雷帕霉素洗脱支架临床应用1年随访

目的:评价雷帕霉素洗脱支架(CypherTM)1 a的安全性及有效性. 方法:回顾分析112例接受CypherTM支架置入术冠心病患者的即刻疗效和临床随访结果. 结果:共处理112例患者173处病变,置入支架227枚,其中132处病变置入159枚CypherTM支架. 除2处严重钙化病变需辅以高压球囊才能充分扩张,1处支架近端发生内膜撕裂,其余全部成功置入. 手术过程及住院期间无严重并发症发生,成功率98.1%. 112例患者中102例得到随诊,平均随访1 a(≥12 mo),1例死亡,10例患者心绞痛再发,其中,6例为普通金属支架内的再狭窄(6例中1例伴CypherTM支架内近端再狭窄),4例为其他分支的新病变. 30例复查了冠状动脉造影,1例CypherTM支架内近端再狭窄. 结论:CypherTM支架临床应用安全,能显著降低再狭窄率.     

雷帕霉素洗脱支架晚期贴壁不良致支架内血栓形成 1 例

1临床病例男性患者,67岁,2型糖尿病7年,因冠心病、恶化劳累性心绞痛于2006年3月23日行冠脉造影,提示冠状动脉三支病变,前降支中段99%弥漫狭窄,回旋支中段70%局限性狭窄,右冠状动脉中段80%弥漫不规则狭窄。于前降支、回旋支、右冠脉病变处分别植入雷帕霉素洗脱支架(F ireb ird)3     

雷帕霉素洗脱支架与金属裸支架的临床对照研究

目的评价雷帕霉素洗脱支架预防支架内再狭窄的有效性和安全性。方法入选我院2003年2月至2006年6月首次行经皮冠状动脉介入治疗（PCI），并于植入支架后6～12个月复查冠状动脉造影的患者共54例，83处病变，按有无药物涂层分为雷帕霉素洗脱支架组（SES）31枚，金属裸支架组（BMS）56枚。随访12个月，比较两组间成功率、并发症发生率、心血管事件发生率（MACE）、再狭窄率及晚期管腔丢失等指标。结果两组支架植入术的成功率100％，无残余狭窄，无任何并发症。术后12个月随访结果：SES组与BMS组再狭窄率分别为3．2％和23．2％，晚期管腔丢失分别为（0．02±0．34）mm和（0．80±0．56）mm，靶血管再次血运重建率分别为3．2％和12．5％，心血管不良事件发生率分别为3．2％和14．3％。结论雷帕霉素洗脱支架有较强的安全性、有效性，与金属裸支架相比雷帕霉素洗脱支架明显降低盘榘内再狭窄率和心血管事件发生率。     

Partner西罗莫司药物洗脱支架治疗冠心病复杂病变临床分析

目的：探讨国产西罗莫司药物洗脱支架Partner在冠心病复杂病变患者中应用的有效性及安全性。方法：回顾我院2006年11月至2008年4月接受置入西罗莫司药物洗脱支架治疗的冠心病复杂病变患者216例,根据置入支架类型分为Partner组、Cypher组。比较2组冠脉病变和支架植入情况、心脏不良事件（major adverse cardiovascular events,MACE）的发生率和无事件生存率。结果：两组间基线资料匹配,Partner组冠脉病变情况相对更复杂,有更多的慢性闭塞病变、长病变、C型病变,多支病变数多于Cypher组。Partner组置入2枚以上支架有40%,Cypher组置入2枚以上支架有15.5%,组间差异有显著性。随访时间中位数为413 d,上下四分位数间距为287 d到569 d。MACE发生率：Partner组6.0%,Cypher组7.8%（P〉0.05）。两组无事件生存率分别为94.0%和92.2%,差异无显著性。结论：Partner支架在冠心病复杂病变中的应用是安全和有效的,临床效果与进口西罗莫司药物洗脱支架相似。     

国产可降解涂层西罗莫司洗脱支架在冠状动脉长病变中的应用

目的 初步评价国产可降解涂层西罗莫司洗脱支架(Tivoli支架)治疗冠状动脉长病变的可行性、安全性及有效性.方法 2007年8月-2008年2月共有55例原位冠状动脉长病变的患者分别接受Tivoli支架(Tivoli组,28例)和进口左他莫司洗脱支架(Endeavor组,27例)治疗,观察两组患者的手术即刻成功率、术后8个月冠状动脉造影结果、术后270 d时的主要不良心脏事件(MACE)及支架内血栓事件的发生率.结果 治疗前,Tivoli组既往有心肌梗死者占50.0%(14/28),显著高于Endeavor组的11.1%(3/27,P=0.002);左心室射血分数为(0.600±0.044),显著低于Endeavor组的(0.659±0.060)(P=0.003);平均病变长度为(29.5±12.5)mm,显著高于Endeavor组的(22.19±9.43)mm(P=0.006).两组支架植入的成功率均为100%.术后8个月,Tivoli组和Endeavor组的造影随访率分别为92.9%(26/28)和92.6%(25/27),支架内再狭窄的发生率分别为10.5%(4/26)和3.3%(1/25)(P=0.370),支架内晚期管腔丢失分别为(0.37±0.47)和(0.59±0.49)mm(P=0.108);术后270 d的随访率为100%,两组均无死亡、心肌梗死和血栓事件发生,MACE的发生率分别为10.7%(3/28)和7.4%(2/27,P=1.000),均为靶病变血运重建.结论 Tivoli支架在冠状动脉长病变中应用的中期疗效及安全性与进口左他莫司洗脱支架相似,初步表明其用于冠状动脉长病变的治疗是可行的.     

雷帕霉素和紫杉醇药物洗脱支架在冠状动脉长病变中的临床应用分析

目的比较雷帕霉素和紫杉醇两种药物洗脱支架（DES）在冠状动脉长病变中的临床疗效分析。方法选择2007年1月-2008年7月期间分别接受雷帕霉素DES和紫杉醇DES的冠脉长病变患者各35例和32例,观察6个月的主要心脏事件（MACE）。结果雷帕霉素DES和紫杉醇DES两组患者支架置入成功率均为100%,随访6个月其心脏不良事件发生率分别为8.57%和9.37%,差异无统计学意义（P〉0.05）。结论雷帕霉素DES治疗冠状动脉长病变的疗效和安全性与紫杉醇DES相似,更长期的临床疗效比较尚有待于进一步随访观察。     

147例国产雷帕霉素洗脱支架Firebird治疗冠心病疗效观察

目的：评价应用国产药物洗脱支架Firebird的临床疗效.方法：选择2004年9月～2007年3月147例置入Firebird支架治疗的冠心病患者进行临床观察,随访1～30个月,11例复查冠状动脉造影.结果：147例患者共置入Firebird支架279枚,手术即刻成功率100%,住院病死率0.6‰,靶病变血管重建术为0,心脏不良事件发生率为1.3%.随访中未发现与Firebird支架相关的再狭窄依据,其中11例患者经冠脉造影证实无再狭窄.结论：上述观察显示Firebird支架能有效治疗冠脉狭窄,减少冠脉支架术后再狭窄,具有很高的安全性及应用前景.     

国产西罗莫司药物洗脱支架治疗冠心病535例

目的:探讨国产西罗莫司药物洗脱支架在西宁地区治疗冠心病的安全性与有效性。方法:对535例冠心病患者采用经桡动脉或股动脉途径行冠状动脉造影及常规方法行国产药物洗脱支架置入术,记录住院期间主要不良心脏事件(MACE)发生情况,术后1年随访,9～12个月行64排CT或冠状动脉造影复查。结果:535例冠心病患者共置入支架798只,均成功置入病变处。1例心源性休克行急诊经皮冠状动脉介入治疗(PCI)支架置入后3h死于泵衰竭,3例术后出现非Q波型心肌梗死,住院期间MACE发生率为0.75%。535例患者随访12个月,2例死亡,2例支架内血栓形成,1例非致死性心肌梗死,16例再次心绞痛发作,5例再次靶病变血运重建术,总的MACE发生率为4.8%,495例患者6～12个月行64排CT或冠状动脉造影复查,16例支架内再狭窄,再狭窄率3.2%。结论:国产西罗莫司药物洗脱支架治疗冠心病患者安全、有效,有较好的近、中期疗效和较高的效益/价格比,尤其适用于经济欠发达地区,可使更多冠心病患者受益。     

雷帕霉素药物洗脱支架治疗冠状动脉长病变的临床应用

再狭窄是目前限制冠心病介入治疗的一个难点.研究表明进口雷帕霉素药物洗脱支架(Cypher)能有效降低患者的支架内及支架所在节段的再狭窄的发生率[1].本文旨在研究国产雷帕霉素药物洗脱支架(Firebird)在冠心病患者中进行冠脉介入治疗的安全性及疗效.     

国产西罗莫司药物洗脱支架治疗101例冠心病的临床观察

目的 探讨国产西罗莫司药物洗脱支架治疗冠心病的安全性与有效性.方法 对101例冠心病患者采用经皮穿刺(股或桡动脉)选择性冠状动脉造影及常规方法行国产药物洗脱支架置入术,记录住院期间主要不良心脏事件(MACE)发生情况,术后随访1年,6个月后行冠状动脉造影复查.结果 101例冠心病患者共置入156枚国产西罗莫司药物洗脱支架,均成功置入病变处,住院期间MACE发生率为0.101例患者随访(12.1±1.1)个月,8例再次发生心绞痛发作,总的MACE发生率7.9%,其中31例患者6个月后行冠状动脉造影复查,1例支架内再狭窄,再狭窄率3.2%.结论 国产西罗莫司药物支架治疗冠心病患者安全、有效,有较好的近、中期疗效和较高的效益与价格比,适用于经济欠发达地区,可使更多冠心病患者获益,但远期效果有待进一步观察、研究.     

西洛他唑对冠状动脉小血管病变支架术后患者的长期疗效

目的:探讨西洛他唑对冠状动脉小血管病变普通金属支架置入术后再狭窄的防治作用及长期临床疗效的影响.方法:193例接受冠状动脉支架术的患者随机分两组,二联组(阿斯匹林 氯吡格雷)98例,三联组(阿斯匹林 氯吡格雷 西洛他唑)95例.两组均服用阿斯匹林300 mg/d,1 mo后改为100 mg/d长期,以及氯吡格雷75 mg/d,3 mo;三联组术后加用西洛他唑200 mg/d,6 mo.患者于术后6 mo行冠脉造影随访和1a临床随访.结果:二联组和三联组术后6 mo造影再狭窄率分别为33%(17/52)和23%(12/53)(P>0.05).二组术后1a内因心、脑血管事件再住院率分别为26%和16% (P>0.05).两组均无严重出血等副作用,轻微出血亦无明显差异(2% vs 5%,P>0.05).结论:两组造影再狭窄率及1a内因心、脑血管事件再住院率无明显差异,出血等副作用无明显差异.支架术后常规抗血小板治疗基础上合用西洛他唑有降低再狭窄率的趋势.     

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

Background Advanced age independently predicts early and late mortality and major adverse cardiac events （MACE） after percutaneous coronary intervention （PCI）. Randomized clinical trials indicate that siroUmus-eluting stent （SES） implantation reduces target lesion revascularization （TLR）, but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease （CAD） in real-world practice. Methods A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age： a young group （〈65 years old, 244 patients with 369 lesions） and elderly group （≥65 years old, 89 patients with 113 lesions）. Clinical follow-up and quantitative coronary angiography （QCA） were performed seven months after PCh Results Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group （21.3% vs 9.8%, P=-0.006）. Primary success rate was similar in both groups （96.5% in young group vs 95.7% in elderly group, P〉0.05）. During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups （4.7% vs 1.8%; 9.7% vs 8.8%, P〉0.05 respectively）. Both sub-acute and late thrombosis rates were similar in the two groups （0.3% vs 0.9% and 1.2% vs 0.9%, P〉0.05 respectively. TLFI was not significantly different between the two groups （6.5% vs 3.5%;P=-0.246）. The rates of bleeding, stroke, angina rehospitalization during the, follow-up period were also similar in both groups （P〉0.05 respectively）. Conclusion Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.     

Rosiglitazone could improve clinical outcomes after coronary stent implantation in nondiabetic patients with metabolic syndrome

Background Recent studies have shown that thiazolidinediones （TZDs） could reduce in-stent restenosis and improve clinical outcomes in patients with type 2 diabetes after coronary stent implantation. It remains unclear whether nondiabetic patients with metabolic syndrome after stenting could also benefit from the treatment with TZDs. Methods Three hundred and sixty patients with metabolic syndrome who underwent coronary stent implantation were randomly assigned to a rosiglitazone group （n= 180） or a control group （n= 180）. Patients in the rosiglitazone treatment group were treated with rosiglitazone 1 day before coronary stenting （4 mg once daily） and treatment was continued until the 9 months follow-up; while in the control group, patients were treated with placebo 1 day before the procedure and until the 9 months follow-up. Adverse events were death, myocardial infarction and urgent target vessel revascularization within 9 months after coronary stenting. Results One hundred and fifty two patients in the rosiglitazone group and 145 patients in the control group survived during the follow-up. Baseline characteristics among patients in the two groups were well balanced. There was no significant difference in target vessels or the procedure of stent implantation. Compared with the control group, treatment with rosiglitazone was associated with a lower rate of death, myocardial infarction and urgent target vessel revascularization （7.2% vs 14.5%, P=0.044）. Conclusion Rosiglitazone could reduce the risk of the adverse cardiovascular event and improve clinical outcomes in nondiabetic patients with metabolic syndrome after coronary stent implantation.     

雷帕霉素和紫杉醇药物洗脱支架治疗冠心病复杂病变的临床近远期疗效比较

目的 比较雷帕霉素（CYPHER）和紫杉醇（TAXUS）药物洗脱支架（DES）在冠心病复杂病变中的临床近、远期疗效。方法本研究选自2002年4月至2004年6月接受雷帕霉素和紫杉醇DES治疗的冠心病患者分别611例（642处病变,共置入698个雷帕霉素支架）和450例（534处病变,共置入600个紫杉醇支架）,复杂病变的种类包括长段弥漫性狭窄、慢性完全闭塞性病变、分叉病变、支架内再狭窄,以及冠状动脉开口病变和左冠状动脉主干病变。结果 雷帕霉素和紫杉醇DES置入成功率分别为99,2％（606／611）和98．8％（445／450）,住院期间心脏事件[死亡、急性心肌梗死、靶病变血管重建,主要不良心脏事件（MACE）]发生率分别为0．65％和1．30％（P〉0．05）,6～8个月随访率分别为97.5％（596／611）和96．2％（433／450）,随访期间MACE发生率分别为2．3％和3．2％（P〉0．05）,再狭窄发生率分别为7．3％和14．0％（P〉0．05）,血栓形成发生率分别为0．49％和0．89％（P〉0．05）。结论 对于冠心病复杂性病变,雷帕霉素和紫杉醇DES均有良好的临床近、远期疗效,在再狭窄发生率方面雷帕霉素支架优于紫杉醇支架。     

One-year clinical outcomes of Chinese sirolimus-eluting stent in the treatment of unselected patients with coronary artery disease

The application of drug-eluting stent （DES）, either sirolimus-eluting stent （Cypher, Cordis, USA） or paclitaxel-eluting stent （Taxus, Boston Scientific, USA）, in treatment of patients with coronary artery disease （CAD） has achieved great success. The high cost of imported DES （either Cypher or Taxus） gave the birth to a China-made, polymer-based, sirolimus-eluting stent （Firebird, Microport Company,     

Long term clinical outcomes in patients with moderate renal insufficiency undergoing stent based percutaneous coronary intervention

Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention （PCI） and the effect of drug-eluting stent implantation in these patients remain unclear. This study determined the long-term effect of moderate renal insufficiency on death and major adverse cardiac events （MACE） after stent based PCI and examined whether drug-eluting stent implantation could favourably influence clinical outcome. Methods Major adverse cardiac events and causes of mortality were determined for 1012 patients undergoing percutaneous intervention from January 1, 2002 to December 31, 2004 at Shanghai Ruijin Hospital. Based on estimated creatinine clearance levels, long term outcomes were compared between patients with estimated creatinine clearance 〈60 ml/min （renal insufficiency group; n=410） and those with estimated creatinine clearance ≥60 ml/min （control group; n=602）. Subgroup analysis was also made for patients with renal insufficiency between drug eluting stent （n=264） and bare metal stent implantation （n=146） during PCI. Results During follow-up （average 17 months） after successful PCI, all causes of death （7.1% vs 2.3%, P〈0.01） and cardiac death （3.4% vs 1.0%, all P〈0.01） were significantly higher in renal insufficiency group than in control group. For patients with moderate renal insufficiency, drug-eluting stent implantation reduced significantly all causes of death （5.3% vs 10.9%, P〈0.05） and occurrence of major cardiac adverse events （15.1% vs 24.6%, P〈0.05） compared with bare metal stents. Conclusions Moderate renal insufficiency is an important clinical factor influencing the mortality after PCI in patients with coronary artery disease and the use of drug-eluting stents should be the preferred therapy for the improvement of long-term outcomes in such patients.     

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

Background  The Firebird 2^TM sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2^TM cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.

Methods  The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry. Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.

Results  Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events (MACE) was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction (MI), and 6 target vessel revascularization (TVR). At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis (ST) occurred in 0.43% (22/5058) of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.

Conclusion  The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

     

球囊支架对吻术治疗冠状动脉分叉病变的疗效观察

目的 观察球囊支架对吻术治疗冠状动脉分叉病变的临床疗效。方法 连续入选2015年5月至2016年4月45例于同济大学附属东方医院心内科行球囊支架对吻术的冠状动脉分叉病变的患者,观察患者的临床特点、术中病变特点及术后影像学及短期临床事件情况的发生。结果 45例患者共有48处分叉病变处成功进行了球囊支架对吻治疗。其中大多数病变为(70.8%)为Medina1,1,1型。术后即刻TIMI3级血流,主支为100%,分支为96%。2例患者边支置入支架。术中边支内被拘禁的导丝及球囊均能顺利撤出。住院期间及出院1月内无明显的主要心脏不良事件发生。结论 在单支架方法(必要时分支置入支架)治疗分叉病变时,球囊支架对吻术是一种可行、有效的技术,能有效降低边支闭塞的风险,降低住院期间的主要心脏不良事件的发生率。     

冠脉复杂病变PCI术后伊诺肝素抗凝对临床事件的影响

目的 探讨复杂病变经皮冠状动脉介入治疗（PCI）术后伊诺肝素抗凝对临床事件的影响。方法随机入选复杂冠脉病变（B2、C型病变）行PCI术后无特殊并发症患者293例,随机分为依诺肝素抗凝组与非抗凝组,对入选患者分别在术后住院期间、1个月、12个月时随访并记录主要心血管不良事件（MACEs）。结果 两组住院期间、术后1个月、术后12个月时主要心血管不良事件的发生率无明显差异,住院期间,抗凝组与非抗凝组MACEs的发生率是2.1% VS 1.4%,P＞0.9;主要出血的发生率4.8% VS 2.8%,P=0.369,小出血发生率是26.2% VS 16.1%,P=0.036; 1个月时两组间 MACEs的发生率2.8% VS 2.8%,P＞0. 9; 1年时发生率5.9% VS 5.5%,P=0.78。两组间MACEs累积发生率无显著差异（HR 0.875, 95%CI 0.337-2.273;P=0.79）。抗凝组的平均住院天数多于非抗凝组(P=0.001)。结论 复杂病变PCI术后非抗凝治疗组不仅不增加心血管事件,而且减少出血事件、缩短住院天数,该研究表明即使是复杂冠脉病变,PCI术后若无特殊并发症可无需肝素抗凝治疗。