NVAF合并ACS患者PCI術(shù)后抗栓治療策略的研究
發(fā)布時(shí)間：2018-08-23 20:45
【摘要】：背景與目的:房顫伴有急性冠脈綜合征患者需要聯(lián)合抗凝藥物和抗血小板藥物進(jìn)行抗栓治療,但聯(lián)合用藥在減少血栓事件風(fēng)險(xiǎn)的同時(shí)又增加了出血風(fēng)險(xiǎn),自2013年以來,ACC/AHA與ESC對房顫伴有ACS患者的抗栓策略進(jìn)行了多次更新,但中國并無明確的指南指導(dǎo)這類患者如何用藥,本文旨在回顧性分析北京市房顫合并急性冠脈綜合征患者支架置入術(shù)后抗栓策略的現(xiàn)狀以及不同治療方案的安全性與有效性。第一部分高齡房顫合并急性冠脈綜合征患者支架置入術(shù)后抗栓策略現(xiàn)狀研究方法:通過隨機(jī)抽樣的方法,在北京市的三級甲等醫(yī)院中選取35家醫(yī)院,由于其中部分醫(yī)院的數(shù)據(jù)庫不完整及涉密問題,最終系統(tǒng)回顧性調(diào)查了包括海軍總醫(yī)院在內(nèi)的北京市12家醫(yī)院心內(nèi)科從2010年1月1日至2015年1月1日收治入院的房顫伴ACS并接受PCI治療的患者,納入標(biāo)準(zhǔn)是出院診斷中有房顫,當(dāng)次入院行PCI,年齡大于75歲;排除標(biāo)準(zhǔn)是:風(fēng)濕性心臟病、瓣膜病、外周支架、妊娠、惡性腫瘤。按照治療方案分為三聯(lián)用藥組(阿司匹林+氯吡格雷+華法林)、雙聯(lián)用藥組(阿司匹林+替格瑞洛、阿司匹林+氯吡格雷、氯吡格雷+華法林、西洛他唑+氯吡格雷)和單一抗血小板治療(氯吡格雷)組,比較三聯(lián)用藥組與雙聯(lián)用藥組患者的不良心腦血管(MACCEs)事件(包括全因死亡、非致死性心肌梗死、支架血栓、再次血運(yùn)重建、卒中)及出血事件發(fā)生率的差異。結(jié)果:本研究共納入470例患者,平均年齡為78.70±3.32歲;其中男性291例,占61.91%,女性179例,占38.09%;男性多于女性,比例為1.63:1。470例患者中三聯(lián)用藥組共17例,占3.62%,平均用藥時(shí)間5.41±3.59月最短使用時(shí)間為1個(gè)月,最長使用時(shí)間為12個(gè)月,雙聯(lián)治療組共450例,占95.74%,平均用藥時(shí)間為12.15±2.44月,最短使用時(shí)間為1個(gè)月,最長使用時(shí)間為24個(gè)月;單一抗血小板治療組共3例,占0.64%。MACCEs在三聯(lián)組發(fā)生6(35.29%)例,雙聯(lián)治療組發(fā)生128(28.44%)例,單一抗血小板治療組發(fā)生0((0%)例,全因死亡三聯(lián)組3(17.65%)例,雙聯(lián)治療組80(17.78%)例,單一抗血小板治療組0(0%)例;卒中在三聯(lián)組發(fā)生3(17.65%)例,雙聯(lián)治療組31(15.69%)例,單一抗血小板治療組0(0%)例,三聯(lián)組患者中有3例發(fā)生了消化道出血事件,占17.65%,雙聯(lián)治療組患者中有33例發(fā)生了出血事件,占7.33%,單一抗血小板治療組0例發(fā)生消化道出血,占0%。三組用藥的MACCE事件發(fā)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)的發(fā)生率并無統(tǒng)計(jì)學(xué)差異,HAS-BLED評分大于等于3分的出血高�；颊呓M,129例患者全部使用雙聯(lián)治療,而在HAS-BLED小于等于2分的出血低危的患者中,17例(5.03%)患者使用了三聯(lián)治療。采用Log-rank檢驗(yàn)三聯(lián)組與雙聯(lián)用藥組的生存曲線是否有差異,總的MACCEs(Log-rank P=0.310.05)以及死亡事件(Log-rank P=0.860.05)雙抗組與三聯(lián)組的生存曲線并無差異(P0.05),而三聯(lián)組的消化道出血的發(fā)生率高于雙聯(lián)療組(Log-rank P=0.010.05).結(jié)論:1.在年齡大于75歲的患者中,三聯(lián)治療的比例過低,在出血高�；颊咧袩o一例使用三聯(lián)治療,在出血低危患者中,三聯(lián)的使用率也僅有5.03%;2.雙聯(lián)治療仍是目前北京各大醫(yī)院的主要治療策略;3.三聯(lián)用藥組與雙聯(lián)用藥組相比,MACCEs發(fā)生率及死亡率無差異,但是三聯(lián)用藥的消化道出血的發(fā)生率較雙聯(lián)用藥組高。第二部分PPI使用對NVAF合并ACS患者PCI術(shù)后預(yù)后的回顧性分析方法:通過隨機(jī)抽樣的方法,在北京市的三級甲等醫(yī)院中選取35家醫(yī)院,由于其中部分醫(yī)院的數(shù)據(jù)庫不完整及涉密問題,最終系統(tǒng)回顧性調(diào)查了包括海軍總醫(yī)院在內(nèi)的北京市12家醫(yī)院心內(nèi)科從2010年1月1日至2015年1月1日收治入院的房顫伴ACS并接受PCI治療的患者,符合標(biāo)準(zhǔn)的患者最終共納入1967人。按照治療方案分為PPI組和未使用PPI組,PPI包括奧美拉唑、雷貝拉唑、泮托拉唑、埃索美拉唑和蘭索拉唑;比較兩組之間的消化道出血事件以及終點(diǎn)事件(MACCEs)(包括全因死亡、非致死性心肌梗死、支架血栓、再次血運(yùn)重建和卒中)發(fā)生率的差異。計(jì)量資料以均數(shù)±標(biāo)準(zhǔn)差(x±s)表示,組間比較采用獨(dú)立樣本的t檢驗(yàn);計(jì)數(shù)資料以百分?jǐn)?shù)來表示,組間比較采用χ2檢驗(yàn)。采用Kaplan-Meier生存曲線來分析事件的發(fā)生率,采用Log-rank法進(jìn)行檢驗(yàn),所有數(shù)據(jù)P0.05認(rèn)為是有顯著性統(tǒng)計(jì)學(xué)差異。結(jié)果:1967例患者中,PPI組共488例,占24.8%,平均年齡為66.33±9.75歲;未使用PPI組有患者1479例,占75.2%,平均年齡66.79±9.72歲;平均隨訪時(shí)間為3.48± 1.02年。PPI組和未使用PPI組的患者消化道出血事件分別發(fā)生31例(6.35%)和99例(6.69%),兩組的消化道出血發(fā)生風(fēng)險(xiǎn)無顯著性統(tǒng)計(jì)學(xué)差異(P=0.810.05)。將患者以HAS-BLED評分分層分析后,在出血風(fēng)險(xiǎn)高危的患者中,PPI組和未使用PPI組的患者消化道出血事件分別發(fā)生2例(1.96%)和25例(9.09%),兩組的消化道出血風(fēng)險(xiǎn)不同(P=0.0240.05),使用PPI可降低出血高危組患者的出血風(fēng)險(xiǎn);在出血低�；颊呓M,使用了 PPI的患者消化道出血發(fā)生了 29例(7.25%),未使用PPI患者組消化道出血發(fā)生了 74例(6.22%),兩組相比,消化道出血的發(fā)生并無顯著性的統(tǒng)計(jì)學(xué)差異(P=0.4980.05)。在使用了氯吡格雷組的患者中,分為PPI組和未使用PPI組,觀察兩組MACCEs的發(fā)生率及卒中的發(fā)生率,MACCEs在使用了 PPI組的患者中發(fā)生了 79例(16.63%),未使用PPI的患者中發(fā)生297例(20.65%)(P=0.1140.05);缺血性卒中在使用了 PPI的患者中發(fā)生了 13例(2.74%),未使用PPI的患者中發(fā)生了 69例(4.80%)(P=0.0640.05)。缺血性卒中和MACCEs的發(fā)生風(fēng)險(xiǎn)在兩組之間并無差異。結(jié)論:1.本研究結(jié)果表明,質(zhì)子泵抑制劑的使用可減少出血高危組房顫合并急性冠脈綜合征且置入支架的患者的消化道出血事件的發(fā)生率2.本研究結(jié)果顯示,質(zhì)子泵抑制劑的使用不會增加使用氯吡格雷患者的缺血性卒中風(fēng)險(xiǎn)及MACCEs風(fēng)險(xiǎn),所以PPI的使用不影響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.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R541.4;R541.75
本文編號：2199873
[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.
【學(xué)位授予單位】：南方醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R541.4;R541.75
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