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.     

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。     

75岁以上急性冠状动脉综合征患者应用药物洗脱支架一年随访结果

目的探讨雷帕霉素药物洗脱支架在老年急性冠状动脉综合征患者经皮冠状动脉介入治疗(PCI)中应用的安全性和有效性。方法对112例年龄75岁以上的急性冠状动脉综合征患者的125处罪犯病变行PCI治疗,共置入了140枚雷帕霉素药物洗脱支架。结果112例PCI均成功,未发生与PCI有关的并发症。2例于术后18 h内死于心源性休克,1例术后第3天死于心脏破裂,未发生主要不良心血管事件。进行1年临床随访,有1例术后3个月发生猝死,另有2例术后5个月再次行冠状动脉血管重建术,无其他主要不良心血管事件发生。结论雷帕霉素药物洗脱支架在老年急性冠状动脉综合征患者的急诊PCI中应用有较强的安全性和有效性。     

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。     

紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架治疗冠心病的临床效果比较

目的:比较紫杉醇微孔载药支架和进口雷帕霉素药物洗脱支架在经皮冠状动脉介入治疗中的临床疗效。方法: 筛选73例行经皮冠状动脉介入治疗术的冠心病患者,随机分为两组,紫杉醇微孔载药支架组（紫杉醇组,35例）和进口雷帕霉素药物洗脱支架组（雷帕霉素组,38例）。支架植入术后6个月复查冠状动脉造影（CAG）。随访6个月,对比两组支架内血栓形成、主要心血管不良事件（包括心源性死亡、非致死性心肌梗死、靶病变血运重建）和支架内再狭窄发生率。结果: 随访6个月,两组均未出现急性、亚急性和晚期支架内血栓形成、非致死性心肌梗死和心源性死亡。心绞痛、支架内再狭窄和靶病变血运重建发生率均无统计学差异。结论: 紫杉醇微孔载药支架与进口雷帕霉素药物洗脱支架在治疗冠状动脉简单病变时具有相同的近、中期临床疗效和安全性。     

国产雷帕霉素药物洗脱支架在急诊PCI中的疗效分析

目的 探讨国产雷帕霉素药物洗脱支架在急性心肌梗死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 对41例急性心肌梗死患者罪犯血管行急诊PCI,共置入了46枚国产雷帕霉素药物洗脱支架.其中前壁心肌梗死18例,下壁心肌梗死21例,高侧壁心肌梗死2例.结果 41例急诊PCI均获成功,38例置入支架,3例仅行单纯球囊扩张,未发生与PCI相关的并发症,住院期间1例因输液反应导致支架内亚急性血栓形成死亡,其余未发生主要不良心血管事件.随访12个月,有1例术后8个月再次行冠状动脉血运重建术,其余未发生主要不良心血管事件.结论 国产雷帕霉素药物洗脱支架在急诊PCI应用中有较高的安全性和有效性.     

进口与国产雷帕霉素洗脱支架一年临床疗效比较

目的对因冠状动脉粥样硬化性心脏病接受择期经皮冠状动脉介入治疗（PCI）的患者,对比接受国产雷帕霉素药物洗脱支架（Firebird）和进口雷帕霉素药物洗脱支架（CypherSelect）治疗后1年的临床疗效。方法连续入选2004年1月至2006年12月于北京安贞医院接受介入治疗置入国产和进口雷帕霉素药物洗脱支架（SES）的冠心病患者2000例,根据置入支架类型,分为国产Firebird组（Firebird;1004例）和进口Cypher组（Cypher;996例）。随访1年的临床疗效。初级终点为两组患者支架术后主要心血管不良事件（MACE）的发生率,包括全因死亡、非致死性心肌梗死及靶血管重建。次级终点为1年内的支架内血栓发生率。结果 1年的随访结果显示,国产和进口雷帕霉素药物洗脱支架（SES）组的MACE发生率差异无统计学意义（17.8%比18.6%,P=0.666）。两组患者的死亡（4.7%比5.1%,P=0.649）、心肌梗死（4.2%比4.8%,P=0.493）和靶血管重建率（9.0%比8.6%,P=0.795）均相近。两组患者12个月确定/可能性支架内血栓的发生率亦差异未见统计学意义（1.1%比1.0%,P=0.841）。多因素回归分析表明,DES类型不是1年内MACE的独立预测因素。结论国产FirebirdSES和进口CypherSES在术后1年内具有相同的临床疗效和安全性。     

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.     

ST段抬高的急性心肌梗死急诊置入药物洗脱支架与普通金属裸支架的比较

目的对比观察雷帕霉素药物洗脱支架（Cypher）与普通金属支架（Bx-sonic）在急性ST段抬高心肌梗死（STEAMI）急诊冠脉介入（PCI）治疗中应用的安全性和临床疗效。方法选择我院急诊住院的82例STEAMI患者,在发病时间12h内急诊行直接PCI治疗,其中50例于梗死相关血管的靶病变植入Cypher支架（Cypher支架组）,32例植入Bx-sonic支架（普通支架组）。并对其临床资料,病变特征,术后住院期间及随访期间再梗死、死亡、靶血管再成形等心脏不良事件发生率进行分析。结果两组支架术患者住院期间心脏不良事件发生率无显著差异。平均随访（6.2±2.3）个月,Cypher支架组心绞痛发生率较普通支架组显著减低（5%vs21%,P<0.01）。Cy-pher支架组无心脏事件生存率显著高于普通支架组（95%vs78%,P<0.01）。普通支架组支架内再狭窄率较Cy-pher支架组高。再梗死、心源性死亡、中风等不良事件发生率无显著差异。结论雷帕霉素药物洗脱支架与普通支架一样在STEAMI急诊PCI中是安全有效的。     

国产药物洗脱支架对急性ST段抬高型心肌梗死预后的影响

目的探讨国产药物支架(DES)对急性ST段抬高型心肌梗死(STEMI)预后的影响。方法对2004-03～2009-04共216例确诊为STEMI的患者分为两组,药物支架(DES)组(n=117)和裸支架(BMS)组(n=99),术后长期随访,观察术后12个月随访终点时支架内再狭窄发生率(ISR)及主要心血管不良事件(包括死亡、急性心肌梗死、靶血管再成形等)发生率。结果 216例患者经皮冠状动脉介入(PCI)治疗均成功。介入治疗3～12个月后随访结果显示,DES组再狭窄率明显低于BMS组(P0.05),两组心血管不良事件发生率差异无统计学意义(P0.05)。结论 DES在STEMI患者中有较好的安全性及临床疗效,再狭窄率明显低于BMS(P0.05)。     

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.     

Clinical outcomes of dexamethasone-eluting stent implantation in ST-elevation acute myocardial infarction.

OBJECTIVES: The aim of our study was to evaluate the safety and midterm clinical results of dexamethasone-eluting stent (DexES) implantation in ST-segment elevation acute myocardial infarction (STEMI). BACKGROUND: Inflammation plays a pivotal role in both inestabilization of coronary atherosclerotic plaques and development of restenosis after stent placement. Antiinflammatory agents may attenuate those mechanisms and improve clinical outcomes. There is little information about clinical results of DexES and no data are available about their utilization during percutaneous coronary intervention (PCI) in STEMI. METHODS: Consecutive patients with STEMI that underwent primary or rescue PCI in our institution were treated with DexES. Clinical follow-up with routine realization of noninvasive test for detection of myocardial ischemia and coronariography if necessary, were performed. The objective of the study was to evaluate the rate of MACE (death, reinfarction, or target lesion revascularization) during midterm follow-up. RESULTS: The procedure was successful in 96.7% of cases. There were no in-hospital deaths or reinfarctions. One acute stent thrombosis occurred and no subacute thrombosis were observed. During a mean follow-up period of 384 days, cardiac-related death was 1.1%, there were no reinfarctions or late stent thrombosis and target lesion revascularization rate was 4.2%. CONCLUSION: We conclude that utilization of DexES for PCI in STEMI is safe and provides good midterm clinical outcomes.     

Single-center randomized evaluation of paclitaxel-eluting versus conventional stent in acute myocardial infarction (SELECTION)

OBJECTIVES: To evaluate the superiority of the paclitaxel-eluting stent (PES) in reducing neointimal hyperplasia (NIH) over its corresponding bare metal stent (BMS) during primary percutaneous coronary intervention (PCI). BACKGROUND: Primary PCI with stent implantation is the repercussion strategy of choice for ST-elevation myocardial infarction (STEMI); nonetheless restenosis rate is still high. Drug-eluting stents have been proven to reduce restenosis rate in many settings, but their use during primary PCI is still controversial. METHODS: Consecutive patients with STEMI <12 hours were randomized to receive PES or BMS. The primary end-point was the percentage of the stent volume obstructed by neointimal proliferation (NIH) measured by intravascular ultrasound (IVUS) at a 7-month angiographic follow-up. Secondary end-points were binary restenosis rate and major adverse cardiac events (MACE, i.e., death, nonfatal myocardial infarction, and target lesion revascularization). RESULTS: Eighty patients with STEMI were randomized into the PES or BMS group. Patients were well matched for baseline characteristics and the index procedure was always successful. In-hospital and 1-month MACE were 2.5% per group. NIH at 7 months was 4.6% versus 20% (P< 0.01), late lumen loss 0.1 versus 1.01 mm (P = 0.01). MACE were 7.5% versus 42.5% (P = 0.001) with no difference in death and recurrent myocardial infarction rates. Late-acquired incomplete stent apposition (ISA) rate was 5.1% versus 2.7% (P = 0.65). One subacute stent thrombosis was reported in each group. CONCLUSIONS: PES was superior to its corresponding BMS in reducing NIH in the STEMI setting without any increase in early and long-term clinical adverse events.     

糖尿病患者植入雷帕霉素药物洗脱支架的疗效分析

目的:评价糖尿病对雷帕霉素药物洗脱支架临床疗效的影响。方法:选择2002年12月至2005年5月应用雷帕霉素药物洗脱支架(Cypher)的冠心病合并糖尿病患者262例(糖尿病组)和非糖尿病患者262例(对照组),平均随访8个月,患者均复查冠状动脉造影,分析不良心脏事件(心性死亡,急性心肌梗死或靶病变重建)和冠状动脉造影复查结果,评价糖尿病对Cypher支架临床近远期疗效的影响。结果:1.2组支架植入成功率均为100%,糖尿病组无死亡,6例于术后第2天发生急性心肌梗死,对照组无死亡,11例于随访6个月时发生急性心肌梗死;2.复查冠状动脉造影显示糖尿病组和对照组晚期管腔绝对内径丢失分别为(0.06±0.02)mmvs(0.04±0.02)mm(P>0.05),相对内径丢失分别为(2.32±0.19)%vs(1.63±0.14)%(P=0.03)。因再狭窄行靶血管重建者分别为33例(12.60%)和26例(9.92%)(P>0.05)。回归分析显示,相关血管大小和相对管腔内径丢失与再狭窄有关。结论:糖尿病患者应用Cypher支架安全有效,但相对内径丢失明显,糖尿病合并小血管可能是雷帕霉素药物洗脱支架再狭窄的影响因素。     

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.     

西罗莫司洗脱支架在老年急性心肌梗死血管长病变中的安全性和有效性

目的 评价老年ST段抬高心肌梗死(STEMI)患者经皮冠状动脉介入术(PCI)中置入国产西罗莫司洗脱支架(SES)治疗靶血管长病变的安全性和有效性.方法 连续入选就诊于北京安贞医院抢救中心进行急诊PCI的STEMI患者.所有资料均前瞻性录入数据库,常规进行随访.筛选梗死相关血管长病变部位串联置入2枚以上国产SES的老年患者为研究对象,置入单个国产SES的老年患者作为对照组进行回顾性分析.安全性分析指标为住院及随访6个月期间的死亡、心肌梗死和血栓发生率.临床分析指标为靶病变血管重建率.结果 775例STEMI患者中,老年患者62例,累计64处梗死相关血管病变处串联置入2枚以上国产SES(长病变组),187例老年患者置入单个支架(对照组),两组患者一般临床情况比较差异无统计学意义.长病变组患者平均置入2.2枚支架,平均病变长度(45.3±10.4)mm,支架长度(52.2±11.0)mm.随访6个月,长病变组和对照组的血栓发生率分别为1.6%和1.1%,差异无统计学意义(P>0.05).两组患者均无死亡发生.长病变组的支架内再狭窄率和靶病变血管重建率高于对照组,分别为8.1%和4.8%与6.9%和3.7%,但差异无统计学意义(均为P>0.05).结论 老年患者直接PCI过程中串联置入国产SES治疗靶血管长病变未产生不良后果,短期安全性良好.     

Sirolimus-eluting stents in real-world patients with ST-segment elevation acute myocardial infarction

Recently, the use of sirolimus-eluting stents (SES) has been demonstrated to significantly reduce the rate of adverse events among selected patients with ST-segment elevation acute myocardial infarction (STEMI). We present real-world experience from a single center registry evaluating the safety and efficacy of primary percutaneous coronary intervention (PCI) in unselected patients with STEMI using SES. Clinical outcome at 300-day follow-up in two cohorts of 225 consecutive patients who underwent bare metal stent (BMS) (January 2004-February 2005, n = 123) or SES (March 2005-December 2006, n = 102) implantation was examined. The primary endpoint was a composite of major adverse cardiovascular events (MACE: death, nonfatal reinfarction, and target vessel revascularization [TVR]). The incidence of short-term MACE was similar between the SES group and BMS group (30-day rate of MACE: 4.9% versus 8.9%, P = 0.30). Angiographically documented stent thrombosis within 30 days after primary PCI was not diagnosed in any patient in the SES group and occurred in 1 patient treated with BMS (0 versus 0.8%, P = 1.0). At 300 days, SES implantation significantly reduced the incidence of MACE (7.8% versus 22.8%, hazard ratio [HR] 0.32 [95% confidence interval (CI) 0.15 to 0.71], P = 0.005), mainly due to a marked reduction in the risk of TVR (1.0% versus 17.1%, HR 0.05 [95% CI 0.01 to 0.39], P < 0.001). There was no new onset of documented stent thrombosis between 30 and 300 days in either group. Thus, this real-world registry confirmed the safety and efficacy of SES with remarkably lower rates of TVR and MACE in the setting of primary PCI for unselected patients with STEMI in a real-world scenario.     

雷帕霉素洗脱支架冠状动脉造影随访结果分析

目的通过对接受雷帕霉素洗脱支架(sirolimus-eluting stent,SES)治疗的冠心病患者冠状动脉造影随访,观察其临床实际应用的效果。方法339例患者接受治疗,所有患者均接受了临床随访,165例患者于置入术后6~12个月行冠状动脉造影复查。结果冠状动脉造影随访时,支架近端边缘晚期管腔丢失显著高于支架内及支架远端边缘(0.17 mmvs0.08 mmvs0.09 mm),再狭窄率为9.7%,再血管化率4.84%,再狭窄以局限性狭窄为主。在339例患者中,有4例患者于支架置入后5天~4个月发生猝死。猝死发生率为1.18%。1例于支架置入后14天发生支架内亚急性血栓形成,发生率0.50%。晚期血栓形成1例(术后12个月),主要心血管不良事件为1.70%。结论对复杂的冠状动脉病变SES有较好的疗效,能显著降低支架后再狭窄,减少靶血管的再血管化率。