ST段抬高心肌梗死靶血管超长病变应用西罗莫司洗脱支架的临床与随访结果

目的:评价ST段抬高心肌梗死患者靶血管超长病变部位串联置入西罗莫司洗脱支架的安全性和有效性.方法:2007-01至2007-12间连续入选行急诊经皮冠状动脉介入治疗(PCI)的ST段抬高心肌梗死患者297例,资料均前瞻性录入数据库.筛选靶血管超长病变部位串联置入2枚或2枚以上西罗莫司洗脱支架的患者进行分析.终点分析指标:住院期间和随访6个月时的主要不良心脏事件(包括心因性死亡、非致死性心肌梗死和靶病变重建)发生率.结果: 研究期间内发现31例患者共计31处长病变置入2枚或以上支架.每位患者平均病变长度(47.2±10.3) mm,平均置入2.1枚支架,平均支架长度(53.2±10.5) mm,均获得手术成功.所有患者均完成临床随访,74.2%的患者完成6个月的冠状动脉造影随访.主要不良心脏事件发生率为8.7%,主要归因于靶病变重建,没有发生心因性死亡和致死性心肌梗死.结论:直接PCI过程中串联置入西罗莫司支架治疗靶血管长病变未产生不良后果,临床效果良好.其长期的安全性和有效性有待大规模的临床试验进一步证实.     

延迟支架置入术在高血栓负荷急性ST段抬高型心肌梗死患者急诊冠状动脉介入治疗中的应用

目的观察高血栓负荷急性ST段抬高型心肌梗死(STEMI)患者直接经皮冠状动脉介入治疗(PCI)后靶病变的变化及延迟支架置入情况。方法入选48例高血栓负荷STEMI患者,急诊予单纯球囊扩张和(或)冠状动脉血栓抽吸,梗死相关动脉前向血流心肌梗死溶栓试验(TIMI)血流分级3级,7 d后复查冠状动脉造影(CAG),根据靶病变血管狭窄情况必要时置入支架治疗。观察靶病变变化的相关数据,包括狭窄程度、长度、近端参考血管直径、远端参考血管直径,比较老年患者(≥60岁)和中青年患者(<60岁)支架置入比例。结果 7 d后复查CAG显示靶病变直径狭窄程度较直接PCI时减轻(35.5%±14.1%比48.8%±11.0%,P<0.01)、病变长度缩短[(15.69±5.36)mm比(18.94±5.37)mm,P<0.01],靶病变近端参考血管直径[(3.29±0.33)mm比(3.24±0.32)mm,P=0.02]和远端参考血管直径[(3.18±0.33)mm比(3.08±0.33)mm,P<0.01]增大;其中,39.6%(19/48)患者因靶病变狭窄>50%置入支架,老年患者和中青年患者置入支架比例分别是56%(9/16)、31%(10/32)(P=0.04)。结论对于中青年高血栓负荷不适宜直接支架置入术的STEMI患者急诊予单纯球囊扩张和(或)血栓抽吸即时开通梗死相关动脉,再延迟必要时支架置入治疗策略是安全、有效的。     

国产药物洗脱支架对急性ST段抬高心肌梗死患者的疗效观察

目的探讨国产雷帕霉素药物洗脱支架Firebird在急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择STEMI且在发病12h内接受急诊置入Firebird支架的患者96例,记录住院期间、术后9个月时不良心脏事件(MACE)的发生率。结果96处梗死相关病变置入150枚Firebird支架,支架置入成功率为100%,介入治疗后血流TIMI3级86例(89.6%),无复流现象3例,其中术中死亡1例;心脏破裂死亡2例;早期支架内血栓形成2例,其中死亡1例。住院期间MACE发生率为5.2%(5/96),PCI临床成功率为86.5%(83/96)。对82例患者进行了6～24个月的随访,平均(9.6±3.4)个月,因心力衰竭死亡2例,随访时MACE发生率2.4%(2/82)。结论国产雷帕霉素药物洗脱支架Firebird在STEMI急诊PCI中应用安全有效。     

生物可降解涂层药物洗脱支架在急性心肌梗死中的应用

目的探讨国产生物可降解涂层药物洗脱支架(Excel支架)在急性ST段抬高心肌梗死急诊PCI中应用的安全性和有效性。方法选择确诊为急性ST段抬高心肌梗死患者35例,于发病12h内行急诊冠状动脉造影和PCI治疗,冠状动脉造影后明确病变,然后于梗死相关血管的靶病变置入Excel支架。术后常规口服阿司匹林和氯吡格雷两联抗血小板药。观察术中、住院、出院后1个月和6个月及12个月随访终点时的主要心脏不良事件发生率、支架内血栓发生率、支架内再狭窄发生率。结果 35例患者急诊PCI治疗均获成功,35支梗死相关血管的35处病变共置入Excel支架42枚,手术过程中未发生与介入治疗有关的并发症。1个月随访终点时无死亡病例,无支架内亚急性血栓病例,主要心脏不良事件发生率0%。出院后12个月随访终点时无死亡病例,其中有1例因心功能不全入院,主要心脏不良事件发生率2.7%,支架内血栓发生率0%;共有34例患者在支架术后12个月复查冠状动脉造影,支架内再狭窄发生率0%。结论生物可降解涂层药物洗脱支架在急性ST段抬高心肌梗死急诊PCI中应用是安全和有效的。     

药物洗脱支架(cypherTM)在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗中的应用

目的　探讨雷帕霉素药物洗脱支架 (cypherTM)在急性ST段抬高心肌梗死 (STEMI)急诊经皮冠状动脉介入治疗 (PCI)中应用的安全性和有效性。方法　选择 2 0 0 2年 11月至 2 0 0 4年 2月的STEMI患者 96例 ,随机分为两组 :药物洗脱支架组 ( 4 8例 )和普通支架组 ( 4 8例 ) ,所有患者均于发病12h内行急诊PCI治疗 ,一组置入cypherTM ,另一组置入普通支架。结果　 96例患者急诊PCI治疗均获得成功。 4 8支梗死相关血管 (IRA)的 4 8处罪犯病变置入 4 9枚药物洗脱支架 ,另 4 8支IRA的 4 9处病变置入 4 9枚普通支架。未发生与介入治疗有关的并发症 ,其中 1例置入cypherTM 者术后出现脑梗死 ,于第 7天死于多器官功能衰竭。药物支架组和普通支架组相比较 ,PCI后造影结果和临床结果差异均无显著性。随后对 95例病人进行了 1～ 9个月随访 (平均 4 5± 2 6个月 ) ,药物支架组患者未发生任何心血管事件 ,普通支架组有 2例发生心绞痛。结论　cypherTM 在STEMI急诊PCI中应用与普通支架一样有较强的安全性和有效性     

血流储备分数指导下ST段抬高型心肌梗死多支血管病变患者非梗死相关血管分期完全血运重建的临床研究

目的评估血流储备分数(FFR)在急性ST段抬高型心肌梗死(STEMI)多支血管病变患者非梗死相关血管(non-IRA)分期经皮冠状动脉介入治疗(PCI)完全血运重建中的临床价值。方法选取陕西中医药大学第二附属医院心血管内科2015年6月至2016年5月已成功行PCI开通梗死相关血管(IRA),拟分期PCI治疗(间隔≥7 d)non-IRA的STEMI多支血管病变患者90例,按随机数字表法分为FFR指导下完全血运重建组(FFR组)45例和冠状动脉造影指导下完全血运重建组(CAG组)45例。FFR组狭窄>90%的non-IRA病变直接行PCI治疗,对狭窄70%~90%的病变行FFR检查,仅对FFR<0.80的non-IRA行PCI治疗;CAG组对狭窄≥70%的non-IRA依据术者经验行PCI治疗,处理的靶血管参照血管直径≥2.5 mm。比较两组PCI时间、支架置入数量、造影剂用量、住院时间、住院费用和围术期并发症,随访患者术后6个月主要不良心脑血管事件发生情况。结果 FFR组支架置入数量[(1.68±0.75)枚比(2.83±0.54)枚,t=7.662,P<0.001]和造影剂用量[(164.8±35.7)ml比(195.0±41.9)ml,t=4.271,P=0.04]均明显少于CAG组;术后随访6个月,FFR组再次血运重建率显著低于CAG组(4.7%比19.5%,P=0.04),两组主要不良心脑血管事件发生率差异无统计学意义(均为P>0.05)。结论 STEMI多支血管病变患者在FFR指导下对non-IRA行分期完全血运重建可减少支架置入数量、造影剂用量及术后6个月再次血运重建率。     

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。     

药物洗脱支架与金属裸支架在急性ST段抬高心肌梗死急诊介入治疗中应用长期随访结果的比较

目的 探讨与金属裸支架(BMS)相比,Cypher支架(Cordis公司,美国)在急性ST段抬高心肌梗死(STEMI)急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和长期有效性.方法 连续选择2002年12月至2005年3月间STEMI患者407例,均于发病12 h内行急诊PCI治疗,于梗死相关血管靶病变置入Cypher支架或BMS.对所有病例随访1.5～4.0年(平均28.7±11.7个月),比较两类支架院内及出院后严重心脏不良事件(MACE,包括死亡、再发心肌梗死、靶病变重建等)发生的差异.结果 407例患者中置入Cypher支架者131例,置入BMS者276例.Cypher支架组所置入支架的直径明显小于BMS组(3.0 mm与3.2 mm,P=0.00).两组在随访期间心因性死亡(1.5%与6.9%,P=0.02)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率差异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置入Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.05).两组的支架内血栓形成发生率差异无统计学意义,支架内再狭窄发生率以及靶病变重建率 异亦无统计学意义,但Cypher支架较之BMS有明显降低的趋势.结论 在STEMI的急诊PCI治疗时,置人Cypher支架具有较好的安全性和长期有效性,与BMS相比可以降低远期复合MACE以及心因性死亡的发生率. 2)以及随访期间总的主要不良心脏事件(MACE)(6.1%与12.7%,P=0.04)差异均有统计学意义.应用Cox回归比例风险模型计算Cypher支架组在随访期间发生总MACE的相对危险度为0.45(P＜0.     

雷帕霉素药物洗脱支架治疗急性心肌梗死六个月随访结果

目的探讨雷帕霉素药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊经皮冠状动脉介入治疗（PCI）中应用的安全性和有效性.方法选择2002年11月至2004年12月间的急性ST段抬高心肌梗死患者168例,于发病12 h内行急诊PCI治疗,于梗死相关血管的靶病变置入Cypher支架.记录1个月和6个月随访终点时的主要心脏不良事件（包括死亡、再发心肌梗死、靶血管再成形等）发生率、支架内血栓发生率、支架内再狭窄发生率.结果 168例患者急诊PCI治疗均获得成功.168支梗死相关血管的171处罪犯病变共置入175枚Cypher支架,未发生与介入治疗有关的并发症.1个月随访终点时死亡3例（死亡率1.8%）;支架内亚急性血栓1例;主要心脏不良事件发生率2.4%.6个月随访终点时死亡4例（死亡率2.4%）;主要心脏不良事件发生率4.2%;支架内血栓发生率1.2%;支架内再狭窄发生率1.8%.结论药物洗脱支架（Cypher）在急性ST段抬高心肌梗死急诊PCI中应用与普通支架一样有较强的安全性和有效性,并可以明显降低再狭窄率.     

新型氮氧化钛生物有效支架与国产雷帕霉素药物洗脱支架在老年冠状动脉血运重建临床应用的对比研究

目的对比研究氮氧化钛生物有效性支架（Titan2-BAS）与国产雷帕霉素药物洗脱支架（SES）在老年冠状动脉血运重建临床应用中的疗效。方法共入选125例老年冠心病患者,男75例,女50例。根据植入的支架不同分为A组（Titan2-BAS）79例,B组（SES）46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个月,B组至少12个月。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主要不良心脏事件（MACE,指死亡、急性心肌梗死、靶血管重建等）发生率。结果（1）A组病变内径（3.1±0.3）mm,长度为（25±3.6）mm,B组病变内径（3.1±0.4）mm,长度为（24±4.2）mm,两组无显著差异。（2）A组129处〉75%狭窄病变共植入Titan2-BAS146枚,1枚支架未能通过病变（右冠状动脉）,通过率99.3%;B组72处病变共植入SES82枚,通过率100%,两组无显著差异。（3）随访1～17个月,平均5.3个月。两组均无死亡病例;A组无急、晚期血栓。B组1例术后2d出现支架内血栓;A组1例术后3个月行靶血管重建,B组无靶血管重建;综合以上,两组MACE发生率无显著差异（1.3%对2.2%）。结论Titan2-BAS与SES在老年冠状动脉血运重建方面的近期及远期疗效相近,Titan2-BAS不增加MACE发生率。     

两种国产西罗莫司洗脱支架治疗ST段抬高型心肌梗死患者的疗效和安全性研究

目的 比较两种国产西罗莫司洗脱支架(Excel与Firebird)对急性ST段抬高型心肌梗死(STEMI)患者行直接经皮冠状动脉介入治疗(PCI)的有效性和安全性.方法 入选我院急性STEMI患者249例,根据植入支架类型,随机分为Excel支架组136例(54.6%)和Firebird支架组113例(45.4%).随访6～24个月,平均12个月行定量冠状动脉造影复查.比较两组患者手术即刻成功率,术后住院及随访过程中主要不良心脏事件(包括心原性死亡、再发心肌梗死和靶病变血运重建)发生率及晚期管腔丢失、支架再狭窄、支架内血栓发生率.结果 两组患者术前临床基线特征及冠状动脉病变情况、直接PCI术后即刻情况差异均无统计学意义(P＞0.05);术后平均12个月随访中,两组患者死亡分别为2例(1.47%)与1例(0.88%),无心原性死亡,非致死心肌梗死分别为1例(0.74% )与1例(0.88%),靶血管再次血运重建分别为2例(1.47%)与2例(1.77%),差异无统计学意义(均P＞0.05).定量冠状动脉造影随访两组支架内最小管腔内径、节段内最小管腔内径、支架内晚期管腔丢失、节段内晚期管腔丢失,差异无统计学意义(均P＞0.05);支架内再狭窄、节段内再狭窄、支架内血栓形成的发生率差异亦无统计学意义(均P＞0.05).结论 STEMI患者直接PCI应用两种国产西罗莫司洗脱支架均有效、安全.

Abstract：

Objective To compare the efficacy and safety of two kinds of homemade sirolimus-eluting stents (Firebird and Excel) for treatment of acute ST segment elevation myocardial infarction (STEMI) in patients who underwent percutaneous coronary intervention (PCI). Methods The 249 consecutive patients with STEMI who underwent PCI were randomly divided into two groups: Excel group (n=136) and Firebird group (n=113). They were followed up for 6-24 months, and coronary angiography was reviewed average 12 months later. The primary endpoints were major adverse cardiac events, including death, reinfarction and target vessel revascularization. The second endpoints included late luminal loss and restenosis 12 months after treatment. Results There were no significant differences in baseline data, coronary arterial lesion before operation, and immediateness condition after PCI between the two groups (all P＞0.05). Within follow-up, there were 2 (1.47%) death cases and 1 (0.88%) death case, 1 (0.74%) and 1 (0.88%) nonfatal myocardial infarction case, 2 (1.47%) and 2 (1.77%) target vessel revascularization cases in the two groups respectively (all P＞0.05). There were no significant differences in late luminal loss of in-stent and in-segment, the rates of in-stent restenosis, in-segment restenosis and stent thrombosis, the in-stent minimal lumen diameter and in-segment minimal lumen diameter between the two groups (all P＞0.05). Conclusions The two kinds of homemade sirolimus-eluting stents may have similar efficacy and safety in patients with STEMI treated with primary PCI.     

糖尿病急性ST段抬高心肌梗死应用雷帕霉素药物洗脱支架1年随访分析

目的探讨雷帕霉素药物洗脱支架在糖尿病急性ST段抬高心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法选择2002年11月至2005年10月间首都医科大学附属北京朝阳医院心脏中心收治的糖尿病急性STEMI患者106例,于发病12h内行急诊PCI治疗,置入雷帕霉素药物洗脱支架。记录术后1个月和12个月随访终点时的心血管事件发生率、支架内血栓发生率及支架内再狭窄发生率。结果105例患者急诊PCI治疗获得成功。106支梗塞相关血管(IRA)的110处罪犯病变处置入雷帕霉素药物洗脱支架134枚,未发生与介入治疗有关的并发症。1个月随访终点时死亡4例(3.77%),发生急性心肌梗死1例,心血管事件总发生率为4.72%;发生支架内血栓1例;血运重建1例。12个月随访终点时除1个月时死亡的4例外未再发生死亡病例,共发生心血管事件11例(10.38%),发生支架内血栓2例(1.89%),52例接受冠状动脉造影复查患者中发生支架内再狭窄6例(11.54%)。结论雷帕霉素药物洗脱支架在STEMI急诊PCI中应用有较高的安全性和有效性,并可以明显降低再狭窄率。     

The risks and benefits of drug-eluting stents in the setting of STEMI

Primary percutaneous coronary intervention (PCI) represents the treatment of choice in patients with ST-segment elevation myocardial infarction (STEMI). In randomized trials excluding STEMI patients, using drug-eluting stents (DES) significantly reduced angiographic restenosis and target vessel revascularization compared with bare metal stents (BMS); however, concerns exist regarding an increased follow-up incidence of stent thrombosis after DES implantation. This complication, which is associated with higher mortality and morbidity rates, may be more frequent among STEMI patients receiving DES versus BMS. Various registries, randomized trials, and two recent meta-analyses on patients undergoing primary PCI have shown that using DES is safe and is associated with significantly reduced rates of restenosis and repeat intervention without an increased risk of myocardial infarction or stent thrombosis at intermediate-term follow-up. However, large trials with hard clinical end points and longer follow-up are needed before routine DES use can be recommended in patients undergoing primary PCI.     

Randomized trial of Sirolimus-Eluting Stent Versus Bare-Metal Stent in Acute Myocardial Infarction (SESAMI).

OBJECTIVES: To confirm whether sirolimus-eluting stents (SES) safely reduce the incidence of restenosis in patients with ST-segment elevation acute myocardial infarction compared with bare-metal stents (BMS). BACKGROUND: In the setting of primary angioplasty, stent restenosis occurs in up to 27% of patients. The introduction of drug-eluting stents has drastically reduced the incidence of restenosis in clinically stable patients. METHODS: We conducted a randomized trial of 320 patients with acute ST-segment elevation myocardial infarction assigned to receive SES or BMS. The primary end point was binary restenosis at 1-year angiographic follow-up. RESULTS: At 1 year, the incidence of binary restenosis was lower in the SES group than in the BMS group (9.3% vs. 21.3%, respectively; p = 0.032), as were the rates of target lesion revascularization (4.3% vs. 11.2%; p = 0.02), target vessel revascularization (5% vs. 13.1; p = 0.015), major adverse cardiac events (6.8% vs. 16.8%; p = 0.005), and target vessel failure (8.7% vs. 18.7%; p = 0.007). The incidence of angiographically documented stent thrombosis was 1.2% (n = 2) in the SES group and 0.6% (n = 1) in the BMS group. CONCLUSIONS: In patients with acute myocardial infarction, SES are superior to BMS, reducing the incidence of binary restenosis by 56%, target lesion revascularization by 61%, target vessel revascularization by 62%, adverse cardiac events by 59%, and target vessel failure by 53% at 1 year. (Sirolimus Eluting Stenting in Acute Myocardial Infarction; http://www.clinicaltrials.gov/ct/show/NCT00288210; NCT00288210).     

Clinical and angiographic outcome after sirolimus-eluting stent implantation in aorto-ostial lesions.

OBJECTIVES: This observational study evaluated the clinical and angiographic outcomes of patients with aorto-ostial coronary artery disease treated with sirolimus-eluting stents (SESs) or with bare metal stents (BMSs). BACKGROUND: The safety and effectiveness of SESs for the treatment of aorto-ostial lesions have not been demonstrated. METHODS: We identified 82 consecutive patients who underwent percutaneous coronary interventions in 82 aorto-ostial lesions using the SES (32 patients) or BMS (50 patients) and compared the two groups of patients. The incidence of major adverse cardiac events (MACE), including death or Q-wave myocardial infarction (MI), target lesion revascularization (TLR), and target vessel revascularization (TVR), were recorded in-hospital and at a 10-month follow-up. RESULTS: All stents were implanted successfully. There were no statistically significant differences regarding major in-hospital complications between the two groups. At 10-month follow-up, two (6.3%) patients in the SES group and 14 (28%) patients in the BMS group underwent TLR (p = 0.01); MACE were less frequent in the SES group compared to the BMS group (19% vs. 44%, p = 0.02). Angiographic follow-up showed lower binary restenosis rates (11% vs. 51%, p = 0.001) and smaller late loss (0.21 +/- 0.31 mm vs. 2.06 +/- 1.37 mm, p < 0.0001) in the SES group. CONCLUSIONS: The main finding of our study is that, compared to the BMS, implantation of the SES in aorto-ostial lesions appears safe and effective, with no increase in major in-hospital complications and a significant improvement in restenosis and late event rates at 10-month follow-up.     

Concurrent implantation of sirolimus- and paclitaxel-eluting stents in the same vessel.

OBJECTIVE: To assess the safety and efficacy of concurrent implantation of sirolimus-eluting (SES) and paclitaxel-eluting (PES) stents in the same coronary artery. BACKGROUND: When it is impossible to deliver multiple drug eluting stents (DES) of the same type, the operator must opt to implant a different DES or a bare metal stent. There are currently no published data evaluating this approach. METHODS: We identified all cases in which one or more SES and PES were implanted in either the same lesion or adjacent segments of the same vessel during a single procedure between March 2003 and March 2005. Endpoints analyzed were; in-hospital major adverse cardiac events (MACE), and follow-up MACE (including stent thrombosis). RESULTS: We identified 44 patients with 89 lesions. This was a complex cohort of patients with a median of 3.5 stents implanted, 3 lesions and 2 vessels treated and a median stent length implanted of 80.5 mm, while 83% of the lesions were type B2/C. Eight patients had peri-procedural myocardial infarction. During follow-up; 1 cardiac death occurred, no patients had a myocardial infarct or stent thrombosis, 11 underwent target lesion and vessel revascularization (25%) and 13 had a major adverse cardiac event (29.5%). CONCLUSIONS: In this cohort of patients, the concurrent use of SES and PES in the same vessel was associated with outcomes in keeping with the complexity of disease treated. Our data show that it is not unreasonable to implant different DES in the same vessel, although we would not advocate this as routine practice.     

Treatment of lesions with a high risk of stenosis. Comparative study in 300 patients of rapamycin- and Paclitaxel-eluting polymer-based stents, and bare metal stents

INTRODUCTION AND OBJECTIVES: Rapamycin- and taxol-eluting stents have been shown to reduce restenosis, but there are no large-scale studies of their usefulness in lesions with a high risk of restenosis, or of the relative merits of the two devices. This prospective study compared their safety and efficacy in lesions with a high risk of restenosis. PATIENTS AND METHOD: We included consecutive patients with lesions to treat that met at least one of the following criteria: a) in-stent restenosis; b) diffuse (>20 mm) restenosis; c) small vessel (< or =2.5 mm) restenosis; or d) total occlusion. Patients received different devices along three consecutive study periods: bare metal (conventional) stents, sirolimus-eluting (rapamycin) stents and paclitaxel-eluting (taxol) stents. RESULTS: One hundred patients in each group were included, for a total of 300 patients. In the sirolimus group, after 8.5+/-2 months of follow-up, there were 2 late thromboses (2%) and only 1 patient (1%) required target lesion revascularization. In the paclitaxel group 2 patients (2%) had in-hospital stent thrombosis (1 acute, 1 subacute), and after 9+/-2.5 months of follow-up only 1 patient (1%) needed target lesion revascularization. In the conventional group, after 8+/-2 months of follow-up, there was 1 subacute thrombosis (1%) and 15 patients (15%) had clinical restenosis requiring target lesion revascularization. Event-free survival curves were significantly better with drug-eluting stents (P<.01 vs conventional stents). CONCLUSION: Rapamycin- and taxol-eluting stents were safe for lesions with a high risk of restenosis. These stents were associated with a lower rate of target lesion revascularization during follow-up compared to bare metal stents.     

Comparison of safety and efficacy of sirolimus-eluting stents versus bare metal stents in patients with ST-segment elevation myocardial infarction

Sirolimus-eluting stents (SESs) are superior to bare metal stents (BMSs) for percutaneous coronary intervention, but data regarding SESs in ST-segment elevation myocardial infarction (STEMI) are limited. We investigated the clinical outcomes of patients with STEMI who were treated with SESs. We measured clinical characteristics and acute and long-term outcomes in 306 consecutive patients with STEMI who received a SES (n = 156) or a BMS (n = 150). Patients were followed for death, nonfatal reinfarction, and target vessel revascularization. Patients with SESs had a 0.6% in-hospital mortality rate versus 5.3% in patients with BMSs (p = 0.015). Six-month mortality rates were 1.9% (SES) and 10.1% (BMS, p = 0.003). At 6 months, patients with SESs were less likely to have target vessel revascularization (1.3% vs 8.1%, p = 0.005) and achieve the composite end point (3.2% vs 16.1%, p = 0.0001). No subacute thrombosis or clinical restenosis occurred in the SES group. Patients who received BMSs were older, received more stents, and had more myocardial damage, worse renal function, and lower ejection fractions than did those in the SES group. By multivariate discriminant analysis, stent type (SES vs BMS) was the most significant determinant of the 6-month composite end point (p = 0.01) and the need for target vessel revascularization (p = 0.02). In conclusion, SESs are safe and effective in STEMI at 6 months.