药物洗脱支架治疗冠状动脉支架内再狭窄和冠状动脉原发病变的随访研究

目的:比较药物洗脱支架(DES)治疗早期(≤1年)、晚期(1年)支架内再狭窄病变(ISR)与冠状动脉原发病变(De novo)患者的长期临床疗效。方法:收集自2008年10月至2011年12月,北京安贞医院因ISR接受DES置入治疗并完成临床随访的患者资料,根据DES术后发生ISR的时间是否1年分为早期ISR组与晚期SR组。选择同期因冠状动脉原发病变(De novo)置入DES治疗的部分患者作为冠状动脉原发病变组(De novo组)。比较三组患者术后1年的主要不良心血管事件[MACE,包括全因死亡、心肌梗死(MI)和靶病变再次血运重建(TLR)]。结果:早期ISR组入选患者80例,晚期ISR组入选患者124例,De novo组入选患者494例。早期ISR组和晚期ISR组糖尿病患病率明显高于De novo组,差异有统计学意义(36.3%vs.41.1%vs.27.1%,P0.01);早期ISR组不稳定型心绞痛比例明显低于晚期ISR组和De novo组,差异有统计学意义(27.5%vs.63.7%vs.70.6%,P0.01);其余基线资料差异无统计学意义(P0.05)。三组在病变部位、病变类型及病变长度方面比较,差异均无统计学意义(P0.05),而早期ISR组与晚期ISR组直径明显小于De novo组,差异有统计学意义[(2.71±0.36)vs.(2.68±0.41)vs.(3.08±0.54)mm,P0.01)]。早期ISR组MACE发生率明显高于晚期ISR组与De novo组(30%vs.15.3%vs.14.2%,P0.01),其中早期ISR组TLR明显高于晚期ISR组与De novo组,差异有统计学意义(26.3%vs.12.1%vs.10.7%,P0.01),而晚期ISR组与De novo组比较差异无统计学意义(15.3%vs.14.2%,P0.05)。结论:DES治疗ISR患者安全有效,但治疗早期ISR组病变TLR发生率高于晚期ISR组及De novo病变。     

冠心病PCI术后支架内再狭窄的相关因素分析

目的分析冠心病患者经皮冠状动脉介入治疗(PCI)术后支架内再狭窄(ISR)的影响因素。方法选取2007年1月至2016年1月在遵义医学院附属医院心内科成功行支架植入术的冠心病患者1342例,依据复查造影结果分为ISR组(89例)和非ISR组(1253例)。回顾性分析两组患者病史资料、血液生物化学指标、心脏超声指标、冠状动脉病变、支架情况、服药情况及主要不良心血管事件(MACE)等,采用多因素Logistic回归分析其与冠状动脉支架术后ISR的关系。结果入选患者ISR发生率为6.6%。ISR组糖尿病患病率、术后吸烟率、停用阿司匹林、1年内停用氯吡格雷患者比例明显高于非ISR组(P0.05);ISR组服用大剂量他汀患者比例低于非ISR组(P0.05)。ISR组复杂病变、串联支架数高于非ISR组(P0.05);ISR组植入支架长度较非ISR组长(28.43±6.58 mm比26.27±7.08 mm,P=0.001);ISR组植入支架直径(2.92±0.41 mm比3.04±0.43 mm,P=0.003)、术后最小管腔内径(MLD)(2.44±0.34 mm比2.57±0.35 mm,P0.001)较非ISR组偏小;ISR组术后直径狭窄率高于非ISR组(8.46%比7.60%,P=0.018);ISR组早期获得低于非ISR组(1.77±0.43 mm比1.87±0.43 mm,P=0.043)。多因素Logistic回归分析显示,糖尿病、术后吸烟、停用阿司匹林、支架长度、支架直径、串联支架、术后MLD、术后直径狭窄率为冠状动脉支架术后ISR的独立危险因素。随访至8个月发现,ISR组复发心绞痛、靶病变再次血运重建(TLR)、复合MACE发生率明显高于非ISR组(P0.001);随访至1年发现,ISR组复发心绞痛、TLR、心肌梗死(MI)、复合MACE发生率明显高于非ISR组(P0.05)。ISR组支架血栓发生率明显高于非ISR组(P0.001)。结论糖尿病、吸烟、停用阿司匹林、支架直径、支架长度、串联支架、术后MLD、术后直径狭窄率是PCI术后ISR的危险因素,PCI术后ISR可能增加MACE发生率。     

支架内再狭窄病变分型对单纯紫杉醇药物涂层球囊治疗患者预后的影响

目的 研究在单纯紫杉醇药物涂层球囊(PCB)治疗条件下，支架内再狭窄(ISR)分型与患者临床预后的关系。 方法 从2015年12月至2017年6月在我院行冠状动脉造影证实为ISR并行单纯PCB治疗的283例患者中筛选出仅具有单个靶病变的患者246例。将这246例患者分为局灶型病变组（n = 101）及非局灶型病变组（n = 145）。主要终点事件为术后12个月靶病变血运重建（TLR），次要终点事件为12个月主要心血管不良事件（MACE），包括TLR、心源性死亡、心肌梗死（MI），及靶血管血运重建、全因性死亡、支架内血栓形成。 结果 两组患者临床基线资料无显著差异。非局灶组普通预扩球囊的使用率高于局灶组（P < 0.01），长度较长（P = 0.01）。局灶组切割球囊的直径大于非局灶组（P<0.01）。同时局灶组药物涂层球囊直径大于非局灶组（P<0.01），而长度小于非局灶组（P < 0.01）。随访12个月显示非局灶组的血运重建、TLR(P < 0.05)、MACE等事件的发生率均显著高于局灶组（均P < 0.05）。对这246例患者做无事件生存率分析显示局灶组无TLR事件生存率及无MACE事件生存率均显著优于非局灶组(均P < 0.05)。 结论 ISR分型是单纯PCB治疗后患者临床事件发生的重要预测因素；PCB应用于支架内再狭窄病变是安全有效的。     

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。     

老年急性ST段抬高心肌梗死患者应用国产雷帕霉素药物洗脱支架5年临床随访

目的评估老年急性ST段抬高心肌梗死(STEMI)患者应用国产支架的长期安全性。方法入选年龄≥60岁的急性STEMI患者113例,随机分为国产雷帕霉素药物洗脱支架(DES)组56例和金属裸支架(BMS)组57例。随访5年,观察支架内血栓形成和主要心脏不良事件(MACE)发生率情况。结果 5年随访期间,DES组与BMS组病死率分别为7.1%和7.0%(P>0.05);DES组靶病变重建、MACE分别为10.7%、23.2%,BMS组分别为28.1%、42.1%(P<0.05)。DES组支架内血栓、极晚期支架内血栓发生率分别为8.9%、3.6%;BMS组分别为7.0%、1.8%,2组比较差异无统计学意义。结论老年急性STEMI患者应用国产雷帕霉素DES较BMS明显降低MACE,且极晚期血栓发生率无明显升高。     

支架内再狭窄病变再次介入治疗后造影复查结果分析

目的:评价支架内再狭窄(ISR)病变再次行介入治疗后的造影复查结果,试图寻找合适的治疗方法。方法:行冠状动脉再狭窄病变介入治疗后进行冠状动脉造影复查的患者58例,分析其临床资料及冠状动脉造影图像。根据再次介入治疗方法不同分为置入药物支架(DES)和非DES治疗(包括单纯球囊扩张、双导丝球囊或切割球囊扩张、放射治疗和裸支架置入)组,分析再狭窄率及主要心血管不良事件(MACE)发生情况。结果:共涉及58处ISR病变,前降支病变占56.90%;70.69%为裸支架的ISR病变;32.76%的病变为支架内局限性狭窄,支架内弥漫性狭窄病变占18.97%,10.24%为支架完全闭塞病变;其中50%的ISR患者接受了病变处DES治疗,20.69%接受了单纯的普通球囊扩张;复查造影时间为平均(13.12±8.03)个月;ISR病变DES组发生病变处再狭窄和发生MACE情况明显低于接受其他治疗组(再狭窄发生率17.24%:51.72%,P<0.05;MACE发生率20.69%:51.72%,P<0.05);对有可能影响ISR病变介入治疗后再次发生ISR的各种因素进行Logistic分析可见,再次治疗的方法是再次发生ISR的独立危险因素。结论:对于ISR病变置入DES近中期效果明显优于其他介入治疗方法。     

血管内皮生长因子、支架直径和支架长度对支架内再狭窄的联合预测价值

目的 探讨血管内皮生长因子（vascular endothelial growth factor,VEGF）、支架直径和支架长度对冠状动脉药物洗脱支架(drug-eluting stent, DES)置入术后支架内再狭窄（in-stent restenosis,ISR）患者的联合预测价值。 方法 收集2014年6月至2016年8月在承德市中心医院心内科行DES置入的不稳定型心绞痛患者332（男178,女154）例。根据术后1年复查冠脉造影结果将其分为ISR组（n=41）和非ISR组（n=291）,比较两组的一般临床资料及冠脉支架手术资料。采用酶联免疫吸附试验（ELISA）测定冠脉支架置入术前、术后6个月、术后12个月患者血清VEGF的水平,比较两组间VEGF的表达差异。 结果 ISR组及非ISR组患者术前VEGF水平无明显差异[（499±39）ng/L vs（503±35）ng/L];术后两个时间点ISR组VEGF水平显著低于非ISR组[（377±33）ng/L vs（462±56）ng/L;（184±34）ng/L vs（361±45）ng/L],差异均有统计学意义（均P<0.01）。Logistic回归分析表明:术后VEGF水平（OR=0.95,95%CI:0.92-0.97;P<0.01）是ISR的保护性因素;2型糖尿病（OR=14.81,95%CI:1.96-111.81;P<0.01）、术后吸烟（OR=32.74,95%CI:4.74-226.03;P<0.01）与ISR密切相关,是ISR的独立危险因素;支架长度（OR=1.26,95%CI:1.09-1.46;P<0.01）与ISR成正相关;支架直径（OR=0.03,95%CI:0.00-0.23;P<0.01）与ISR呈反相关。经绘制ROC曲线及支架直径、支架长度的联合指标的ROC曲线显示VEGF对ISR的预测价值较好,而VEGF联合支架长度及直径指标优于单独指标。 结论 术后VEGF水平与ISR密切相关,是ISR的一项独立预测因素,可作为临床评估ISR的一项指标,而VEGF联合支架直径和支架长度指标对预测ISR效能最优。     

雷帕霉素洗脱支架治疗多支冠状动脉病变的临床研究

目的:探讨多支冠状动脉病变患者置入雷帕霉素洗脱支架(Cypher支架)预防再狭窄的疗效及安全性。方法:2001年12月-2004年5月连续725例接受多支冠状动脉支架置入术的冠心病患者,剔除急性心肌梗死及再次血运重建患者。Cypher支架组187例,普通金属支架(普通支架)组538例。比较两组支架术后的近期及远期结果。结果:除糖尿病患者比例在Cypher支架组较高外,两组患者冠心病危险因素、心功能、冠状动脉病变严重程度、介入手术成功率及并发症发生率均无显著差异。690例患者平均随访(18.8±11.7)个月,Cypher支架组和普通支架组造影随访率分别为52.4%vs58.2%(P>0.05)。尽管Cypher支架组患者冠心病危险因素多、平均年龄63.5岁、不稳定性心绞痛占66.3%、糖尿病占41.6%、3支血管病变占57.8%、B2/C型复杂病变占86.2%,但造影复查再狭窄率和主要不良心脏事件(MACE)发生率均明显低于普通支架组(3.1%vs16.6%,5.5%vs16.7%,P均<0.01),心功能改善率高于普通支架组(63.1%vs30.6%,P<0.01)。两组完全血运重建率无显著差异(81.3%vs86.8%,P>0.05),但发生MACE的患者中,Cypher支架组不完全血运重建者比例高于普通支架组(60.0%vs23.5%,P<0.05);两组发生MACE的患者中完全血运重建患者比例均低于本组总的完全血运重建率(Cypher支架组:40.0%     

不同药物洗脱支架四年临床结果比较

目的 观察雷帕霉素与紫杉醇药物洗脱支架(DES)置入后再狭窄率、支架内血栓形成及4年临床结果.方法 回顾性分析2003年1-10月连续237例置入DES患者6个月再狭窄率与靶病变重建率(TLR)、4年随访主要不良心脏事件(MACE)、靶血管重建(TVR)和支架血栓形成的发生率.结果 雷帕霉素组与紫杉醇组比较,6个月两组TLR、支架内再狭窄、MACE、心肌梗死差异均无统计学意义,但后者有更高的晚期管腔丢失(P=0.022).4年免于TVR生存率分别为88.97%与82.28%(P=0.127),免于MACE生存率分别为83.8%与79.2%(P=0.056).多变量分析每个病变置入支架数(P=0.001)和糖尿病(P=0.001)与TVR相关,多支病变(P=0.0013)和糖尿病(P:0.0001)与MACE相关.4年总的支架内血栓发生率(1.47%与1.98%)无统计学意义,肯定的很可能的和可能的支架内血栓形成两组之间也无统计学意义(P>0.05).结论 两种药物洗脱支架均具有较好的安全性和临床近、远期效果,但紫杉醇洗脱支架晚期管腔丢失较多.     

Vascular brachytherapy for patients with drug-eluting stent restenosis

Background: The rate of drug‐eluting stent (DES) in‐stent restenosis (ISR) exceeds 10% in complex subsets of patients and lesions. The optimal management of DES ISR remains undetermined. Vascular brachytherapy (VBT) is proven to be effective for the treatment of bare metal stent ISR but its outcome for DES ISR has not been established. Methods: Ninety‐nine consecutive patients who presented with ISR following DES implantation in 122 lesions were subjected to conventional percutaneous coronary intervention with adjunct VBT using either beta radiation (Beta Rail in 74 patients [82.2%] and the Galileo system in 13 patients [14.4%]) or gamma radiation (Checkmate system in 3 patients [3.3%]). Patients were followed clinically for major adverse cardiac events (MACE) during 1‐year follow‐up. Results: A high proportion of patients in this cohort presented with complex ISR; 31.1% had recurrences of ISR to the same site, 55% had diffuse or proliferate pattern of restenosis, and 23 lesions (18.9%) were located in a saphenous vein graft. Procedural success and uneventful in‐hospital course were documented in all patients post VBT. At 12 months' follow‐up, the target lesion revascularization (TLR) rate was 11% and the overall MACE rate was 26%. Patients with multiple episodes of ISR to the same site had a TLR of 16% and MACE rate of 35.5%. Conclusions: VBT for the treatment of DES ISR was found to be effective and safe and should be considered for the treatment of DES ISR, in particular in complex patients with multiple recurrences.     

Same or Different Drug‐Eluting Stent Re‐Implantation for Drug‐Eluting Stent Restenosis: An Assessment Including Second‐Generation Drug‐Eluting Stents

Objectives

We examined the long‐term outcomes of implanting a different type of drug‐eluting stent (DES), including second‐generation DES, for treatment of DES‐in stent restenosis (ISR).

Background

Treatment for DES‐ISR has not been standardized.

Methods

The subjects were 80 patients with 89 lesions underwent DES implantation for DES‐ISR. The patients were divided into the group of patients receiving the same DES for DES‐ISR (Homo‐stent: 24 patients, 25 lesions) and a different DES for DES‐ISR (Hetero‐stent: 56 patients, 64 lesions). The primary endpoint was survival free of major adverse cardiovascular events (MACE), including cardiac death, myocardial infarction, and target vessel revascularization (TVR). The secondary endpoint was late loss at 8–12 months follow‐up. In the subgroup of patients who were treated with second‐generation DES for DES‐ISR, we also assessed the survival free of MACE.

Results

During a mean follow‐up of 45.1 ± 21.2 months, 26 patients experienced MACE. There was no significant difference in the survival free of MACE (Log rank P = 0.17). In the sub‐analysis of second generation DES, MACE was significantly higher in the Homo‐stent group compared to the Hetero‐stent group (Log rank P = 0.04). Late loss was significantly higher in the Homo‐stent group than in the Hetero‐stent group (0.86 ± 1.03 vs. 0.38 ± 0.74 mm, P = 0.03). This trend was prominent in the first‐generation DES group.

Conclusions

Although there was no significant difference in MACE between the Hetero‐stent and the Homo‐stent groups including both first and second‐generation DES, the sub‐analysis demonstrated different DES implantation for DES‐ISR significantly improved the MACE rate among patients treated with second‐generation DES. (J Interven Cardiol 2016;29:311–318)

     

Long-term outcomes after management of restenosis or thrombosis of drug-eluting stents.

OBJECTIVES: The purpose of this study was to examine the outcomes of patients who developed coronary in-stent restenosis (ISR) or stent thrombosis (STH) inside drug-eluting stents (DES). BACKGROUND: Drug-eluting stents have markedly reduced the incidence of restenosis. However, when restenosis occurs within a DES, its optimal management remains unclear. METHODS: We retrospectively analyzed clinical and angiographic data from 92 patients who underwent revascularization for ISR (n = 84) or STH (n = 8) within a DES at our institution. Regular follow-ups were available up to 2 years. We recorded the occurrence of major adverse cardiac events (MACE), defined as deaths from all causes, myocardial infarction (MI), or target lesion revascularization (TLR), among patients treated by the "DES sandwich" technique or by other treatment methods. RESULTS: In-hospital MACE included 1 periprocedural MI and 2 deaths. Over a mean follow-up of 15 +/- 6 months, the overall rates of death, MI, and TLR were 8.7%, 2.2%, and 30.6%, respectively. By actuarial analysis, the 12-month TLR and MACE rates were 28.2% and 42.9%, respectively. CONCLUSIONS: Current treatments of ISR or STH in DES are associated with a high long-term rate of MACE.     

Comparison between drug-coated balloon angioplasty and second-generation drug-eluting stent placement for the treatment of in-stent restenosis after drug-eluting stent implantation

Even though drug-coated balloon (DCB) angioplasty has emerged as a treatment option for drug-eluting stent in-stent restenosis (DES–ISR), the most effective treatment strategy for DES–ISR is still under debate. Therefore, we compared long-term clinical outcomes following DCB treatment of DES–ISR with those following 2nd-generation drug-eluting stent (DES) treatment. We identified 248 DES–ISR lesions in 238 patients that were treated with either 2nd-generation DES implantation (n = 56) or DCB angioplasty (n = 192). We compared the incidences of major adverse cardiac events (MACEs) in the two groups during the 2-year period following treatment. MACE was defined as cardiac death, non-fatal myocardial infarction, or target-vessel revascularization. The percentage of patients with diabetes and the mean age of patients in the DCB group were greater than in the DES group. The DCB group also had a smaller reference vessel diameter. The DES group had a larger post-intervention minimal luminal diameter. We found no significant difference in the MACE rate between the two groups during the 2 years following treatment (11.0 % in the DCB group vs. 8.9 % in the DES group, p = 0.660). Reference segment diameter was the only independent predictive factor for MACE in the post-treatment period (hazard ratio 0.35, 95 % confidence interval: 0.15–0.82, p = 0.016). Clinical efficacy of DCB angioplasty for treatment of DES–ISR was comparable to that of 2nd-generation DES implantation as measured by the rate of MACEs in the two groups. Reference segment diameter was the only statistically significant independent predictor for MACE in the 2-year period following treatment.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, Inc.     

Registry data evaluating the effectiveness of drug-eluting stents for the treatment of symptomatic in-stent restenosis

BACKGROUND: In this new-era of drug-eluting stents (DES) the impact of symptomatic in-stent restenosis (ISR) is diminishing. However, world wide bare-metal stents remain widely used and therefore, it is imperative to establish a simple and effective form of treatment. The objective of this registry database was to evaluate the 'real-world' effectiveness of DES for the treatment of symptomatic bare-metal stent ISR. METHODS: All patients presenting with symptomatic ISR were evaluated between February 2003 and February 2005. Patients had 9-month angiographic follow-up with primary endpoint evaluation of binary restenosis (>50%). Secondary endpoints included in-segment late loss, target lesion revascularization (TLR) and the difference in late loss between sirolimus (n=23) and paciltaxel (n=36) eluting stents. RESULTS: Fifty eight patients with fifty nine ISR lesions were evaluated, 36% of patients had diabetes mellitus. All procedures were performed safely with no adverse peri-procedural events documented. At 9-month follow-up the median in-segment late loss was 0.24 mm (IQR 0.1, 0.53), with a binary restenosis rate of 17%. At long-term follow-up greater than 1 year, the incidence of TLR was 10%. No difference in the angiographic parameter of in-segment late loss was seen between the sirolimus and paclitaxel-eluting stents. CONCLUSIONS: In this cohort of patients with long-term angiographic and clinical follow-up, DES is an effective and safe treatment for symptomatic bare-metal stent ISR.     

Incidence and predictors of recurrent restenosis following implantation of drug-eluting stents for in-stent restenosis.

OBJECTIVES: We investigated the incidence and predictors of recurrent restenosis after drug-eluting stent (DES) implantation for in-stent restenosis (ISR) in routine clinical practice. BACKGROUND: Although DESs have been increasingly used for treatment of ISR, little is known about the predictors of DES failure. METHODS: We determined the incidence of recurrent restenosis and major adverse cardiac events (MACE) in 224 consecutive patients with 239 lesions treated with sirolimus-eluting (n=217 lesions) or paclitaxel-eluting (n=22 lesions) stents for the first episode of ISR. RESULTS: The procedural success rate was 99.2%, and in-hospital complications did not occur in any patient. Follow-up angiography at 6 months was obtained in 73.7% of patients. Angiographic re-restenosis rate was 12.6%, and target lesion revascularization was required in 7.6% of patients. Of the 22 incidents of re-restenosis, 15 were focal (68.2%), 5 were diffuse (22.7%), and 2 were total (9.1%) restenosis. Univariate analysis showed that lesion length, use of paclitaxel-eluting stent, and number of stents per lesion were significant predictors of re-restenosis. In multivariate analysis, however, lesion length and use of paclitaxel-eluting stent were independent predictors of re-restenosis. During the follow-up (mean, 18.3+/-8.1 months), there were 4 deaths (1 cardiac, 3 noncardiac), but no nonfatal myocardial infarctions (MIs). MACE occurred in 18 patients. The cumulative probability of MACE-free survival was 92.9+/-1.8% at 1 year and 90.5+/-2.4% at 2 years. CONCLUSIONS: DESs are highly effective for treatment of ISR, with recurrent restenosis related to lesion length and type of DES.     

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.     

One-year outcomes with angiographic follow-up of paclitaxel-eluting balloon for the treatment of in-stent restenosis: insights from Spanish multicenter registry

Introduction: Even in the drug‐eluting stent (DES) era treatment of in‐stent restenosis (ISR) is still a relatively common problem for which a satisfactory solution is yet to be found. We wished to assess the efficacy of a new paclitaxel‐coated drug‐eluting balloon (DEB) in the treatment of these lesions. Methods: In this prospective multicenter registry 126 patients with ISR, treated with a new paclitaxel‐eluting balloon (3.0 μg/m² balloon surface area), were included. All lesions were predilated using conventional balloon angioplasty. The DEB was inflated for a minimum of 60 seconds. Dual antiplatelet therapy was recommended for at least 1 month. The only exclusion criteria were acute STEMI and cardiogenic shock. Results: Thirty‐three percent of patients were diabetic and 51% presented acutely. Interestingly, 48% had ISR of DES, 54% had ISR in a small vessel, and 29% involved bifurcation lesions. The pattern of ISR was focal in 59% and the most treated artery was the left anterior descending artery (LAD). Angiographic success was 96%. In 2 centers, repeat angiography was performed in 79% and restenosis observed in 6 patients (17.6%). MACE rate at a median of 12 (6–13) months was 16.7% (4.0% cardiac death, 4.0% MI, and 12.0% TLR). There was only 1 probable thombotic event (ARC). As compared with BMS‐ISR, patients with DES‐ISR were more often diabetic (40 vs. 28%) and had more re‐restenosis (TLR 14.8 vs. 9.2%). Conclusion: In a real‐world population, treatment of ISR (including 48% DES‐ISR) with this DEB provides good mid‐term results with 12% TLR at 1 year, especially in ISR pattern IC (9% MACE). (J Interven Cardiol 2011;24:518–528)