冠状动脉药物洗脱支架与支架内血栓

支架内血栓是冠状动脉支架术后少见但却严重危及生命的并发症。药物洗脱支架由于降低了再狭窄率而使冠状动脉粥样硬化性心脏病介入治疗领域发生了革命性的变化,但对其增加晚期血栓的顾虑成为目前关注的热点。支架内血栓的形成除了支架本身的致栓作用外,还与患者、病变及手术等因素相关。此外,过早中断双联抗血小板治疗、延迟再内皮化及晚期支架贴壁不良等均与支架内血栓密切相关。本文就支架内血栓的定义、发生机制及对策等进行综述。     

药物洗脱支架植入术后支架内血栓形成的临床分析

目的分析药物洗脱支架内血栓形成的临床相关因素及处理方法.方法选自2009年7月至2012年7月行经皮冠状动脉介入治疗(percutaneous coronary intervention,PC)I的703例冠心病(coronary heart disease,CHD)患者,记录发生药物洗脱支架内血栓形成患者的一般情况、冠脉病变特点、PCI治疗情况及抗血小板药物治疗情况,分析其支架内血栓形成的原因及血栓形成后的处理方法.结果 703例接受药物洗脱支架治疗的CHD患者中,有7例患者共发生了9例次(1.28%),10个靶病变在PCI治疗后20 h～7个月内发生了支架内血栓形成.结论支架内血栓形成可能与以下因素相关:有吸烟、高脂血症、高血压、高尿酸等冠心病高危因素者;多支架植入、支架贴壁不良、混用不同类型的支架、无高压后扩张、长病变、分叉病变等;抗栓治疗不充分等.另外,溶栓及急诊再次介人治疗是支架内血栓形成的有效治疗方法.     

极晚期药物洗脱支架贴壁不全研究进展

药物洗脱支架植入伴随着支架贝占壁不良.根据血管内超声支架贴壁不良分为消退型支架贴壁不良、持久性支架贴壁不良良晚期支架贴壁不良.晚期支架贴壁不良可能机制为血管正性重塑,其可能原因是血管壁炎性反应.形成晚期支架贴壁不良的相关危险因素是药物洗脱支架、长病变、慢性闭塞病变、急性心肌梗死等.约物涂层支架贴壁不良患者血栓事件发生率明显高于无支架贴壁不良患者.如果发现支架贴壁不良应长期口服双重抗血小板药物治疗.     

钴合金裸支架与雷帕霉素药物涂层支架在冠心病患者应用中的对比研究

目的比较冠状动脉内钴合金裸支架与雷帕霉素药物支架特点、临床应用的安全性和有效性,探讨钴合金裸支架治疗单支冠状动脉病变冠心病患者的安全性和临床疗效。方法分析经选择性冠状动脉造影(CAG)证实为单支病变血管直径狭窄>70%的冠心病患者204例,81例冠状动脉内置入钴合金裸支架;123例冠状动脉内置入雷帕霉素药物涂层支架,观察术后疗效、12个月内主要不良心脏事件(MACE)发生率及再狭窄率。结果两组手术成功率均为100%。两组患者置入支架的成功率、住院期间急性及亚急性血栓形成率及12个月随访MACE发生率、再狭窄率等差异无统计学意义。结论钴合金裸支架可以安全有效的应用于单支冠状动脉病变的治疗。     

冠状动脉支架内急性亚急性血栓形成的诊治体会

目的探讨冠状动脉支架内急性亚急性血栓形成的原因和处理方法。方法回顾性分析我院开展冠脉介入手术以来发生的诊断明确的冠脉支架内急性亚急性血栓形成的5例患者的病历资料。结果 9年间总共有928例患者行冠脉介入手术,共发生冠脉支架内急性亚急性血栓形成5例,发生率0.54%。冠脉支架内急性亚急性血栓形成与冠脉血管病变长,严重钙化病变,血管细小,支架膨胀不全,支架贴壁不良,支架未完全覆盖病变,支架重叠连接处未重整,术后未坚持应用双联抗血小板药物及抗血小板药物抵抗有关。冠脉支架内急性亚急性血栓形成对溶栓效果不佳,需急诊行PTCA、血栓抽吸导管开通相关血管,并强化抗凝抗血小板治疗。结论冠脉支架内急性、亚急性血栓形成与患者血管病变特点及介入操作等因素有关。再次急诊PTCA、血栓抽吸导管开通相关血管是治疗支架内血栓形成的首选方法。     

支架内再狭窄的危险因素及防治策略

经皮冠状动脉介入治疗是目前冠心病治疗的有效方法之一,而支架内再狭窄一定程度上影响了其临床疗效。支架内再狭窄的机制复杂、尚未明确,其预防及治疗是非常棘手的临床问题。支架内再狭窄的防治策略包括有效控制危险因素、药物治疗、球囊成形术及支架置入术。随着支架内再狭窄研究的深入、支架材料及工艺不断改进,生物可降解支架的问世使攻克支架内再狭窄这一难题成为可能。越来越多的人也认识到基因在支架内再狭窄发生中的重要作用。     

药物洗脱支架治疗冠状动脉支架内再狭窄的临床观察

目的观察药物洗脱支架治疗冠脉支架内再狭窄的临床疗效。方法对入选的患者行药物洗脱支架治疗,术后观察心脏不良反应事件的发生情况。结果 44例患者中发生不良反应事件22例,其中胸痛复发19例,TVR7例,ISR处原支架的类型是影响术后疗效的重要因素,本研究认为DES术后ISR的疗效好于BMS术后ISR（P=0.002）。而患者的年龄、性别、病变血管的直径和病变部位、病变的严重程度以及DES涂层材料的不同与治疗效果无明显的相关性。结论药物洗脱支架是治疗冠状动脉支架内再狭窄的有效手段。     

药物涂层支架内的血栓形成

支架内再狭窄的发生,对经皮冠状动脉成形术(PCI)的预后有显著的影响。经研究证明,糖尿病、冠脉直径、冠脉病变长度和部位等都是影响植入金属裸支架(BMS)后发生支架内再狭窄的相关因素[1]。至于支架内血栓形成的发生率,近来已引起临床医师越来越多的重视,特别是药物涂层支架引起的晚期支架内血栓形成[2]。经过对金属裸支架、西罗莫司涂层支架、聚合物的材料的紫杉醇药物涂层支架的对比研究,发现植入药物涂层支架(DES)患者有较高的晚期支架内血栓形成发生率[3]。关于晚期支架内血栓形成的定义,目前还没有统一的规定。一般认为支架植入后至…     

药物洗脱支架治疗冠状动脉支架内再狭窄的临床观察

目的观察药物洗脱支架治疗冠脉支架内再狭窄的临床疗效。方法对入选的患者行药物洗脱支架治疗,术后观察心脏不良反应事件的发生情况。结果 44例患者中发生不良反应事件22例,其中胸痛复发19例,TVR7例,ISR处原支架的类型是影响术后疗效的重要因素,本研究认为DES术后ISR的疗效好于BMS术后ISR(P=0.002)。而患者的年龄、性别、病变血管的直径和病变部位、病变的严重程度以及DES涂层材料的不同与治疗效果无明显的相关性。结论药物洗脱支架是治疗冠状动脉支架内再狭窄的有效手段。     

药物洗脱支架对糖尿病合并冠状动脉支架内再狭窄的远期效果

目的观察药物洗脱支架治疗糖尿病合并冠状动脉支架内再狭窄的远期效果。方法选取2015年6月至2017年5月西峡县人民医院收治的187例冠状动脉支架内再狭窄患者,其中合并糖尿病的75例作为观察组,未合并糖尿病的112例作为对照组。所有入选患者均接受药物洗脱支架治疗。对比两组冠脉病变情况、支架置入情况、手术成功率、1 a内再次血运重建率及治疗前后炎症因子水平。结果两组手术成功率均为100%;两组冠脉病变数、支架置入数、1年内再次血运重建率比较,差异无统计学意义(均P>0.05)。两组治疗后hs-CRP、IL-6和TNF-ɑ水平均较治疗前降低(均P<0.05),组间差异无统计学意义(均P>0.05)。结论药物洗脱支架治疗糖尿病并冠状动脉支架内再狭窄安全有效,值得临床推广。     

A case of stent thrombosis occurred at 5 years after sirolimus-eluting stent implantation

Drug-eluting stents (DES) have reduced the rate of repeated revascularization of target lesions. For this reason, DES are considered to be superior to bare-metal stents in reducing the restenosis rate. However, some problems have been reported after implantation of DES. One of them, stent thrombosis, has arisen as a fatal complication. Dual antiplatelet therapy is recommended for at least 12 months after implantation of DES to prevent stent thrombosis. Here, we report a case of very late stent thrombosis that occurred 1 week after discontinuation of clopidogrel at 5 years (1832 days) after implantation of a sirolimus-eluting stent.     

Drug-eluting coronary stents--a note of caution

There are two types of coronary stents: bare-metal stents (BMS) that cost about $800 each, and drug-eluting stents (DES) that cost about $3,300 each. DES reduce the rate of restenosis but have a higher incidence of late stent thrombosis, particularly if dual antiplatelet therapy with aspirin and clopidogrel is interrupted. Stent thrombosis has a myocardial infarction rate of 70% and a mortality rate of 31%-45%. Randomised studies of BMS versus DES show no increase in myocardial infarction or death with DES in simple coronary lesions, but in clinical practice, DES are mainly used in complex coronary disease where the rate of stent thrombosis is higher. Registry data suggest an increased rate of death and myocardial infarction of 0.5%-1.0% per annum with DES. Clinicians need to be aware of the risks associated with prematurely ceasing dual antiplatelet therapy in patients with DES.     

Meta-analysis of stent thrombosis after drug-eluting stent implantation: 4-year follow-up

Background Drug-eluting stents （DES） are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents （BMS）. The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios （OR） were calculated for each outcome and presented with 95% confidence intervals （CI）.Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS （late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91）.Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.     

Local aneurysmal dilatation mimicking stent malapposition and concurrent vulnerable plaque within neointima of normal lumen after drug-eluting stent implantation: primary new findings from optical coherence tomography

Very late stent thrombosis is a life-threatening complication of implantation of drug-eluting stent (DES). The mechanisms are still unidentified. Stent malapposition is supposed to be one debated reason. Here we report a case of 33 months after DES implanted. Observed by optical coherence tomography, we detected a lipid-rich plaque with defective fibrous cap within the neointima and many local aneurysmal dilatations between stent struts, which mimic “malapposition” on the angiogram. These indicated that vulnerable plaque hidden in the neointima at the stent segment might be a potential mechanism of very late stent thrombosis after DES implantation.

     

Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease

Background Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents （DES） implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease （CAD） in China.
Methods From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up： 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird, After two years of follow-up, there were 2176 patients （1245 Cypher, 558 Taxus and 373 Firebird）. All patients were treated with aspirin and clopidogrel over at least 9 months.
Results Among 8190 patients, 17 patients had acute stent thrombosis （0.24%）： 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis： 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%： 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%： 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%： 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.
Conclusion The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.     

壳聚糖/肝素西罗莫司药物洗脱支架对猪冠状动脉血栓形成及早期快速内皮化的作用

目的 将壳聚糖/肝素涂层膜应用于西罗莫司药物洗脱支架(DES),明确壳聚糖/肝素西罗莫司DES对猪冠状动脉血栓形成及早期快速内皮化的作用。 方法 将壳聚糖/肝素层层自组装涂层膜应用于西罗莫司DES,并采用非对称涂抹方式使支架血液面为壳聚糖/肝素涂层,而支架血管壁面为聚乳酸(PLA)-西罗莫司。实验分为裸金属支架(BMS)组、壳聚糖/肝素支架组、西罗莫司DES组和壳聚糖/肝素西罗莫司DES组,采用动静脉分流模型和高负荷血栓模型验证壳聚糖/肝素西罗莫司DES的抗血栓作用;采用为期1周的猪冠状动脉球囊损伤动物实验观察壳聚糖/肝素西罗莫司DES对早期内皮化的作用。 结果 在动静脉分流模型中,壳聚糖/肝素西罗莫司DES和壳聚糖/肝素支架表面未形成血栓,而BMS和西罗莫司DES表面覆满血栓;在高负荷血栓模型中,壳聚糖/肝素西罗莫司DES和壳聚糖/肝素支架在6 h内未出现支架内血栓,而BMS和西罗莫司DES分别在(59.0±8.5) min和(67.0±7.8) min时出现支架血栓,差异有统计学意义(P<0.01)。在猪冠状动脉球囊损伤动物模型中,壳聚糖/肝素西罗莫司DES和壳聚糖/肝素支架置入7 d后内皮覆盖率分别为(82.7±16.4)%和(80.7±14.1)%,高于 BMS和西罗莫司DES\[分别为(64.3±11.0)%和(59.8±8.4)%,P<0.01\]。 结论 壳聚糖/肝素涂层西罗莫司DES具有较好的抗血栓作用,且能够在早期促进支架内皮化。     

Drug-eluting stent: where is the way out?

Since the first Palmaz-Schatz bare-metal stent (BMS)was implanted in human body in 1985,coronary stenting successfully resolved problem of the high restenosis rate in balloon dilatation era and soon became the primary means of clinical treatment of coronary artery disease.In order to meet the requirement of further reduction of the restenosis rate,drug-eluting stent (DES)was developed more than a decade later.With the excellent clinical efficacy,DESs established a milestone in the field of percutaneous coronary intervention (PCI).However,since the "stent thrombosis (ST) storm"triggered in 2006,the late ST after DES implantation quickly became a challenging problem.1.2 To solve this problem,a lot of advances have been achieved.Among them,biodegradable polymers and abluminal coating are two new technologies with bright future.     

支架内血栓形成的相关因素和预防策略

目前,冠状动脉内支架植入术是冠心病血运重建的主要方法,支架植入可显著减少靶血管的急性闭塞和再狭窄。虽然支架术后支架内血栓形成少见,但危害极大,临床上可表现为急性心肌梗死或猝死。在药物洗脱支架广泛使用的今天,支架内血栓形成引起了业内人士的高度警惕和重视。现就冠状动脉支架内血栓形成的相关因素及预防策略进行综述。     

药物洗脱支架与金属裸支架置入术后对糖尿病患者远期死亡、心肌梗死和支架血栓发生情况的影响

目的本研究通过比较糖尿病患者置入金属裸支架(bare metal stents,BMS)vs药物洗脱支架(drug eluting stents,DES)后发生死亡、心肌梗死(myocardial infarction,MI)、再次血运重建和支架血栓的情况,以评价糖尿病患者置入DES后的远期安全性和有效性。方法本研究于2003年7月～2005年12月连续入选了834例因冠心病合并糖尿病在首都医科大学附属北京安贞医院心内科行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者,按置入支架类型将患者分为DES组(n=583)和BMS组(n=251)。主要终点事件为24个月时全因病死率;次要终点事件为24个月时非致死性MI、再次血运重建以及主要不良心血管事件(major adverse cardiac events,MACE)的发生率。结果本研究结果经多因素回归分析显示,DES组明显降低了24个月时死亡[3.2%vs 5.1%,危险比(hazard ratio,HR)0.34,95%可信区间(confidential interval,CI)0.12～0.94,P=0.038]和心性死亡的风险(2.2%vs 4.4%,HR=0.29,95%CI:0.13～0.87,P=0.027),非致死性MI和心性死亡与非致死性MI复合终点发生风险比较差异无统计学意义;明确和可能的支架血栓的发生风险比较差异也没有统计学意义(1.9%vs 2.0%,HR=0.96,95%CI:0.51～2.17,P=0.351)。DES明显降低了再次血运重建的风险(10.5%vs 20.7%,HR=0.24,95%CI:0.11～0.78,P<0.001)和靶血管再次血运重建的风险(8.9%vs 17.1%,HR=0.33,95%CI:0.16～0.87,P<0.001);与BMS组比较DES组的MACE的风险也明显降低,差异有统计学意义(15.8%vs 27.9%,HR=0.19,95%CI:0.09～0.85,P<0.001);其主要与DES组患者的死亡和靶血管再次血运重建的风险降低有关。结论与BMS相比,DES可显著降低糖尿病患者的24个月时死亡、再次血运重建和MACE的风险,而未增加非致死性MI和支架血栓的风险。置入DES后死亡风险的降低原因,主要与DES降低再狭窄后的死亡和MI风险,获得更高的完全血运重建率以及未增加支架血栓的风险相关。