Role of bare metal stent in drug eluting stent era

Although drug eluting stent (DES) reduced the target vessel revascularization, there are still some unsolved concerns such as late stent thrombosis, late catch up, adequate duration of dual antiplatelet agents and surgical complication after DES implantation. Individually bare metal stent should be used considering several factors such as patient characteristic, lesion characteristic, the tolerance of dual antiplatelet therapy for long-term, informed consent and also surgery after PCI.     

老年人冠状动脉裸金属支架植入术后冠脉造影及临床随访观察

目的观察老年人冠脉裸金属支架(bare metal stent,BMS)术后冠脉造影随访结果及临床事件。方法冠心病患者在成功冠脉内裸金属支架术后患者进行冠状动脉造影随访复查,根据患者年龄分为≥60岁的老年组及<60岁的非老年组,对两组支架植入术后冠脉造影随访资料及临床资料进行对比分析。结果老年组89名患者共植入121个裸金属支架,非老年组53例患者植入71个。两组在病变类型、狭窄程度、残余狭窄、支架长度、直径间差异无统计学意义。随访期间老年组与非老年组分别有心力衰竭10例(11.2%)与1例(1.9%)(P<0.05)。冠脉造影发现,两组分别有47个及24个支架发生支架内再狭窄,分别为38.8%及33.8%(P>0.05),再狭窄类型在两组间差异无统计学意义。老年组及非老年组中有新病变或病变进展者非别为22例(24.7)%及23例(43.4%)(P<0.05)。结论老年人成功冠脉裸金属支架植入术后,冠脉造影随访发现支架内再狭窄发生率与非老年人相似,但发生心力衰竭者明显高于非老年人。     

Concurrent drug eluting/bare metal stent implantation during percutaneous coronary intervention in target vessel: outcomes and 1-year follow-up

Aim  

We aimed at analyzing the safety of concurrent drug eluting stent (DES)/bare metal stent (BMS) placement in the same target segment using the dataset of the German Drug Eluting Stent Registry (DES.DE).     

Fire Bird支架与Cypher支架治疗冠心病并糖尿病患者疗效比较

[摘要] 目的: 观察药物涂层支架在冠心病合并糖尿病患者介入治疗的临床疗效。方法:并发糖尿病的冠心病患者82例常规冠状动脉造影，进行经皮冠状动脉介人治疗，其中40例植入国产雷帕霉素药物涂层支架（Fire Bird组），42例植入Cypher支架（Cypher组），术前术后常规使用阿司匹林和氯比格雷，术后进行随访。结果:冠状动脉造影显示2支以上血管病变占70. 56%，Fire Bird组植入雷帕霉素药物涂层支架74枚，Cypher支架72枚，所有患者均获得成功。平均随访5.8 ±1.6个月，其中Fire Bird组复发心绞痛9例，1例发生心肌梗死; Cypher组复发心绞痛8例，无心肌梗死发生， Fire Bird组发生再狭窄2例，Cypher组发生再狭窄2例。两组无支架内血栓形成和死亡。结论: 同Cypher支架比，Fire Bird支架对冠心病并发糖尿病患者近期和远期疗效确切，能减少再狭窄的发生。     

雷帕霉素药物洗脱支架置入前后稳定型心绞痛患者血清CXC趋化因子16的变化

背景:CXC趋化因子16作为一种炎症反应中的趋化因子冠状动脉粥样硬化发生机制中发挥重要作用。目的:观察雷帕霉素药物洗脱支架置入前后稳定型心绞痛患者血清中CXC趋化因子16的变化。方法:选择郑州大学第一附属医院心内科住院行冠状动脉支架置入并置入1或2枚雷帕霉素药物洗脱支架的稳定型心绞痛患者40例,另选同期于本院经冠状动脉造影显示无异常的健康者10名作为对照组。对受试者进行CXC趋化因子16、超敏C-反应蛋白检测,并分析其相互关系。结果与结论:与对照组相比,血清CXC趋化因子16在支架置入前、置入后0.5,2,24h均升高(P<0.05);与置入前相比,置入后0.5,2h升高(P<0.01)。置入后0.5,2,24h患者血清超敏C-反应蛋白较对照组显著升高(P<0.01),其中置入后0.5h与2h差异无显著性意义(P>0.05),2h高于24h(P<0.01)。血清CXC趋化因子16和超敏C-反应蛋白水平呈正相关性(r=0.632,P=0.017)。     

雷帕霉素药物洗脱支架置入前后稳定型心绞痛患者血清CXC趋化因子16的变化

背景：CXC趋化因子16作为一种炎症反应中的趋化因子冠状动脉粥样硬化发生机制中发挥重要作用。目的：观察雷帕霉素药物洗脱支架置入前后稳定型心绞痛患者血清中CXC趋化因子16的变化。方法：选择郑州大学第一附属医院心内科住院行冠状动脉支架置入并置入1或2枚雷帕霉素药物洗脱支架的稳定型心绞痛患者40例,另选同期于本院经冠状动脉造影显示无异常的健康者10名作为对照组。对受试者进行CXC趋化因子16、超敏C-反应蛋白检测,并分析其相互关系。结果与结论：与对照组相比,血清CXC趋化因子16在支架置入前、置入后0.5,2,24h均升高（P〈0.05）;与置入前相比,置入后0.5,2h升高（P〈0.01）。置入后0.5,2,24h患者血清超敏C-反应蛋白较对照组显著升高（P〈0.01）,其中置入后0.5h与2h差异无显著性意义（P〉0.05）,2h高于24h（P〈0.01）。血清CXC趋化因子16和超敏C-反应蛋白水平呈正相关性（r=0.632,P=0.017）。     

药物洗脱支架与金属支架生物相容性比较及支架置入后的血管再狭窄

药物洗脱支架与裸金属支架相比,最大的改进就是在原有裸金属支架平台上,增加了药物载体和药物.虽然冠状动脉支架的成功率和安全性有了提高,但是再狭窄仍然足限制支架应用的一个障碍.药物洗脱支架置入后的过敏反应已有报道.文章在药物洗脱支架与普通金属裸支架的生物相容性比较分析的基础上,对药物洗脱支架置入后的再狭窄进行了临床研究,探讨了支架再狭窄产生的原因并从临床实例角度综合研究了药物洗脱支架置入后再狭窄的新进展与启示.     

药物洗脱支架与金属支架置入后再狭窄及其生物相容性比较

目的:比较并总结金属裸支架与药物洗脱支架的生物相容性及支架置入后的冠状动脉再狭窄,展望生物可降解支架的临床应用.方法:以药物洗脱支架,金属裸支架,生物相容性,再狭窄为检索词,检索中国期刊全文数据库(1999-01/2009-06),以drugeluting stent,bare metal stent,biocompatibility,restenosis为检索词,检索PubMed数据库(1999-01/2009-06),文献检索语种限制为中文和英文.以再狭窄率,支架的生物相容性及炎症因子的表达为评价指标.纳入药物洗脱支架与金属支架置入后血管再狭窄的临床研究:排除动物实验.结果:计算机初检得到523篇文献,根据纳入排除标准,对金属裸支架与药物洗脱支架置入后血管再狭窄的临床研究进行分析.经皮冠状动脉支架置入己成为治疗冠状动脉粥样硬化性心脏病最常用的治疗方法,其主要包括球囊扩张、普通金属裸支架置入、药物洗脱支架置入.用普通金属裸支架取代球囊扩张,使支架内再狭窄由50％下降到20%-30%;药物洗脱支架改善了冠状动脉介入治疗的愈后,但同时也带来了许多新问题.大多数药物洗脱支架由药物、药物载体、支架平台3部分组成,其中金属支架和聚合物不能被人体吸收.金属置入物和药物载体长期存留于血管中,影响内皮化、引起局部的慢性炎症反应和后期的血栓形成.结论:药物洗脱支架在防止支架内再狭窄及再次血运重建明显优于普通金属裸支架.生物可降解支架的临床应用,在一定程度上减少了药物载体对血管内皮的影响.     

Inhibition of neointimal proliferation after bare metal stent implantation with low-pressure drug delivery using a paclitaxel-coated balloon in porcine coronary arteries

A variety of mechanical and laser-based methods remove or shift atherosclerotic plaques and reopen the artery to its original lumen. Subsequent treatment with drug-coated balloons (DCB) may smooth the vessel wall but does not require high-pressure inflation. We investigated the efficacy of paclitaxel-coated balloons inflated with only 2 atm after bare metal stent implantation in coronary arteries of 24 pigs. Angiography and histomorphometry was performed on day 28. DCB inflated with 2 atm caused similar reduction of late lumen loss (LLL) as high-pressure inflation with 12 atm (0.89 ± 0.58 vs. 0.72 ± 0.39 mm, p = 0.34). Both DCB treatments significantly (p < 0.01) reduced LLL versus uncoated balloons (1.50 ± 0.51 mm). Treatment with low-pressure DCB resulted in less maximal intimal thickness (0.45 ± 0.15 vs. 0.67 ± 0.25 mm) and neointimal area (2.93 ± 0.73 vs. 3.82 ± 1.27 mm²) than treatment with uncoated balloons (p < 0.05). In conclusion, low-pressure treatment with DCB was similarly effective as high-pressure treatment justifying clinical trials in vessels which will benefit from inhibition of neointimal proliferation but may not tolerate high inflation pressure.     

血管内支架、冠状动脉支架及药物涂层支架

血管内支架的技术性能主要包括生物相容性、机械力学性能、抗腐蚀性和血液相容性。术后出现支架内再狭窄是血管内支架的主要并发症。冠状动脉血管内支架的设计分为传统设计方法和有限元分析方法,支架壁厚和金属表面积是支架设计的两个重要参数,其加工材料多为表面改性剂和可降解材料。药物涂层支架的涂层材料可分为无机涂层材料、高分子涂层材料和蛋白涂层材料,可以携带药物或者基因。通过有限元分析技术,可以了解支架的应力分布情况等信息,估计支架在血管内的疲劳寿命,减轻支架对血管壁的损害,优化支架结构设计,能够极大地促进心脑血管支架的研发进程。     

Randomized comparison of early inflammatory response after sirolimus-eluting stent vs bare metal stent implantation in native coronary lesions

BACKGROUND: The clinical significance of early inflammatory response after coronary stent implantation has been controversial. Sirolimus-eluting stent (SES) has been shown to be better outcomes compared with bare metal stent (BMS). We prospectively investigated the early inflammatory response after SES or BMS implantation in patients with single-vessel lesion, and evaluated the relationship between inflammation and late clinical outcomes in a randomized design. METHODS: Forty-eight patients with single-vessel disease were randomized into SES or BMS implantation group (n=24 respectively). Blood samples were taken before stenting, 1 h, 24 h and 8 months afterward. The plasma concentrations of C-reactive protein (CRP) and interleukin-6 (IL-6) were determined by ELISA. The clinical and angiographic follow-up were performed at 8 months after stenting. RESULTS: There was no difference in baseline characteristics, plasma CRP and IL-6 concentrations between the 2 groups. However, plasma IL-6 concentrations at 1 h after stenting were higher in both groups than in baseline (p<0.01). In addition, the plasma CRP and IL-6 concentrations at 24 h after stenting were significantly higher in both groups compared with baseline (p<0.01 respectively). Likewise, plasma CRP and IL-6 concentrations were significantly higher in BMS group compared with SES group at 24 h after stenting (p<0.05 respectively). At the follow-up (mean 8 months after stenting), the rate of in-stent restenosis (ISR) and target lesion revascularization (TLR) were higher in BMS group than in SES group (p<0.05 respectively) although the plasma CRP and IL-6 concentrations are similar between the groups. CONCLUSIONS: Single coronary stenting could trigger an early inflammatory response. However, patients undergoing SES implantation has less augmentation of early inflammatory markers after stenting compared to patients treated with BMS, which was positively related the incidence of ISR and TLR at follow-up. This may reflect the potential impact of SES implantation on the early inflammatory response and late clinical outcomes.     

冠状动脉内药物洗脱支架或金属裸支架置入对患者血小板功能的影响

背景:冠状动脉内置入药物洗脱支架可以显著降低冠状动脉介入治疗后再狭窄的发生率和主要心血管不良事件,提高患者的生活质量,在临床得到了广泛应用.但近期的多项荟萃分析说明,与金属裸支架相比,药物洗脱支架显著增加晚期支架血栓形成,增加全因性死亡率.目的:观察冠状动脉支架置入前、后和随访6个月血小板膜糖蛋白的变化,对比分析短、中期内置入药物洗脱支架或金属裸支架对血小板活化影响的差异.方法:对2007-06/2009-06因急性冠脉综合征成功进行冠状动脉内支架置入治疗的104例患者进行回顾性分析,其中使用药物洗脱支架68例,金属裸支架36例.同时纳入34例因疑诊急性冠脉综合征而进行造影,证实血管完全正常的患者为对照组.比较各组患者外周血中CD62p,CD63和凝血酶敏感蛋白的阳性表达率.结果与结论:在相同抗血小板治疗6个月时,与金属裸支架组相比,药物洗脱支架置入对患者血小板活化的影响仍较明显,这可能与药物洗脱支架的晚期支架血栓形成增加有关.目前所提倡的12个月的标准抗凝治疗是否足够,以及血小板活化功能检测对支架置入治疗后抗血小板治疗的临床指导意义等仍需进一步研究.     

药物洗脱支架与裸支架置入治疗冠心病的安全性及生物相容性比较

药物洗脱支架与裸金属支架相比,最大的改进就是在原有的裸金属支架平台上,增加了药物载体和药物.药物洗脱支架的药物载体主要是多聚物涂层,其目的是用于承载足够的药量,并在药物洗脱支架置入人体后能有效控制药物的分解、扩散和释放.在临床治疗中,聚合物载体的生物相容性及完整性会影响到药物洗脱支架的安全性,而聚合物载体对药物的控释性则影响到药物洗脱支架有效性.从目前的发展趋势来看,涂层药物要具备保护内皮的功能,在最大程度上保持支架表面的光滑度,从而提高支架的生物相容性,使支架平台和多聚载体可吸收、药物释放体系更科学,将是未来药物洗脱支架的发展方向.     

冠心病患者支架植入术后服药依从性现状的调查及分析

目的了解冠心病患者支架植入术后的服药依从性。方法采用MORISKY问卷评价表评价患者支架植入术后的服药依从性,并对相关因素进行分析。结果 108例患者中40例服药依从性差,多元Logistic回归分析显示,服药依从性差与年龄、文化程度、支架植入时间、家庭月收入、医疗报销、药物费用、服药种类相关。结论冠心病支架植入术后患者服药依从性较差,影响因素较多,应加强术后健康教育和出院后随访。     

冠状动脉支架置入后相关炎症因子的变化及其干预

背景:冠状动脉粥样硬化性心脏病支架置入治疗后的炎症反应以及其严重程度与再狭窄明显存在相关性,医学工作者试图从中寻找新思路预防支架置入后再狭窄,提高治疗质量.目的:评价各种干预措施以及监测手段在冠状动脉置入术后炎症治疗中的应用价值和临床前景.方法:电子检索EMbase(1980-01/2011-05),MEDLINE(1966-01/2011-05),中国生物医学文献数据库(CBM,1978/2011-05)和中国期刊全文数据库(CNKI),筛查相关文章的参考文献.中文检索词冠状动脉支架,炎症因子,炎症,CRP,再狭窄,英文检索词为Coronary stent,inflammatory cytokines,inflammation,CRP,restenosis.结果与结论:临床试验结果显示支架置入后炎症反应明显加重,使用雷帕霉素药物洗脱支架,添加地塞米松、塞来昔布、瑞舒伐他汀等可更大程度上降低支架置入后炎症反应.动物试验发现使用雷帕霉素洗脱支架可减少支架置入段新生内膜的形成和缩小炎症面积.提示各种干预措施可降低支架置入后炎症反应从而降低远期再狭窄的发生,可进一步改良加以应用于临床观察其疗效.     

急性心肌梗死置入药物洗脱支架与裸金属支架的安全性及即时效应比较

背景:药物洗脱支架越来越多应用于冠状动脉狭窄患者,效果良好.但急诊应用于急性心肌梗死患者的研究报道较少.目的:对比观察Firebird支架(雷帕霉素洗脱支架)与普通金属裸支架在急性ST段抬高型心肌梗步死急诊经皮腔内冠状动脉介入治疗中应用的安全性和临床疗效.设计、时间及地点:回顾性分析,病例来自2006-01/2008-09洛阳150医院心内科.对象:选择洛阳150医院心内科收治的ST段抬高型急性心肌梗死行直接经皮腔内冠状动脉介入治疗患者94例,男71例,女23例,年龄47～76岁.方法:94例患者随机分为2组,Firebird支架组:均在靶病变置入Firebird支架1或2枚;普通支架组:在靶病变置入金属裸支架1或2枚.主要观察指标:两组患者的安全性、临床疗效及随访情况.结果:①94例患者介入治疗均获得成功.Firebird支架组52例,共置入68枚药物涂层支架;普通支架组42例,共置入56枚普通支架.两组平均置入支架个数、手术成功率、支架置入并发症发生率、置入前置入后平均狭窄程度及操作时间等差异均无显著性意义(P＞0.05);两组选用的支架内径相比,Firebird支架明显偏小(P＜0.01);两组支架长度相比,Firebird 支架显著偏长(P＜0.05).②住院期间观察两组患者心肌酶峰值,Tnl峰值,血管开通后2h ST段下降幅度,左室功能差异均无显著性意义(P＞0.05).两组靶血管重建Firebird支架组1例,普通支架组2例,差异亦无显著性意义(P＞0.05).两组各有2例患者死亡,住院期间心脏事什发生率差异无显著性意义(P＞0.05).Firebird支架组和普通支架组平均住院时间差异无显著性意义[(11.3±4.2),(12.4±4.6)d,P＞0.05].⑨出院后随访1～10个月,平均(6.5±2.4)个月,两组患者无心源性死亡、再梗死.普通支架组心绞痛发生率35.5%较Firebird支架组21.0%显著增高(P＜0.01). Firebird支架组无心脏事件生存率95%;显著高于普通支架组78%(P＜0.01).结论:雷帕霉素药物洗脱支架与普通支架一样在ST段抬高型急性心肌梗死急诊经皮腔内冠状动脉介入中是安全有效的.     

冠状动脉支架置入后相关炎症因子的变化及其干预

背景：冠状动脉粥样硬化性心脏病支架置入治疗后的炎症反应以及其严重程度与再狭窄明显存在相关性,医学工作者试图从中寻找新思路预防支架置入后再狭窄,提高治疗质量。目的：评价各种干预措施以及监测手段在冠状动脉置入术后炎症治疗中的应用价值和临床前景。方法：电子检索EMbase（1980-01/2011-05）,MEDLINE（1966-01/2011-05）,中国生物医学文献数据库（CBM,1978/2011-05）和中国期刊全文数据库（CNKI）,筛查相关文章的参考文献。中文检索词＂冠状动脉支架,炎症因子,炎症,CRP,再狭窄＂,英文检索词为＂Coronary stent,inflammatory cytokines,inflammation,CRP,restenosis＂。结果与结论：临床试验结果显示支架置入后炎症反应明显加重,使用雷帕霉素药物洗脱支架,添加地塞米松、塞来昔布、瑞舒伐他汀等可更大程度上降低支架置入后炎症反应。动物试验发现使用雷帕霉素洗脱支架可减少支架置入段新生内膜的形成和缩小炎症面积。提示各种干预措施可降低支架置入后炎症反应从而降低远期再狭窄的发生,可进一步改良加以应用于临床观察其疗效。     

Assessment of potential relationship between wall shear stress and arterial wall response after bare metal stent and sirolimus-eluting stent implantation in patients with diabetes mellitus

BACKGROUND: Wall shear stress (WSS) has been associated with neointimal hyperplasia (NIH) following bare metal stent (BMS) implantation. Drug-eluting stents (DES) almost abolish NIH. Conversely, diabetes mellitus amplifies NIH response. The association between WSS and arterial wall response following DES and BMS implantation in diabetic patients remains to be evaluated. METHODS: The study involved 20 diabetic patients randomized to BMS (n = 9) or sirolimus-eluting stent (SES; n = 11) implantation in native coronary arteries. A computational fluid dynamic model applied 3D intravascular ultrasound (IVUS) and two-plane angiographic to measure WSS (Pa). IVUS assessments were performed post-procedure and at 9-months follow-up. The target segment encompassed the stent plus 5 mm distal and proximal edges. A total of 93 subsegments were evaluated: in-stent segments divided in three subsegments (proximal, mid and distal; n = 60) and proximal and distal edges (n = 33). RESULTS: Stent length was similar between BMS (17.4 +/- 7.3 mm) and SES (19.8 +/- 6.8 mm) groups. NIH was observed in all BMS subsegments (n = 27) versus one subsegment in the SES group (n = 33). WSS ranged from 0.52 to 4.20 Pa in the BMS and from 0.42 to 3.06 Pa in the SES group. There was no correlation between WSS and NIH in either stent group. In addition, there were no correlation between the change of external elastic membrane (EEM) or plaque growth at the edges and WSS. CONCLUSION: WSS was not associated with NIH after implantation of SES or BMS in diabetic patients. Plaque growth or the change of EEM at the edges were not associated with WSS either.     

Immediate and long-term outcomes after "Ephesos" coronary stent implantation in patients with stable or unstable angina

AIM: An open non-randomized trial was initiated to assess clinical and angiographic results of using the coronary stent "Ephesos" in 457 patients with stable or unstable angina pectoris and native coronary affections. MATERIAL AND METHODS: 268 stents have been implanted in 231 patients with stable angina (SA) and 271 stents--in 226 patients with unstable angina (UA). 46% lesions were complicated. The length of stenosis was 12.9 +/- 6.7 mm in the group SA and 14.1 +/- 7.4 mm in the group UA, 30% stenoses were long. RESULTS: Successful stenting was stated in 99% without cases of acute thrombosis. Non-fatal myocardial infarction took place in hospital in 1.3% of SA patients and in 2.6% of UA patients. Incidence of cardiac complications (death, recurrent angina pectoris, myocardial infarction, restenosis, repeated revascularization) for 6-month follow-up was 15.6% in SA group and 18.1% in UA group. At angiographic control, the index of vascular diameter loss made up 0.22 +/- 0.2 in SA group and 0.3 +/- 0.27 in UA group. Incidence of restenosis was 12 and 14%, respectively. 18-month follow-up found no differences in frequency of complications: 21.6 and 22.6% in groups SA and UA, respectively. CONCLUSION: Implantation of the stent "Ephesos" is effective in prevention of thrombosis and restenosis in patients with stable or unstable angina pectoris at high risk of intervention.     

Long-term outcome after drug-eluting stent implantation in comparison with bare metal stents: a single centre experience

Background  

The aim of our study was to evaluate the effect of drug-eluting stents (DES) compared with bare-metal stents (BMS) on all-cause mortality and target vessel revascularization (TVR) in a “real-world” clinical setting.