【摘要】：第一部分金屬裸支架、第一代和第二代藥物洗脫支架用于急性心肌梗死患者的有效性與安全性比較研究研究背景冠狀動脈粥樣硬化性心臟病(簡稱冠心病)是常見的心血管疾病,嚴(yán)重危害人類的健康。與單純藥物治療相比,經(jīng)皮冠狀動脈介入術(shù)(PCI)顯著改善了冠心病患者的治療效果及預(yù)后。經(jīng)過多年的技術(shù)開發(fā)與臨床應(yīng)用,冠狀動脈支架先后經(jīng)歷了不同的發(fā)展階段。與最初的金屬裸支架(BMS)相比,近年來開發(fā)的藥物洗脫支架(DES)進(jìn)一步提高了經(jīng)皮冠狀動脈介入術(shù)(PCI)的有效性與安全性。急性心肌梗死(AMI)是冠心病發(fā)展過程中的嚴(yán)重事件,其病理學(xué)基礎(chǔ)通常為不穩(wěn)定粥樣硬化斑塊發(fā)生破裂,導(dǎo)致激活的血小板聚集于病變部位形成急性血栓、并阻塞冠狀動脈內(nèi)血流,導(dǎo)致心臟組織因缺血缺氧而發(fā)生急性壞死,AMI嚴(yán)重影響患者的預(yù)后,需要積極防治。冠狀動脈內(nèi)置入BMS和DES是治療AMI的重要手段,但是對于我國患有急性ST段抬高型心肌梗死(STEMI)、并接受PCI術(shù)的患者而言,BMS與第一代和第二代藥物洗脫支架(G1-DES和G2-DES)的有效性和安全性尚缺乏較大規(guī)模的研究報(bào)告。研究目的本研究目的：在明確診斷為STEMI、并接受急診PCI術(shù)的患者當(dāng)中,比較BMS、 G1-DES和G2-DES的有效性與安全性差異,為冠狀動脈支架的優(yōu)化臨床應(yīng)用提供真實(shí)世界的證據(jù)。研究方法本研究回顧性納入了2004年4月至2014年5月之間于中國醫(yī)學(xué)科學(xué)院阜外醫(yī)院明確診斷為STEMI,并接受急診PCI術(shù)的1,623例連續(xù)患者。排除標(biāo)準(zhǔn)包括：(1)因支架內(nèi)再狹窄、或支架內(nèi)血栓形成而導(dǎo)致的STEMI,共排除95例患者,(2)置入除BMS、G1-DES或G2-DES以外類型的支架、或同時置入不同種類型支架的患者,共排除305例患者。最終納入1,223例患者數(shù)據(jù)。根據(jù)患者置入支架類型將其分為3組,分別為BMS組、G1-DES組和G2-DES組。隨訪時間為1年,隨訪調(diào)查的終點(diǎn)包括有效性終點(diǎn)和安全性終點(diǎn)。有效性終點(diǎn)為主要不良心血管事件(MACE),包括由靶血管相關(guān)心肌梗死(TV-MI)、靶血管重建(TVR)、靶病變重建(TLR)和心源性死亡組成的聯(lián)合終點(diǎn),以及上述獨(dú)立終點(diǎn)事件；安全性終點(diǎn)為支架內(nèi)血栓,本研究所報(bào)告的支架內(nèi)血栓根據(jù)ARC定義為確定的(definite)和可能性大的(probable)支架內(nèi)血栓。經(jīng)過1年隨訪后,應(yīng)用卡方檢驗(yàn)、Kaplan-Meier法比較了靶血管相關(guān)心肌梗死(TV-MI)、靶血管重建(TVR)、靶病變重建(TLR)、心源性死亡和支架內(nèi)血栓的發(fā)生率,并應(yīng)用多因素Cox比例風(fēng)險(xiǎn)回歸模型、以及Logistic回歸模型比較了上述不良事件在不同支架類型之間的發(fā)生風(fēng)險(xiǎn)。研究結(jié)果在確診為STEMI并接受急診PCI術(shù)的1,223名連續(xù)患者當(dāng)中,1年隨訪結(jié)果表明與BMS組相比,G1-DES和G2-DES組的MACE事件發(fā)生率顯著降低(分別為20.4%、4.2%和4.1%,P 0.001; BMS與G1-DES相比,P 0.001; BMS與G2-DES相比,P0.001),而在G1-DES和G2-DES組之間,MACE事件發(fā)生率無顯著差異(P=0.969)。在MACE事件當(dāng)中,TV-MI發(fā)生率在分別為2.6%(BMS)、 0.3%(G1-DES)和1.0%(G2-DES),三組間比較結(jié)果具有顯著性差異(P=0.017),而事后分析表明G1-DES組的TV-MI事件低于BMS組(P=0.009),在BMS組和G2-DES組之間(P=0.070)、以及在G1-DES組和G2-DES組之間(P=0.216)均無顯著差異。此外與BMS組相比,G1-DES和G2-DES組的TVR、TLR和心源性死亡率顯著降低(TVR分別為10.4%、2.5%和1.8%；TLR分別為7.8%、1.1%和1.2%；心源性死亡率分別為9.2%、1.7%和1.8%；P值均為0.001),而上述事件發(fā)生率在G1-DES和G2-DES組之間無顯著差異(P值分別為0.458、0.999和0.908)。1年內(nèi)血栓支架發(fā)生率在三組間未見差別(P=0.354)。Kaplan-Meier曲線顯示在G1-DES組和G2-DES組當(dāng)中,1年內(nèi)無TLR生存率和無心源性死亡生存率明顯高于BMS組(P值均為0.001),而G1-DES組和G2-DES組之間則無此差異(P值分別為0.927和0.700)。多因素Cox比例風(fēng)險(xiǎn)回歸分析顯示與BMS相比,G1-DES和G2-DES是降低TVR (G1-DES, HR 0.24,95%CI[0.11-0.50], P0.001; G2-DES, HR= 0.40,95%CI [0.27-0.58], P 0.001)和TLR (G1-DES, HR= 0.15,95%CI [0.05-0.43], P 0.001; G2-DES, HR= 0.39,95% CI [0.25-0.61], P 0.001)的保護(hù)性因素,而TVR和TLR的發(fā)生風(fēng)險(xiǎn)在上述兩組之間無顯著差異。Logistic回歸分析顯示,支架類型不是導(dǎo)致支架內(nèi)血栓的危險(xiǎn)因素。研究結(jié)論(1)在確診為急性ST段抬高型心肌梗死、并接受急診PCI治療的患者當(dāng)中,BMS組MACE事件發(fā)生率明顯高于G1-DES和G2-DES組,而在G1-DES和G2-DES組之間MACE事件發(fā)生率無顯著差異；(2)與金屬裸支架相比,置入G1-DES或G2-DES能夠在1年之內(nèi)降低TVR和TLR的發(fā)生率和發(fā)生風(fēng)險(xiǎn),而在G1-DES和G2-DES之間尚無明顯差別；(3)在置入上述三種類型支架后1年內(nèi),支架內(nèi)血栓的發(fā)生率和發(fā)生風(fēng)險(xiǎn)無明顯差異；此外,TV-MI和心源性死亡風(fēng)險(xiǎn)在三組間無顯著差異。第二部分急性冠狀動脈綜合征患者置入第一代和第二代藥物洗脫支架的有效性與安性比較研究研究背景急性冠狀動脈綜合征(ACS)包括急性ST段抬高型心肌梗死(STEMI)、非ST段抬高型心肌梗死(NSTEMI)和不穩(wěn)定型心絞痛,其共同的病理學(xué)機(jī)制為不穩(wěn)定斑塊破裂或侵蝕引起不同程度的血栓形成,從而導(dǎo)致冠狀動脈內(nèi)血流急性減少。ACS通常表現(xiàn)為突發(fā)性,且具有潛在致命性,故應(yīng)受到重視并積極防治。既往研究報(bào)道與穩(wěn)定型冠心病相比,ACS是增加支架內(nèi)血栓的獨(dú)立危險(xiǎn)因素,因此在針對ACS介入治療過程中需要謹(jǐn)慎選擇冠狀動脈支架類型。針對G1-DES和G2-DES用于ACS患者介入治療的有效性和安全性比較結(jié)果尚有爭議,而目前尚未見文獻(xiàn)報(bào)道G1-DES和G2-DES用于中國ACS患者的作用比較研究。研究目的本研究擬在確診為ACS并接受冠狀動脈支架置入術(shù)的患者中,明確G1-DES和G2-DES的有效性和安全性差異,從而為我國ACS患者介入治療支架類型選擇提供一定理論依據(jù)。研究方法本研究前瞻性篩選納入2013年1月至2013年12月中國醫(yī)學(xué)科學(xué)院阜外醫(yī)院確診為急性冠狀動脈綜合征,并接受PCI治療的連續(xù)患者�；颊吲懦龢�(biāo)準(zhǔn)包括(1)僅接受經(jīng)皮冠狀動脈腔內(nèi)成形術(shù)(PTCA)治療,而未接受支架置入的患者；(2)G1-DES或G2-DES以外類型的支架、或同時置入不同種類型支架的患者；(3)診斷為急性心肌梗死或不穩(wěn)定型心絞痛以外的非ACS患者。最終納入3,929例患者數(shù)據(jù),包括急性ST段抬高型心肌梗死心肌梗死862例,非ST段抬高型心肌梗死284例和不穩(wěn)定型心絞痛2,783例。根據(jù)患者置入支架的類型,將其分為G1-DES組和G2-DES組。隨訪時間為2年,隨訪終點(diǎn)事件同上文所述,本研究所報(bào)告的支架內(nèi)血栓包括確定的(definite)、可能性大的(probable)和可能的(possible)支架內(nèi)血栓。采用傾向性評分匹配法,以1：1比例匹配了兩組患者,匹配后患者數(shù)目為2,284例,隨后應(yīng)用卡方檢驗(yàn)、Kaplan-Meier法和多因素Cox比例風(fēng)險(xiǎn)回歸模型在兩組間分析并比較了終點(diǎn)事件的發(fā)生率和危險(xiǎn)因素。研究結(jié)果在接受PCI治療的ACS患者當(dāng)中,由傾向性評分匹配法篩選了2,248例患者,G1-DES組和G2-DES組各包含1,124例患者。2年隨訪結(jié)果顯示,兩組間MACE事件發(fā)生率無顯著差異(分別為4.8%和3.9%,P=0.302)。在G1-DES和G2-DES兩組之間TV-MI發(fā)生率無顯著差異(分別為0.7%和0.7%,P0.999),而TVR(分別為5.5%和3.5%,P=0.019)/TLR(分別為4.1%和2.5%,P=0.033)和心源性死亡率(分別為0.5%和1.40%,P=0.032)則明顯不同。在G1-DES和G2-DES之間,急性、亞急性、晚期、極晚期和2年累計(jì)支架內(nèi)血栓發(fā)生率均無顯著差異(急性支架內(nèi)血栓：0.0%和0.2%,P=0.500；亞急性支架內(nèi)血栓：0.0%和0.1%,P0.999;晚期支架內(nèi)血栓：0.2%和0.2%,P=0.790;2年累計(jì)支架內(nèi)血栓：0.7%和0.5%,P=0.826)。經(jīng)Kaplan-Meier分析發(fā)現(xiàn),在G2-DES組TLR生存率顯著增高(P=0.038),而無心源性死亡生存率顯著降低(P=0.039)。多因素Cox比例風(fēng)險(xiǎn)回歸分析結(jié)果顯示,與G1-DES相比,(G2-DES是能夠降低TLR的保護(hù)性因素(HR=0.592,95% CI[0.370-0.947],P=0.029),而TV-MI、心源性死亡和累計(jì)支架內(nèi)血栓的發(fā)生風(fēng)險(xiǎn)在兩組間無明顯差異(TV-MI:HR=1.121,95%CI[0.380-3.303],P=0.836；心源性死亡：ⅠIR=2.469,95%CI[0.883-7.057],P=0.084；累計(jì)支架血栓：HR=1.197, 95%CI[0.471-3.041],P=0.706)。研究結(jié)論(1)在確診為急性冠狀動脈綜合征并接受PCI治療的患者當(dāng)中,G1-DES和G2-DES之間MACE事件發(fā)生無無顯著性差異；(2)與G1-DES相比,G2-DES是能夠降低靶病變重建的保護(hù)性因素；(3)在G1-DES和G2-DES之間,靶病變相關(guān)心肌梗死、心源性死亡和累計(jì)支架內(nèi)血栓的發(fā)生風(fēng)險(xiǎn)無顯著差異。
[Abstract]:Background Coronary atherosclerotic heart disease (CHD) is a common cardiovascular disease that seriously endangers human health. Compared with drug therapy alone, percutaneous coronary intervention (PTCA) Coronary stents have undergone different stages of development after years of technical development and clinical application. Drug-eluting stents (DES) have been developed in recent years to further improve percutaneous coronary intervention (PCI) compared with bare metal stents (BMS). Acute myocardial infarction (AMI) is a serious event in the development of coronary heart disease. Its pathological basis is usually the rupture of unstable atherosclerotic plaques, resulting in the aggregation of activated platelets in the lesion site to form acute thrombosis, and obstruction of coronary artery blood flow, resulting in acute ischemia and hypoxia of heart tissue. Coronary artery implantation of BMS and DES is an important method for the treatment of AMI, but for patients with acute ST-segment elevation myocardial infarction (STEMI) and undergoing PCI in China, BMS is effective and safe with the first and second generation drug-eluting stents (G1-DES and G2-DES). Objective: To compare the efficacy and safety of BMS, G1-DES and G2-DES in patients with STEMI who underwent emergency PCI and to provide real-world evidence for optimal clinical application of coronary stents. 1,623 consecutive patients were diagnosed as STEMI in Fuwai Hospital of Chinese Academy of Medical Sciences from April to May 2014 and underwent emergency PCI. The exclusion criteria included: (1) STEMI due to in-stent restenosis or stent thrombosis, excluding 95 patients; (2) stent placement other than BMS, G1-DES or G2-DES, or the same. 305 patients were excluded when different types of stents were placed. The final data of 1,223 patients were included. The patients were divided into three groups according to the type of stents, namely BMS group, G1-DES group and G2-DES group. Catheter events (MACE) included a combined endpoint consisting of target vessel-related myocardial infarction (TV-MI), target vessel reconstruction (TVR), target lesion reconstruction (TLR) and cardiac death, as well as the above independent endpoint events; the safety endpoint was in-stent thrombosis, which was defined as definite and highly probable by ARC in this study. After a year of follow-up, Kaplan-Meier method was used to compare the incidence of target vessel-related myocardial infarction (TV-MI), target vessel reconstruction (TVR), target lesion reconstruction (TLR), cardiac death and stent thrombosis. Multivariate Cox proportional hazard regression model and Logistic regression model were used to compare the above results. Out of 1,223 consecutive patients diagnosed with STEMI and undergoing emergency PCI, 1-year follow-up showed a significantly lower incidence of MACE events in G1-DES and G2-DES groups (20.4%, 4.2% and 4.1%, respectively, P 0.001; BMS and G1-DES, P 0.001; BMS and G2-DES, P There was no significant difference in the incidence of MACE events between G1-DES and G2-DES groups (P = 0.969). Among MACE events, the incidence of TV-MI was 2.6% (BMS), 0.3% (G1-DES) and 1.0% (G2-DES), respectively. There was a significant difference among the three groups (P = 0.017), and the post-event analysis showed that the incidence of TV-MI events in G1-DES group was lower than that in BMS group (P = 0.009). There was no significant difference between BMS group and G2-DES group (P = 0.070), and between G1-DES group and G2-DES group (P = 0.216). In addition, compared with BMS group, TVR, TLR and cardiac mortality in G1-DES and G2-DES groups were significantly reduced (TVR were 10.4%, 2.5% and 1.8%, TLR was 7.8%, 1.1% and 1.2%, cardiac mortality was 9.2%, 1.7% and 1.8%, respectively. There was no significant difference in the incidence of these events between G1-DES and G2-DES groups (P 0.458, 0.999 and 0.908, respectively). There was no difference in the incidence of stent thrombosis between the three groups within one year (P = 0.354). Kaplan-Meier curves showed that TLR-free survival and cardiac death-free survival rates were significantly higher in G1-DES and G2-DES groups within one year (P = 0.354). MultivariatCox proportional hazard regressianalysis showed that G1-DES and G2-DES decreased TVR (G1-DES, HR 0.24, 95% CI [0.11-0.50], P 0.001; G2-DES, HR = 0.40, 95% CI [0.40, 95% CI [0.27-0.58], P 0.57-0.58], P 0.001) and TLR (G1-DES, G1-DES, HR 0.24, 95% CI [0.11-0.50], P 0.001; G2-DES, HR = 0.40, HR = 0.40, 95% CI [0.27-0.58], P 0.58], P.001) and TLR (G1-DES, G1-DES, HR 0.15, 95% 0.05-0 There was no significant difference in the risk of TVR and TLR between the two groups. Logistic regression analysis showed that stent type was not a risk factor for stent thrombosis. The incidence of MACE events in BMS group was significantly higher than that in G1-DES and G2-DES groups, but there was no significant difference between G1-DES and G2-DES groups; (2) G1-DES or G2-DES could reduce the incidence and risk of TVR and TLR within one year compared with bare metal stents, but there was no clear difference between G1-DES and G2-DES. (3) There was no significant difference in the incidence and risk of in-stent thrombosis between the three groups within one year after stent placement. In addition, there was no significant difference between the three groups in the risk of cardiac death and the incidence of in-stent thrombosis. Background Acute coronary syndromes (ACS) include acute ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina pectoris. The common pathological mechanism of ACS is that unstable plaque rupture or erosion causes thrombosis in varying degrees, which leads to acute decrease of coronary blood flow. Previous studies have reported that ACS is an independent risk factor for increased stent thrombosis compared with stable coronary artery disease. Therefore, careful selection of stent types should be made during interventional therapy for ACS. G1-DES and G2-DES should be used for ACS. The efficacy and safety of G1-DES and G2-DES in patients with ACS in China are still controversial, but there is no comparative study on the efficacy and safety of G1-DES and G2-DES in patients with ACS in China. Methods A prospective study was conducted to select consecutive patients with ACS who were admitted to Fuwai Hospital of Chinese Academy of Medical Sciences from January 2013 to December 2013 and received PCI treatment. Endovascular percutaneous transluminal angioplasty (PTCA) was performed in patients without stenting; (2) patients with stenting other than G1-DES or G2-DES, or with different types of stenting at the same time; (3) patients with non-ACS other than acute myocardial infarction or unstable angina. Data from 3,929 patients, including acute ST-segment elevation myocardial infarction, were finally included. 862 cases of myocardial infarction, 284 cases of non-ST-segment elevation myocardial infarction and 2,783 cases of unstable angina pectoris were divided into G1-DES group and G2-DES group according to the type of stent implantation. The follow-up period was 2 years, and the end-point events were as described above. The stent thrombosis reported in this study included definite and probable. Tendency score matching method was used to match 2,284 matched patients. Chi-square test, Kaplan-Meier method and multivariate Cox proportional hazard regression model were used to analyze and compare the incidence and risk factors of end-point events between the two groups. There was no significant difference in the incidence of MACE events (4.8% and 3.9% respectively, P = 0.302) between the G1-DES and G2-DES groups. TVR (5.5% and 3.5%, P = 0.019) / TLR (4.1% and 2.5%, P = 0.033) and cardiac mortality (0.5% and 1.40%, P = 0.032) were significantly different. There was no significant difference in the cumulative incidence of stent thrombosis between G1-DES and G2-DES (acute, subacute, late, very late and 2 years, respectively). Subacute in-stent thrombosis: 0.0% and 0.1%, P = 0.500; late in-stent thrombosis: 0.2% and 0.2%, P = 0.790; 2-year cumulative in-stent thrombosis: 0.7% and 0.5%, P = 0.826). Kaplan-Meier analysis showed that TLR survival rate was significantly increased (P = 0.038) in G2-DES group, but the survival rate of non-cardiogenic death was significantly decreased (P = 0.039). Case risk regression analysis showed that compared with G1-DES, (G2-DES was the protective factor (HR = 0.592,95% CI [0.370-0.947], P = 0.029) and there was no significant difference between the two groups in the risk of cardiac death and cumulative stent thrombosis (TV-MI: HR = 1.121, 95% CI [0.380-3.303], P = 0.836; and cardiac death: I IR = 2.469, 95.029). Accumulative stent thrombosis: HR = 1.197, 95% CI [0.471-3.041], P = 0.706. Study conclusions (1) There was no significant difference in MACE events between G1-DES and G2-DES in patients with acute coronary syndrome who received PCI treatment; (2) G2-DES was able to reduce the protection of target lesion reconstruction compared with G1-DES. Factors: (3) There was no significant difference between G1-DES and G2-DES in the risk of target-related myocardial infarction, cardiac death, and cumulative stent thrombosis.
【學(xué)位授予單位】：北京協(xié)和醫(yī)學(xué)院
【學(xué)位級別】：博士
【學(xué)位授予年份】：2016
【分類號】：R541.4

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