国产Firebird 2TM与进口Endeavor-Sprint药物洗脱支架临床应用比较

目的对比研究国产Firebird 2TM雷帕霉素药物洗脱钴基合金支架与进口Endeavor-Sprint药物洗脱支架临床应用的安全性及疗效。方法对100例冠心病患者进行介入治疗,随机分为Firebird组和Endeavor组,每组50例,比较两组支架植入后效果。结果两组患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数比较差异无统计学意义(P>0.05),平均血管直径和平均靶病变长度比较差异无统计学意义(P>0.05);两组手术成功率为100%。Firebird组无血栓形成事件发生,Endeavor组发生1例亚急性血栓形成事件,且进行血运重建。Firebird组28例复查冠状动脉造影,1例再狭窄;Endeavor组19例复查冠状动脉造影,2例有再狭窄,两组比较差异无统计学意义(P>0.05)。结论 Firebird 2TM雷帕霉素药物洗脱钴基合金支架具有良好的安全性和满意的近、中期疗效。其与进口Endeavor-Sprint药物洗脱支架比较无明显差别。     

Firebird药物洗脱支架联合国产替罗非班治疗急性冠脉综合征的安全性及疗效

目的 评估Firebird药物洗脱支架(DES)加替罗非班与Cypher支架加替罗非班治疗急性冠脉综合征(ACS)病人的安全性和有效性.方法 2005年7月至2007年7月323例ACS病人,其中接受Firebird支架(Firebird组)161例,接受Cypher支架(Cypher组)162例.两组同时加用替罗非班.首先给予负荷量10μg·kg-1,3 min内静注完毕,之后以0.15 μg·kg-1·min-1的速度微量泵持续静点36 h.比较两组支架植入后即刻到近期的有效性和安全性,并于30 d内进行随访,比较有效性和主要不良心脏事件的发生率.结果 Firebird组与Cypher组比较,术前左室射血分数、靶病变的部位、血小板计数、血红蛋白、红细胞压积差异均无统计学意义.两组手术成功率均为100%,术后出血并发症、血小板计数、血红蛋白、红细胞压积差异均无统计学意义,两组各有2例发生支架内急性血栓(1.2% vs 1.2%,P＞0.05).均无亚急性血栓发生、非致死性心肌梗死各2例(1.3% vs 1.3%)、靶血管再次重建分别为1例(0.6%),2例(1.3%)、再住院分别为2例(1.3%)1例(0.6%)差异均无统计学意义(均P＞0.05).30 d随访均未见支架内再狭窄.结论 Firebird药物洗脱支架加用冠替罗非班治疗ACS均有较好的安全性和有效性,具有与Cypher支架相似的临床疗效.     

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

Background  The Firebird 2^TM sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2^TM cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.

Methods  The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry. Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.

Results  Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events (MACE) was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction (MI), and 6 target vessel revascularization (TVR). At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis (ST) occurred in 0.43% (22/5058) of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.

Conclusion  The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

     

高龄多支冠脉病变患者国产药物支架介入治疗疗效观察

目的 探讨高龄冠心病多支病变患者国产药物洗脱支架介入治疗的长期效果,以确定该组患者的疗效.方法 入选36例高龄冠心病多支病变患者,成功植入药物支架,长期随访.结果 36例冠心病患者共118支病变血管,处理相关血管71支(60%),植入药物支架共51枚(Firebird支架43枚,Cypher支架8枚),非药物支架50枚,手术即刻成功率97%.随访3月内纽约心脏协会心功能Ⅰ～Ⅱ级改善29例(81%),心绞痛症状明显改善31例(86%),运动耐量提高Ⅰ～Ⅱ级28例(77.8%);6～12个月内6例(16.7%)发生主要心脏事件.药物支架组的主要心脏事件和支架内再狭窄发生率均显著低于非药物支架组(11.8%、29.0%,P≤0.05;6.1%、17.7%,P≤0.01).结论 高龄多支冠脉病变患者使用国产药物支架疗效安全可靠.     

Comparison of drug-eluting stent and bare-mental stent in the complex small vessel intervention

Nowadays, coronary intervention has been dramatically improved in the drug-eluting stent era. The drug-eluting stent represents the dominant percutaneous coronary intervention modality beacause it significantly reduces the restenosis rate compared with bare mental stent. Such benefit was initially demonstrated in coronary vessels 3 mm or more in diameter.1,2 However, restenosis after coronary stent implantation is influenced by vessel size and length, and stent occlusion is more frequent in sm…     

PARTNER~(TM)药物洗脱支架的临床应用

目的:评价PARTNERTM药物洗脱支架的临床疗效及安全性。方法:选择2006年1～12月111例冠心病患者,所有患者行经皮冠状动脉介入治疗置入PARTNERTM药物洗脱支架,术后对患者进行随访,观察有无胸痛复发、心电图改变及重要心血管不良事件的发生。结果:111例患者共180处病变置入196枚PARTNERTM药物洗脱支架,手术成功率100%,胸痛缓解无复发,术后无重要心血管不良事件发生。结论:PCI术中应用国产PARTNERTM雷帕霉素药物洗脱支架近期疗效满意,应用安全方便。     

国产药物洗脱支架在冠心病中的临床应用

目的评价国产药物洗脱支架(Firebird)临床应用的安全性和有效性。方法对110例冠心病患者置入Firebird支架治疗,术后对患者进行随访,观察有无胸痛复发、心电图异常改变、重要心脏不良事件发生等。结果110例患者共置入Firebird支架146枚,手术即刻成功率100%。对患者至少随访3个月,平均8个月,无重要心脏不良事件发生,38例患者6个月后复查造影2例出现再狭窄,再狭窄率5.2%。结论Firebird支架置入即刻成功率高,能有效预防PCI术后再狭窄,治疗冠心病安全、有效。     

药物洗脱支架和金属裸支架对冠心病患者近远期疗效比较

目的对比观察药物洗脱支架(DES)和金属裸支架(BMS)治疗冠心病(CHD)患者近远期临床疗效的影响。方法收集我院2005年1月至2007年1月CHD患者305例,随机分为治疗组和对照组,其中治疗组接受DES治疗,对照组接受BMS治疗,于术后1、3、6、9和12个月进行电话或门诊随访,并于12个月做冠状动脉造影,观察不良心脏事件、支架内血栓及再狭窄的发生率,并评价两组不同因素对再狭窄的影响。结果治疗组置入支架成功率为98.7%,而对照组置入支架成功率为100%。在主要临床事件方面,治疗组主要心脏不良事件、支架内狭窄发生率明显低于对照组,二者相比有显著性差异(P<0.01);而近期血栓事件发生率为2.58%,与对照组相比无显著性差异(P>0.05)。亚组分析,治疗组中在弥漫病变、重叠支架、长支架时的再狭窄率小,与对照组相比,具有显著性差异(P<0.01)。结论在经皮冠状动脉介入治疗术支架置入中,DES具有较低的不良心脏事件、近期血栓及再狭窄的发生率,同BMS相比有显著的优势,近远期疗效是安全、可靠的。     

Inflammatory response, drug-eluting stent and restenosis

Cardiovascular diseases are the major cause of mortality in the Western world and it is expected that this will rem-ain so during the foreseeable future. 1 Among them, coronary artery disease （CAD） is the most important underlying cause of death due to cardiovascular disease.^2 Current treatment of pattents with CAD includes mainly risk factor management, drug therapy and revascularization techniques.     

垠艺支架与Firebird支架治疗冠心病合并糖尿病患者疗效比较

目的:探讨药物涂层支架在冠心病合并糖尿病患者介入治疗中的临床疗效。方法:并发糖尿病的冠心病患者90例常规冠状动脉造影,进行经皮冠状动脉介入治疗,其中44例植入国产雷帕霉素药物涂层支架(Firebird组),46例植入国产紫杉醇药物涂层支架(垠艺组),术前术后常规使用阿司匹林和氯吡格雷,术后进行随访。结果:冠状动脉造影显示2支以上血管病变占83.3%,Firebird组植入雷帕霉素药物涂层支架77枚,垠艺组植入垠艺支架82枚,所有患者均获得成功。平均随访6.2±1.3个月,其中Firebird组复发心绞痛3例,1例发生心肌梗死。垠艺组复发心绞痛3例,1例发生心肌梗死。Firebird组发生再狭窄2例,垠艺组发生再狭窄2例。两组无支架内血栓形成和死亡。结论:垠艺支架对冠心病并发糖尿病患者的近期疗效与Firebird支架相似。     

“真实世界”药物涂层支架（DES）植入后5年随访研究

目的研究第一代药物洗脱支架治疗冠心病远期（5年）临床疗效。明确晚期主要心血管事件的发生率。方法对2004年1月-12月就诊于我中心并成功植入DES的156例冠心病患者进行随访调查,为单中心非对照的登记研究,随访5年的主要心血管事件发生率。主要终点：观察主要不良心血管事件（Major Adverse Cardiac Events,MACE）发生情况;次要终点：心绞痛复发和非靶血管的血运重建。结果 156例冠心病DES植入者成功随访,随访时间（5.21±0.32）年。主要MACE发生32例（21%）,其中心原性死亡5例（3.2%,心原性猝死3例,心衰和急性心肌梗死各1例）,靶病变/靶血管的再次血运重建19例（12.2%）,再次非致命性心梗8例（5.1%）,心绞痛复发43例（27.6%）,其他血管血运重建及CABG治疗6例。脑出血、感染、肿瘤死亡各1例。Logistic回归分析显示氯吡格雷服用时间（P=0.016,OR=1.1,95%CI：1.018-1.188）和多支血管病变（P=0.039,OR=3.35,95%CI：1.06-10.55）是MACE发生的独立危险因素。结论多支血管病变者MACE发生率增加;服用氯吡格雷时间长者并未在MACE发生方面绝对获益。     

Meta-analysis of stent thrombosis after drug-eluting stent implantation: 4-year follow-up

Background Drug-eluting stents （DES） are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents （BMS）. The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios （OR） were calculated for each outcome and presented with 95% confidence intervals （CI）.Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS （late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91）.Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.     

A more than 2-year follow-up of incomplete apposition after drug-eluting stent implantation

Background Incomplete stent apposition （ISA） has been demonstrated to be more common after drug-eluting stent （DES） implantation than after bare metal stent （BMS） implantation, Clinical outcomes of ISA remain controversial and the predictive accuracy of previous studies was limited by the short follow-up period of only 12-18 months. In the present study, we present the outcomes of a more than 2-year follow-up in patients with ISA after DES implantation, Methods From the clinical and core intravascular ultrasound （IVUS） database of the hospital, we identified 76 patients who had undergone DES implantation in de novo lesions between January 2004 and June 2005 and had received IVUS examination at a scheduled 6-month follow-up. A total of 13 （17.1%） patients had documented I SA at the follow-up by IVUS. Clinical follow-up was available up to 41 months after DES implantation and up to 33 months after identification of ISA, Results Over a mean follow-up of （34：~5） months （range 24-41 months）, 3 of the 13 patients （23.1%） suffered from ST elevated myocardial infarction with one death. Angiography confirmed the very late stent thrombosis （ST） in the area with ISA, All the 3 patients were implanted with sirolimus elulJng stents in left anterior descending artery （LAD） and the very late ST occurred at 29, 31 and 32 months after DES implantation, and separately at 20, 23 and 23 months after the identification of ISA, All of the 3 patients had antiplatelet therapy continued before suffering from ST, and had been apparentJy stable on antiplatelet monotherapy with aspirin for a long peried following dual antiplatelet therapy with aspirin and clopidogrel for more than 12 months. Conclusion ISA of DES may be associated with a high incidence of very late stent thrombosis, even in clinically stable patients with dual antiplatelet therapy of at least 12 months after the procedure.     

冠状动脉支架内急性亚急性血栓形成的诊治体会

目的探讨冠状动脉支架内急性亚急性血栓形成的原因和处理方法。方法回顾性分析我院开展冠脉介入手术以来发生的诊断明确的冠脉支架内急性亚急性血栓形成的5例患者的病历资料。结果 9年间总共有928例患者行冠脉介入手术,共发生冠脉支架内急性亚急性血栓形成5例,发生率0.54%。冠脉支架内急性亚急性血栓形成与冠脉血管病变长,严重钙化病变,血管细小,支架膨胀不全,支架贴壁不良,支架未完全覆盖病变,支架重叠连接处未重整,术后未坚持应用双联抗血小板药物及抗血小板药物抵抗有关。冠脉支架内急性亚急性血栓形成对溶栓效果不佳,需急诊行PTCA、血栓抽吸导管开通相关血管,并强化抗凝抗血小板治疗。结论冠脉支架内急性、亚急性血栓形成与患者血管病变特点及介入操作等因素有关。再次急诊PTCA、血栓抽吸导管开通相关血管是治疗支架内血栓形成的首选方法。     

Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation

Context  Recent studies of drug-eluting intracoronary stents suggest that current antiplatelet regimens may not be sufficient to prevent late stent thrombosis. Objective  To assess the association between clopidogrel use and long-term clinical outcomes of patients receiving drug-eluting stents (DES) and bare-metal stents (BMS) for treatment of coronary artery disease. Design, Setting, and Patients  An observational study examining consecutive patients receiving intracoronary stents at Duke Heart Center, a tertiary care medical center in Durham, NC, between January 1, 2000, and July 31, 2005, with follow-up contact at 6, 12, and 24 months through September 7, 2006. Study population included 4666 patients undergoing initial percutaneous coronary intervention with BMS (n = 3165) or DES (n = 1501). Landmark analyses were performed among patients who were event-free (no death, myocardial infarction [MI], or revascularization) at 6- and 12-month follow-up. At these points, patients were divided into 4 groups based on stent type and self-reported clopidogrel use: DES with clopidogrel, DES without clopidogrel, BMS with clopidogrel, and BMS without clopidogrel. Main Outcome Measures  Death, nonfatal MI, and the composite of death or MI at 24-month follow-up. Results  Among patients with DES who were event-free at 6 months (637 with and 579 without clopidogrel), clopidogrel use was a significant predictor of lower adjusted rates of death (2.0% with vs 5.3% without; difference, –3.3%; 95% CI, –6.3% to –0.3%; P = .03) and death or MI (3.1% vs 7.2%; difference, –4.1%; 95% CI, –7.6% to –0.6%; P = .02) at 24 months. However, among patients with BMS (417 with and 1976 without clopidogrel), there were no differences in death (3.7% vs 4.5%; difference, –0.7%; 95% CI, –2.9% to 1.4%; P = .50) and death or MI (5.5% vs 6.0%; difference, –0.5%; 95% CI, –3.2% to 2.2%; P = .70). Among patients with DES who were event-free at 12 months (252 with and 276 without clopidogrel), clopidogrel use continued to predict lower rates of death (0% vs 3.5%; difference, –3.5%; 95% CI, –5.9% to –1.1%; P = .004) and death or MI (0% vs 4.5%; difference, –4.5%; 95% CI, –7.1% to –1.9%; P<.001) at 24 months. However, among patients with BMS (346 with and 1644 without clopidogrel), there continued to be no differences in death (3.3% vs 2.7%; difference, 0.6%; 95% CI, –1.5% to 2.8%; P = .57) and death or MI (4.7% vs 3.6%; difference, 1.0%; 95% CI, –1.6% to 3.6%; P = .44). Conclusions  The extended use of clopidogrel in patients with DES may be associated with a reduced risk for death and death or MI. However, the appropriate duration for clopidogrel administration can only be determined within the context of a large-scale randomized clinical trial.      

药物洗脱支架置入后长期临床预后与氯吡格雷应用的关系

背景：近来关于冠状动脉内药物洗脱支架（DES）的研究表明目前的抗血小板方案不足以预防晚期支架内血栓形成。目的：评估冠心病患者接受DES和裸金属支架（BMS）置入后长期临床预后与氯吡格雷应用的关系。设计、地点和患者：对2000年1月1日至2005年7月31日间在Duke心脏中心接受冠状动脉支架置入术的连续患者进行观察研究。分别在6个月、12个月、24个月时进行随访，直至2006年9月7日。研究对象为4666例接受首次PCI支架置入的患者，其中3165例接受BMS，1501例接受DES。[第一段]     

不同药物洗脱支架植入对ST段抬高心肌梗死患者的疗效及预后研究

目的初步探讨ST段抬高心肌梗死患者在接受急诊PCI后,不同药物洗脱支架对患者的疗效,及血清标志物和ST段的恢复之间的关联。方法前瞻性连续入选ST段抬高型急性心肌梗死患者118人,分为雷帕霉素洗脱支架（66人）与紫杉醇洗脱支架组（52人）,统一测定心肌肌钙蛋白（cTnI）、肌酐激酶（CK-MB）、NT-pro-BNP水平、12导联心电图,并对所有入选患者进行12个月临床随访。结果应用两种支架植入100%获得手术成功,术后死亡、支架内血栓和靶病变血运重建等不良事件发生率差异无统计学意义,6-12个月造影随访雷帕霉素组、紫杉醇组再狭窄率分别为8.33%、10.52%。PCI前NT-pro-BNP水平较高的患者ST段不容易完全恢复。结论应用雷帕霉素药物洗脱支架和紫杉醇药物洗脱支架植入对ST段抬高心肌梗死患者的疗效并没有显著的差异。血浆NT-pro-BNP水平是一个能反映介入治疗后ST段恢复的新型独立预后指标。     

药物洗脱支架在预防支架内再狭窄中的作用及临床应用进展

冠状动脉支架植入术已成为冠心病治疗中一种有确切疗效的重要手段,但相当高(10％-50％)的支架内再狭窄率限制了支架植入术的发展。而可在局部缓慢释放抑制血管内皮和平滑肌增殖药物的药物洗脱支架(DES)的应用,明显降低了支架内再狭窄率,大大延缓了支架术后再次行经皮冠状动脉介入治疗的时间。目前临床应用的DES有雷帕霉素洗脱支架和紫杉醇洗脱支架。其显著降低支架内再狭窄率的作用已为越来越多的已完成或正在进行的临床试验所证实。