国产雷帕霉素药物洗脱支架的临床应用

目的观察应用国产雷帕霉素药物洗脱支架治疗冠心病的近期疗效及安全性。方法观察接受国产雷帕霉素药物洗脱支架治疗的冠心病患者,即刻疗效和随访结果。结果本组111例患者,137个血管段,植入190枚国产雷帕霉素药物洗脱支架,其中13个血管段为支架内再狭窄,分叉病变23个,慢性闭塞病变7个;单支血管病变56例,二支血管病变38例,三支血管病变17病。平均血靶管直径2.92±0.31mm,平均靶病变长度30.3±8.15mm。在(7.2±4.1)个月的随访期内,无急性和亚急性支架内血栓形成,无再发心肌梗死及死亡,有18例冠状动脉造影复查,无支架及节段内再狭窄。结论国产雷帕霉素药物洗脱支架治疗冠心病安全有效。     

雷帕霉素洗脱支架治疗支架内再狭窄的临床及冠状动脉造影随访观察

目的评价雷帕霉素洗脱支架(商品名Cypher支架,强生公司产品)治疗支架内再狭窄的疗效及安全性。方法27例支架内再狭窄且有临床缺血症状的患者接受了Cypher支架治疗,其中23例患者的支架内再狭窄为弥漫、复杂病变,有5例同时置入了2个Cypher支架。术后对所有患者进行临床随访及冠状动脉造影复查。结果所有支架均成功置入,无残余狭窄或残余狭窄<10%,未见任何并发症。平均随访时间8.9±2.1(5～14)年,临床随访率96.3%,造影随访率92.6%。随访期间,无一例患者死亡。有1例支架近端边缘节段血管发生了再狭窄导致临床心绞痛复发,2例支架近端边缘节段有轻微的新生内膜增殖,但狭窄程度<25%,其余24例均无明显的晚期管腔丢失。本组支架内平均晚期管腔丢失(0.09±0.02)mm、支架远端边缘节段(0.10±0.03)mm、支架近端边缘节段(0.20±0.06)mm。靶血管血运重建率3.8%。结论Cypher支架治疗支架内再狭窄安全、可行,它能有效防止这类病变的新生内膜增殖和再次再狭窄。     

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。     

雷帕霉素洗脱支架治疗冠脉左前降支近中段病变的临床疗效评价

目的评价雷帕霉素洗脱支架治疗冠脉左前降支近中段病变的临床疗效。方法以冠脉造影显示左前降支近中段狭窄病变并分别置入雷帕霉素洗脱支架(SES组)或裸金属支架(BMS组)的患者各100例为研究对象。记录患者的一般情况、临床和冠脉病变特征,术后1年临床随访和冠脉造影复查。结果两组患者匹配良好,仅SES组置入支架的长度显著长于BMS组(21.07±7.45mmvs18.25±6.82mm,P=0.0057)。在随访中,无心源性死亡,SES组1例因支架内再狭窄发生急性心肌梗死。冠脉造影复查显示SES组再狭窄率较BMS组显著降低(7.4%vs25.9%,P=0.002),并直接导致不良事件发生率的下降。结论药物洗脱支架显著降低左前降支近中段狭窄病变介入治疗后再狭窄发生率,可作为血运重建的一种有效策略。     

可降解涂层与不可降解涂层雷帕霉素洗脱支架在急性心肌梗死直接经皮冠状动脉介入治疗中的疗效比较

目的 比较可降解涂层雷帕霉素洗脱支架(Excel)与不可降解涂层雷帕霉素洗脱支架(Cypher Select)在急性ST段抬高型心肌梗死直接经皮冠状动脉介入治疗中的有效性和安全性.方法 连续入选的228例急性ST段抬高型心肌梗死患者随机分至Cypher组(113例)和Excel组(115例).主要终点为术后12个月主要不良心脏事件(包括死亡、心肌梗死和靶血管重建),次要终点为9个月晚期管腔丢失和支架再狭窄.结果 术后9个月Cypher组和Excel组分别有43例(38.1%)和48例(42.1%)患者接受冠状动脉造影随访,两组支架内晚期管腔丢失[(0.17±0.26)mm比(0.18±0.33)mm,P=0.483]、节段内晚期管腔丢失[(0.19±0.36)mm比(0.20±0.42)mm,P=0.419)和支架内再狭窄(2.3%比2.1%,P=0.937)、节段内再狭窄(4.7%比6.3%,P=0.738)的发生率差异无统计学意义.术后12个月Cypher组和Excel组死亡(3.5%比2.6%,P=0.692)、心肌梗死(1.8%比2.6%,P=0.658)、靶血管重建(1.8%比2.6%,P=0.658)、主要不良心脏事件(5.3%比6.1%,P=0.788)及支架内血栓形成(4.4%比3.5%,P=0.724)的发生率差异无统计学意义.结论 可降解涂层与不可降解涂层雷帕霉素洗脱支架在直接经皮冠状动脉介入治疗急性ST段抬高型心肌梗死中的近期疗效和安全性可能是一致的,其远期效果有待进一步研究.     

国产雷帕霉素药物洗脱支架对急性心肌梗死的疗效观察

目的观察国产雷帕霉素药物洗脱支架(Partner)对急性心肌梗死(AMI)的临床疗效。方法将2005年5月至2006年8月天津武警医学院附属医院心内科116例AMI行急诊经皮冠状动脉介入治疗(PCI)的患者,依所置入支架不同,分为进口Cypher组(n=52)和国产Partner组(n=64)。观察两组患者住院及随访期间主要心脏不良事件(MACE)的发生和血管再狭窄情况。结果两组患者梗死相关动脉的分布差异无显著性意义。Cypher组置入支架55枚,Partner组置入支架64枚。所有患者急诊PCI手术均成功,住院及随访期间无MACE发生。Cypher组11例(21.15%)、Partner组18例(28.13%)完成了6个月冠脉造影随访,再狭窄率均为0。结论国产雷帕霉素药物洗脱支架应用于AMI治疗安全、有效。     

雷帕霉素洗脱支架治疗冠状动脉分叉病变的临床疗效评价

目的:评价雷帕霉素洗脱支架(CYPHERTM支架)治疗冠状动脉分叉病变的近、远期疗效。方法:76例冠状动脉分叉病变且有临床缺血症状的患者接受了主支CYPHERTM支架及分支血管球囊扩张术,术后对患者进行临床随访及冠状动脉造影复查,回顾性分析其结果。结果:76例中有35例行吻合球囊扩张术,主支无残余狭窄或残余狭窄<10%,分支残余狭窄<50%,住院期间无严重并发症如支架内血栓形成、急性心肌梗死、紧急外科冠状动脉搭桥术或死亡等。患者平均随访时间(8.3±1.9)个月,有1例患者心绞痛复发,无心肌梗死或死亡。冠状动脉造影的随访率81.6%,主支平均晚期管腔丢失(0.08±0.02)mm,分支血管晚期管腔丢失(0.20±0.05)mm。靶血管血运重建率5.26%。结论:应用主支CYPHERTM支架和分支血管球囊扩张的方法治疗分叉病变安全、可行,并可有效防止主支血管再狭窄。     

Cypher~(TM)支架治疗冠心病的疗效观察

目的评价雷帕霉素洗脱冠状动脉支架(CypherTM)应用于冠心病的临床疗效及再狭窄情况。方法选择接受CypherTM支架治疗的348例冠心病患者,观察术后即刻效果、术后6个月心脏性死亡、心肌梗死、再次血管重建及冠状动脉造影复查情况。病例中包括ST段抬高的急性心肌梗死86例,非ST段抬高的急性心肌梗死21例,不稳定型心绞痛149例,稳定型心绞痛92例。结果支架植入成功率99.3%,住院期间无死亡,术后出现急性和亚急性血栓各1例,1例晚期血栓致心肌梗死,1例心衰死亡,另有5例随访中进行了血管重建术,术后6个月主要心脏不良事件发生率2.9%。术后6个月56例冠状动脉造影复查的再狭窄率为7.1%(支架内为1.8%),支架内平均晚期管腔丢失为0.16mm(病变段内为0.20mm),靶病变重建率为5.4%。结论应用CypherTM支架治疗冠心病是安全和有效的,主要心脏不良事件发生率低,支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

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.     

应用雷帕霉素药物洗脱支架治疗小冠状动脉病变98例疗效观察

目的评价西罗莫可(雷帕霉素)药物洗脱支架治疗小冠状动脉病变(<3.0mm)的临床疗效。方法选择2004年1月—2004年12月入院的98例冠心病病人,常规行冠状动脉造影,获得直径小于3.0mm的病变血管共107支,前降支49支,回旋支18支,右冠状动脉15支,对角支18支,钝缘支7支,血管直径2.74mm±0.23mm。107支病变血管共植入Cypher支架118个。结果107支病变血管中,75支血管经球囊预扩张后植入支架,32支血管行直接支架术,手术成功率100%,无急性/亚急性支架内血栓形成。术后全部病例症状消失。随访14个月±3个月,全部存活。其中53例在术后10个月接受冠状动脉造影随访,5例经造影证实为支架内再狭窄,再狭窄率9.4%。4例出现新部位血管病变,再次经皮冠状动脉成形术(PTCA)治疗,随访6个月,无心绞痛症状发生。结论雷帕霉素药物洗脱支架可以明显降低小冠状动脉病变支架内再狭窄率,临床疗效肯定。     

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.     

Sirolimus-eluting stents inhibit neointimal hyperplasia in diabetic patients. Insights from the RAVEL Trial.

Patients with diabetes mellitus have less favourable outcomes after percutaneous coronary intervention (PCI) than non-diabetics. We performed a subgroup analysis of the multicentre RAVEL trial to examine the impact of the sirolimus-eluting stent (SES) on outcomes in diabetic patients. The RAVEL study randomized 238 patients to treatment with either sirolimus-eluting or bare metal stents. Forty-four patients were diabetic; 19 received sirolimus-eluting stents and 25 were treated with bare metal stents. The differences in outcomes between diabetic and non-diabetic patients treated with SES (n=101) were also assessed. Follow-up angiography was performed at 6 months. Major adverse cardiac events (MACE) defined as death, myocardial infarction (MI), or target lesion revascularization (TLR) were analysed at 12-month follow-up. Six-month in-stent late lumen loss was significantly lower for the diabetic SES than the bare stent group (0.07+/-0.2 vs 0.82+/-0.5mm; P<0.001) and similar to that in non-diabetics treated with SES (-0.03+/-0.27mm). There was zero restenosis in the SES groups (diabetic and non-diabetic) compared to a 42% rate in the diabetic population assigned to bare metal stents (P=0.001). After 12 months, there was one non-Q-wave MI and one non-cardiac death in the diabetic SES group, while 12 patients in the bare metal stent group had MACE (one death, two MI, nine TLR) (P=0.01)-an event-free survival rate of 90% vs 52%, respectively (P<0.01). There were no TLRs in both SES groups compared to 36% rate in the diabetic bare metal stent group (P=0.007).Conclusion Diabetics treated with SES were associated with a virtual abolition of neointimal proliferation and low event rates at long-term follow-up.     

Feasibility analysis of coronary angiography by transradial approach with 4F catheter

Objective:To assess the feasibility of coronary angiography by transradial approach with 4F catheter.Methods:The procedural details,picture quality,local complication were recorded for coronary by transradial approach with 4F catheter in 138 patients.Results:The success rate of angiography was 97.7%;fluoroscopy time was(5.05±3.23)minutes,total procedural time was(20.51±3.37)minutes;the incidence of dislodgement,excessive engagement of either coronary artery was 7.8%,9.4%,repectively;the angiographic scores for left anterior descending,circumflex and right coronary arteries were(2.87±0.40),(2.88±0.39),(2.90±0.35),respectively.The spasm complication occurred 4.3% in radial artery and 1.5% in coronary artery.There were no occlusion of radial artery during follow up.Conclusion:4F catheter could be the first chosen in some selecting patients for its nice maneuverability,fine images and fewer vascular complications.     

Angiographic and clinical outcome following sirolimus-eluting stent (Cypher) implantation. A single center experience

OBJECTIVES: To investigate the late outcomes of sirolimus-eluting stent implantation in patients with coronary artery disease. BACKGROUND: Drug-eluting stents reduce intimal hyperplasia, which is the main cause of in-stent restenosis. Sirolimus-eluting stents significantly reduce clinical and angiographic restenosis and improve event-free survival. METHODS: The study population consisted of 207 patients (273 stents) who had undergone coronary Cypher stent implantation. Patients were eligible for enrollment if there was symptomatic coronary artery disease or positive exercise testing, and angiographic evidence of single or multivessel disease with a target lesion stenosis of > or = 70% in a > or = 2.25 mm vessel. Follow-up coronary angiography was performed 18 months after stent deployment. Patients were followed-up for a mean of 24.7 +/- 7.4 months. RESULTS: All patients survived after stent implantation, but 5 (2.4%) patients experienced acute ST elevation myocardial infarction and 4 (1.9%) patients developed non-Q wave myocardial infarction following angioplasty. Recurrent angina pectoris was observed in 16 (7.7%) patients (11 stable angina pectoris and 5 unstable angina pectoris). Angiographic evidence of restenosis was observed in these 20 (9.66%) patients. The 5 other patients had noncritical angiographic restenosis. Eleven (5.3%) patients underwent angioplasty because of restenosis, and coronary artery bypass grafting was conducted in the other 9 (4.3%) patients. CONCLUSION: The results of the present study indicate that Cypher stents could be implanted with a very high success rate and have encouraging long-term angiographic and clinical results.     

雷帕霉素涂层支架治疗老年人冠心病的疗效及再狭窄的随访分析

目的 观察雷帕霉素涂层冠状动脉Cypher支架治疗老年冠心病患者的临床疗效及再狭窄情况。方法 2002年11月至2005年5月在我院心导管室接受Cypher支架治疗的328例60岁以上的老年冠心病患者，观察术后即刻效果，随访6个月记录心脏性死亡、心肌梗死、再次血管重建事件，并进行冠状动脉造影复查。328例中，ST段抬高的急性心肌梗死66例，非ST段抬高的急性心肌梗死21例，不稳定心绞痛149例，稳定型心绞痛92例。结果 支架植入成功率99．1％（325／328），住院期间无死亡。随访6个月出现急性和亚急性血栓各1例，晚期血栓致心肌梗死2例，心力衰竭死亡1例，进行血管重建术7例。住院其间主要心脏不良事件发生率0．6％（2／328），6个月心脏不良事件发生率3．7％（12／328）。术后6个月84例患者冠状动脉造影复查显示，再狭窄率为8．3％（7／84），支架内为2．4％（2／84），靶病变重建率为5．9％（5／84）。结论 应用Cypher支架治疗老年人冠心病是安全和有效的，主要心脏不良事件发生率低，支架内再狭窄率和靶病变重建率明显低于普通金属支架。     

Drug-eluting stents compared with thin-strut bare stents for the reduction of restenosis: a prospective, randomized trial.

AIM: Drug-eluting stents have considerably reduced restenosis. Their relative merits have been assessed on the basis of comparisons made with control bare stents with thick struts. However, increased strut thickness negatively affects restenosis. No direct comparisons between drug-eluting stents and bare stents with thin struts have been performed. The aim of this study was to evaluate the relative efficacy of sirolimus-eluting stents (Cypher) as compared with that of bare stents with thin struts (BeStent 2). METHODS AND RESULTS: A total of 500 patients with coronary artery disease were randomly assigned to receive a Cypher stent or BeStent. The primary endpoint was angiographic restenosis defined as a stenosis diameter > or = 50% at 6-month angiographic follow-up. The secondary endpoint was the need for target vessel revascularization (TVR) during the year following the procedure. Follow-up angiography was performed in 81.8% of the patients. Patients treated with Cypher stents had a lower angiographic restenosis rate [8.3 vs. 25.5%, relative risk, 0.33 (95% confidence interval, 0.19-0.56), P<0.001] and a lower incidence of TVR [7.2 vs. 18.8%, relative risk, 0.38 (0.22-0.66), P<0.001]. For smaller vessels (< 2.8 mm), the angiographic restenosis rates were 7.0% with the Cypher stent and 34.2% with the BeStent (P<0.001). For larger vessels (> or = 2.8 mm), angiographic restenosis rates were 10.0% with the Cypher stent and 13.1% with the BeStent (P=0.52). CONCLUSION: The drug-eluting stent, Cypher, is associated with a significantly lower risk of restenosis compared with the bare thin-strut BeStent. The advantage of the Cypher stent is vastly reduced in large vessels.     

Stents liberadores de rapamicina sin polímero frente a stents liberadores de paclitaxel con polímero: un análisis de datos de pacientes procedentes de ensayos aleatorizados

Introduction and objectives

The angiographic and clinical efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents remain a matter of debate. We sought to investigate angiographic and clinical measures of efficacy of polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents.

Methods

Patient data from the randomized intracoronary stenting and angiographic restenosis-test equivalence between the 2 drug-eluting stents (ISAR-TEST) clinical trial and the LIPSIA Yukon clinical trial (randomized comparison of a polymer-free sirolimus-eluting stent vs a polymer-based paclitaxel-eluting stent in patients with diabetes mellitus) were pooled. The angiographic (primary) endpoint was in-stent late lumen loss at 6 months to 9 months. The clinical (secondary) endpoints were death or myocardial infarction, cardiac death or myocardial infarction, target lesion revascularization, and myocardial infarction.

Results

A total of 686 patients (polymer-free sirolimus-eluting stents, n=345 vs polymer-based paclitaxel-eluting stents, n=341) and 751 lesions (polymer-free sirolimus-eluting stents, n=383 vs polymer-based paclitaxel-eluting stents, n=368) were included in the study. Control angiography (606 lesions, 80.6%) showed comparable in-stent late lumen loss for polymer-free sirolimus-eluting stents vs polymer-based paclitaxel-eluting stents (0,53 [0,59] mm vs 0,46 [0,57] mm; P=.15). Median follow-up was 34.8 months. Polymer-free sirolimus-eluting stents and polymer-based paclitaxel-eluting stents were associated with comparable risk of death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,49-2.80; P=.71), cardiac death or myocardial infarction (relative risk=1.17; 95% confidence interval, 0,72-1.89; P=.50), target lesion revascularization (relative risk=0,98; 95% confidence interval, 0,65-1.47; P=.93), and myocardial infarction (relative risk=1.79; 95% confidence interval, 0,85-3.76; P=.12).

Conclusions

In this pooled analysis, polymer-free sirolimus-eluting stents were comparable to polymer-based paclitaxel-eluting stents with respect to both angiographic and clinical efficacy.Full English text available from:www.revespcardiol.org.     

急性心肌梗死患者药物支架置入术后支架贴壁不良特征及对预后的影响

目的探讨急性心肌梗死患者置入西罗莫司药物洗脱支架后,支架贴壁不良(ISA)的特征及ISA对临床预后的影响。方法选择197例冠心病(300处病变)患者置入西罗莫司药物洗脱支架。根据临床表现分为急性心肌梗死组(67例,117处病变),不稳定性心绞痛组(73例,99处病变),稳定性心绞痛组(57例,84处病变)。术后1年血管造影时利用血管内超声观察各组患者支架置入处ISA的发生率和特征.根据ISA造声情况又分为贴壁不良患者和非贴壁不良患者.并在复查后1年临床随访主要不良心脏事件(包括靶病变再次血运重建,非致命性心肌梗死,心源性死亡和全因死亡)。结果急性心肌梗死组支架置入后,有17例患者(17处病变.25.4%)在1年随访检查时存在ISA,明显高于不稳定性心绞痛组(7例患者,7处病变,9.6%)和稳定性心绞痛组[(4例患者,4处病变,7.0%),P=0.005]。多因素回归分析显示,病变长度(OR=1.068,P=0.037)、急性心肌梗死(OR=2.399,P=0.031)和非糖尿病(OR=6.472.P=0.013)是晚期ISA的独立危险因素。对ISA患者1年临床随访显示,ISA患者与非ISA患者主要心脏不良事件无统计学差异(7.1% vs 2.4%,P=0.203)。结论急性心肌梗死患者置入西罗莫司药物洗脱支架后ISA的发生率较高。支架置入后晚期ISA与临床事件的关系仍需进一步研究。     

Periprocedural and late consequences of overlapping Cypher sirolimus-eluting stents: pooled analysis of five clinical trials.

OBJECTIVES: The purpose of this research was to determine the relative safety and efficacy of multiple (> or =2) overlapping Cypher sirolimus-eluting stents (SES) (Johnson & Johnson, New Brunswick, New Jersey). BACKGROUND: Overlapping coronary stents are common. The periprocedural and late clinical and angiographic consequences of overlapped coronary stents are not clearly defined, particularly for drug-eluting stents. METHODS: All patients enrolled into five clinical trials of the SES were analyzed. Three of these trials were prospective randomized comparisons of the SES to the bare-metal stent (BMS), and two were prospective non-randomized trials of SES-treated patients with historical controls. All clinical and angiographic outcomes in overlap-stent-treated patients were compared by stent type and with single-stent-treated patients for the same stent device. RESULTS: In all, 575 patients with stent overlap (337 SES, 238 BMS) and 1,162 patients with single stents (697 SES, 465 BMS) were analyzed. Stent overlap was associated with a greater late lumen loss in stent and more frequent angiographic restenosis regardless of stent type. Among overlap-stent-treated patients, the SES provided similar magnitude of restenosis benefit as observed for single-stent-treated patients. Overlapped SES was not associated with an increase in myocardial infarction. CONCLUSIONS: The strategy of SES overlap, when required, is both safe and efficacious in reducing restenosis with no increase in the incidence of myocardial infarction or major adverse cardiovascular events, when compared with a bare metal coronary stent prosthesis.     

Use of sirolimus-eluting stents in complex lesions: clinical and angiographic follow-up

INTRODUCTION AND OBJECTIVES: The RAVEL and SIRIUS studies have demonstrated important reductions in clinical and angiographic restenosis in lesions treated with sirolimus-eluting stents. However, inclusion criteria in both studies excluded complex lesions. We studied immediate and long-term results with this stent in these complex lesions. PATIENTS AND METHOD: Prospective, observational study with clinical and angiographic follow-up of patients who met the exclusion criteria used in the RAVEL and SIRIUS studies. All patients were treated in our catheterization laboratory between June 2002 and April 2003 with the Cypher stent, and 57 patients (68 lesions) were studied in all. The most frequent lesion characteristics were excessive length 26.5%; ostial lesions 25%, bifurcations 23.5%, and severe calcifications 22.1%. Almost half (47%) of the patients had diabetes and 68% had multivessel disease. RESULTS: PTCA was successful in all patients. There was one major adverse cardiovascular event (MACE) before discharge (1 acute Q-wave myocardial infarction). Two episodes of subacute thrombosis occurred during the first week. During long-term clinical follow-up (8.7 [3.1] months) of all patients, there were 4 MACE (7%): 1 cardiac death, 1 acute myocardial infarction and 2 revascularizations of the target vessel. Intersegmental restenosis was observed by angiography in 4 lesions (8%). CONCLUSIONS: Implantation of the Cypher stent in complex lesions is safe and is associated, after 6 months of follow-up, with a low incidence of clinical events and a very low percentage of angiographic restenosis.