RESEARCH注册研究：完全闭塞病变置入雷帕霉素洗脱支架后3年临床效果观察

目前，对于完全闭塞病变（CTO）置入药物洗脱支架（DES）后的疗效是介入医生关注的重点，有研究显示，DES能够显著降低CTO患者6个月靶血管血运重建率和支架内再狭窄的发生。但是，CTO置入DES的长期疗效尚不明确。     

药物涂层支架术后防治血管再狭窄的临床研究进展

经皮冠状动脉(简称冠脉)血运重建术(percutaneousecoronary interangioplasty,PCI)现已成为冠脉血运重建的主要方法。但是,由于术中机械损伤和支架本身的致栓性和血管内膜增生,血管再狭窄成为影响其疗效的最主要因素。药物涂层支架(drug eluting stents,DES)以支架为载体携带药     

生物可降解血管内支架：希望和挑战

生物可降解血管内支架（BDS）具有较好的生物相容性和可吸收性，能在短期内支撑血管，达到血运重建的目的。由于完成使命后可在体内降解，生物可降解支架可以避免金属永久支架引起的并发症。目前的研制主要包括可降解聚合物材料、金属镁和铁。上世纪80年代BDS已经进入临床且取得了一定的效果，它使血管成形术向前跨进了一步。目前的生物可降解血管内支架存在着一些缺陷，需要进一步改进和验证。     

冠状动脉生物可降解支架的研究现状

【】随着老年化的进展,冠心病成为威胁人类生命的重要杀手。随着血管介入的不断发展,冠心病的诊治水平达到新的突破。但是金属裸支架长期存留会导致血管内再狭窄的发生。生物可降解支架的出现是必然的趋势,本文通过概述生物可降解支架的目前临床试验、发展历程,指出当前各种支架所面临的问题,并对其未来进行展望。     

药物涂层支架在冠心病治疗中的应用

近年来，随着人们生活水平的提高及生活方式的改变，患冠心病的人越来越多，且发病年龄呈下降趋势，冠心病已成为心脑血管疾病中的高发病。目前冠心病的治疗方式主要有内科介入治疗（PCI）、外科冠状动脉血管移植手术（CABG，即冠脉搭桥手术）以及内科药物治疗。而冠状动脉内支架置入术已成为冠心病介入治疗最主要的手段和方式，约80％的接受介入治疗的患者置入了支架。支架置入术开始用于临床时主要用在做冠状动脉球囊扩张时并发血管夹层、急性闭塞或濒临闭塞等情况，紧急置入支架以保持血流畅通，避免急诊外科手术及急性心肌梗死的发生。     

可卡因可增加经皮冠状动脉介入术后支架内血栓的风险

美国学者McKee等对71例可卡因成瘾患者行经皮冠状动脉介入术（PCI）后9个月的心血管事件进行观察，发现支架内血栓发生率为7．6％，而正常对照组为0．6％（P〈0.001），心肌梗死、猝死或再次血管血运重建差别无统计学意义。因此作者认为，可卡因增加了支架内血栓形成的几率。     

抗血小板与抗凝药物在冠状动脉内支架植入术后的应用

由冠状动脉阻塞所致的缺血性心脏病在临床上较为常见,经皮冠状动脉腔内成形术（ＰＴＣＡ）是冠心病的主要治疗手段之一。冠状动脉内支架植入术是在ＰＴＣＡ基础上发展起来的介入技术,其应用在很大程度上提高了介入技术对于血管病变的临床价值。但坎是ＰＴＣＡ还是冠脉内支架植入术均面临着急性血管闭塞和再狭窄的难题,特别是冠状动脉内支架植入术显著激活血小板而增加了亚急性支架血栓形成的风险。目前,主要预防措施是应用抗血小     

支架内再狭窄的治疗

1969年 ,ＣｈａｒｌｅｓＤｏｔｔｅｒ报道了在犬动脉中植入弹簧线圈状支架的实验结果 ,第一次提出了血管内修复的观点 ,今天支架置入技术已经成为冠状动脉血运重建的主要手段。最初 ,支架仅获准用于球囊扩张术后急性血管闭塞的预防与治疗 ,但是完成于 1994年的Ｂｅｎｅｓｔｅｎｔ及ＳＴＲＥＳＳ研究证明支架可以改善手术近期疗效 ,降低再狭窄的发生率[1,2 ] 。同时 ,随着新一代抗血栓药物和无鞘支架的问世 ,以及介入技术的改良 ,使得支架使用量呈指数性增长。但是支架并未“治愈”再狭窄 ,还导致一个新的问题的出现 支架内再狭窄(Ｉｎ …     

FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架成功置入后长期临床结果观察:单中心、大规模注册研究

目的:比较成功置入FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架后长期临床观察结果。方法:本研究入选了2004-04至2006-10期间,在我院择期置入FIREBIRD雷帕霉素洗脱支架与TAXUS紫杉醇洗脱支架共计3 110例患者,并按置入支架的种类分为FIREBIRD组(2 274例)和TAXUS组(836例)。临床随访资料包括术后30天、1年和2年的死亡、心肌梗死、支架内血栓形成、靶病变血运重建、靶血管血运重建和主要心脏不良事件。本研究通过COX比例风险模型比较了倾向性评分匹配前后两组间的2年临床随访结果。结果:两组倾向性评分匹配前COX比例风险模型分析显示FIREBIRD组靶病变血运重建(风险比0.381,95%可信区间0.262～0.541)、靶血管血运重建(风险比0.512,95%可信区间0.383～0.681)以及主要心脏不良事件(风险比0.527,95%可信区间0.410～0.677)的风险低于TAXUS组。经过倾向性评分匹配后COX比例风险模型分析仍显示FIREBIRD组靶病变血运重建(风险比0.330,95%可信区间0.188～0.578)、靶血管血运重建(风险比0.412,95%可信区间0.263～0.643)以及主要心脏不良事件(风险比0.476,95%可信区间0.332～0.681)的风险低于TAXUS组。结论:与TAXUS紫杉醇洗脱支架相比,置入FIREBIRD雷帕霉素洗脱支架可降低靶病变血运重建、靶血管血运重建及主要心脏不良事件发生的风险。     

成功置入FIREBIRD支架和CYPHER支架远期临床疗效比较:单中心注册研究分析结果

背景:近年来的数据显示,西罗莫司洗脱支架(SES)不仅可以减少再狭窄的发生率,同时也能减少靶血管血运重建率。CYPHER支架和FIREBIRD支架是目前中国使用最广泛的SES。然而,目前尚缺乏比较国人使用CYPHER支架和FIREBIRD支架远期有效性和安全性的数据资料。方法:自2004-04至2006-06我院共3 979例成功植入SES的患者入选本注册研究。入选患者根据支架类型分为FIREBIRD组2 274例,CYPHER组1 705例。随访指标包括术后24个月死亡、心肌梗死、血栓形成、靶病变血运重建、靶血管血运重建和主要心脏不良事件(死亡、心肌梗死和靶血管血运重建的复合终点)。采用Cox’s比例风险模型评估两组倾向性评分匹配后所有终点的相对风险。结果:经倾向性匹配后,术后24个月两组所有临床事件的发生率差异均无统计学意义(P>0.05)。两组间各终点发生的风险差异均无统计学意义(P>0.05)。两组间学术研究联合会(ARC)定义的所有血栓形成发生率均相似(P>0.05)。结论:使用国产FIREBIRD支架与进口CYPHER支架相比具有相同的有效性和安全性。     

The use of intra-coronary optical coherence tomography for the assessment of sirolimus-eluting stent fracture

Drug-eluting stents (DES) have made a tremendous impact on the practice of percutaneous coronary intervention. Recently however, long-term DES failures have become a focal point, particularly with restenosis and thrombosis. An uncommon, yet important cause of DES failure is stent fracture. Of the two established first generation DES, the sirolimus-eluting stent (SES) has been particularly linked to cases of stent fracture, likely as a result of its closed cell design compared with other DES employing an open cell system. We present 2 cases of SES fracture confirmed using high-resolution intravascular optical coherence tomography giving unique insights into the in-vivo appearance of this complication.     

Vascular responses to drug eluting stents: importance of delayed healing

Polymer-based sirolimus- (Cypher) and paclitaxel-eluting (Taxus) drug eluting stents have become the treatment of choice for patients with symptomatic coronary artery disease undergoing percutaneous coronary intervention (PCI). Although these stents reduce rates of restenosis compared with bare metal stents (BMS), late thrombosis, a life threatening complication, has emerged as a major safety concern. Our understanding of the pathophysiology of late DES thrombosis is derived from animal and human pathologic samples taken after implantation of these devices. These data indicate that both DES cause substantial impairment in arterial healing characterized by lack of complete reendothelialization and persistence of fibrin when compared with BMS. This delayed healing is the primary substrate underlying all cases of late DES thrombosis at autopsy. Several additional risk factors for late stent thrombosis such as penetration of necrotic core, malapposition, overlapping stent placement, excessive stent length, and bifurcation lesions represent additional barriers to healing and should be avoided if DES are to be used to minimize the risk of late thrombosis. Because the time course of complete healing with DES in man is unknown, the optimal duration of antiplatelet treatment remains to be determined.     

药物涂层支架在复杂冠脉病变中的临床应用

复杂冠脉病变是冠心病介入治疗中的难点及热点,近年来的研究及临床实践表明,药物涂层支架在其中的临床应用取得了令人鼓舞的成绩,但也暴露出了许多问题。现主要针对药物涂层支架在复杂冠脉病变中应用的一些研究结果作一综述。     

The Effects of Novel,Bioresorbable Scaffolds on Coronary Vascular Pathophysiology

Percutaneous coronary intervention (PCI) has rapidly evolved over the past 30 years as technology has sought to improve clinical outcomes by addressing pathophysiologic complications arising from the intervention. Stents were designed to resolve the drawbacks of balloon angioplasty by providing radial support to prevent vessel recoil, by sealing coronary dissections, and by preventing abrupt vessel closure. The conceptualization of an ideal drug-eluting fully bioresorbable scaffold (BRS), whether metallic or polymeric, would theoretically address the adverse aspects of permanent metallic stents. In this review of the literature, we will discuss the impact these novel fully BRS platforms have on vascular pathophysiology following PCI.     

Bioresorbable vascular scaffolds for the treatment of coronary artery disease: Clinical outcomes from randomized controlled trials

The permanent metal prosthesis common to bare metal stents (BMS) as well as both first‐ and second‐generation drug‐eluting stents (DES) following treatment of coronary artery disease represents a long‐lasting substrate for late adverse coronary events including restenosis, thrombosis, and neoatherosclerosis. Following resorbtion, bioresorbable scaffolds (BRS) may eliminate this nidus and improve late outcomes through restoration of the vessel to more normal vascular structure and function. BRS represents a single platform which incorporates the mechanical features of metallic stents to provide safe and effective revascularization, suppression of restenosis and prevention of constrictive remodeling with long‐term restoration of the treated vessel to a more natural state. The landscape of BRS is rapidly evolving with new materials which target various performance goals for the duration of vascular support and polymer resorption time. The Absorb bioresorbable vascular scaffold (Absorb BVS), recently approved by United States Food and Drug Administration, has extensive clinical evidence to date in support of its clinical efficacy and safety. Recently published data from well‐executed randomized clinical trials (RCTs) as part of the ABSORB Clinical development program along with other investigator‐initiated trials provide insights into the safety and performance of this device in patients with de novo coronary lesions as well in the setting of ST‐segment elevation myocardial infarction (STEMI). This review provides a comprehensive, outcomes based understanding of the available evidence from RCTs that offer head‐to‐head comparisons of Absorb BVS with metallic everolimus‐eluting stents (EES). © 2016 Wiley Periodicals, Inc.     

The conversion in application of percutaneous coronary intervention following the introduction of drug eluting stents

In order to determine the changes in the pattern of techniques applied during elective coronary intervention, data from 688 patients prior to Sirolimus. Drug-Eluting Stents (DES) approval was compared to 438 patients who underwent coronary intervention after DES approval. There was increased intervention to higher risk lesions, including smaller vessels and re-stenotic lesions after DES approval. Total number of stents per patient significantly decreased, despite longer stent length per patient or per lesion after DES approval. No significant difference was found in multivessel interventions.     

Coexistent in-stent restenosis, late incomplete stent apposition and mural thrombus in a zotarolimus-eluting stent

Drug-eluting stents (DES) have been demonstrated to dramatically reduce the rate of in-stent restenosis (ISR). However, some studies found an increased rate of late incomplete stent apposition (ISA) and late stent thrombosis (ST) in DES compared to traditional bare-metal stents (BMS). Endeavor stent, a new cobalt-alloy DES coated with phosphorylcholine and zotarolimus, has been reported to have a very favorable safety profile with few documented late-acquired ISA and late ST. In the present report, we described an interesting case with coexistent ISR, late ISA and mural thrombus in an Endeavor zotarolimus-eluting stent 8 months after primary percutaneous coronary intervention.     

Revascularization of unprotected left main coronary artery disease with percutaneous coronary intervention: the role of drug-eluting stents

The percutaneous revascularization of left main coronary artery stenosis has until recently been reserved for patients at prohibitive surgical risk or for selected emergent cases. This adopted practice of coronary artery bypass grafting, as the standard of care for left main coronary artery stenosis, has largely occurred secondary to disappointing results with bare metal stents implanted in the left main coronary artery. However, in the current era of drug-eluting stents (DES) which significantly reduce restenosis compared to bare metal stents, there has been a renewed interest in examining the role of percutaneous coronary intervention as a means of revascularization of left main disease. This article discusses recent and ongoing studies investigating the role of percutaneous intervention of left main disease, with an emphasis on the use of DES for this purpose.     

Safety and efficacy of drug-eluting stents and bare metal stents in acute coronary syndrome

Compared with medical therapy, percutaneous coronary intervention has been shown to reduce the rates of death and recurrent ischemia in patients presenting with acute coronary syndromes (ACS). In the current interventional era, both drug-eluting stents (DES) and bare-metal stents (BMS) have been widely used, despite the fact that the use of DES in the context of ACS was initially an “off-label” indication and that ACS has been associated with stent thrombosis (ST). In contrast to the wealth of data available for the use of DES in patients with ST-elevation myocardial infarction, data regarding the performance of DES in non–ST-elevation ACS is restricted to a handful of registries with conflicting data. The aim of this review was to summarize the safety and efficacy of DES in the entire spectrum of ACS.     

Coronary rupture and pseudoaneurysm formation after extravascular migration of a paclitaxel eluting stent implanted in the left circumflex coronary artery

As the implantation of drug eluting stents (DES) has become one of the most common clinical practices in interventional cardiology, the complications secondary to this procedure appear to have emerged increasingly over the past decade, with many cases of development of new coronary artery true aneurysms after DES implantation being reported. Here we present a case of coil embolization of a coronary pseudoaneurysm which presumably formed after extravascular migration of a DES.