雷帕霉素洗脱支架在冠心病合并2型糖尿病患者中的应用

目的评估冠心病合并2型糖尿病患者冠状动脉内植入雷帕霉素洗脱支架的临床疗效.方法 155例冠心病合并2型糖尿病患者接受冠状动脉内支架术,其中81例植入雷帕霉素洗脱支架(SES组),74例接受普通金属裸支架(BMS组),比较两组的临床一般情况、冠脉造影、支架植入术和远期综合心脏事件发生率.结果两组患者冠脉病变特点和支架植入术情况无统计学差异(P>0.05),住院期间均无严重并发症发生.平均随访1年中,SES组远期心脏不良事件发生率显著低于BMS组(P<0.001). 结论冠心病合并2型糖尿病患者植入雷帕霉素洗脱支架安全有效;与普通金属裸支架相比,雷帕霉素洗脱支架能显著降低心脏不良事件发生率.     

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&#177;0．34）mm和（0．80&#177;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。     

冠心病合并2型糖尿病高龄患者经皮冠状动脉介入治疗的临床观察

目的：有关冠心病合并2型糖尿病患者的冠状动脉介入治疗存在很大争议,高龄患者的治疗未被重视。文章分析冠心病合并2型糖尿病高龄患者（年龄≥80岁）冠状动脉内支架置入术的安全性和远期临床疗效。方法：比较132例冠心病合并糖尿病高龄患者（冠心病合并糖尿病组,其中置入裸支架106例,置入雷帕霉素药物涂层支架26例）与284例不伴糖尿病冠心病高龄患者（冠心病组,其中置入裸支架237例,置入雷帕霉素药物涂层支架47例）冠状动脉内支架置入术的疗效。结果：2组患者的基线资料差异无统计学意义（P〉0.05）。冠心病合并糖尿病组与冠心病组比较,冠状动脉病变更复杂、更严重,B2型和C型病变多（63.25%vs40.53%,P〈0.05）。2组手术成功率均为100%,近期疗效好,均无严重并发症发生。冠心病合并糖尿病组出现9例穿刺部位血肿（2.33%）,冠心病组出现11例穿刺部位血肿（4.87%）。远期随访显示冠心病合并糖尿病高龄患者发生心脑血管不良事件高于不伴糖尿病冠心病高龄患者,但发生率差异无统计学意义（11.5%vs9.7%,P=0.21）,再次血运重建率前者明显高于后者（9.1%vs3.9%,P〈0.05）。结论：冠心病合并糖尿病高龄患者的冠状动脉病变更复杂、更严重,与不伴有糖尿病的冠心病高龄患者相比,行冠状动脉内支架置入术同样安全有效。     

药物洗脱支架和金属裸支架治疗冠状动脉小血管病变的疗效

目的 评估雷帕霉素洗脱支架(SES)治疗小管径冠状动脉内粥样硬化病变的疗效. 方法 回顾性分析448例小血管病变SES植入病人和124例裸金属支架(BMS)植入病人的长期疗效.统计并比较住院期间及9个月不良心血管事件发生率(MACE). 结果 SES组治疗复杂病变更多,平均支架长度更长,9个月后再狭窄率明显低于BMS组(1.6% vs 9.9%,P＜0.001);MACE发生率也显著低于BMS组(4.3% vs 13.90%;P＜0.001). 结论 与BMS组相比,在小血管复杂病变中植入SES是有效的,能明显减少术后9个月再狭窄和靶病变血运重建率.     

雷帕霉素洗脱支架治疗冠心病的临床应用

目的探讨雷帕霉素(Rapamycin)洗脱支架临床应用的安全性和有效性。方法对88例冠心病患者行雷帕霉素洗脱支架植入术，记录一般情况、术中支架植入情况以及随访结果。结果88例冠心病患者共植入雷帕霉素洗脱支架119枚，手术成功率100％，术中及术后无主要心血管事件发生。结论用雷帕霉素洗脱支架植入治疗冠心病是安全有效的，在防治经皮经腔冠状动脉血管成形术(PTCA)术后再狭窄方面有良好的应用前景。     

不同冠脉重建策略在冠心病合并糖尿病患者中的短期临床疗效比较

目的:评价裸金属支架、药物洗脱支架及冠状动脉旁路移植术在合并糖尿病的冠心病多支病变患者中的短期临床疗效.方法:本研究纳入123个接受裸金属支架(BMS)、药物洗脱支架(DES)植入或行CABG治疗的合并糖尿病的多支病变冠心病患者.回顾性收集住院病历资料及临床随访资料.比较不同冠脉重建策略组患者住院期间及随访12个月的主要不良心脑血管事件(MACCE)的发生率.结果:CABG组患者住院期间MACCE发生率(6.45%)显著高于DES组(1.89%)及BMS组(2.56%).主要表现在死亡率和卒中发生率的增高.DES组与BMS组无明显差异.CABG组在随访1年时MACCE发生率(7.41%)略低于DES组(9.76%),但没有显著性差异,二者均低于BMS组(21.21%).结论:在合并糖尿病的冠心病多支病变患者的冠脉重建中,CABG短期疗效较差,但是可以显著降低远期不良事件.DES有较好的短期疗效,并且和CABG一样,可以通过减少冠脉重建的比率获得较好的远期疗效.     

国产生物可降解涂层雷帕霉素药物支架临床应用长期随访观察

目的：观察国产生物可降解涂层雷帕霉素洗脱支架治疗冠心病原发病变的长期有效性和安全性。方法：88例冠心病住院患者经单一国产生物可降解涂层雷帕霉素洗脱支架介入治疗,并予长期随访。主要研究终点为术后1年的主要不良心脏事件,次要研究终点为术后长期随访中的各种不良事件及平均14个月冠脉造影判定的支架内再狭窄发生率。结果：88例患者105处病变共植入131枚支架,术后1年内有3例患者复发心绞痛住院,复查造影2例证实为支架内再狭窄,1年主要心脏不良事件发生率为3.4%;术后平均随访22个月,其中2例患者非心源性死亡,2例心源性死亡,无美国学术研究联合会（ARC）定义的血栓事件发生;31例（35%）患者（45处病变）术后平均14个月接受冠脉造影复查,定量冠脉造影测量4处靶病变再狭窄,再狭窄率为8.8%。结论：国产生物可降解涂层雷帕霉素药物支架用于冠状动脉原发病变的介入治疗是有效且安全的。     

老年冠心病合并糖尿病患者雷帕霉素洗脱支架置入术后5年随访研究

目的探讨老年冠心病合并糖尿病患者经皮冠状动脉介入（PCI）置入雷帕霉素洗脱支架（SES）治疗的远期疗效。 方法回顾性随机入选2003年1月至2007年12月住院期间老年冠心病合并糖尿病患者行PCI 100例,并入选同时期100例无糖尿病的冠心病患者行PCI为对照组。随访5年,随访包括心绞痛复发、死亡、心肌梗死、卒中和再次血运重建的主要不良心脑血管事件。结果 两组支架术成功率均为100%。随访率100%,随访5年,糖尿病组与非糖尿病组术后并发症发生率（8.0%、7.0%）、卒中发生率（5%、3.0%）、心源性死亡率（0%、0%）差异无显著性（均为ρ〉0.05）。再次血运重建率（30.0%、14.0%）、非致死性心肌梗塞（6.0%、2.0%）心绞痛复发率（42%、20%）、全因死亡率（10%、2.0%）糖尿病组高于非糖尿病组;但心源性病死率均为0%。结论：老年患者选择性冠脉内置入药物洗脱支架安全,成功率高,远期疗效尚好,但糖尿病仍是远期不良预后的独立预测因素。     

冠心病合并糖尿病患者金属裸支架和药物支架植入术的治疗效果及安全性评价

目的:评价冠心病合并糖尿病患者冠状动脉植入金属裸支架和药物洗脱支架的治疗效果及安全性。方法:96例冠心病合并糖尿病患者均行支架植入术,其中31例植入金属裸支架,65例植入药物洗脱支架。结果:①两组患者病变支数及病变累及部位构成比间差异无显著性意义(P>0.05);②两组患者冠状动脉内支架植入数目间差异无显著性意义(P>0.05);③两组患者再狭窄发生率间差异有显著性意义(P<0.01)。结论:冠心病合并糖尿病患者介入治疗安全,疗效明显,但因病变严重、累及冠状动脉支数较多,金属裸支架植入后病变复发、再狭窄发现率高,建议首选植入药物洗脱支架。     

冠心病合并糖尿病患者金属裸支架植入术的治疗效果及安全性评价

目的评价冠心病合并糖尿病患者冠状动脉金属裸支架植入术的治疗效果及安全性。方法104例冠心病患者均行金属裸支架植入术,其中31例合并糖尿病。结果(1)两组患者病变支数及病变累及部位构成比间差别均有显著性意义(P<0.05);(2)两组患者冠状动脉内支架植入成功率间差别有显著性意义(P<0.05);(3)两组患者再狭窄发生率间差别有显著性意义(P<0.05)。结论冠心病合并糖尿病患者介入治疗安全,疗效明显,但因病变严重、累及冠状动脉支数较多,支架植入后病变复发、再狭窄发生率高,故不推荐采用金属裸支架植入术,建议首选植入药物洗脱支架或行冠状动脉搭桥术。     

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease

Background  The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conduced to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes.
Methods  One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC).
Results  The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P>0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P=0.524), re-MI (0 vs 2.0%, P=0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P=0.299) and very late thrombosis (0 vs 3.0%, P=0.295) between 1-year and 3-year follow-up.
Conclusion  The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

     

Influence of insulin resistance on long-term outcomes in patients

Background Insulin resistance（IR）is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention（PCI）with sirolimus-eluting stent（SES）implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group（n=104）and non-IR group（n=363）.The patients were followed up for one year.The rate of major adverse cardiac events（MACEs） including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up （all P〈0.05）.IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction（OR=2176,95% CI=1.35-5.47,P=0.034）.Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI（P〈0.05）.Subgroup analysis revealed that IR（OR=3.35,95% CI=1.07-13.59,P=0.013）and multi-vessel disease（OR=2.19,95%CI=1.01-5.14,P=0.044）were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.     

冠心病合并2型糖尿病的冠状动脉造影特点及支架置入术的疗效观察

目的分析冠心病合并2型糖尿病患者的冠状动脉造影结果,并评估冠脉内支架置入术的临床疗效.方法比较206例冠心病合并糖尿病患者(A组)与492例无糖尿病冠心病患者(B组)的冠状动脉造影结果,并比较118例冠心病合并糖尿病患者(C组)与311例无糖尿病冠心病患者(D组)冠脉内支架置入术的疗效.结果与无糖尿病冠心病相比,冠心病合并糖尿病的冠脉病变更复杂、更严重,外科冠状动脉旁路术多(36.89%vs 19.10%,P＜0.05).两组即刻手术成功率高(100%vs99.68%),前组无严重并发症发生.结论冠心病合并糖尿病患者冠脉内支架置入术安全有效,能显著降低心脏不良事件发生率.     

Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years

Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent （SES） in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease （CAD） who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events （MACE） and Academic Research Consortium defined stent thrombosis （ST） were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients （65. 4%） were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year＇s and 3 years＇ clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE （13.7% vs 6.4%, P 〈0.05） and TVR （9.8% vs 4.0%, P 〈0.05） and the cumulative MACE free survival rate was very significantly lower in the DM group （86.4% vs 93;6%, P 〈0.05）. ST occurred in 7 patients （1.4%） at the end of 3 years＇ follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label （1.5%） and on label groups （1.1%, P=-0.07）. Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.     

氮氧化钛生物有效性支架与雷帕霉素药物洗脱支架临床应用比较

目的：对比研究氮氧化钛生物有效性支架（Titan2-BAS）与雷帕霉素药物洗脱支架（sirolimus-eluting stent,SES）在冠状动脉血运重建方面的临床疗效.方法：141例冠心病患者,根据植入的支架不同分为A组（Titan2-BAS）87例,B组（SES）54例,均采用经桡动脉或尺动脉途径冠脉血运重建.A组阿司匹林与氯吡格雷治疗1~3 mo,B组至少12 mo.计算A,B两组支架病变的通过率、早期支架内血栓发生率及随访MACE发生率（指死亡、急性心肌梗死、靶血管重建等）.结果：①A组病变内径（3.1±0.4）mm,长度为（24±3）mm,B组病变内径（3.0±0.5）mm,长度为（22±4）mm,两组无显著差异（P〉0.05）.②A组146处〉75%狭窄病变共植入Ti-tan2-BAS 168枚,1枚支架未能通过病变（RCA）,通过率99.3%;B组86处病变共植入SES94枚,通过率100%,两组无显著差异（P〉0.05）.③随访1~17 mo,平均5.8 mo.两组均无死亡病例;A组无急、晚期血栓.B组1例术后2 d出现支架内血栓;A组1例术后3 mo行靶血管重建,B组无靶血管重建;两组MACE发生率无显著差异（P〉0.05）.结论：在本研究样品量情况下,Titan2-BAS与SES在冠脉血运重建方面的近期及远期疗效相近,Titan2不增加MACE发生率.     

Clinical outcomes of serolimus-eluting stents versus bare metal stents in ST-segment elevation myocardial infarction patients: a meta-analysis

Background The benefits and safety of sirolimus-eluting stent （SES） have not been systematically quantified in different trials in ST-segment elevation myocardial infarction （STEMI） patients with primary or rescue percutaneous coronary intervention （PCI）. A meta-analysis of randomised trials comparing SES and bare-metal stent （BMS） was performed. Methods A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events （MACEs）. The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.
Results Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group （9.7% vs 20.3%, OR 2.45, 95% Cl 1.88-3.19, P 〈 0.00001）. No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group （5.1% vs 14.8%, OR 3.30, 95%CI 2.37-4.60, P 〈 0.00001）. No significant difference was found between the pooled rates of stent thrombosis （1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95%CI 0.79-3.26, P = 0.19）.
Conclusions SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.     

雷帕霉素洗脱支架对吻术与单支架术对冠状动脉分叉病变疗效的影响

目的比较雷帕霉素洗脱支架对吻技术与单支架技术对真性分叉病变的近、远期疗效的影响。方法 200名分叉病变患者,随机分为对吻支架术和单支架术两组。随访1年,观察两组节段内再狭窄率、死亡率、非致死性心肌梗死率、靶病变再次血运重建率和支架内血栓形成率。结果术后1年,单支架组与对吻支架组相比,再狭窄率、死亡率、心肌梗死发生率、靶病变再次血运重建率、支架内血栓发生率及严重心血管不良事件发生率差异均无统计学意义（P〉0.05）;分支预扩张后,出现夹层的患者分析提示单支架与对吻支架组节段内再狭窄率、靶病变再次血运重建率及严重心血管不良事件发生率差异有统计学意义（P〈0.05）,而支架内血栓率、死亡率及心肌梗死率差异无统计学意义（P〉0.05）。结论对于直径较大的分叉病变患者,对吻支架技术的近、远期疗效与单支架术相近。预扩张后分支出现夹层应采用对吻支架术,没有夹层则应采用单支架植入。