紫杉醇药物洗脱球囊与西罗莫司药物洗脱支架治疗再狭窄的比较

目的:本研究旨在对中国人群中紫杉醇药物洗脱球囊(PEB)和西罗莫司洗脱支架(SES)治疗支架内再狭窄(ISR)的有效性进行比较。方法:连续入选2014年9月至2015年6月,经冠状动脉造影确诊ISR并接受PEB或SES治疗的患者,根据所接受的治疗策略将患者分别纳入PEB组和SES组。观察两组患者住院期间主要不良心血管事件(MACE)发生率,术后12个月进行电话或门诊随访了解两组MACE发生情况。结果:共纳入患者166例,其中PEB组63例,SES组103例;两组中药物洗脱支架再狭窄(DES-ISR)患者116例,包括PEB组44例和SES组72例;根据Mehran分型,点状病变患者33例,非点状病变患者133例。住院期间两组患者均未发生MACE。(13±2)个月临床随访发现,PEB组共发生MACE 6例,包括非致死性心肌梗死(MI)2例和靶血管血运重建(TVR)5例;SES组MACE 9例,包括全因死亡3例和TVR 7例;两组间MACE发生率差异无统计学意义(9.7%vs.9.2%,P=0.92)。两组间的全因死亡、非致死性心肌梗死、靶病变血运重建和靶血管血运重建发生率均差异无统计学意义(P0.05)。DES-ISR患者中,PEB组和SES组的MACE发生率差异无统计学意义(7.0%vs.10.3%,P=0.74)。而在点状病变和非点状病变患者中,两组间MACE发生率均差异无统计学意义(P0.05)。结论:中国人群中紫杉醇药物洗脱球囊与西罗莫司药物洗脱支架,治疗支架内再狭窄的有效性差异无统计学意义,且在DES-ISR、点状病变和非点状病变患者中两种治疗方式也无明显差异。     

药物洗脱支架与金属裸支架对冠状动脉临界病变的远期疗效

目的:评估药物洗脱支架与金属裸支架对于治疗冠状动脉临界病变的远期疗效。方法:自身冠状动脉首次介入治疗病变(在线定量冠状动脉造影分析50%≤管腔狭窄直径≤70%)的患者入选本研究,共计151例患者分为药物洗脱支架组(n=102)和金属裸支架组(n=49),两组的基本临床特征和冠状动脉造影结果差异无统计学意义。术前、术后和随访6～12个月时进行定量冠状动脉造影分析,并在住院期间、30天和6～12个月时观察严重不良心脏事件的发生。结果:151例患者支架置入成功率均为100%。住院期间严重不良心脏事件发生率,在药物洗脱支架组和金属裸支架组差异无统计学意义(0%和2.0%,P=0.15)。在随访30天时,两组均无死亡和支架内血栓形成。6～12个月随访期间,药物洗脱支架组和金属裸支架组比较①严重不良心脏事件发生率(3.9%vs8.1%,P=0.97),②靶病变重复血管重建率(2.9%vs6.1%,P=0.39),③急性心肌梗死发生率(1.96%vs2.04%,P=0.95),差异均无统计学意义。12个月时药物洗脱支架组和金属裸支架组比较,支架内血栓发生率和病死率差异也无统计学意义(1.96%vs0%,P=0.34;0%vs4.08%,P0.05)。定量冠状动脉造影分析显示:远期管腔丢失药物洗脱支架组明显低于金属裸支架组[(0.23±0.73)mmvs(0.95±0.94)mm,P=0.01],两组比较差异有统计学意义;而支架内再狭窄率两组比较差异无统计学意义(12.9%vs25.0%,P=0.34)。结论:药物洗脱支架和金属裸支架对于治疗自身冠状动脉临界病变安全有效,两组远期严重不良心脏事件发生率差异无统计学意义。     

药物洗脱球囊与第二代药物洗脱支架治疗药物支架内再狭窄的观察性研究

目的:对中国汉族人群中药物洗脱球囊(DEB)和第二代药物洗脱支架(DES)内再狭窄(ISR)的疗效进行非劣效性比较。方法:连续入选2014年9月至2015年8月,因DES-ISR而接受DEB或第二代DES治疗的患者,根据所接受的治疗策略将患者分别纳入DEB组和第二代DES组。记录两组患者住院期间主要不良心血管事件(MACE)发生率,并于术后12个月通过电话或门诊进行临床随访。结果:共纳入DES-ISR患者183例,包括DEB组74例,DES组109例;根据Mehran分型,非点状病变患者147例。住院期间两组患者均未发生MACE;(12.4±2.9)个月临床随访发现,DEB组共发生MACE 8例,包括心源性死亡1例、非致死性心肌梗死(MI)2例和靶血管血运重建(TVR)6例;第二代DES组MACE 3例,均为TVR。DEB组的MACE发生率高于第二代DES组(11.0%vs.2.8%,P=0.03),并且DEB组的无事件生存率劣于第二代DES组(89.0%vs.97.2%,P非劣效=0.94),而在非点状病变患者中,DEB组患者的无事件生存率仍劣于第二代DES组患者(87.9%vs.96.6%,P非劣效=0.92)。结论:药物洗脱球囊在中国汉族人群中治疗药物洗脱支架内再狭窄的疗效劣于第二代药物洗脱支架,且在非点状病变患者中仍劣于第二代药物洗脱支架。     

药物洗脱支架和金属裸支架对高龄患者安全性和效果的研究

目的:对比评价药物洗脱支架和金属裸支架对75岁以上高龄患者的安全性和有效性.方法:2005-11至2006-12我院75岁以上接受冠状动脉支架置入术的患者269例,年龄在75～87岁;其中,药物洗脱支架组140例,金属裸支架组129例.30天、6～12个月进行临床随访,对比2组全因死亡和主要不良心脏事件(MACE,包括心脏性死亡,非致死性心肌梗死和靶病变血运重建的发生率).结果:药物洗脱支架组支架直径显著小于金属裸支架组(P＜0.05),支架长度显著大于金属裸支架组(P＜0.05).30天MACE药物洗脱支架组与金属裸支架组差异无统计学意义(P＞0.05).术后6～12月随访,两组只有靶病变血运重建率在药物洗脱支架组显著低于金属裸支架组(P＜0.001),在总随访率、造影复查率、造影复查时间、MACE和全因死亡率等之间均无显著差异(P均＞0.05).药物洗脱支架组晚期血栓发生率为1.4%,金属裸支架组未见晚期血栓发生.结论:药物洗脱支架和金属裸支架对75岁以上的高龄患者具有同样的疗效和安全性,并且MACE有减少的趋势,但药物洗脱支架有发生晚期血栓的可能性.     

Firebird2~(TM)和Excel药物洗脱支架治疗冠心病的近期疗效比较

目的:比较Excel药物洗脱支架和Firebird 2TM药物洗脱支架在冠心病患者中应用的近期疗效。方法:将2009年12月至2010年9月,在安贞医院连续住院的264例原位冠状动脉病变的患者,纳入本项前瞻性随机对照研究。其中137例仅置入Firebird 2TM药物洗脱支架,127例仅置入Excel药物洗脱支架。规律随访患者,比较2组患者支架术后的心脏不良事件发生率。随访的具体内容包括主要终点事件(全因死亡、靶血管血运重建、非致死性心肌梗死、血栓事件)和次要终点事件(不稳定心绞痛、缺血性脑卒中及心功能衰竭)。分析支架多聚物涂层对心脏不良事件的影响。结果:2组患者年龄、性别、吸烟史、高血压、脂质异常、糖尿病、既往介入治疗、既往心肌梗死、既往冠状动脉旁路手术及本次入院诊断急性心肌梗死所占比例方面差异均无统计学意义。Firebird 2TM药物洗脱支架组患者平均支架个数较Excel药物洗脱支架组个数分别为(1.93±1.13)个和(1.57±0.94)个。临床随访1.84～10.78个月,平均(5.36±1.91)个月,2组患者均未发生心源性死亡、靶病变血管导致的心肌梗死、靶病变缺血导致的血运重建及支架血栓事件。Firebird 2TM药物洗脱支架组患者不稳定心绞痛1例,心力衰竭(心衰)1例,Excel药物洗脱支架组,不稳定心绞痛3例,心衰1例,Kaplan-Meier生存曲线显示2组患者全部终点事件没有差别。结论:Firebird 2TM药物洗脱支架和Excel药物洗脱支架,在冠心病患者中应用的近期安全性方面疗效相似。     

佐他莫司洗脱支架与依维莫司洗脱支架5年临床疗效比较

目的比较佐他莫司和依维莫司两类药物洗脱支架的长期临床安全性和有效性。方法纳入2011年1月至2012年12月于武汉亚洲心脏病医院接受经皮冠状动脉介入治疗的患者480例,根据置入支架类型,分为佐他莫司洗脱支架组(ZES组,244例)和依维莫司洗脱支架组(EES组,236例)。随访5年的临床疗效。初级终点是主要不良心血管事件,包括全因死亡、非致死性心肌梗死、靶血管再次血运重建。次级终点为支架内再狭窄及支架内闭塞。结果 5年随访结果显示,两组患者全因死亡率和非致死性急性心肌梗死发生率比较,差异均无统计学意义(均P0.05)。EES组患者靶血管再次血运重建(5.1%比10.2%,P=0.040)、支架内再狭窄(5.9%比11.5%,P=0.036)和支架内闭塞(2.1%比6.1%,P=0.038)发生率均显著低于ZES组,差异均有统计学意义。结论 EES的5年临床安全性和有效性优于ZES。     

依维莫司药物洗脱支架和西罗莫司药物洗脱支架对冠心病疗效的Meta分析

目的比较依维莫司药物洗脱支架(everolimus-eluting stent,EES)与西罗莫司药物洗脱支架(sirolimuseluting stent,SES)治疗冠状动脉粥样硬化性心脏病(冠心病)的疗效。方法计算机检索Pub Med、MEDLINE、Cochrane Central Register of Controlled Trials、CNKI全文数据库,收集2007年1月至2013年12月公开发表的有关EES和SES疗效比较的随机对照试验(randomized controlled trials,RCT),手检已获文献的参考文献、会议摘要及相关网站。对文献质量进行严格评价后,对符合要求的RCTs进行资料提取并采用Rev Man4.2软件进行Meta分析。结果共纳入14项RCTs,Meta分析显示,EES组与SES组之间主要心血管事件(MACE)发生率(OR=0.94,95%CI:0.76~1.17,P=0.60)、心源性死亡发生率(OR=0.97,95%CI:0.74~1.27,P=0.81)、心肌梗死发生率(OR=1.03,95%CI:0.83~1.27,P=0.80)、血运重建发生率(OR=0.89,95%CI:0.76~1.04,P=0.15)均差异无统计学意义;但EES组确定或者可能的支架内血栓发生率低于SES组,差异有统计学意义(OR=0.65,95%CI:0.44~0.97,P=0.04)。结论在冠心病支架介入治疗中,EES能更显著降低支架术后的支架内血栓的发生率,但在主要心血管事件发生率、心源性死亡发生率、心肌梗死发生率、血运重建发生率与SES相似。     

药物洗脱支架置入术后晚期支架内再狭窄患者再次介入治疗的短期预后及危险因素分析

目的:本研究旨在探索老龄和非老龄药物洗脱支架置入术后晚期支架内再狭窄(L-ISR)患者的临床特征,再次经皮冠状动脉介入治疗(PCI)后的短期预后及相关危险因素。方法:共入选218例在我院初次置入药物洗脱支架并于2016年因L-ISR而需要再次入院接受治疗的患者。根据患者年龄分为老龄组(年龄≥65岁,n=77)和非老龄组(年龄<65岁,n=141)。患者的入院特征、临床表现以及介入治疗特点和手术结果等被纳入分析评估,并随访患者PCI后12个月内的主要不良心血管事件(MACE)包括心原性死亡、非致死性心肌梗死及靶病变血运重建(TLR)。结果:L-ISR患者中75.7%的患者因不稳定性心绞痛入院,64.7%的患者再次置入支架。与非老龄组相比,老龄组有更高比例的脑卒中、心房颤动、既往冠状动脉旁路移植术并且支架置入至发现支架内再狭窄的时间更长,体重指数(BMI)更小、冠心病家族史比例更低(P均<0.05)。两组患者入院时的临床症状表现相似,主要表现为不稳定性心绞痛,其他基线资料比较差异均无统计学意义(P均>0.05)。与老龄组患者相比,非老龄组患者的MACE发生率较高,但差异无统计学意义(6.4%vs 3.9%,P=0.546)。多因素回归分析发现,左心室收缩功能障碍(OR=6.317,95%CI:1.145~34.843, P=0.034)是L-ISR患者介入治疗后短期MACE发生的独立危险因素。结论:左心室收缩功能障碍与L-ISR患者短期MACE发生相关。在临床实践中,识别该类人群可能更有助于L-ISR患者的危险分层和二级预防。     

冠状动脉长病变患者置入雷帕霉素洗脱支架和紫杉醇洗脱支架2年临床观察

目的 评价冠状动脉长病变患者成功置入Firebird雷帕霉素洗脱支架和Taxus紫杉醇洗脱支架2年后的有效性和安全性.方法 本研究入选了2004年4月至2006年10月期间,在阜外心血管病医院行择期经皮冠状动脉介入治疗(PCI)的冠状动脉长病变患者826例.入选患者分为Firebird 组(666例)和Taxus组(160例).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 两组病变长度[(45.62±15.25) mm比(44.09±13.67)mm]及置入支架长度[(51.22±16.64) mm比(49.63±15.86)mm]相似(P＞0.05).术后2年,Firebird组靶病变血运重建率(3.46％比10.00％,P=0.0005)、靶血管血运重建率(5.42％比11.25％,P=0.008)及MACE发生率(10.99％比20.00％,P=0.002)方面显著低于Taxus组.两组患者术后2年支架肯定或可能血栓形成的发生率差异均无统计学意义.经倾向性评分调整后,与Taxus组相比,应用Firebird支架治疗的患者在术后2年时MACE风险降低(危险比0.622,95％ CI:0.401 ～0.965,P=0.034),而其他临床事件的风险比差异无统计学意义.结论 对于冠状动脉长病变患者而言,使用Firebird雷帕霉素洗脱支架MACE发生率较低,而靶病变血运重建率和靶血管血运重建率方面不劣于Taxus紫杉醇洗脱支架,且风险有下降趋势.     

药物洗脱支架联用普通金属支架治疗多支冠状动脉病变的疗效评价

目的探讨多支冠状动脉病变患者药物洗脱支架与普通金属支架(普通支架)联用预防再狭窄的疗效及安全性。方法801例行多支冠状动脉内支架置入术达到完全血运重建的冠心病患者分3组。药物洗脱支架组206例、药物洗脱支架与普通支架联用组(联用组)158例及普通支架组437例。比较3组支架术后近期及远期结果。结果3组患者冠心病危险因素、心功能、冠状动脉病变程度、支架术成功率及并发症发生率均无显著差异。术后平均随访(17.3±10.9)个月,总随访率和造影随访率无显著差异。联用组普通支架置入于31.3%的前降支病变(均为A、B1型病变)及81.6%的回旋支病变和69.9%的右冠状动脉病变。与普通支架组相比,药物洗脱支架组和联用组造影再狭窄率明显降低,分别为20.3%vs7.3%和8.8%(P均<0.05),且主要不良心脏事件发生率均较低,分别为18.4%vs6.5%和9.9%(P均<0.05)。但药物洗脱支架组与联用组相比上述各指标无显著差异。结论多支冠状动脉病变患者单用药物洗脱支架或合理联用普通支架后再狭窄率降低,安全性近似,均优于单用普通支架。     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 2011 Wiley Periodicals, Inc.     

Comparison of 2‐year outcomes between zotarolimus‐eluting and everolimus‐eluting new‐generation cobalt–chromium alloy stents in real‐world diabetic patients

Background : To date, it remains unknown whether different types of new‐generation drug‐eluting stents have a differential impact on long‐term outcomes in diabetic patients. Methods and Results : In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new‐generation CoCr zotarolimus‐eluting stents (R‐ZES: 136 patients, 196 lesions) or everolimus‐eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2‐year follow‐up period. MACE was defined as all‐cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R‐ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2‐year follow‐up, there was no significant difference in occurrence of MACE (R‐ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all‐cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity‐score matching did not alter the aforementioned associations. Conclusion : After 2 years of follow up similar outcomes (MACE, all‐cause mortality/MI, TLR) were observed in real‐world diabetic patients, including those with complex lesions and patient characteristics, treated with R‐ZES and EES. © 2015 Wiley Periodicals, Inc.     

Clinical outcomes of everolimus- and zotarolimus-eluting stents in patients with acute myocardial infarction for small coronary artery disease

Background and purposeThere were limited data about comparison of zotarolimus-eluting stents (ZES) and everolimus-eluting stents (EES) in patients with small coronary artery disease (CAD), especially in patients with acute myocardial infarction (AMI). The objective of this study was to compare the clinical outcomes of ZES and EES in patients with AMI for small CAD.Methods and subjectsA total 1565 AMI patients treated with Endeavor-ZES (n = 651) (Medtronic CardioVascular, Santa Rosa, CA, USA) or Xience V/Promus-EES (n = 914) (Abbott Vascular, Temecula, CA/Boston Scientific, Natick, MA, USA) for small CAD (stent diameter ≤2.75 mm) in KAMIR (Korea Acute Myocardial Infarction Registry) were enrolled. After propensity score matching to adjust for baseline clinical and angiographic characteristics, we compared a total 1302 patients (651 ZES and 651 EES) about major adverse cardiac events (MACE) at 1-year. Subgroup analysis about 1-year clinical outcomes was undertaken in patients who were discharged alive.ResultsBaseline clinical and angiographic characteristics were similar between the two groups after propensity score matching. Total MACE did not differ between the two groups before (9.8% vs. 8.2%, p = 0.265) and after (9.8% vs. 9.4%, p = 0.778) propensity score matching. The EES group showed lower rate of 1-year cardiac death (5.4% vs. 3.3%, p = 0.041), target lesion failure (TLF; 6.9% vs. 4.3%, p = 0.022), and stent thrombosis (1.4% vs. 0.4%, p = 0.042) compared with the ZES group. However, there were no differences in 1-year cardiac death, TLF, and stent thrombosis in propensity score matched populations. Other various 1-year clinical outcomes showed no difference between the two groups. Subgroup analysis in patients who were discharged alive showed similar outcomes between the two groups at 1-year follow-up.ConclusionIn-this propensity score matched analysis, EES and ZES showed no significant difference in clinical outcomes at 1-year follow-up in patients with AMI for small CAD.     

Three-Year Outcomes After Revascularization With Everolimus- and Sirolimus-Eluting Stents From the SORT OUT IV Trial

ObjectivesThe study sought to compare the risk of late outcome with a focus on very late definite stent thrombosis of the everolimus-eluting stent (EES) with that of the sirolimus-eluting stent (SES) at 3-year follow-up.BackgroundIn the SORT OUT IV (SORT OUT IV Trial), comparing the EES with the SES in patients with coronary artery disease, the EES was noninferior to the SES at 9 months. The SORT OUT IV trial provides long-term head-to-head randomized comparison of the EES with the SES.MethodsWe prospectively randomized 2,774 patients in the SORT OUT IV trial. Follow-up through 3 years was complete in 2,771 patients (99.9%). The 3-year pre-specified endpoints were composites of safety and efficacy (major adverse cardiac events [MACE]: cardiac death, myocardial infarction, target vessel revascularization, and definite stent thrombosis).ResultsAt 3 years, the composite endpoint MACE occurred in 9.8% of the EES group and in 11.1% of the SES group (hazard ratio [HR]: 0.89, 95% confidence interval [CI]: 0.70 to 1.12). Overall rate of definite stent thrombosis was lower in the EES group (0.2% vs. 1.4%; HR: 0.15, 95% CI: 0.04 to 0.50), which was largely attributable to a lower risk of very late definite stent thrombosis: 0.1% versus 0.8% (HR: 0.09, 95% CI: 0.01 to 0.70).ConclusionsAt 3-year follow-up, the MACE rate did not differ significantly between EES- and SES-treated patients. A significant reduction of overall and very late definite stent thrombosis was found in the EES group. (The SORT OUT IV TRIAL [SORT OUT IV]; NCT00552877).     

A Randomized Comparison between Everolimus-Eluting Stent and Cobalt Chromium Stent in Patients with Acute ST-Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention Using Routine Intravenous Eptifibatide: The X-MAN (Xience vs. Multi-Link Stent in Acute Myocardial Infarction) Trial,A Pilot Study

The objective of this study is to determine the efficacy and safety of an everolimus-eluting stent (EES/Xience; Abbott Vascular, Santa Clara, CA) compared with a cobalt chromium stent (CoCr/Multi-Link Vision; Abbott Vascular) in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) with routine administration of eptifibatide infusion. This is a prospective, single center, randomized trial comparing EES (n = 75) and CoCr stent (n = 75) implantation in patients with acute STEMI undergoing primary PCI. Intravenous eptifibatide administration was mandatory by protocol in this pilot study. The primary efficacy endpoint was major adverse cardiac events (MACE) at 30 days, defined as the composite of death, reinfarction, and target vessel revascularization. Secondary safety endpoints were stent thrombosis at 30 days and in-hospital bleeding event. Acute reperfusion parameters were also assessed. One-month MACE rate did not differ between EES and CoCr group (1.3 vs. 1.3%, p = 1.0). No stent thrombosis cases were observed in the EES group. The groups did not differ with respect to in-hospital bleeding events (5 vs. 9%, p = 0.37), achievement of final thrombolysis in myocardial infarction flow 2 or 3 (p = 0.21), achievement of myocardial blush grade 2 or 3 (p = 0.45), creatine kinase-MB level at 8 to 12 hours after stenting (p = 0.29), and left ventricular ejection fraction (p = 0.21). This pilot study demonstrates that after one-month follow-up, the use of EES is as safe and effective as the use of CoCr stents in patients with acute STEMI undergoing primary PCI with routine administration of intravenous eptifibatide.     

7-Year Outcomes of a Randomized Trial Comparing the First-Generation Sirolimus-Eluting Stent Versus the New-Generation Everolimus-Eluting Stent: The RESET Trial

Objectives

The aim of this study was to compare 7-year outcomes between the first-generation sirolimus-eluting stent (SES) and the new-generation everolimus-eluting stent (EES) in a randomized clinical trial.

Extended follow‐up safety and effectiveness of the Endeavor zotarolimus‐eluting stent in real‐world clinical practice: Two‐year follow‐up from the E‐Five Registry

Objectives: To present data from the cohort of patients in the all‐comers Endeavor zotarolimus‐eluting stent (ZES) registry (E‐Five) who underwent 2‐year follow‐up. Background: The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E‐Five evaluated the ZES in over 8,000 real‐world patients, at 188 sites followed to 1 year. A subset of sites continued follow‐up through 2 years to evaluate late‐term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics. Methods: E‐Five, a prospective, multicenter, nonrandomized global registry, collected 2‐year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow‐up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis. Results: The outcomes in the 2‐year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively. Conclusions: Long‐term efficacy and safety outcomes were maintained between 1 and 2 years for the 2‐year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events. © 2010 Wiley‐Liss, Inc.     

Comparison of the performance of zotarolimus- and everolimus-eluting stents by optical coherence tomography and coronary angioscopy

Overall stent performance should be characterized by geometric luminal gain acquisition, neointimal coverage of the stent struts, and stabilization of the underlying inflammatory neoatheroma. The aim of this study was to compare the performance of zotarolimus-eluting stent (ZES), everolimus-eluting stent (EES) and bare metal stent (BMS) using optical coherence tomography (OCT) and coronary angioscopy. For 36 stented coronary lesions (BMS, 12 lesions; ZES, 11 lesions; EES, 13 lesions) in 27 patients, we calculated neointimal area and uncovered stent strut rate based on OCT findings at 10 months after stent placement. The grades of neointimal coverage and yellow color, both of which were classified from 0 to 3, were also assessed by coronary angioscopy. The plaque area of the ZES lesions was larger than that of the EES lesions (P < 0.05) but smaller than that of the BMS lesions (P < 0.05). The OCT-based uncovered rate of the ZES lesions was less than that of the EES lesions (P < 0.01), but similar to that of the BMS lesions. The stent coverage grade by angioscopy was higher in the ZES lesions than in the EES lesions (P < 0.05), but similar to the BMS lesions. The yellow grade was less in the ZES lesions than in the EES lesions (P < 0.01), but similar to the BMS lesions. ZES might be better than BMS in terms of neointimal thickening, and better than EES in terms of neointimal coverage as well as prevention of neoatheroma formation. ZES may have superior performance compared with EES.     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

心肌桥介入治疗后支架内再狭窄及其再次治疗效果的观察

目的观察心肌桥病变介入治疗的再狭窄率及其治疗效果。方法选择有症状的单纯心肌桥改变且收缩期严重狭窄(≥95%)者17例作治疗组(A组),对照组选择单纯前降支动脉粥样硬化严重狭窄(≥70%)者54例(B组),两组均应用普通冠脉支架介入治疗。结果两组介入手术均成功,两组支架植入后的血管内径及支架长度比较无显著差别(P>0.05)。A组6个月内8例(47%)出现再狭窄,B组8例再狭窄(14.8%),A组和B组的再狭窄率有显著差别(P<0.05);两组中再狭窄病人均再次接受治疗。平均随访20月,A组8例中7例未再发生支架内狭窄及心绞痛事件,1例再次支架内狭窄,B组再次介入治疗的6例中1例再次支架内狭窄。结论心肌桥病变的介入治疗远期疗效尚好,但远期支架内再狭窄率较高,需再次介入治疗。