冠心病合并糖尿病患者置入雷帕霉素洗脱支架和紫杉醇洗脱支架长期有效性及安全性观察

目的:评价冠心病合并糖尿病患者成功置入Firebird雷帕霉素洗脱支架和Taxus紫杉醇洗脱支架后的长期有效性和安全性。方法:本研究入选了2004-04至2006-10在我院行择期支架置入术的冠心病合并糖尿病患者740例。入选患者分为Firebird组(518例)和Taxus组(222例)。临床随访资料包括术后30天、1年和2年的死亡、心肌梗死、血栓、靶病变血运重建和靶血管血运重建。本研究比较了两组间各种临床事件的累积发生率差异。同时通过倾向性评分调整后的Cox比例风险模型比较两组间的2年临床随访结果。结果:术后2年时,与Taxus组相比,Firebird组患者全因死亡率[1.54%比4.98%;风险比0.354(95%可信区间:0.129～0.971),P<0.05]和靶血管血运重建率[6.18%比10.41%;风险比0.555(95%可信区间:0.315～0.979),P<0.05]风险均显著降低。结论:对于冠心病合并糖尿病患者而言,置入Firebird雷帕霉素洗脱支架与置入Taxus紫杉醇洗脱支架相比,全因死亡率和靶血管血运重建率较低。     

可降解雷帕霉素洗脱支架对猪冠状动脉支架置入术后内膜增生的影响

目的:考察可降解雷帕霉素洗脱支架对冠状动脉支架置入术后近期及远期内膜增生影响.方法:所有24只小型猪随机分为1个月及3个月两部分,每部分再随机分为A、B、C 3小组,每小组4只,分别于左冠状动脉前降支及右冠状动脉置入裸支架、聚合物洗脱支架及雷帕霉素洗脱支架,于术后1个月或3个月后动物处死前行冠状动脉造影,处死后用组织形态学方法观察内膜增生情况.结果:47枚支架均成功地置人24头小型猪的冠状动脉,术后均存活.术后即刻冠状动脉造影显示均通畅,处死前冠状动脉造影显示,1个月部分A组及B组各相关动脉均通畅,而C组有1支冠状动脉完全闭塞;3个月部分各动脉均通畅.形态学分析,与裸支架比较,1个月及3个月结果均显示聚乳酸洗脱支架对内膜增生无刺激作用;1个月结果显示药物支架可使管腔直径增加18.0%(P＜0.05),管腔面积增加22.6%(P＜0.05),面积狭窄百分比减少43%(P＜0.05),内膜面积减少35.1%(P＞0.05);3个月部分结果显示,药物洗脱支架对内膜增生的抑制作用消失,甚至有刺激内膜增生的趋势.结论:以聚乳酸为载体的可降解雷帕霉素洗脱支架在小型猪冠状动脉模型虽能抑制1个月血管内膜增生,但远期效果欠佳,其临床意义有待观察.     

生物可降解涂层雷帕霉素洗脱支架的中长期有效性和安全性

第一代药物洗脱支架的有效性已得到大量临床研究的充分证实,但其晚发血栓等不良反应亦引起广泛关注[1,2].支架表面不可降解的多聚涂层所造成的局部过敏、炎症反应可能是诱发血栓的原因之一[3].本研究旨在观察第二代国产可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)植入后的中长期有效性和安全性.     

雷帕霉素药物洗脱支架与紫杉醇药物洗脱支架治疗冠心病疗效的Meta分析

目的 比较雷帕霉素药物洗脱支架（sirolimus-eluting stent,SES）与紫杉醇药物洗脱支架（paclitaxel-eluting stent,PES）治疗冠心病的疗效与安全性.方法 计算机检索PubMed、MEDLINE、Cochrane Central Register of Controlled Trials、CNKI全文数据库,收集2006年1月至2011年10月公开发表的有关SES和PES疗效和安全性比较的随机对照试验（RCTs）.对文献质量进行严格评价后,符合要求的RCTs进行资料提取及采用RevMen 5.1软件进行Meta分析.结果 共纳入9项RCTs,Meta分析显示：SES组与PES组病死率（OR=0.98,95%CI：0.74～1.31,P＞0.05）、心肌梗死率（OR=0.86,95%CI：0.69～1.07,P＞0.05）和支架内血栓发生率（OR=0.94,95%CI：0.67～1.32,P＞0.05）均无统计学差异,但靶病变血运重建（TLR）率（OR=0.67,95%CI：0.51～0.89,P＜0.05）、主要心脏不良事件（MACE）发生率（OR=0.08,95%CI：0.68～0.94,P＜0.05）和支架内再狭窄率（OR=0.44,95%CI：0.24～0.79,P＜0.05）的差异有统计学意义.结论 两种药物洗脱支架治疗冠心病患者的病死率、心肌梗死率和支架内血栓发生率相似,但与PES比较,SES能明显降低支架术后TLR、MACE和支架内再狭窄的发生率.     

国产可降解涂层雷帕霉素洗脱支架的中期有效性和安全性

目的:评估第二代国产生物可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)的中期有效性和安全性.方法:连续观察71例住院的冠心病患者,常规冠状动脉造影及支架植入.主要观察术后平均18个月的无主要不良心脏事件(MACE,包括心源性死亡、心肌梗死、靶血管再次介入治疗)生存率、术后急性、亚急性及晚发血栓的发生率.结果:71例患者90支血管的104处病变共植入了113枚支架.1例患者手术后3 d死亡,70例患者完成了随访.随访期间未发生支架内再狭窄.术后18个月无MACE生存率为98.6%,术后亚急性血栓发生率1.4%.结论:国产第二代生物可降解涂层雷帕霉素洗脱支架有良好的中期效果和安全性.     

国产可降解涂层雷帕霉素洗脱支架的中期有效性和安全性

目的:评估第二代国产生物可降解涂层雷帕霉素洗脱支架(EXCELTM,JWMS,China)的中期有效性和安全性。方法:连续观察71例住院的冠心病患者,常规冠状动脉造影及支架植入。主要观察术后平均18个月的无主要不良心脏事件(MACE,包括心源性死亡、心肌梗死、靶血管再次介入治疗)生存率、术后急性、亚急性及晚发血栓的发生率。结果:71例患者90支血管的104处病变共植入了113枚支架。1例患者手术后3d死亡,70例患者完成了随访。随访期间未发生支架内再狭窄。术后18个月无MACE生存率为98.6%,术后亚急性血栓发生率1.4%。结论:国产第二代生物可降解涂层雷帕霉素洗脱支架有良好的中期效果和安全性。     

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.     

CYPHER药物洗脱支架治疗支架内再狭窄的临床疗效

目的:探讨CYPHER药物洗脱支架治疗支架内再狭窄的经验及临床疗效.方法:9例支架内再狭窄患者接受了12枚CYPHER药物洗脱支架治疗,其中右冠状动脉病变4例,前降支病变7例,左旋支病变1例.结果:12处支架内再狭窄病变均成功放置药物支架,手术成功率100%.所有患者临床症状明显改善,无并发症发生.所有患者于术后6个月复查冠状动脉造影,无一例发生再狭窄.结论:CYPHER药物洗脱支架治疗支架内再狭窄安全、有效、可行.     

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。     

支架断裂——雷帕霉素洗脱支架置入后冠脉再狭窄原因之一

雷帕霉素洗脱支架（SES）已被证实可有效预防血管内膜过度增生，但SES置入后仍可发生支架内再狭窄（ISR），支架断裂（SF）被认为是其发生的少见原因之一。多数报道的病例中SF发生于SES中部从而导致局灶性ISR，提示SF与局灶性ISR之间存在潜在的关系。韩国学者Lee等的研究评价了SES置入后SF的发生率及其特征，证实SF为导致ISR发生的主要原因之一。     

The long-term value of sirolimus- and paclitaxel-eluting stents over bare metal stents in patients with diabetes mellitus.

AIMS: To investigate the outcome of a real world diabetic patient cohort treated with bare metal stents (BMS), sirolimus-, or paclitaxel-eluting stents (SES and PES, respectively). Due to the different mechanisms of action of both drugs it is currently unknown which device is the best option to treat these high-risk patients. METHODS AND RESULTS: The study compares the 2-year clinical outcome of 708 consecutive diabetic patients (25% insulin treated) treated with either a BMS (n = 252), a SES (n = 206), or a PES (n = 250), as part of the RESEARCH and T-SEARCH registries. Target vessel revascularization was 19.5% in the BMS group, vs. 15.3% in the SES group and 9.7% in the PES group. PES (21.2%), but not SES (28.9%), were superior to BMS (29.7%) in reducing major adverse cardiac events. After propensity analyses, none of the differences remained significant. The incidence of stent thrombosis (ST) was high in both DES groups. CONCLUSION: There was a trend towards a more favourable outcome associated with the use of PES over BMS. There was no significant difference between SES and PES in each of the clinical endpoints, and neither in the NIDDM patients, which are hypothesized to be better-off with PES.     

Comparison of paclitaxel-eluting stent and sirolimus-eluting stent expansion at incremental delivery pressures

OBJECTIVES: We sought to compare the adequacy of paclitaxel-eluting stent (PES) and sirolimus-eluting stent (SES) expansion based on intravascular ultrasound (IVUS) imaging criteria at conventional delivery pressures. METHODS: Forty-six patients underwent SES implantation and 42 patients underwent PES implantation for de novo native coronary lesions<33 mm in length with reference lumen diameters of 2.5-3.5 mm. Stents were serially expanded with gradual balloon inflations at 14 and 20 atm. IVUS imaging was performed prior to intervention and after each balloon inflation. Stent expansion (minimal stent cross-sectional area/reference lumen cross-sectional area) was measured. Inadequate stent expansion was defined using the MUSIC criteria (all struts apposed, no tissue protrusion, and final lumen cross-sectional area>80% of the reference or >90% if minimal lumen cross-sectional area was <9 mm2). RESULTS: The baseline characteristics of the two groups were similar except for shorter lesion length, larger mean lumen cross-sectional area, larger lumen diameter, and lower plaque burden in the PES group. Stent expansion was inadequate in 80% of patients with SES versus 63% of patients with PES at 14 atm, although this was not statistically significant. After 20 atm, 48% of patients with SES remained underexpanded as compared with 35% of patients with PES. CONCLUSION: Drug-eluting stents showed significant underexpansion by MUSIC criteria at conventionally used inflation pressures. Higher balloon inflations are required especially during deployment of a SES. IVUS guidance is recommended to ensure optimal results and outcomes with both stents.     

Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial.

AIMS: Sirolimus stent implantation has been demonstrated to be safe and effective in diabetics; however, the long-term outcomes in this high-risk population remain unknown. The aim of this study was to determine the long-term safety and efficacy of the sirolimus-eluting stent (SES) when compared with the bare metal stent (BMS) in patients included in the DIABETES (DIABETes and sirolimus Eluting Stent) trial. METHODS AND RESULTS: The prospective multicentre DIABETES trial randomized 160 diabetic patients with one or more significant coronary stenoses in one, two, or three vessels to either SES or BMS implantation. One-year dual antiplatelet therapy (aspirin plus clopidogrel) was routinely prescribed. Clinical follow-up was scheduled at 1, 9, 12, and 13 months and 2 years. Baseline clinical and angiographic characteristics were comparable between groups. At 2 years, the rate of target lesion revascularization was significantly lower in the SES group compared with the BMS group (7.7 vs. 35.0%, P < 0.001). However, the total revascularization rate at 2 years increased in both groups due to progression of atherosclerosis in coronary segments remote from the target lesion (rate of atherosclerosis progression: 7.7% in SES group vs. 10% in BMS group; P = 0.7). During dual antiplatelet treatment (1 year), there was no stent thrombosis in the SES group, whereas two patients presented it in the BMS group. However, after clopidogrel withdrawal, three patients allocated to the SES group presented stent thromboses vs. none in the BMS group. CONCLUSION: SES implantation in diabetic patients remains effective at 2-year follow-up. However, clinical efficacy appeared to be reduced by the occurrence of stent thrombosis between 1 and 2 years.     

Cardiogenic shock caused by simultaneous subacute stent thrombosis after implantation of sirolimus-eluting stents

Stent thrombosis is a feared complication of percutaneous coronary intervention, although there is a low incidence of thrombotic events following drug-eluting stent implantation. We report a case with cardiogenic shock complicated by acute myocardial infarction due to simultaneous subacute stent thrombosis occurring 3 days after implantation of two sirolimus-eluting stents in the proximal left anterior descending artery (LAD) and in the proximal right coronary artery (RCA).     

高龄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

目的探讨糖尿病与非糖尿病高龄老年冠心病冠状动脉置入雷帕霉素洗脱支架（SES）远期疗效的差异。方法纳入2004年1月～2007年12月高龄老年冠心病合并糖尿病患者64例作为糖尿病组,纳入同期不合并糖尿病的高龄老年冠心病患者60例作为对照组,所有患者均行PCI术置入SES支架。随访5年,比较两组的治疗效果和主要心脑血管不良事件（MACCE,包括非心源性死亡、心源性死亡、卒中、心绞痛复发、非致死性心肌梗死和再次血运重建）发生率。结果两组5年随访率均为100%,糖尿病组MACCE发生率（57.8%,37/64）高于对照组（30.0%,18/60）,差异有统计学意义（P＜0.05）。与对照组相比,糖尿病组非心源性死亡率及再次血运重建的发生率更高（分别为：7.80% vs.1.67%,15.6% vs.8.33%,P均＜0.05）。两组心源性死亡发生率、心绞痛复发率、非致死性心肌梗死、卒中的发生率均无统计学差异（P＞0.05）。结论高龄老年冠心病患者合并糖尿病不增加PCI术后心源性死亡率,但会增加再次血运重建的发生率。     

Successful treatment of a coronary cameral fistula secondary to elective sirolimus-eluting stent implantation

Coronary cameral fistulae, communications between the coronary tree and the chambers of the heart, are a rare complication of percutaneous coronary intervention. The functional significance and management of these fistulae remain uncertain. We report such a case in a patient undergoing elective sirolimus-eluting stent implantation and provide a review of the literature.     

心肌梗死患者抗醛固酮治疗心功能变化的临床研究

Objective:To evaluate the effect of diabetes on outcome of sirolimus-eluting stent.Methods:From December 2002 to May 2005,262 diabetes and 262 non-diabetics treated with sirolimus-eluting stents were studied.The follow-up angiography was performed in 8-month.Major adverse cardiac events(MACE)defined as death,myocardial infarction,or target lesion revascularization and follow-up angiography were analyzed.Results:Successful rate of stent implantation was 100%.There was no death during the procedure,hospitalization,and follow-up period.Acute myocardial infarction occurred in 1 diabetic at 2 days after PCI,and in 2 non-diabetics at follow-up period.Angiographic follow up at 8 months showed that absolute late lumen loss was 0.06 vs 0.04mm(P>0.05),relative late lumen loss was 2.32% vs 1.63%,and TLR rate was 12.60% vs 9.92% in diabetic group and non-diabetic group respectively.Logistic regression analysis showed that reference vessel lumen and relative late lumen loss were significantly associated with restenosis.Conclusion:Cypher stent implantation in diabetes is safe and effective,while relative late lumen loss may be related to restenosis.In a word,diabetes with small vessel may be considered to be risk factor for restenosis after Cypher stents implantation.     

西罗莫司洗脱支架预防再狭窄量效关系的实验研究

目的观察不同剂量的国产西罗莫司洗脱支架预防再狭窄的有效性。方法广西种小型猪18只，分别植入不同剂量西罗莫司洗脱支架，常规剂量组：为有效的西罗莫司涂层常规剂量140μg／cm^2；0．75剂量组和0．5剂量组：分别含西罗莫司常规剂量的75％（105μg／cm^2）和50％（70μg／cm^2）。在术后28d和90d，用组织病理检查冠状动脉内膜增生程度，免疫组化检测内膜平滑肌细胞中增殖细胞核抗原和TUNEL法检测凋亡细胞。结果支架部位血管腔面积以常规剂量组最大。0．75剂量组次之，而0．5剂量组最小。支架植入后3组血管新生内膜均可见增殖细胞核抗原阳性细胞。以常规剂量组最少。凋亡细胞仅见于常规剂量组和常规剂量组新生内膜。观察至90d，3组动物均未见血栓。结论预防再狭窄以常规剂量组的药物洗脱支架效果最好，有抑制内膜过度增生的作用，0．75剂量组达到同常规剂量组相似的预防冉狭窄效果。     

Different vascular response to concurrent implantation of sirolimus- and zotarolimus-eluting stents in the same vessel

Drug-eluting stents (DES) have become routine therapy in clinical practice because restenosis is significantly reduced in patients treated with these devices. New generations of DES bearing newer antiproliferative drugs have been developed. Sirolimus was the first antiproliferative drug eluted by a DES (SES) while Zotarolimus represents a sirolimus-derived, newer antiproliferative drug borne by a different kind of DES (ZES). This report describes two cases of different vascular response to concurrent side by side implantation of SES and ZES in the same vessel and highlights significant early restenosis of ZES as compared with SES.     

西罗莫司洗脱支架预防再狭窄量效关系的实验研究

目的观察不同剂量的国产西罗莫司洗脱支架预防再狭窄的有效性。方法广西种小型猪18只，分别植入不同剂量西罗莫司洗脱支架，常规剂量组：为有效的西罗莫司涂层常规剂量140μg／cm^2；0．75剂量组和0．5剂量组：分别含西罗莫司常规剂量的75％（105μg／cm^2）和50％（70μg／cm^2）。在术后28d和90d，用组织病理检查冠状动脉内膜增生程度，免疫组化检测内膜平滑肌细胞中增殖细胞核抗原和TUNEL法检测凋亡细胞。结果支架部位血管腔面积以常规剂量组最大。0．75剂量组次之，而0．5剂量组最小。支架植入后3组血管新生内膜均可见增殖细胞核抗原阳性细胞。以常规剂量组最少。凋亡细胞仅见于常规剂量组和常规剂量组新生内膜。观察至90d，3组动物均未见血栓。结论预防再狭窄以常规剂量组的药物洗脱支架效果最好，有抑制内膜过度增生的作用，0．75剂量组达到同常规剂量组相似的预防冉狭窄效果。