冠状血管内生物可吸收支架的最新进展

新型冠状血管内生物可吸收支架是未来支架的发展方向,是目前冠心病介入治疗最前沿的课题。自从1976年德国医生安德里亚·格隆茨戈首次提出支架的设想、到20世纪90年代冠脉支架广泛应用临床以来,已经出现了第三代可吸收药物洗脱支架。但目前以不锈钢和钴铬合金为基础的药物洗脱支架(DES)仍不能从根本上解决亚急性血栓形成和再狭窄的问题。于是,生物可吸收支架(BVS)开始成为关注的焦点和热点。可吸收支架理论上有多个可能的好处:支架被吸收后可恢复血管正常收缩性,阻止血管再狭窄的发生;重建普通支架置入后消失的血管动力;可在同一病变处进行多次介入干预;对患先天性疾病的儿童可使用,不需要频繁的再干预。因此,目前,国际上已有几家公司和研究机构正在进行这方面的研究。     

生物涂层可降解支架在冠心病患者临床应用中的作用

药物洗脱支架(DES)显著降低冠状动脉介入治疗术(PCI)后再狭窄的发生率,大大减少主要心血管不良事件(MACE),提高患者的生活质量[1-5].但几项临床试验的荟萃分析显示,与金属裸支架(BMS)相比,DES虽可降低再狭窄及靶血管重建,但增加晚期支架血栓形成,进而增加全因性死亡[6,7],这与DES引起内皮愈合延迟、不可降解聚合物永久残留导致的局部血管壁炎症反应和纤维素沉积有关,支架边缘再狭窄(RS)和晚期支架血栓(LST)形成是主要原因[8-10].     

药物洗脱球囊与药物洗脱支架治疗冠状动脉支架内再狭窄患者的效果

目的分析并比较药物洗脱球囊与药物洗脱支架治疗冠状动脉支架内再狭窄患者的效果。方法选取天津海滨人民医院2017年6月至2020年5月收治的200例冠状动脉支架内再狭窄患者作为研究对象,随机分为试验组与对照组,各100例。试验组运用药物洗脱球囊治疗,对照组运用药物洗脱支架治疗,比较两组术后冠状动脉造影结果(支架内最小管腔直径、支架再狭窄率、晚期管腔丢失)、心血管不良事件发生情况。结果两组术后支架内最小管腔直径、支架再狭窄率、晚期管腔丢失情况及心血管不良事件发生率比较,差异均无统计学意义(P>0.05)。结论药物洗脱球囊与药物洗脱支架治疗冠状动脉支架内再狭窄患者的效果相近,且两种治疗方式均有较高的安全性。     

冠心病患者血清脂蛋白相关磷脂酶A2水平与冠状动脉药物洗脱支架置入术后支架内再狭窄的关系

目的:探讨冠心病患者血清脂蛋白相关磷脂酶A2水平(Lp-PLA2)与冠状动脉药物洗脱支架(DES)置入术后支架内再狭窄(ISR)的关系。方法:选取2017年10月至2018年9月期间初次于南京市第一医院就诊的227例经冠状动脉造影(CAG)确认心外膜冠状动脉存在严重狭窄并行经皮冠状动脉介入治疗(PCI)、置入DES的患...     

药物洗脱支架治疗不同阶段的支架内再狭窄病变情况分析

目的：探讨在支架内再狭窄病变患者的早期治疗与晚期治疗时采用药物洗脱支架治疗的远期临床效果。方法：选取2018年3月～2019年3月在本院进行治疗的支架内再狭窄病变患者，总计100例。按照病变阶段将其分成早期组和晚期组，所有患者均接受药物洗脱支架治疗，并对其进行为期1年的随访，观察两组患者不良心血管事件发生率。结果：两组患者在病变部位、病变长度和病变类型方面对比差异不大，P<0.05；早期患者发生心血管不良事件较高，P<0.05。结论：在治疗支架内再狭窄病变患者采取药物洗脱支架治疗效果较好，但早期患者采用该种方法治疗发生靶病变再次血运重建率较高。     

药物洗脱支架

20世纪70年代后期开始出现的以导管为基础的经皮冠状动脉血管腔内介入治疗技术在30多年的历程中得到迅速发展,在技术上主要经历了3个阶段:(1)20世纪70年代末至80年代后期以球囊扩张(PTCA)为主的技术;(2)自80年代后期冠状动脉内支架植入术的广泛使用;(3)21世纪初药物洗脱支架(drug-eluting stent,DES)的新时代.DES与普通支架的结构特征相同,两者之间的主要不同是DES表面有一层可以释放防止再狭窄药物的聚合物涂层,可以使药物在靶病变部位发挥最大效应并且全身毒性最小.     

药物洗脱支架应用现状和展望

支架内再狭窄一直是多年来制约冠心病介入治疗无期疗效的瓶颈，人们形象的称之为冠脉介入治疗的阿喀琉斯之踵（Achilles＇heel）。但随着近年来药物洗脱支架（Drug eluting stent ,DES）的迅猛发展。有望成为支架内再狭窄这一顽症的理想解决方案之一，同时随着相关临床试验的结果公布，DES在冠心病介入治疗中的应用领域也不断扩展，而且DES作为一种新兴的医疗器械仍在作进一步的研发，各种机关报型药物支架的诞生将丰富冠脉介入治疗的手段，为广大冠心病患者造福。     

生物可降解涂层药物洗脱支架

药物洗脱支架已经成为冠脉介入治疗的重要选择,在显著降低再狭窄的同时,仍然存在发生支架内血栓的风险。本文介绍新一代国产生物可降解涂层药物洗脱支架-爱克塞尔支架,关注其设计结构,作用机制以及创新特点。着重综述围绕该支架所进行的临床试验,通过临床试验的结果证实其临床应用的近期和中期的有效性,以及具有降低支架内血栓发生的安全性特点。     

冠状动脉多支病变介入治疗与外科治疗的比较

对于冠状动脉多支病变,目前国际上主要采用的治疗方法是冠状动脉旁路移植术(coronary artery bypass grafting,CABG)和经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI).近半个世纪以来,CABG一直被公认为是治疗冠状动脉复杂病变的经典方法.PCI的发展历史比较短,20世纪80年代冠状动脉内支架植入术才开始进入临床.1984年首先用于临床治疗的是普通球囊血管成形术,无支架植入,术后再次血运重建率较高.1995年第一代支架——裸支架开始用于治疗冠心病患者.裸支架植入术后再次血运重建率较单纯球囊扩张术有所降低,但由于裸支架可能会在某种程度上刺激血管内膜过度增生,导致管腔的再狭窄,因此术后病变血管再次血运重建率仍高于CABG[1].2002年开始广泛应用的药物洗脱支架(drug-eluting stents,DES)很大程度上弥补了这个缺点,其药物涂层有效地降低了支架内再狭窄的发生率,使得PCI的疗效大为改善,应用也更为广泛.PCI与CABG各有优势,究竟哪种术式才是冠状动脉多支病变实现血运重建的首选方法呢?     

非血管药物洗脱支架制备及评价研究进展

近年来,应用支架介入治疗良恶性因素引起的非血管管腔狭窄的方法受到国内外研究者的广泛关注,尤其是恶性肿瘤疾病高发,进一步促进了支架介入治疗的发展.传统的裸支架易刺激管腔黏膜产生再狭窄等一系列并发症,药物洗脱支架的出现有望解决这一问题,成为非血管支架的重要发展趋势之一.该文综合近年的研究及应用文献,对非血管药物洗脱支架的载...     

Update on stents: recent studies on the TAXUS stent system in small vessels

Small vessel size (<3 mm) has been identified as an independent predictive factor of restenosis after percutaneous coronary intervention when using bare metal stents (BMS). It remains controversial whether BMS placement in small vessels has an advantage over balloon angioplasty in terms of angiographic and clinical outcomes. The advent of drug eluting stents (DES), either paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES), has strongly impacted interventional cardiology by significantly reducing restenosis and the need for repeat revascularization. Therefore, it was also expected that DES could substantially reduce restenosis in smaller vessels. However, even in the DES era, small vessel size remains an independent predictor of angiographic and clinical restenosis. To date, only a few studies systematically investigate the clinical effect of DES placement in small vessels. In addition, some potential issues with the use of DES have been raised, such as late stent thrombosis and late restenosis. In order to (i) establish the superiority of DES over BMS; (ii) verify the efficacy and safety of DES; and (iii) critically assess the superiority of one DES over the other in patients with small coronary arteries, further multicenter, randomized clinical trials with larger sample size are warranted.     

Drug-eluting stent: a review and update

The development of stent has been a major advance in the treatment of obstructive coronary artery disease since the introduction of balloon angioplasty. However, neointimal hyperplasia occurring within the stent leading to in-stent restenosis is a main obstacle in the long-term success of percutaneous coronary intervention (PCI). The recent introduction of drug-eluting stents (DES) contributes a major breakthrough to interventional cardiology. Many large randomized clinical trials using DES have shown a remarkable reduction in angiographic restenosis and target vessel revascularization when compared with bare metal stents. The results of these trials also appear to be supported by evidence from everyday practice and non-controlled clinical trials. However, the expanded applications of DES, especially in treating complex lesions such as left main trunk, bifurcation, saphenous vein graft lesions, or in-stent restenosis, are still under evaluation with ongoing studies. With the availability of different types of DES in the market, the issue of cost should not be a deterrent and DES will eventually be an economically viable option for all patients. The adoption of DES in all percutaneous coronary intervention may become a reality in the near future. In this review article, we summarize the recent development and progress of DES as well as compare and update the results of clinical trials.     

Drug eluting stents in acute myocardial infarction

Routine stent-implantation in primary coronary intervention (PCI) for acute myocardial infarction (AMI) has been shown to have a better clinical outcome than balloon angioplasty mainly because of reduction in restenosis rate and reocclusion. Drug eluting stents (DES) have recently been proven to further reduce restenosis and revascularization rate in comparison to bare metal stent (BMS) in elective procedures. Delayed endothelialization of these stents raises concern about a possible increase of thrombotic complications in the setting of AMI. Randomized studies with DES in the treatment of elective patients have shown at 9-12 months follow-up a thrombosis rate of 0-2% comparable to the one of BMS. Sirolimus eluting stents (SES) in AMI have been used in small series of consecutive pts not randomized or in registries with very high successful rate and a stent thrombosis varying between 0 and 4.7%. Paclitaxel eluting stent (PES) have also shown in small series a good immediate performance with a thrombosis rate between 0 and 4.8%. Predictors of acute and subacute stent thrombosis are the same than for BMS: residual dissection, long or overlapping stents, biforcation lesions and discontinuation of antiplatelets treatment. Providing effective mechanical reperfusion with similar results to the current therapeutic standard and decreasing the incidence of late complications, DES appear as an attractive approach for patients admitted with AMI.     

Cost-effectiveness of drug-eluting coronary stents in Quebec, Canada

OBJECTIVES: The aim of this investigation was to assess the incremental cost-effectiveness of replacing bare metal coronary stents (BMS) with drug-eluting stents (DES) in the Province of Quebec, Canada. METHODS: The strategy used was a cost-effectiveness analysis from the perspective of the health-care provider, in the province of Quebec, Canada (population 7.5 million). The main outcome measure was the cost per avoided revascularization intervention. RESULTS: Based on the annual Quebec rate of 14,000 angioplasties with an average of 1.7 stents per procedure and a purchase cost of $2,600 Canadian dollar (CDN) for DES, 100 percent substitution of BMS with DES would require an additional $45.1 million CDN of funding. After the benefits of reduced repeat revascularization interventions are included, the incremental cost would be $35.2 million CDN. The cost per avoided revascularization intervention (18 percent coronary artery bypass graft, 82 percent percutaneous coronary intervention [PCI]) would be $23,067 CDN. If DES were offered selectively to higher risk populations, for example, a 20 percent subgroup with a relative restenosis risk of 2.5 times the current bare metal rate, the incremental cost of the program would be $4.9 million CDN at a cost of $7,800 per avoided revascularization procedure. Break-even costs for the program would occur at DES purchase cost of $1,161 for 100 percent DES use and $1,627 for selective 20 percent DES use for high-risk patients for restenosis (RR = 2.5). Univariate and Monte Carlo sensitivity analyses indicate that the parameters most affecting the analysis are the capacity to select patients at high risk of restenosis, the average number of stents used per PCI, baseline restenosis rates for BMS, the effectiveness ratio of restenosis prevention for DES versus BMS, the cost of DES, and the revascularization rate after initial PCI. Sensitivity analyses suggest little additional health benefits but escalating cost-effectiveness ratios once a DES penetration of 40 percent has been attained. CONCLUSIONS: Under current conditions in Quebec, Canada, selective use of DES in high-risk patients is the most acceptable strategy in terms of cost-effectiveness. Results of such an analysis would be expected to be similar in other countries with key model parameters similar to those used in this model. This model provides an example of how to evaluate the cost-effectiveness of selective use of a new technology in high-risk patients.     

Next-generation drug-eluting stents in coronary artery disease: focus on everolimus-eluting stent (Xience V)

Percutaneous coronary revascularization has been a mainstay in the management of coronary artery disease since its introduction in the late 1970s. Bare-metal stents and, more recently, first-generation drug-eluting stents (DES), such as sirolimus-eluting (Cypher) and paclitaxel-eluting stents (Taxus), have further improved results of percutaneous coronary intervention (PCI) by improving early results and reducing the risk of restenosis. There is currently debate on the safety of these first-generation DES, given the potential for late stent thrombosis, especially after discontinuation of dual antiplatelet therapy. There are well known caveats on the performance of their respective metallic stent platforms, delivery, and dilation systems, and polymer coatings. Second-generation DES, such as zotarolimus-eluting (Endeavor) and everolimus-eluting stents (Xience V), have recently become available in the USA and/or Europe. The Xience V stent holds the promise of superior anti-restenotic efficacy as well as long-term safety. In addition, this stent is based on the Multi-link platform and delivery system. Recently available data already suggest the superiority of the Xience V stent in comparison to the Taxus stent in terms of prevention of restenosis, without significant untoward events. Nonetheless, the number of patients studied and the follow-up duration are still too limited to enable definitive conclusions. Only indirect meta-analyses can be used to date to compare the Xience V with the Cypher. This systematic review tries to provide a concise and critical appraisal of the data in support of the Xience V everolimus-eluting stent.     

Drug-Eluting Stents in the Management of Coronary Artery Disease

Of the >1 million patients who undergo coronary intervention in the US annually, 10–45% develop stent restenosis. Designed to inhibit tissue growth following coronary intervention, the drug-eluting stent (DES) is a breakthrough technology that has been shown to reduce restenosis by 80%, dramatically lowering the percentage of patients requiring repeat intervention. The health-economic implications of DES are complex and depend on the perspective from which they are viewed (i.e. hospital, payor, or physician). For hospitals, DES are a truly disruptive technology. Hospitals are caught between substantially higher costs (DES cost 3-fold more than bare-metal stents), inadequate reimbursement for those higher costs, and potentially declining revenue (fewer bypasses and repeat interventions for restenosis). In contrast, DES appear to be very cost effective for payors. Randomized studies have suggested that the higher initial costs of DES are nearly offset by reduced follow-up costs related to fewer repeat angioplasties and bypass surgeries. Furthermore, overall cost reductions to payors will occur as patients are converted from bypass surgery to multi-vessel coronary intervention with DES. Their high price continues to be a barrier to the use of DES, while the concerns about safety and stent thrombosis have substantially diminished. With greater competition, declining DES prices, and further studies demonstrating safety and efficacy in a wider range of real-world patients, DES will become the default platform for transcatheter coronary intervention in the near future.     

Developments in coronary artery stenting: primum non nocere

The occurrence of restenosis and acute vessel closure postballoon angioplasty was the driving force for the introduction of coronary artery stenting in the 1980s. Although the first generation of coronary artery stents were highly valuable and efficient in scaffolding (non-)threatened coronary vessels, they proved to be associated with iatrogenic side effects such as in-stent neointimal hyperplasia. The efforts to tackle these side-effects eventually lead to the most significant progress within the field of interventional cardiology in the past decennium, namely drug-eluting stents (DES). Analysts estimate that the total amount of DES implantations worldwide will be more than 5 million this year. Although this worldwide increase in percutaneous coronary interventions (PCI) is impressive, some pitfalls such as the incidence of neointimal hyperplasia, stent fracture and a local hypersensitivity reaction against the polymer coating are worrisome. According to critics, the possible causal relationship with higher rates of very-late stent thrombosis could be a ticking time bomb. These concerns paved the way for the development of novel stents, ranging from DES with biodegradable polymer coating to completely biodegradable stents. Like all progress in medical interventions, it is essential to not harm the patient throughout this complex evolvement process of coronary stents. The current review not only discusses the benefits and safety issues associated with currently utilized coronary stents but in particular highlights novel coronary stents that are being investigated in (pre-)clinical trials at this moment.     

介入器械的普及应用推动了冠脉介入治疗的发展

近年来,中国心脑血管疾病患病率逐年提高,急剧增长的心脏病患者刺激了中国心脏介入手术和冠脉支架需求的快速增长,PCI手术、冠脉支架(药物洗脱支架)植入数量也大幅增加.本文主要针对心血管介入治疗器械的应用及其技术指标进行论述,并对该领域内主要器械的技术发展趋势进行了展望.     

预防再狭窄的冠状动脉支架的研究进展

针对冠状动脉支架植入后的再狭窄问题．分析得出血管损伤、血流动力学形态的变化和血管壁面剪应力的下降或振荡而引起的内膜增生和血栓形成是再狭窄的主要成因。文中对显著影响再狭窄的材料的生物相容性、支架表面处理．支架结构设计和血流动力学分析等关键技术进行了综述,重点从体内实验、体外实验和计算流体动力学（CFD）等方面介绍了支架植入后血流动力学情况的研究现状。最后描述了作者所在实验室提出的定量研究支架血管耦合系统力学行为的CFD模型和实验方法。