比較兩種藥物洗脫支架在冠心病合并糖尿病患者中的有效性與安全性
發(fā)布時間：2018-12-16 17:51
【摘要】：目的:本研究旨在評估國產(chǎn)無聚合物涂層Nano支架與持久聚合物涂層Firebird2TM支架在冠心病合并糖尿病患者中長期應(yīng)用的有效性和安全性。方法:選取自2015年1月至2015年12月在青島大學(xué)附屬醫(yī)院心內(nèi)科住院,診斷為冠心病合并糖尿病的患者,在PCI術(shù)前將患者隨機(jī)分為Nano組和Firebird2TM組。無聚合物涂層Nano支架和持久聚合物涂層Firebird2TM支架均為國產(chǎn)第二代藥物洗脫支架。所有患者均建議術(shù)后12個月行冠脈造影隨訪。術(shù)后患者通過電話、門診或再住院等方式進(jìn)行臨床隨訪。主要研究終點為主要不良心臟事件(MACE):包括全因死亡、心肌梗死(MI)、靶血管血運(yùn)重建(TVR)。次要研究終點為:確定/可能的支架血栓、術(shù)后12個月支架內(nèi)晚期管徑丟失大小(LLL)。結(jié)果:本研究共納入314例糖尿病患者(662處病變),其中Nano組168例(351處病變),置入了302枚支架;Firebird2TM組納入146例(311處病變),置入273枚支架。Nano組與Firebird2TM組間基線資料分布:如年齡、性別、吸煙史、高血壓、低密度脂蛋白水平(LDL-C)、左室射血分?jǐn)?shù)(LVEF)等均無顯著性差異。兩組患者的冠脈造影資料:病變部位主要集中在前降支(36.47%vs.44.37%,P=0.31)和右冠狀動脈(36.18%vs.32.48%,P=0.32),但在兩組之間沒有顯著性差異。病變類型、平均支架個數(shù)、平均支架長度、平均支架直徑及球囊后擴(kuò)張的比例等均無顯著性差異。臨床隨訪15個月后,Nano組與Firebird2TM組相比,主要終點MACE事件發(fā)生率有降低趨勢(6.55%vs.8.22%,相對危險度RR 0.80,95%置信區(qū)間[CI]:0.36-1.75),但沒有明顯統(tǒng)計學(xué)意義(P=0.57),其中Nano組與Firebird2TM組相比,全因死亡(1.79%vs.1.37%,RR 1.30,95%CI:0.22-7.70,P=0.92)、心肌梗死(1.19%vs.2.05%,RR 0.58,95%CI 0.10-3.42,P=0.87)、靶血管血運(yùn)重建(3.57%vs.4.79%,RR 0.75,95%CI:0.26-2.17,P=0.59)在兩組間也無顯著差異。術(shù)后12個月行造影隨訪,Nano組31例,Firebird2TM組24例,通過定量冠脈造影分析(QCA)測量支架內(nèi)晚期管徑丟失大小,Nano組支架內(nèi)晚期管徑丟失(0.32±0.23mm)較Firebird2TM組低(0.47±0.25mm),差異有明顯統(tǒng)計學(xué)意義(P=0.03)。確定/可能的支架血栓在Nano組與Firebird2TM組間的發(fā)生率均較低(0.6%vs.0.68%,RR 0.87,95%CI:0.06-13.77,P=1.00)。結(jié)論:1、在15個月的臨床隨訪中,國產(chǎn)無聚合物涂層Nano支架與持久聚合物涂層Firebird2TM支架在冠心病合并糖尿病患者中臨床應(yīng)用具有相似的有效性和安全性。2、術(shù)后12個月造影隨訪,QCA測量支架內(nèi)晚期管徑丟失大小,Nano支架內(nèi)管徑丟失大小較Firebird2TM支架小,表明Nano支架在抑制支架內(nèi)再狹窄的作用較Firebird2TM支架明顯。3、Nano支架作為國產(chǎn)新型無聚合物涂層藥物洗脫支架的代表,沒有晚期聚合物相關(guān)的不良反應(yīng),但與持久聚合物涂層Firebird2TM支架相比,其晚期支架內(nèi)血栓風(fēng)險及需要再次血運(yùn)重建的比例在兩組之間并沒有發(fā)現(xiàn)明顯差異。
[Abstract]:Objective: to evaluate the efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods: patients who were hospitalized in Department of Cardiology, affiliated Hospital of Qingdao University from January 2015 to December 2015, were randomly divided into Nano group and Firebird2TM group before PCI. The non-polymer-coated Nano stent and the durable polymer-coated Firebird2TM stent are the second-generation drug-eluting stents made in China. All patients were advised to follow up 12 months after coronary angiography. Postoperative patients were followed up by telephone, outpatient or re-hospitalization. The main endpoint of the study was major adverse cardiac events (MACE):), including all-cause death, myocardial infarction, (MI), target vessel revascularization, (TVR). The secondary end point of the study was to determine / likely stent thrombosis, and the size of late stent diameter loss (LLL).) was 12 months after operation. Results: a total of 314 diabetic patients (662 lesions) were included in this study, including 168 cases (351 lesions) in Nano group and 302 stents were implanted. Firebird2TM group included 146 patients (311 lesions) and placed 273 stents. The distribution of baseline data between Nano group and Firebird2TM group was as follows: age, sex, smoking history, hypertension, low density lipoprotein level (LDL-C). There was no significant difference in left ventricular ejection fraction (LVEF). Coronary angiography data of the two groups: the lesions were mainly located in the anterior descending branch (36.47 vs.44.37) and the right coronary artery (36.18 vs.32.48), but there was no significant difference between the two groups. There was no significant difference in the types of lesions, the number of stents, the length of stents, the mean diameter of stents and the ratio of posterior balloon dilatation. After 15 months of clinical follow-up, the incidence of major end-point MACE events in the Nano group was lower than that in the Firebird2TM group (6.55 vs 8.222.The relative risk RR 0.80% 95% confidence interval [CI]: 0.36-1.75). But there was no significant statistical significance (P < 0. 57), in which the Nano group was all due to death compared with the Firebird2TM group (1. 79 vs.1.37 and RR 1. 30 and 95 CI: 0. 22-7. 70 P0. 92). Myocardial infarction (1.19 vs 2.05), RR 0.58 + 95% CI 0.10-3.42 P0.87, target vessel revascularization (3.57 vs 4.79), RR 0.75% 95CI: 0.26-2.17, There was no significant difference between the two groups. 12 months after operation, 31 cases in Nano group and 24 cases in Firebird2TM group were followed up. The size of late diameter loss in stent was measured by quantitative coronary angiography (QCA). The loss of stent diameter in Nano group (0.32 鹵0.23mm) was significantly lower than that in Firebird2TM group (0.47 鹵0.25mm) (P < 0.03). The incidence of determined / probable stent thrombus was lower in Nano group and Firebird2TM group (0.6vs.0.68% RR 0.87C95 CI: 0.06-13.77PU 1.00). Conclusion: 1. During the 15-month follow-up, the clinical efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease and diabetes mellitus were similar. After 12 months follow up, QCA was used to measure the size of late diameter loss in stent, and the diameter loss of Nano stent was smaller than that of Firebird2TM stent, which indicated that Nano stent could inhibit restenosis obviously than Firebird2TM stent. As the representative of new drug-eluting stents without polymer coating, Nano stents have no late polymer-related adverse reactions, but compared with long-lasting polymer-coated Firebird2TM stents. There was no significant difference in the risk of late stent thrombosis and the need for revascularization between the two groups.
【學(xué)位授予單位】：青島大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R541.4;R587.1
本文編號：2382790
[Abstract]:Objective: to evaluate the efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease (CHD) and diabetes mellitus (DM). Methods: patients who were hospitalized in Department of Cardiology, affiliated Hospital of Qingdao University from January 2015 to December 2015, were randomly divided into Nano group and Firebird2TM group before PCI. The non-polymer-coated Nano stent and the durable polymer-coated Firebird2TM stent are the second-generation drug-eluting stents made in China. All patients were advised to follow up 12 months after coronary angiography. Postoperative patients were followed up by telephone, outpatient or re-hospitalization. The main endpoint of the study was major adverse cardiac events (MACE):), including all-cause death, myocardial infarction, (MI), target vessel revascularization, (TVR). The secondary end point of the study was to determine / likely stent thrombosis, and the size of late stent diameter loss (LLL).) was 12 months after operation. Results: a total of 314 diabetic patients (662 lesions) were included in this study, including 168 cases (351 lesions) in Nano group and 302 stents were implanted. Firebird2TM group included 146 patients (311 lesions) and placed 273 stents. The distribution of baseline data between Nano group and Firebird2TM group was as follows: age, sex, smoking history, hypertension, low density lipoprotein level (LDL-C). There was no significant difference in left ventricular ejection fraction (LVEF). Coronary angiography data of the two groups: the lesions were mainly located in the anterior descending branch (36.47 vs.44.37) and the right coronary artery (36.18 vs.32.48), but there was no significant difference between the two groups. There was no significant difference in the types of lesions, the number of stents, the length of stents, the mean diameter of stents and the ratio of posterior balloon dilatation. After 15 months of clinical follow-up, the incidence of major end-point MACE events in the Nano group was lower than that in the Firebird2TM group (6.55 vs 8.222.The relative risk RR 0.80% 95% confidence interval [CI]: 0.36-1.75). But there was no significant statistical significance (P < 0. 57), in which the Nano group was all due to death compared with the Firebird2TM group (1. 79 vs.1.37 and RR 1. 30 and 95 CI: 0. 22-7. 70 P0. 92). Myocardial infarction (1.19 vs 2.05), RR 0.58 + 95% CI 0.10-3.42 P0.87, target vessel revascularization (3.57 vs 4.79), RR 0.75% 95CI: 0.26-2.17, There was no significant difference between the two groups. 12 months after operation, 31 cases in Nano group and 24 cases in Firebird2TM group were followed up. The size of late diameter loss in stent was measured by quantitative coronary angiography (QCA). The loss of stent diameter in Nano group (0.32 鹵0.23mm) was significantly lower than that in Firebird2TM group (0.47 鹵0.25mm) (P < 0.03). The incidence of determined / probable stent thrombus was lower in Nano group and Firebird2TM group (0.6vs.0.68% RR 0.87C95 CI: 0.06-13.77PU 1.00). Conclusion: 1. During the 15-month follow-up, the clinical efficacy and safety of domestic uncoated Nano stents and long-lasting polymer coated Firebird2TM stents in patients with coronary heart disease and diabetes mellitus were similar. After 12 months follow up, QCA was used to measure the size of late diameter loss in stent, and the diameter loss of Nano stent was smaller than that of Firebird2TM stent, which indicated that Nano stent could inhibit restenosis obviously than Firebird2TM stent. As the representative of new drug-eluting stents without polymer coating, Nano stents have no late polymer-related adverse reactions, but compared with long-lasting polymer-coated Firebird2TM stents. There was no significant difference in the risk of late stent thrombosis and the need for revascularization between the two groups.
【學(xué)位授予單位】：青島大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2017
【分類號】：R541.4;R587.1
【參考文獻(xiàn)】
相關(guān)期刊論文 前8條
1 隋輝;陳偉偉;王文;;《中國心血管病報告2014》要點介紹[J];中華高血壓雜志;2015年07期
2 梁濱;孫偉;朱皓;鄭振國;張研;尹達(dá);周旭晨;;國產(chǎn)EXCEL~(TM)與Friebird2~(TM)藥物洗脫支架在ACS治療中的應(yīng)用對比觀察[J];山東醫(yī)藥;2015年12期
3 韓欣宇;楊魏;;生物可降解鎂合金支架研究現(xiàn)狀和進(jìn)展[J];醫(yī)學(xué)綜述;2015年06期
4 竇克非;尹棟;吳元;楊躍進(jìn);徐波;陳玨;劉海波;姚民;秦學(xué)文;吳永健;李建軍;喬樹賓;尤士杰;陳紀(jì)林;高潤霖;陳在嘉;;FIREBIRD雷帕霉素洗脫支架與TAXUS紫杉醇洗脫支架成功置入后長期臨床結(jié)果觀察:單中心、大規(guī)模注冊研究[J];中國循環(huán)雜志;2012年04期
5 李毅;韓雅玲;荊全民;張磊;王效增;馬穎艷;王耿;王斌;鄧捷;張權(quán)宇;;涂層可降解雷帕霉素洗脫支架術(shù)后6個月雙聯(lián)抗血小板治療的長期療效與安全性:CREATE研究4年隨訪結(jié)果分析[J];中華老年多器官疾病雜志;2012年02期
6 陳紀(jì)林;楊躍進(jìn);黃靜涵;秦學(xué)文;喬樹賓;姚民;劉海波;徐波;吳永健;袁晉青;陳玨;尤士杰;戴軍;李建軍;高潤霖;;冠心病真實世界中藥物洗脫支架置入術(shù)后血栓形成的發(fā)生率[J];中華心血管病雜志;2007年12期
7 曾龍驛;;英國前瞻性糖尿病研究(UKPDS)解讀[J];中國卒中雜志;2007年07期
8 中國心臟調(diào)查組;胡大一;潘長玉;;中國住院冠心病患者糖代謝異常研究——中國心臟調(diào)查[J];中華內(nèi)分泌代謝雜志;2006年01期
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