雷帕霉素洗脱支架治疗支架术后的再狭窄

目的探讨雷帕霉素洗脱支架(CypherTM)在支架术后再狭窄介入治疗中的安全性和有效性。方法分析在支架术后发生再狭窄而再次介入治疗并置入CypherTM支架的21例患者的即刻疗效和血管造影随访结果。结果21例患者介入治疗均获得成功,21处病变共置入24枚CypherTM支架。住院期间未发生有关的严重并发症。随访期6~12个月,平均为(9.2±3.0)个月内未出现心脏事件。21例患者共有18例复查了冠状动脉造影,CypherTM支架内均无再狭窄。结论CyperTM支架在再狭窄的介入治疗中安全有效。     

CYPHER药物洗脱支架治疗支架内再狭窄的临床疗效

目的:探讨CYPHER药物洗脱支架治疗支架内再狭窄的经验及临床疗效.方法:9例支架内再狭窄患者接受了12枚CYPHER药物洗脱支架治疗,其中右冠状动脉病变4例,前降支病变7例,左旋支病变1例.结果:12处支架内再狭窄病变均成功放置药物支架,手术成功率100%.所有患者临床症状明显改善,无并发症发生.所有患者于术后6个月复查冠状动脉造影,无一例发生再狭窄.结论:CYPHER药物洗脱支架治疗支架内再狭窄安全、有效、可行.     

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。     

经桡动脉植入Firebird药物支架86例临床观察

目的 观察经桡动脉途径植入Firebird药物支架在冠状动脉性心脏病(冠心病)介入治疗中的安全性和有效性.方法 回顾性分析86例经桡动脉途径植入国产药物洗脱支架冠心病患者的临床资料,观察术中并发症发生率、术后随访主要心血管不良事件发生率和血管再狭窄率.结果 共植入国产药物洗脱支架113枚.86例患者住院期间无血栓形成和临床随访无主要心血管事件发生,术后6个月冠状动脉造影复查无支架内再狭窄.结论 经桡动脉途径在冠心病介入治疗中安全有效,国产药物支架近期能够有效预防冠状动脉介入治疗后血管再狭窄.     

国产Firebird药物涂层支架与裸支架在急性心肌梗死患者中的对比研究

目的:通过对比研究的方法评价国产Firebird药物涂层支架与Driver裸支架在急性心肌梗死患者中应用的安全性和有效性。方法:将诊断为急性ST段抬高型心肌梗死(且发病在12h以内)的患者分为2组,接受Firebird药物涂层支架治疗(Firebird组)者36例,接受Driver裸支架治疗(Driver组)者40例。观察2组住院期间和6个月随访期间的心血管事件及支架内再狭窄的发生情况。结果:住院期间2组均无急性、亚急性血栓形成及心绞痛事件发生;Firebird组6个月随访无心绞痛复发事件,9例复查冠状动脉造影未见支架内再狭窄;Driv-er组6例于随访期复发心绞痛,行冠状动脉造影显示支架内再狭窄,再次置入Firebird药物涂层支架,另有7例于术后6个月复查冠状动脉造影未见明显支架内再狭窄。结论:国产Firebird药物涂层支架在急性心肌梗死患者中应用具有较好的安全性和有效性。     

国产西罗莫司药物洗脱支架治疗冠心病331例的疗效及安全性

目的探讨国产西罗莫司药物洗脱支架治疗冠心病的安全性与有效性。方法对331例冠心病患者采用经股动脉途径冠状动脉造影及常规方法行国产药物洗脱支架置入术,记录住院期间主要不良心脏事件(MACE)发生情况,术后1年随访,6~9个月行冠状动脉造影复查。结果331例冠心病患者共置入支架597只,均成功置入病变处;1例心源性休克行急诊经皮冠状动脉介入治疗(PC I)支架置入后3 h死于泵衰竭,1例发生血管破裂转外科行急诊冠状动脉旁路移植术,3例术后出现非Q波型心肌梗死,住院期间MACE发生率为1.5%。301例患者随访12.3±3.2个月,2例死亡,2例支架内血栓形成,1例非致死性心肌梗死,16例再次心绞痛发作,5例再次靶病变血运重建术,总的MACE发生率为4.3%;110例患者6~9个月行冠状动脉造影复查,6例支架内再狭窄,再狭窄率5.5%。结论国产西罗莫司药物洗脱支架治疗冠心病患者安全、有效,有较好的近、中期疗效和较高的效益/价格比,尤其适用于经济欠发达地区,可使更多冠心病患者受益;但其远期效果有待进一步研究。     

药物涂层球囊治疗冠状动脉药物洗脱支架内再狭窄临床分析

目的分析药物涂层球囊(DCB)在治疗冠状动脉药物涂层支架内再狭窄病变中的疗效。方法回顾性分析20例冠状动脉药物洗脱支架内再狭窄患者接受药物涂层球囊治疗的临床资料及随访结果。结果 20例患者共21处再狭窄病变接受DCB治疗,术中即刻成功率95.23%,1处病变在应用DCB治疗后并发夹层并出现TIMI 2级血流,然后植入药物洗脱支架(DES)治疗。所有病例术后随访至今无心绞痛再发,未发生主要心血管不良事件。其中12例患者在术后6~9个月接受冠状动脉造影复查,复查时靶病变最小管腔直径与术后即刻直径比较,按病变血管统计,差异无统计学意义(P0.05);合计统计比较差异有统计学意义(P0.05)。结论 DCB治疗DES支架内再狭窄即刻及短期疗效肯定,可以作为支架内再狭窄的一种新的治疗手段。     

雷帕霉素洗脱支架治疗冠心病弥漫长病变的近中期疗效观察

目的:评价雷帕霉素洗脱支架(CYPHER支架)治疗冠心病弥漫性长病变的安全性、有效性和近中期疗效。方法:73例择期行经皮冠状动脉介入治疗(PCI)的冠心病患者,冠状动脉造影证实为弥漫性长病变≥60mm,在PCI治疗过程中置入Cypher支架。结果:73例患者PCI治疗均获得成功。共置入Cypher支架209枚,术后5例发生非Q波心肌梗死,1例术后3d发生亚急性支架内血栓形成,行急诊PCI、冠状动脉内rt-PA溶栓治疗痊愈,1例术后发生假性动脉瘤,其他患者住院期间均无严重并发症。随访12个月,所有患者未发生严重心血管事件;43例(58.9%)患者术后6～9个月行冠状动脉造影复查,4例发生支架内再狭窄,行外科搭桥术。结论:Cypher支架治疗冠心病弥漫长病变安全、有效,近中期效果良好。     

国产新型可生物降解药物洗脱支架临床应用212例

目的 评价Excel药物洗脱支架在212例冠状动脉疾病患者介入治疗中的临床疗效及安全性.方法 2006年2月至2007年4月入住成都军区昆明总医院心内科的212例冠状动脉疾病患者接受Excel药物洗脱支架置入术,观察手术成功率、术中并发症及8～21个月随访期间主要不良心脏事件发生率并复查冠状动脉造影情况.结果 手术即刻成功210例,成功率99.1%, 共置入Excel支架420枚,其中125例(29.8%)为直接支架术.住院期间1例猝死.206例患者随访8～21个月,6例再发心绞痛;50例于术后6～9个月复查冠状动脉造影,其中2例发生支架内再狭窄,并进行血运重建.结论 Excel支架作为一种新型的国产可生物降解药物洗脱支架在冠状动脉疾病介入治疗中近、中期临床观察是安全、有效的.     

雷帕霉素洗脱支架预防再狭窄23例的临床观察

目的:观察雷帕霉素洗脱支架对减少再狭窄的效果及安全性。方法:对入选的23例患者应用球囊预扩张后置入雷帕霉素支架,术后1、3、6个月进行临床随访,术后6个月造影随访。结果:23例患者25只支架全部置入成功。术后6个月发生重要心脏不良事件、靶血管失败、支架内血栓形成及穿刺处血管并发症各1例。术后6个月23例患者中18例进行了造影复查,仅1例(5.6%)发生支架内再狭窄,病变血管为前降支,狭窄程度为50%。结论:应用雷帕霉素洗脱支架进行冠状动脉介入治疗有效、安全。     

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。     

Sirolimus-eluting stents for the prevention of restenosis in a worst-case scenario of diffuse and recurrent in-stent restenosis.

For recurrent in-stent restenosis (ISR), surgical revascularization or brachytherapy is still the principal therapeutic options. The present investigation explores the efficacy of a sirolimus-eluting stent to prevent restenosis in these lesions with a high risk of recurrence. In 22 consecutive patients with a recurrent and diffuse ISR, a sirolimus-eluting stent was implanted to cover the restenotic lesion. All patients were followed clinically for at least 1 year and underwent a repeat angiography after 7 months. A quantitative coronary angiographic analysis was done. The target vessel failure was 14% in the sirolimus-eluting stent group, with an angiographic late loss of only 0.39 +/- 0.54. No subacute stent thrombosis was observed, and the 1-year event-free survival was 86%. The three cases with restenosis were all focal and could be successfully treated by additional drug-eluting stent implantation. This study showed the efficacy of a sirolimus-eluting stent for the prevention of restenosis in a worst-case scenario of recurrent and diffuse ISR. The observed restenosis rate is lower than that reported after brachytherapy and suggests that sirolimus-eluting stents are a promising treatment option for ISR.     

ISR II study: a long-term evaluation of sirolimus-eluting stent in the treatment of patients with in-stent restenotic native coronary artery lesions.

The aim of this pilot study was to determine the safety and long-term efficacy of treating intrastent restenosis (ISR) with the slow-release sirolimus-eluting stent Bx Velocity (Cypher stent) without intravascular ultrasound (IVUS) guidance. Of patients who received a bare metal stent implantation and presented an ISR, 30-80% of the patients will develop a second restenosis within the stent, at the stent edges or both. To date, intravascular brachytherapy using beta- and gamma-radiation has been the only effective treatment for ISR. Twenty-three patients with ISR and evidence of ischemia were treated with Cypher stent. Clinical information was collected 1, 8, 12, and 24 months after stent implantation. During the first 8 months of the study, in-stent lumen diameter remained essentially unchanged from postprocedure in 80% of the case. The target lesion repeat revascularization (TLR) was 17%, of which 50% were oculostenotic reflexes. Only one patient presented a restenosis greater than 70%. During the 2-year study period, the TLR rate was 17%; the major adverse coronary event rate was 26%, and the non-Q-wave myocardial infarction (MI) rate was 9%. There were no reports of death, coronary artery bypass grafting, or Q-wave MI during the study. This study demonstrates the feasibility of using sirolimus-eluting stents without IVUS guidance for the treatment of ISR, providing long-term stability of immediate results.     

A randomized comparison of sirolimus-eluting stent implantation with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions: rationale and design of the PRImary Stenting of Occluded Native coronary arteries III (PRISON III) study

Primary intracoronary drug-eluting stent placement after the successful crossing of total coronary occlusions decreases restenosis rate at long-term follow-up compared with bare-metal stent implantation. The PRISON II trial was the first randomized study to show the safety and efficacy of sirolimus-eluting stents in patients with totally occluded native coronary arteries. The sirolimus-eluting stent is superior to the bare-metal stent in treating patients with total coronary occlusions, with significant reduction in angiographic binary in-stent and in-segment restenosis resulting in significantly reduced need for target lesion and target vessel revascularization. Whether sirolimus-eluting stents are superior to other drug-eluting stents in total coronary occlusions is unknown. In this prospective, randomized trial, sirolimus-eluting stent implantation will be compared with zotarolimus-eluting stent implantation for the treatment of total coronary occlusions. A total of 300 patients will be followed for up to 5 years with angiographic follow-up at 8 months. Quantitative coronary analysis will be performed by an independent core laboratory. The primary end point will be in-segment late luminal loss at 8 months angiographic follow-up.     

Drug-Eluting Stents for In-Stent Restenosis and Acute Myocardial Infarction

In-stent restenosis (ISR) remains the "Achilles' heel" of percutaneous stent angioplasty treatment of patients with atherosclerotic disease of the coronary arteries. Recently, drug-eluting stents (DES) have ushered in a revolution in the treatment of these patients, yet, to date, their efficacy and safety have been demonstrated primarily for native de novo coronary lesions. For ISR, intracoronary brachytherapy using beta- or gamma-radiation is considered the standard of care. Nevertheless, DES are used for ISR lesions in clinical practice. This review outlines the few results currently available from small observational studies and larger registries. The designs of two ongoing randomized trials evaluating the sirolimus-eluting and the paclitaxel-eluting stent versus brachytherapy in patients with ISR lesions are also presented. Patients with acute myocardial infarction (AMI) have mostly been investigated in the context of small, uncontrolled studies and registries. The incomplete evidence to date is that implantation of sirolimus-eluting stents in patients with AMI is safe and effective.     

Effectiveness and safety of the sirolimus-eluting stents coated with bioabsorbable polymer coating in human coronary arteries.

BACKGROUND: Although the sirolimus-eluting stent (CYPHER, Cordis, USA) has shown a dramatic reduction of restenosis, there are still some concerns about its efficacy and safety. Its durable polymer coating may enhance neointimal proliferation and residual sirolimus, which cannot be released from polymer, may result in incomplete reendothelization. As a drug reservoir, bioabsorbable polymer (polylactic acid, PLA) is more rational. OBJECTIVE: We aimed to determine the safety and efficacy of sirolimus-eluting stent coated with PLA (EXCEL, JW Medical Systems, China) in the treatment of human coronary arterial diseases. METHODS: The study included 31 patients with de novo coronary lesions, with vessels 2.5-3.5 mm in diameter. The primary end points included the percentage of in-stent restenosis of the luminal diameter and in-stent late luminal loss at 6 months, as determined by quantitative angiography. The secondary end point was the major adverse cardiac events (MACE) 30 days and 6 months after the index procedure. RESULTS: Forty-eight EXCEL stents were successfully delivered in the 34 lesions, and multiple stents were implanted in 35.3% of lesions. All patients were discharged without clinical complications and completed clinical follow-up at 1 and 6 months. No MACE had occurred. Twenty patients (30 stents) completed 6 months of angiographic follow-up. No in-stent or in-lesion restenosis (diameter stenosis > or =50%) was observed. In-stent late loss was (0.07 +/- 0.17) mm. CONCLUSIONS: The implantation of EXCEL stent is feasible and safe and elicits minimal neointimal proliferation. This new stent has potential advantages regarding the long-long-term result over the commercially stent as the new stent has no sustained stimulation to the local tissue.     

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。     

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。     

Sirolimus-eluting stents for the treatment of in-stent restenosis

The treatment of in-stent restenosis (ISR) remains one of the major therapeutic challenge for the interventional cardiologist. All percutaneous mechanical approaches have shown disappointing results and the recurrence of ISR was reported to be unacceptably high. Currently, the only proven effective therapy available for the treatment of ISR, at least for the most complex lesions, is vascular brachytherapy. However, this therapy is limited by potential side effects and logistic requirements. The introduction of drug-eluting stents, that carry and release antiproliferative agents, have demonstrated to virtually eliminate ISR in de novo lesions. In the light of this promising results for de novo lesions, sirolimus-eluting stents (SES) were recently used for the treatment of ISR in 2 pilot studies. In Sao Paulo, 25 patients with ISR treated with SES (1.4 stent per lesion) presented 4% ISR and no clinical events at 1 year. In Rotterdam, 16 patients with severe ISR were treated with 26 SES. Intravascular ultrasound evaluation demonstrated successful inhibition of neointimal hyperplasia with 1.1% volume obstruction of the stent, which is similar to the Sao Paulo series (0.8%). At 9 months clinical follow-up, 3 patients had experienced 4 major adverse cardiac events (2 deaths and 1 acute myocardial infarction necessitating repeat target vessel angioplasty). With the results presently available, SES implantation can be considered safe and potentially efficacious in the treatment of ISR. However, multicenter, long-term randomized studies are warranted in order to evaluate this new treatment concept.