprazole, esomeprazole and lansoprazole; gastrointestinal bleeding events and end point events (MACCEs) were compared between the two groups. Including all-cause mortality, non-fatal myocardial infarction, stent thrombosis, revascularization, and stroke, the differences in incidence were measured using mean (+) standard deviation (x (+) s) and independent sample t test for inter-group comparisons, percentages and_2 test for inter-group comparisons. Kaplan-Meier survival curve was used to analyze events. Results: Among the 1967 patients, 488 (24.8%) were in PPI group with an average age of 66.33 (+ 9.75), 1479 (75.2%) were in non-PPI group with an average age of 66.79 (+ 9.72), and the average follow-up time was 3.48 (+ 1.02) years. There were 31 cases (6.35%) and 99 cases (6.69%) of gastrointestinal bleeding events in PI group, respectively. There was no significant difference in the risk of gastrointestinal bleeding between the two groups (P = 0.810.05). After stratified analysis with HAS-BLED score, there were 2 cases (1) of gastrointestinal bleeding events in PPI group and non-PPI group, respectively. The risk of digestive tract bleeding was different between the two groups (P = 0.0240.05). The risk of digestive tract bleeding was reduced by PPI in the high-risk group. In the low-risk group, 29 cases (7.25%) had gastrointestinal bleeding in the patients who used PPI and 74 cases (6.22%) had gastrointestinal bleeding in the patients who did not use PPI. There was no significant difference in the incidence of MACCEs (P = 0.4980.05). Patients in the clopidogrel group were divided into PPI group and non-PPI group. The incidence of MACCEs and stroke in the two groups were observed. 79 patients (16.63%) in the PPI group and 297 patients (20.65%) in the non-PPI group (P = 0.1140.05). Ischemic stroke occurred in 13 (2.74%) patients with PPI and 69 (4.80%) patients without PPI (P = 0.0640.05). There was no difference in the risk of ischemic stroke and MACCES between the two groups. CONCLUSION: 1. The results of this study showed that the use of PPIs could reduce the incidence of AF with acute coronary artery disease in the high risk group of bleeding. The results of this study showed that the use of PPI did not increase the risk of ischemic stroke and MACCEs in clopidogrel-treated patients, so the use of PPI did not affect the antithrombotic effect of clopidogrel.
【学位授予单位】:南方医科大学
【学位级别】:硕士
【学位授予年份】:2017
【分类号】:R541.4;R541.75

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