国产雷帕霉素洗脱支架在急性冠脉综合征的临床研究

目的对比研究国产雷帕霉素洗脱支架（Firebird）和进口雷帕霉素洗脱支架（Cypher）在急性冠脉综合征（ACS）患者临床应用疗效。方法本研究选取了我科自2007年8月—2008年7月住院治疗的ACS患者173例,均于发病后12h内行介入治疗（PCI）,随机分为Firebird支架和Cypher支架两组,其中Firebird支架组93例,Cypher支架组80例。173例患者共植入Firebird支架132枚,Cypher支架124枚。结果两组患者一般资料比较差异无统计学意义（P均〉0.05）。两组患者靶血管特征差异无统计学意义（P均〉0.05）。两组患者平均靶血管直径和平均靶病变长度对比,Firebird支架组比Cypher支架组为：（3.11±0.54）mm比（3.0±0.58）mm,（25.42±10.61）mm比（24.72±12.21）mm,P值均〉0.05,统计学无差异性。临床随访6个月,两组均有1例急性支架内血栓形成,各有1例死亡,无亚急性、慢性血栓形成、再发心肌梗死。再发心绞痛、再次血运重建和主要心血管事件（MACE）间差异无统计学意义（P值均〉0.05）。结论国产和进口雷帕霉素洗脱支架治疗急性冠脉综合征近期疗效相似。     

不同雷帕霉素药物洗脱支架在老年冠心病患者中的应用与研究

目的探讨雷帕霉素药物洗脱支架在老年冠心病经皮冠状动脉介入治疗中应用的安全性和有效性。方法入选320例冠心病患者,分为国产雷帕霉素药物洗脱支架组(Firebird组)160例,进口雷帕霉素药物洗脱支架组(Cypher组)160例。比较两组置入支架后6个月随访时的临床不良事件和再狭窄率。结果Firebird组共置入支架197枚,Cypher组共置入支架204枚。临床6个月随访示Firebird组临床不良事件3例,Cypher组4例,差异无显著性意义。6个月期随访造影显示Firebird组(66例)和Cypher组(77例)支架内再狭窄各出现1例。结论雷帕霉素药物洗脱支架Firebird和Cypher类似,而且Firebird有更高的效价比。     

国产与进口雷帕霉素药物洗脱支架治疗冠心病的疗效比较

药物洗脱支架是目前治疗冠心病的主要方式之一，它可以使支架内再狭窄的发生率下降至10％以内。目前进口雷帕霉素药物洗脱支架（美国Cordis公司，支架名称Cypher）已广泛应用于冠心病患，而国产药物洗脱支架（上海微创医疗器械公司生产，支架名称Firebird）在临床应用的安全性和有效性有待研究。     

国产与进口雷帕霉素药物洗脱支架临床对比研究

目的对比研究国产雷帕霉素洗脱支架和进口雷帕霉素洗脱支架临床应用疗效.方法本研究总结了我科自2003年11月至2004年8月157例患者,分为Cypher支架组和Firebird支架组,其中Cypher支架组110例,Firebird支架组47例.157例患者共植入Cypher支架150枚,植入Firebird支架70枚.结果两组患者平均年龄,男性比例,吸烟史、高血压、高血脂、糖尿病,稳定性心绞痛、不稳定性心绞痛、急性ST段抬高心肌梗死和急性非ST段抬高心肌梗死、陈旧心肌梗死数据对比,P值均＞0.05,统计学无差异性.两组患者单支血管病变、二支血管病变、三支血管病变、分叉病变、慢性闭塞病变、左主干病变数据对比,P值均＞0.05,统计学分析无差异性.两组患者平均靶血管直径和平均靶病变长度对比[Cypher支架组比Firebird支架组为(2.87±0.29)mm比(2.97±0.40)mm,(20.54±6.14)mm比(18.14±5.68)mm)],P值均＜0.05,统计学分析有差异性.临床随访6个月,两组患者均无急性和亚急性支架内血栓形成,无再发心肌梗死及死亡.再发心绞痛、再次血运重建和MACE对比,P值均＞0.05,统计学无差异性.结论国产和进口雷帕霉素药物洗脱支架近期和远期疗效相似.     

国产雷帕霉素药物洗脱支架治疗冠心病1年临床随访——多中心注册研究

目的:多中心、前瞻性评估国产Firebird雷帕霉素洗脱支架在冠心病患者中应用的安全性及1年临床随访结果.方法:2004年6月至9月,入选上海地区6家医院接受国产雷帕霉素药物洗脱支架治疗的冠心病患者360例.记录各例基础临床、介入治疗情况及1年临床随访结果,并与RESEARCH研究结果进行比较.结果:与RESEARCH研究资料比较,本研究组中患者高胆固醇血症(24.2%对56%)、既往接受CABG(0.3%对9%)或PCI(7.2%对19%)、多支冠脉病变(27.2%对54%)、复杂病变(B2型病变:30%对49%,C型病变:36.4%对43%)及支架术后行后扩张者(13.1%对55%)较少,P均＜0.001.本研究介入治疗成功率高于RE-SEARCH研究(99.2%对97%,P=0.03).术后1年临床随访率93.9%,严重心脏不良事件(MACE,包括死亡、非致命性心梗及靶血管再次血运重建)发生率为8.3%,与RESEARCH研究中药物支架组相似(9.7%,P=0.58),显著低于普通支架组(14.8%,P=0.001).Firebird支架术后1年血栓事件发生率为0.9%. 结论:国产Firebird雷帕霉素洗脱支架治疗冠心病安全、有效,术后1年MACE发生率与RE-SEARCH研究Cypher支架组相似.     

国产雷帕霉素药物洗脱支架治疗冠心病1年临床随访——多中心注册研究

目的：多中心、前瞻性评估国产Firebird雷帕霉素洗脱支架在冠心病患者中应用的安全性及1年临床随访结果。方法：2004年6月至9月,入选上海地区6家医院接受国产雷帕霉素药物洗脱支架治疗的冠心病患者360例。记录各例基础临床、介入治疗情况及1年临床随访结果．并与RESEARCH研究结果进行比较。结果：与RESEARCH研究资料比较,本研究组中患者高胆固醇血症(24．2%对56%)、既往接受CABG(0．3%对9%)或PCI(7．2%对19%)、多支冠脉病变(27．2%对54%)、复杂病变(B2型病变：30%对49%．C型病变：36．4%对43%)及支架术后行后扩张者(13．1%对55%)较少,P均＜0．001。本研究介入治疗成功率高于RE- SEARCH研究(99．2%对97%,P=0．03)。术后1年临床随访率93．9%,严重心脏不良事件(MACE,包括死亡、非致命性心梗及靶血管再次血运重建)发生率为8．3%,与RESEARCH研究中药物支架组相似(9．7%．P=0．58),显著低于普通支架组(14．8%,P=0．001)。Firebird支架术后1年血栓事件发生率为0．9%。结论：国产Firebird雷帕霉素洗脱支架治疗冠心病安全、有效,术后1年MACE发生率与RE- SEARCH研究Cypher支架组相似。     

国产及进口药物涂层支架治疗无保护左主干病变的疗效观察

选择经冠状动脉造影证实无保护左主干病变患者48例,随机分成进口雷帕霉素洗脱支架（Cypher支架）和国产雷帕霉素洗脱支架（Firebird支架）两组,比较两种支架的疗效.临床随访6～9个月,两组心脏主要不良心脏事件、支架内再狭窄率、支架内最小管腔直径（MLD）、节段内MLD、支架内晚期管腔丢失（LLL）、节段内LLL均无统计学意义.认为国产和进口雷帕霉素药洗脱支架在无保护左主干病变中的近期疗效相似.     

国产雷帕霉素药物洗脱支架治疗冠心病前降支弥漫性长病变的疗效分析

目的评价国产雷帕霉素药物洗脱支架在冠心病前降支弥漫性长病变治疗中的安全性和有效性。方法选择我院2004年10月—2007年10月经冠脉造影证实的冠心病前降支弥漫性长病变患者174例,其中接受国产雷帕霉素药物洗脱支架组(简称Firebird组)98例,接受进口雷帕霉素药物洗脱支架组(简称Cypher组)76例。对比两组患者一般临床情况、手术成功率和术后随访主要心脏事件(包括再发心绞痛、再发心肌梗死、再次血运重建、死亡等)发生率。结果两组患者支架手术成功率相似,随访12个月,两组患者均无急性与亚急性支架内血栓形成、无再发心肌梗死。两组再发心绞痛、再次血运重建比较差异无统计学意义。结论国产雷帕霉素药物洗脱支架应用于冠心病前降支弥漫性长病变安全有效,能改善患者的近期和远期预后。     

EXCEL雷帕霉素药物洗脱支架临床应用安全性及近期疗效评价

目的评价国产EXCEL雷帕霉素药物洗脱支架临床应用的安全性及疗效.方法对90例冠心病患者161处病变分三组分别植入EXCEL药物洗脱支架、Cypher药物洗脱支架及普通金属支架共计195枚,观察了EXCEL支架的安全性、即刻及临床近期疗效,并与Cypher及普通支架进行了比较.结果与普通支架相比,EXCEL及Cypher药物洗脱支架组患者年龄大,合并高血压、高脂血症、糖尿病、不稳定性心绞痛、急性心肌梗死及陈旧性心肌梗死例数多(均P＜0.05),EXCEL、Cypher及普通支架三组狭窄程度及病变长度无明显差别,分别经(12.9±2.1)、(13.4±3.3)、(13.0±4.2)atm扩张支架膨胀完全,均可完成对吻扩张,总的植入成功率为99.5%,直接支架81处(41.5%),残余狭窄分别为(4.1±0.4)%、(3.2±0.6)%和(3.5±0.1)%,EXCEL支架组三支病变明显多于Cypher及普通支架组(P＜0.05,P＜0.01),EXCEL支架与普通支架组各有1例穿刺部位的血管并发症,与支架本身无关.EXCEL及Cypher药物支架术中及住院期间主要不良心脏事件(MACE)发生率为0%.75例患者随访超过3个月,随访率83.3%;普通支架组1例猝死,1例进行了靶血管重建,普通支架MACE发生率为2.7%,两种药物洗脱支架随访MACE发生率均为0%;心绞痛复发5例(5.5%),普通支架组4例,1例为同时植入EXCEL和普通金属支架,尚不能明确病变部位.冠脉造影随访计划经皮冠状动脉介入(PCI)术后6个月进行,尚未完成.结论国产EXCEL雷帕霉素药物洗脱支架临床应用安全,近期疗效与Cypher药物洗脱支架相似,PCI后近期主要不良心脏事件的发生率明显低于普通金属支架.     

国产与进口西罗莫司药物洗脱支架治疗冠心病临床疗效对比

目的评估国产西罗莫司药物洗脱冠状动脉(冠脉)支架在冠心病患者中应用的安全性及1年临床随访结果,并与同期应用进口药物洗脱支架(Cypher和Taxus)比较。方法与结果2003年5月至2004年6月,共计673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药物洗脱支架(Firebird,上海微创公司)224例,进口西罗莫司药物洗脱支架(Cypher,美国强生公司)246例,进口紫杉醇药物洗脱支架(Taxus,美国波士顿公司)203例。各组基础临床情况及造影特征均相似,尽管Firebird组患者平均每例置入支架数目较多且支架总长度较长,但其住院总费用仍显著低于其他两组。术后1年临床随访严重心脏不良事件(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)发生率在Firebird组为9·0%、Cypher组为8·4%、Taxus组为11·2%,相互比较差异无统计学意义。造影证实Firebird组2例(0·9%)、Cypher组2例(0·9%)和Taxus组3例(1·6%)发生支架内血栓形成。结论国产西罗莫司药物洗脱冠脉支架治疗冠心病安全,其1年临床疗效与进口西罗莫司及紫杉醇药物洗脱冠脉支架相似。     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。     

Sirolimus, Tacrolimus and Zotarolimus eluting stents to treat bifurcated lesions: a 7-month clinical outcome comparison

AIM: Drug eluting stents (DES) have been shown to reduce restenosis compared with bare metal stents in bifurcated lesions. The aim of this study was to evaluate the long-term clinical outcomes of patients with bifurcated lesions treated by 3 different DES. METHODS: Consecutive patients with symptomatic coronary artery disease on one bifurcated lesion with SB>2.25 mm (on visual estimation) undergoing at the Department of Cardiology of the Catholic University of Rome, Italy were screened. Patients treated with Sirolimus-eluting stent (Cypher Select; SES Group), Tacrolimus-eluting stent (Taxus-Libertè; TA Group) and Zotarolimus-eluting stent (Endeavor Driver; ZOT Group) were enrolled in the study. Clinical and angiographic characteristics of all patients were prospectively recorded. Major adverse clinical events (MACE), including death, acute myocardial infarction (MI) or target lesion revascularization (TVR) by either percutaneous coronary intervention (PCI) or coronary surgery were recorded during the follow-up. Incidence of definite or probable stent thrombosis was calculated according to the ARC criteria. RESULTS: Two hundred and forty-one consecutive patients were enrolled (89 Group CY, 98 Group TA and 54 Group EN). Length of follow-up was 235+/-60 days. Baseline clinical and angiographic characteristic were similar across the groups. The adopted technique for stent implantation was provisional stenting (73.4%), T-stenting technique (7%), crush (7%) and V-stenting (2.6%). The rate of patients finally treated with two stents was similar among groups. The cumulative rate of MACE (9% SES, 12% TA, 11% ZOT: P=0.7) and of TVR (2% SES, 9% TA, 7% ZOT) was similar among groups. No definite stent thrombosis was observed during follow-up, while 1 probable stent thrombosis was observed in TA group. CONCLUSION: The clinical outcome of bifurcated lesions using DES and mainly a technique of single stent implantation is good. In the present observational study, clinical adverse events did not differ in patients with bifurcated lesions treated by Cypher, Taxus or Endeavor stent implantation.     

进口与国产药物洗脱支架治疗急性ST段抬高心肌梗死的预后分析

目的 进口和国产药物洗脱支架（DES）治疗急性ST段抬高心肌梗死（STEMI）的住院期间与远期预后比较.方法 连续入选2009年1月至2010年8月的197例确诊急性STEMI并行冠状动脉介入治疗的患者,按照支架的类型分为国产DES组和进口DES组,比较两组住院期间和长期心脑血管事件发生率.结果 国产DES组共113例（57.4％）,进口DES组84例（42.6％）,两组住院期间全因死亡率（2.7％比4.8％,P=0.515）、严重心力衰竭发生率（2.7％比0,P=0.053）、恶性心律失常发生率（10.6％比3.6％,P=0.098）差异均无统计学意义;两组患者随访中位数41个月,随访期内两组的无事件生存率分别为91.5％和90.9％ （P=0.885）.多因素分析显示,高龄（HR=1.872,95％ CI：1.008～2.118,P=0.023）、高血压史（HR=6.018,95％ CI：1.307～21.716,P=0.021）、脑血管病史（HR=4.995,95％ CI：1.536～16.242,P=0.008）、心功能Killip分级（HR=3.947,95％ CI：1.809～8.612,P=0.001）、高尿酸血症（HR=1.006,95％ CI：1.003～1.010,P＜0.001）是患者远期发生全因死亡、非致死性心肌梗死、再次血运重建、严重心力衰竭、脑血管病的独立危险因素.结论 急性STEMI患者,应用国产与进口DES住院期间及远期预后差异无统计学意义.     

第二代药物洗脱支架治疗无保护左主干病变的疗效及安全性分析

目的探讨第二代药物洗脱支架（DES）置入治疗无保护左主干（ULM）病变患者的疗效及安全性。方法回顾性研究南京医科大学附属南京医院诊断为ULM病变并接受DES治疗的患者216例。接受第一代DES的患者121例为F组,接受第二代DES的患者95例为S组。患者术后常规服用阿司匹林100 mg,每日一次;氯吡格雷150 mg,每日一次（维持至少1年）。主要研究终点为主要不良心血管事件（MACE）,包括心源性死亡、非致死性心肌梗死和再次靶血管血运重建（TVR）;次要终点为12个月时定量冠状动脉造影（CAG）参数。结果在（342±23）d随访期内,总体复合MACE 22例（10.2%）,主要构成为TVR 16例（7.4%）。S组复合MACE为5.3%显著低于F组14.0%（χ2=4.491,P=0.034,RR 2.669,95%CI 1.022~6.975）。S组复合MACE的减少主要表现为TVR减少（χ2=4.465,P=0.035,RR 3.402,95%CI 0.998~11.60）。随访血管造影再狭窄F组与S组分别为17例（14.5%）和8例（8.4%）,差异无统计学意义（χ2=1.647,P=0.199）。血管内超声提示的晚期获得性支架贴壁不良于F组和S组分别为7例（5.8%）和1例（1.1%）,F组有增加趋势,但差异无统计学意义（χ2=3.342,P=0.068）。结论与第一代DES相比较,使用第二代DES治疗ULM病变MACE发生率低,主要表现为TVR减少;第二代DES治疗ULM病变具有更好的疗效和安全性。     

Comparative clinical outcomes of paclitaxel- and sirolimus-eluting stents: results from a large prospective multicenter registry--STENT Group.

OBJECTIVES: The purpose of this study was to compare the 9-month clinical outcomes of patients treated with paclitaxel-eluting stents (PES) or sirolimus-eluting stents (SES) for coronary artery stenosis. BACKGROUND: The STENT (Strategic Transcatheter Evaluation of New Therapies) registry is the first multicenter registry in the U.S. to collect long-term outcomes of drug-eluting stents from "real-world" practice. METHODS: Data on all percutaneous coronary interventions in 8 U.S. hospital centers were collected in the STENT registry between 2003 and 2005. In this prospective, nonrandomized, observational study, the choice of procedures was at the physicians' discretion. Patients who only received a PES (n = 4,671) or SES (n = 4,555) and completed 9-month follow-up (93.8% of eligible) were included for analysis. Primary end points were death, myocardial infarction (MI), and target vessel revascularization (TVR) at 9 months. Secondary outcomes included major adverse cardiac events (MACE) (any of the 3 primary end points) and stent thrombosis. RESULTS: At 9 months, death, MI, and TVR occurred in 2.2%, 2.0%, and 4.1%, respectively, of the PES group and 2.5%, 2.2%, and 4.3%, respectively, of the SES group (p = NS); MACE occurred in 7.5% of the PES group and 8.0% of the SES group (p = 0.37). After adjustments for group differences in baseline characteristics, TVR (hazard ratio [HR] 0.88, 95% confidence interval [CI] 0.70 to 1.32; p = 0.26) and MACE (HR 0.95, 95% CI 0.81 to 1.12; p = 0.56) were similar for PES and SES. Stent thrombosis at 9 months occurred in 0.7% of both groups. CONCLUSIONS: The results of this study show that clinical restenosis and MACE events after PES and SES procedures in "real-world" patients are infrequent and similar at 9 months.     

冠心病真实世界中药物洗脱支架置入术后血栓形成的发生率

目的探讨真实世界（real-world）中药物洗脱支架（drug-elutingstents,DES）置入后血栓的发生率。方法研究为单中心DES注册,在入选标准上无特殊限制。自2001年12月至2007年4月共计8190例冠心病患者接受了DES的治疗,其中使用雷帕霉素DES（Cypher支架,美国Cordis公司）2986例,使用紫杉醇DES（TAXUS支架,美国波士顿科技公司）1587例,使用国产雷帕霉素DES（Firebird,中国微创医疗器械有限公司）3617例。5412例完成了1年的临床随访,其中CypherDES2210例,TAXUSDES1238例和FirebirdDES1964例。完成2年临床随访的2176例包括CypherDES1245例,TAXUSDES558例和FirebirdDES373例。所有患者PCI术后联合应用阿司匹林与氯吡格雷至少9个月。结果在8190例患者中,17例发生急性血栓（0．21％）,7例发生在CypherDES组,4例发生在TAXUSDES组,6例在FirebirdDES组;23例发生亚急性血栓（0．28％）,包括8例在CypherDES组,6例发生在TAXUSDES组和9例在FirebirdDES组。急性和亚急性血栓的发生率为0．49％,其中CypherDES组为0．50％,TAXUSDES组为0．63％和FirebirdDES组为0．41％。三组之间在急性和亚急性血栓发生率方面差异无统计学意义。1年随访结果显示晚期血栓发生率为0．61％,包括CypherDES组为0．63％,TAXUSDES组为0．88％和FirebirdDES组为0．46％,三组之间比较在晚期血栓发生率方面差异无统计学意义。2年随访结果显示,晚期血栓发生率为0．74％,其中CypherDES组为0．72％,TAXUSDES组为0．90％,FirebirdDES组为0．54％,三组之间差异无统计学意义。结论研究结果提示在加强抗血小板治疗情况下,应用第一代DES治疗复杂性冠状动脉病变是安全和有效的,与早期选择性的病变研究相比,晚期血栓发生率无明显增加的趋势。     

Clinical outcomes following drug-eluting versus bare metal stent implantation for lesion subsets excluded from pivotal clinical trials: findings from the GHOST Study (Guthrie Health System Off-Label StenT Study)

Objectives: We assessed outcomes of patients undergoing drug-eluting stent (DES) vs. bare metal stent (BMS) implantation for complex lesions excluded from pivotal clinical trials of DES.
Background: Although DES improve target vessel revascularization (TVR) and major adverse cardiovascular events (MACE) compared to BMS in randomized trials, data on safety and efficacy of DES in complex lesions are insufficient.
Methods: In a single-center registry of 1,354 patients who underwent stent implantation for complex lesions between July 2001 and December 2005, we compared the incidence of death, death or myocardial infarction (MI), stent thrombosis [definite or probable by the Academic Research Consortium (ARC) criteria], TVR, and MACE between patients who received DES (n = 483) versus those who received BMS (n = 871). Mean duration of follow-up was 494 versus 838 days in DES and BMS groups, respectively.
Results: Clinical outcomes in DES versus BMS groups were as follows: death 5.2% versus 11.5% (log-rank P = 0.042); death/MI 11.2% versus 16.7% (P = 0.47), stent thrombosis 2.9% versus 2.6% (P = 0.61), TVR 6.6 versus 18.5% (P < 0.0001), MACE 14.9% versus 29.7% (P = 0.0002), respectively. After adjustment for baseline differences, DES implantation was associated with lower TVR (adjusted hazards ratio HR = 0.38, 95% CI 0.26–0.56, P < 0.0001) and MACE (HR = 0.56, CI 0.42–0.74, P < 0.0001) without significant impact on other outcomes. In 933 patients who underwent DES (n = 483) or BMS (n = 450) implantation in the year 2003 or later, DES implantation similarly lowered TVR and MACE without affecting other outcomes.
Conclusions: Our findings support the safety and efficacy of DES in patient subsets excluded from pivotal randomized clinical trials of DES.     

Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry

The treatment of elderly patients with coronary artery disease (CAD) is challenging because this population is complex and greatly expanding. Drug-eluting stents (DES) generally improve the outcome in high-risk cases. We evaluated the clinical impact of different first-generation DES, i.e., sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), in this context. A prospective, nonrandomized, single-center, allcomers registry consecutively enrolling all patients aged ≥75 years eligible for percutaneous coronary intervention (PCI) with DES was carried out. Only one type of DES was implanted per protocol for each patient. Two groups were identified according to the type of implanted stent, i.e., SES and PES. The primary end point encompassed major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR). The secondary end point encompassed the rate of definite/probable stent thrombosis and target vessel revascularization (TVR). From June 2004 to May 2008, 151 patients were enrolled. Among them, 112 (74.2%) received SES and 39 (25.8%) received PES. Baseline clinical characteristics were similar, while few angiographic features (ostial location, stent diameter, proximal reference vessel diameter) showed minor differences. At the median follow-up of 22.6 months, primary and secondary end points did not significantly differ in terms of MACE (SES 12.5% vs PES 20.5%, P = 0.3), death (SES 5.4% vs PES 7.7%, P = 0.7), myocardial infarction (SES 4.5% vs PES 10.3%, P = 0.2), TLR (SES 2.7% vs PES 2.6%, P = 1.0), stent thrombosis (SES 1.8% vs PES 5.1%, P = 0.3), and TVR (SES 1.8% vs PES 0%, P = 0.6). In this real-world population of elderly patients treated by DES–PCI for CAD, the overall efficacy and safety have been excellent in both DES, and the choice between SES and PES did not influence the clinical outcome.     

药物洗脱支架治疗支架内再狭窄的对照研究

目的 比较3种药物洗脱支架(DES)治疗支架内再狭窄的长期临床效果.方法 回顾性分析阜外医院对支架内再狭窄病例用DES行经皮冠状动脉介入治疗(PCI)的390例患者,其中雷帕霉素药物洗脱支架(Cypher)组187例(C组),紫杉醇药物涂层支架(Taxus)组89例(T组),国产雷帕霉素涂层支架(Firebird)组114例(F组).结果 T组不稳定性心绞痛比率高于另2组,F组左主干病变比率低于另2组,而3支病变比率高于另2组.3组平均临床随访时间为864、848和719 d,主要不良心脏事件发生率差异无统计学意义(P=0.081),3组总的支架内血栓发生率差异无统计学意义(P=0.605).7个月造影随访支架内和血管段再狭窄率T组有增高的趋势(17.9%比29.4%比13.6%.P=0.214和21.8%比35.3%比15.9%,P=0.132).支架内和血管段的晚期丢失T组均明显大于另外2组[(0.31±0.12)mm比(0.75±0.24)mm比(0.31±0.13)mm,P=0.000和(0.33±0.18)mm比(0.61±0.23)mm比(0.31±0.14)mm,P=0.001].结论 3种DES治疗支架内再狭窄病变的长期疗效相似,Cypher和Firebird抑制内膜增生的作用更强.