雷帕霉素洗脱支架治疗多支冠状动脉病变的临床研究

为探讨多支冠状动脉病变患者置入雷帕霉素洗脱支架（Cypher支架）预防再狭窄的疗效及安全性，选择2002年1月-2004年12月连续725例接受多支冠状动脉支架置入的冠心病患者，剔除急性心肌梗死及再次血运重建患者，Cypher支架组187例，普通金属支架（简称普通支架）组538例，比较两组近期及远期结果。结果表明，除糖尿病患者比例在Cypher支架组较高外，两组患者冠心病危险因素、心功能、冠状动脉病变严重程度、介人手术成功率及并发症发生率均无显著差异。690例患者平均随访（18．8&;#177;14．7）个月，Cypher支架组和普通支架组造影随访率分别为52．4％和58．2％（P〉0．05）。尽管Cypher支架组不稳定性心绞痛占2／3、糖尿病占41．6％、3支血管病变占57．8％、B2-C型复杂病变占86．2％，但造影复查再狭窄率和主要不良心脏事件（MACE）发生率均明显低于普通支架组（3．1％比16．6％，5．5％比16．7％，P均〈0．01），心功能改善率高于普通支架组（63．1％比30．6％，P〈0．01）。两组完全血运重建率无显著差异（81．3％比86．8％，P〉0．05），但发生MACE的患者中，Cypher支架组不完全血运重建者比例高于普通支架组（60％比23．5％，P〈0．05）；两组发生MACE的患者中完全血运重建患者比例均低于本组总的完全血运重建率（Cypher支架组40％比81．3％，P〈0．01；普通支架组76．5％比86．8％，P〈0．05）。结论：高危、复杂、多支冠状动脉病变患者置入Cypher支架成功率高，并发症少，再狭窄率低，远期临床疗效良好；病变血管完全血运重建者获益更大。     

火鸟Firebird支架与强生Cypher支架近期效果的临床观察

目的对比国产雷帕霉素药物洗脱支架（Firebird）与进口雷帕霉素药物洗脱支架（Cypher）的安全性及近期疗效。方法选择急性心肌梗死患者136例,分Firebird组78例和Cypher组58例,均按Judkin法行冠状动脉造影后常规经皮冠脉介入治疗置入支架,记录术后6个月随访情况,对比近期临床疗效。结果显示两组患者均无再次血运重建,无再发心梗及主要不良心血管事件发生。两组随访患者中各出现1例支架内再狭窄发生率分别为1．9％和1．4％（P〉0．05）,Firebird支架内缺血性胸前发作1例,Cypher支架组缺性性胸痛发作2例（P〉0．05）两组安全性及近期疗效相似。结论国产Firebird雷帕霉素洗脱支架具有卓越的安全性和良好的近期疗效;Firebird雷帕霉素药物洗脱支架与Cypher雷帕霉素药物洗脱支架的临床近期疗效相似。     

国产西罗莫司洗脱冠状动脉内支架临床疗效研究

目的 观察国产西罗莫司洗脱冠状动脉内支架的临床疗效以及6个月临床随访结果,并评估其安全性和有效性.方法 我院2004年9月至2007年3月,共计226例经冠脉造影证实的冠心病患者接受药物洗脱支架治疗,其中接受国产西罗莫司洗脱支架(EXCEL,山东吉威公司)组120例, 进口西罗莫司洗脱支架(Cypher,美国强生公司)组106例.2组基础情况及冠脉造影特征差异均无统计学意义(P＞0.05).结果 术后6个月随访主要心脏不良事件(MACE,包括心源性死亡、非致命性心肌梗死和靶血管再次血运重建)发生率:EXCEL组9.5%;Cypher组8.7%.再狭窄发生率:EXCEL组10.9%;Cypher组10.0%.2组比较,差异无统计学意义(P＞0.05).2组平均住院费用,EXCEL组明显低于Cypher组.结论 EXCEL治疗冠心病安全有效经济,其6个月临床疗效与Cypher相似.     

雷帕霉素与紫杉醇洗脱支架术治疗多支病变冠心病的疗效比较

为比较雷帕霉素洗脱支架(Cypher)与紫杉醇洗脱支架(TAXUS)治疗多支冠状动脉病变患者的疗效及安全性,选择多支病变冠心病416例,剔除合并左主干病变、急性心肌梗死、再次血管重建及合用普通支架者,随机分为两组:Cypher支架组210例,TAXUS支架组206例,支架置入前两组冠心病危险因素、心功能状况及冠状动脉病变特征无统计学差异,比较两组支架术后近期及远期结果。结果表明两组PCI手术成功率、平均支架置入数(3.24±1.25比3.19±1.38枚/例)及并发症发生率均无统计学差异,术后平均随访(19.5±8.9)个月,两组总随访率、心绞痛复发率、造影复查再狭窄率、主要不良心脏事件发生率、心功能改善率及无事件存活率均无统计学差异。与Cypher支架组比较,TAXUS支架组术后亚急性血栓发生率有增高趋势,但无统计学意义(1.0%比0.5%,P>0.05)。用QCA测量术后6~9个月冠状动脉造影结果,支架内最小管腔直径(MLD),节段内MLD、支架内晚期管腔丢失及节段内晚期管腔丢失两组间比较均无统计学差异。结论:多支冠状动脉病变患者置入Cypher和TAXUS两种药物洗脱支架均能达到成功率高、再狭窄率低、远期临床疗效好的结果,两者疗效及安全性无统计学差异。     

冠状动脉介入治疗应用国产药物洗脱支架术后近期疗效观察

目的对比国产雷帕霉素药物洗脱支架（Firebird）与进口雷帕霉索药物洗脱支架（Cypher）的安全性及近期疗效。方法选择本院2009年10月～2011年12月收治的急性心肌梗死患者140例,分为国产组70例和进口组70例,均在冠状动脉造影后,行经皮冠状动脉介入置入支架治疗,术后随访1年,对比两组近期疗效。结果两组患者均无再发心肌梗死及不良心血管事件发生。两组各发生1例支架内再狭窄。发生率均为1．4％,组间差异无统计学意义（P〉0．05）;国产组与进口组支架内缺血性胸痛发作例数分别为1、2例,两组差异无统计学意义（P〉0．05）。结论国产与进口药物洗脱支架在急性心肌梗死的择期介入治疗中的近期应用效果相似,值得推广。     

雷帕霉素药物洗脱支架在STEMI合并糖尿病患者急诊PCI中的应用

目的 探讨雷帕霉素药物洗脱支架在急性ST段抬高型心肌梗死（STEMI）合并糖尿病患者急诊经皮冠状动脉介入（PCI）中应用的安全性与有效性.方法 选取本院2010年7月～2013年7月收治的STEMI合并2型糖尿病行雷帕霉素药物洗脱支架置入术患者（79例）作为试验组,选取同期收治的STEMI合并2型糖尿病行金属裸支架置入术患者（43例）作为对照组,对比两组患者术后12个月不良心血管事件发生率及术后即刻、24 h、48 h、72 h血小板聚集情况.结果 试验组患者术后12个月死亡、再梗死、再次靶血管重建等主要不良心血管事件发生率均明显低于对照组,差异有统计学意义（P＜0.05）.两组患者术前即刻、术后即刻及术后24 h血小板聚集情况差异无统计学意义（P＞0.05）,试验组患者术后48、72 h血小板聚集情况明显优于对照组,差异有统计学意义（P＜0.05）.两组患者术后24 h、术后1个月等近期再狭窄发生率差异无统计学意义（P＞0.05）,试验组患者术后6、12个月再狭窄发生率（8.86％、11.39％）明显低于对照组（25.58％、32.56％）,差异有统计学意义（P＜0.05）.结论 STEMI合并糖尿病患者行急诊PCI术后置入支架能在一定程度上改善心肌再灌注情况,且雷帕霉素药物洗脱支架相较于金属裸支架具有更好的远期疗效,其远期不良心血管事件发生率明显偏低,心肌组织水平再灌注情况优势明显,有助于改善患者术后的生活水平.     

药物洗脱支架联用普通金属支架治疗多支冠状动脉病变的疗效评价

为探讨多支冠状动脉病变药物洗脱支架（DES）与普通金属支架（普通支架）联用预防再狭窄的疗效及安全性，对我院2002年6月～2004年12月连续801例行多支冠脉内支架置人术达到完全血运重建的冠心病患者分为3组：DES组206例，DES与普通支架联用组（联用组）158例，及普通支架组437例。比较3组支架术后近期及远期结果。3组冠心病危险因素、心功能、冠状动脉病变程度、支架术成功率及并发症发生率均元显著差异。联用组普通支架置人于31．3％的前降支病变（均为A—B1型病变）及81．6％的左回旋支病变和69．9％的右冠状动脉病变。术后平均随访（17．3&;#177;13．9）个月，3组总随访率元显著差异。结果表明，与普通支架组相比，DES组和联用组造影再狭窄率明显降低，分别为21％比7．4％和9．0％（P均〈0．05），且主要不良心脏事件发生率均较低，分别为18．4％比6．5％和9．9％（P均〈0．05）。但DES组与联用组相比上述各指标元显著差异。结论：多支冠状动脉病变患者单用DES或合理联用普通支架后再狭窄降低，安全性近似，均优于单用普通支架。     

药物涂层支架在冠状动脉易再狭窄病变的应用价值

目的评估药物涂层支架（DES）对防治冠状动脉高危病变和糖尿病患者支架植入术后再狭窄的价值。方法126例接受雷帕霉素或紫杉醇DES植入术的冠心病患者为DES组,至少具备下列情况之一：糖尿病或糖耐量异常;前降支病变;小血管病变（直径≤2．5mm）;靶病变再狭窄。同期选择年龄、性别和狭窄程度等因素相匹配的146例行普通支架（BMS）术的冠心病患者为BMS组,比较两组住院和随访期间的心绞痛、非致死性心肌梗死、心源性死亡和靶病变血运重建（TLR）等主要心脏事件（MACE）。结果DES组合并糖尿病、左前降支植入支架数均明显高于BMS组（P〈0．01）;DES平均内径较BMS显著为小（P〈0．01）。MACE发生率DES组（6例,4．8％）显著低于BMS组（40例,27．4％）（P〈0．01）。结论DES能有效地降低冠状动脉高危病变和合并糖尿病患者冠状动脉支架内再狭窄率,进而减少MACE的发生率。     

04026 西罗莫司药物洗脱支架用于冠脉复杂病变的效果依然喜人

第17届经导管心血管治疗（TCT）年会上公布的两项研究结果进一步证明，西罗奠司（sirolimus）药物洗脱支架Cypher用于冠脉复杂病变的效果好。PRISON Ⅱ研究显示，与裸金属支架相比，西罗莫司药物洗脱支架可更有效预防慢性完全闭塞病变的支架内再狭窄。SISR研究显示，与放射治疗相比，西罗莫司药物洗脱支架用于裸金属支架支架内再狭窄的靶血管血运重建的失败率低。     

冠心病患者应用药物洗脱支架临床观察

目的 研究Excel药物洗脱支架治疗冠状动脉原发病变的临床疗效.方法 入选2004年9月2008年3月接受Excel药物洗脱支架治疗的冠心病患者692例.观察术后30 d和3、9及12个月主要心脏不良事件发生率,支架内再狭窄率和靶血管重建率.结果 与中国Cypher select注册研究比较,接受Excel支架治疗的患者和接受Cypher支架治疗的患者在术后12个月支架内再狭窄率(9.1%比9.6%,P>0.05)和主要心脏不良事件发生率(3.8%比6.5%,P>0.05)方面差异无统计学意义.结论 Excel西罗莫司洗脱支架和Cypher西罗莫司洗脱支架近期疗效相似.

Abstract：

Objective To study the effects of excel simlimus eluting stent on patients with coronary heart disease.Methods Totally 692 patients having excel stent therapy were enrolled in this study.Twelve months follow-up for major adverse cardiac events(MACE)rate,restenosis rate and target lesion revascularization rate was performed. Results Compared with Chinese Cypher Select Registry Study,patients having Excel stent therapy had no significant difference in 12 months restenosis rate(9.1%VS 9.6%,P>0.05)and 12 months MACE rate 13.8%vs 6.51%,P>0.05).Conclusion The efficacy and safety of excel sirolimus eluting stent is as good as Cypher eluting stent.     

老年冠心病冠脉支架内再狭窄相关因素调查

目的了解老年冠心病患者冠状动脉支架内再狭窄的发生情况。方法对冠脉造影资料较全的老年冠心病患者中89例患者,复查冠脉造影,观察其再狭窄情况,分析再狭窄相关因素包括年龄、性别、高血压、糖尿病、高血脂及冠脉病变特点、支架性质。结果多支病变占73．9％。89例复查冠脉造影,发现再狭窄率为23．5％;其中,裸支架组的再狭窄率35．2％明显高于药物洗脱支架组。狭窄与无狭窄患者的年龄和血脂水平差异无统计学意义,而并发糖尿病病例数量、支架长度以及支架数量,差异有统计学意义。结论患糖尿病、支架总长度、多个支架、支架性质为再狭窄的相关因素。     

冠状动脉旁路移植术后静脉移植血管内植入两代药物支架的临床结局比较

目的 比较冠状动脉旁路移植（CABG）术后患者静脉移植血管（SVG）病变内植入两代药物涂层支架（DES）的临床结局。方法 选取CABG术后因缺血症状行冠状动脉造影并在SVG内植入DES的患者共108例。其中第一代DES（涂层药物为西罗莫司）植入组69例，第二代DES（涂层药物为佐他莫司或依维莫司）植入组39例，对比2组患者介入治疗的效果和住院期间手术成功率及病死率。对比2组患者出院2年全因死亡、靶血管血运重建（TVR）和急性心肌梗死（AMI）等主要不良心脏事件（MACE）的发生情况。采用Kaplan-Meier法绘制生存曲线并比较2组患者无MACE生存率，并采用Cox回归分析SVG植入支架患者发生MACE的危险因素。结果 2组手术成功率、院内病死率差异无统计学意义。平均随访 2 年，共有 37 例发生 MACE，2 组 MACE 发生率差异无统计学意义（34.8% vs.33.3%，P＞0.05）。第二代组较第一代组TVR比例较低（2.6% vs. 13.0%，P＜0.05）。生存分析表明2组累积无MACE生存率差异无统计学意义（81.2% vs. 79.5%，Log-rank χ2=0.029，P＞0.05）。Cox 回归分析显示糖尿病（HR=2.530，95%CI：1.008～6.345，P=0.041）和支架直径（HR=1.143，95%CI：1.043～1.253，P=0.004）为 SVG 病变植入支架患者发生MACE的独立预测因子。结论 CABG后SVG内植入两代DES的院内病死率及2年随访MACE发生率相似，二代组TVR比例较低。合并糖尿病及植入大直径支架患者预后较差。     

再次置入药物洗脱支架治疗经皮冠状动脉支架置入术后早期与晚期支架内再狭窄的对比研究

目的 比较再次置入药物洗脱支架（DES）治疗置入DES后早期（≤1年）与晚期（＞1年）支架内再狭窄（ISR）患者的临床疗效.方法 收集2008年10月至2011年12月在北京安贞医院因DES置入术后ISR接受再次DES置人治疗并完成临床随访的患者资料.根据DES置入术后发生ISR的时间分为早期ISR组和晚期ISR组.对比2组随访期间的主要不良心血管事件（MACE）[包括全因死亡、心肌梗死和靶病变血运重建（TLR）].结果 总计107例患者入选本研究,其中早期ISR组43例,晚期ISR组64例.2组的患者基线资料、靶病变部位、类型、长度、置入支架特征及ISR类型、再次置入支架特征差异均无统计学意义（P＞0.05）.早期ISR组糖尿病患病率明显低于晚期ISR组[22.7％ （10/44）比42.9％ （27/63）,P＜0.01].晚期ISR组MACE发生率明显低于早期ISR组[15.9％ （10/63）比47.7％ （21/44）,P＜0.01];晚期ISR组TLR率明显低于早期ISR组[12.7％ （8/63））比43.2％ （19/44）,P＜0.01].Logistic回归分析显示,DES术后早期ISR（OR=6.47,95％ CI：2.26～18.50,P＜0.01）是DES治疗ISR后再次TLR的唯一预测因素.结论 再次DES置入治疗DES置入后ISR安全有效,但治疗早期ISR时TLR明显升高.     

血清胆红素水平与冠脉支架植入术后再狭窄的相关性研究

目的探讨冠状动脉(冠脉)内药物涂层支架植入术后支架内再狭窄与血清胆红素的相关性。方法对82例成功行经皮冠脉药物涂层支架植入术的患者术后再次行冠脉造影,以原病变冠脉直径狭窄程度≥50%为支架内再狭窄,按有无再狭窄分为再狭窄组16例和非再狭窄组66例。比较2组胆红素等临床血清学指标及临床资料,探讨血清胆红素是否与支架内再狭窄有关。结果再狭窄组总胆红素水平低于非再狭窄组,差异有统计学意义(P<0.05)。Logistic多因素回归分析显示空腹血糖、尿酸是再狭窄的危险因素,总胆红素是再狭窄的保护因素(P<0.05)。结论血清总胆红素与冠脉支架内再狭窄密切相关,高水平总胆红素可能降低冠脉支架内再狭窄的发生。     

Drug-eluting stents: present and future

In-stent restenosis (ISR) caused by neointimal hyperplasia is the major drawback after percutaneous coronary intervention (PCI) for obstructive coronary disease, occurring in up to 40% of lesions. Recently, one of the most intriguing new therapies developed is drug-eluting stents (DES) that target the central phenomenon of cellular proliferation that causes ISR. The benefits of stent-based drug delivery include maximizing the local tissue levels of therapeutic agents while minimizing systemic toxicity. Numerous DES using different thin-film polymeric drug carrier have been developed and tested, those eluting either antimitotic or antimicrotublar agents such as sirolimus and paclitaxel have been shown effective in clinical trials. Two DES, the J&J Cypher (sirolimus-eluting) and the Boston Scientific Taxus (paclitaxel-eluting) stents, are commercially available in the U.S. after a number of randomized trials demonstrated reductions in late lumen loss, binary restenosis rate, and need for repeat revascularization compared with bare-metal stents (BMS). Because ISR is multifactorial, ideal agents for DES should inhibit thrombus formation, inflammation and cellular proliferation as well as enhance re-endothelialization. The next generation of DES currently undergoing preclinical studies includes new technology, new stent designs and materials, biological polymers, bioabsorbable stents coated with new drugs including stent based gene, as well as cell delivery. The current paper will review and discuss the current and future status of DES.     

Sirolimus-eluting coronary stent.

PURPOSE: The mechanism of action and pharmacokinetics of sirolimus when used as part of a drug-eluting stent (DES) and the efficacy and cost of using DESs versus bare-metal stents are discussed. SUMMARY: The use of balloon angioplasty with or without coronary artery stenting is limited by the phenomenon of in-stent restenosis (ISR). Until very recently, most efforts to overcome ISR had been ineffective. The search to prevent or reduce the frequency of ISR has led to the recent development of novel coronary artery stents designed to deliver a drug that acts locally. The first DES was approved by FDA in April 2003. This stent releases sirolimus, an agent that inhibits vascular smooth-muscle-cell proliferation. To date, four major clinical trials have demonstrated the sirolimus-eluting stent to be safe and effective in preventing restenosis in de novo coronary artery lesions. CONCLUSION: The sirolimus-eluting coronary stent is associated with less ISR than non-drug-containing stents, but further investigation is needed to determine its exact place in the treatment of coronary artery occlusion.     

Do the benefits of new technology outweigh the costs?

Over the past decade, coronary stenting has been shown to reduce the rates of angiographic and clinical restenosis compared with conventional balloon angioplasty; however, the use of bare-metal stents remains limited by a high incidence of restenosis, leading to frequent repeat revascularization procedures and substantial economic burden. Antiproliferative drug-eluting stents have recently demonstrated dramatic reductions in in-stent restenosis compared with conventional bare-metal stenting; however, the high cost of drug-eluting stents has raised important questions about the clinical and economic benefits of this ‘disruptive technology’. Prospective economic evaluations conducted alongside two randomized clinical trials (SIRolImUS-eluting stent in de novo coronary lesions [SIRIUS] trial and the RAndomized study with the sirolimus-eluting VElocity? balloon-expandable stent in the treatment of patients with de novo native coronary artery Lesions [RAVEL]) comparing drug-eluting stents with conventional bare-metal stenting, as well as decision-analytic models, have examined the economic merit of using drug-eluting stents. Findings from these studies suggest that although the initial treatment costs with drug-eluting stents are substantially higher, much of the difference in initial costs could be offset by reductions in follow-up costs, mainly due to a reduced requirement for repeat revascularization procedures. Results from these studies show that the cost effectiveness of drug-eluting stents varies considerably with the underlying clinical and angiographic characteristics of the patient population. While drug-eluting stents should be reasonably cost effective for most patients who currently undergo percutaneous coronary intervention (and cost saving for a sizeable minority), for certain subgroups with very low expected clinical restenosis rates (e.g. 5–10%), the routine use of drug-eluting stents may be questioned, at least on economic grounds. In the future, lower incremental costs for drug-eluting stents should render this technology cost saving for a larger subgroup of patients with PCI, and broaden the ideal target population.     

Partner药物洗脱支架在急诊经皮冠状动脉介入治疗中的临床疗效

目的观察Partner药物洗脱支架在急诊经皮冠状动脉介入治疗(PCI)中的临床疗效。方法选择行急诊PCI的患者68例,分为Partner支架组和Cypher支架组,比较PCI术后即刻最小管腔直径,术后6个月复查冠状动脉造影,比较两组患者的再狭窄率。结果Partner支架组术后即刻最小管腔直径为(3.1±0.8)mm,Cypher支架组为(3.1±0.3)mm,两组相比差异无统计学意义(P>0.05);6个月冠状动脉造影显示再狭窄率Partner支架组为4%,Cypher支架组为3%,两组相比差异无统计学意义。结论在急诊PCI中,应用Partner药物洗脱支架安全有效。     

Comparison of Efficacy of Low- (80 mg/day) and High- (160–320 mg/day) Dose Valsartan in the Prevention of In-Stent Restenosis after Implantation of Bare-Metal Stents in Type B2/C Coronary Artery Lesions

BACKGROUND AND OBJECTIVE: Results from the VALVACE (VALsartan Versus ACE inhibition after bare metal stent implantation) trial suggest that prevention of in-stent restenosis after implantation of bare-metal stents in type B2/C coronary artery lesions is possible after administration of valsartan 80 mg/day. However, the restenosis rate in patients with stable angina was relatively high (27%) with this dosage and no different from patients taking ACE inhibitors. Therefore, a 1 : 1 matched comparison on a case-control basis was initiated in a prospective controlled registry using a higher dose of valsartan, 160-320 mg/day. METHODS: A total of 450 patients (241 men, mean age 62.7 +/- 9.1 years) with matched demographic and angiographic characteristics to patients in the VALVACE trial were treated with high-dose oral valsartan 160-320 mg/day over 6 months until control angiography. Angiographic restenosis rate, target lesion revascularization (TLR) and target vessel revascularization (TVR) rates, major adverse cardiac event (MACE) rate (death, myocardial infarction, and stent thrombosis) and mean late lumen loss were analysed after 6 months. Results were compared with the results of the VALVACE trial. Analysis of the combined results of the current study together with the VALVACE trial data enabled calculation of the gender- and dose-dependent effects of valsartan. RESULTS: In the high-dose valsartan group, the angiographic restenosis rate in 368 patients with control angiography was 7.3% compared with 19.5% in the low-dose group (VALVACE) [p < 0.0001]. Mean late lumen loss was 0.37 +/- 0.3 mm in the high-dose group compared with 0.53 +/- 0.31 mm in the VALVACE trial (p < 0.01). TLR and TVR rates were 4.3% in the high-dose group compared with 9% in the VALVACE trial (p < 0.01). The MACE rate was 0% in the high-dose group compared with 1.5% in the VALVACE trial (p < 0.01). Summarizing the data for valsartan, the in-stent restenosis rates in men were 22.7%, 13.3%, 6.7%, and 5.4% in patients receiving 80, 160, 240, and 320 mg/day, respectively. In women, the in-stent restenosis rates were 13.3% and 6.3% in patients receiving 80 and 160 mg/day, respectively; no restenosis occurred in patients receiving higher doses. CONCLUSION: Administration of high-dose oral valsartan 160-320 mg/day after implantation of bare-metal stent in type B2/C coronary artery lesions reduces angiographic in-stent restenosis, TLR, TVR, late lumen loss, and MACE rates more effectively than low-dose valsartan 80 mg/day.