国产爱克赛尔药物洗脱支架与Cypher药物洗脱支架、金属裸支架在冠心病介入治疗近、中期疗效的比较

目的：探讨国产爱克赛尔药物洗脱支架、进口Cypher药物洗脱支架、金属裸支架治疗急性心肌梗死（AMI）或不稳定型心绞痛（UA）临床疗效的差异。方法：将126例在我院行PCI的冠心病患者分为三组,爱克赛尔药物洗脱支架组（65例）,进口Cypher药物洗脱支架组（36例）,金属裸支架组（25例）,分析支架置入后6个月的支架内血栓发生率及6个月再狭窄率。结果：三组患者在术后血管通畅,心功能和住院期间心脏事件方面差异均无统计学意义,6～8个月后随访时,均无支架内血栓发生,国产爱克赛尔药物洗脱支架组的支架内再狭窄率为5.9%;进口Cypher药物洗脱支架组的支架内再狭窄率为3.7%;裸支架组的支架内再狭窄率为33.3%。结论：国产爱克赛尔药物洗脱支架、进口Cypher药物洗脱支架治疗AMI患者并未增加6个月内支架内血栓的发生,再狭窄率两者差异无统计学意义;与裸支架相比,两者6个月的再狭窄率显著降低。     

国产雷帕霉素药物洗脱支架的临床应用观察

目的评价国产雷帕霉素药物洗脱支架的安全性和有效性。方法对32例冠心病患者,予以置入56个国产雷帕霉素药物洗脱支架(Firebird)治疗,并进行6个月以上随访。结果即刻成功率为100%。6个月以上随访,无重要心脏不良事件,无病变靶血管重建术,再狭窄率为0%。结论Firebird能有效预防冠脉支架术后再狭窄,并具有很高的安全性。     

国产药物洗脱支架的疗效评价

目的 评价国产药物洗脱支架治疗冠状动脉病变的临床疗效.方法 对47例冠心病冠脉病变患者置入药物涂层长支架(63枚).随访2～12个月,记录病死率、靶血管重建率及主要心血管事件发生率.结果 对47例患者进行随访,病死率、靶血管重建率和主要心脏事件发生率分别为2.1%、2.1%和6.4%.结论 国产药物洗脱支架在进行冠状动脉支架置入治疗中是安全和有效的.     

药物洗脱支架在冠心病介入治疗中的临床应用

目的:观察药物洗脱支架治疗冠心病的有效性及安全性。方法:对27例冠心病患者的33处病变植入33枚雷帕霉素药物洗脱支架(Cypher)。B型病变23处(69.70%),C型10处(30.30%)。结果:全部病例均成功植入,共植入33枚Cypher支架,成功率100%。术前靶病变狭窄程度及术后残余狭窄程度分别为(80.3±12.4)%和(5.6±0.7)%,目标血管的参考直径及长度分别为(3.07±0.68)mm和(15.2±1.86)mm,植入支架的平均直径及长度分别为(3.00±0.13)mm和(19.52±5.37)mm。随访观察6个月,再狭窄发生率0%,心脏不良事件发生率0%,靶病变重建率0%。结论:Cypher支架可安全有效地预防冠心病介入治疗术后再狭窄。     

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Firebird雷帕霉素药物洗脱支架的临床观察

目的:评价国产Firebird雷帕霉素药物洗脱支架的安全性和有效性.方法:68例冠心病患者,予以置入100个国产Firebird雷帕霉素药物洗脱支架治疗,并进行6月以上至2年随访.结果:即刻成功率为100%.6月以上至2年随访无重要心脏不良事件,无病变靶血管重建术,再狭窄率为0%,无支架内血栓形成.结论:国产Firebird雷帕霉素洗脱支架治疗冠心病安全有效,能有效预防冠脉支架术后再狭窄.     

国产雷帕霉素洗脱支架和进口紫杉醇洗脱支架的3年临床随访

目的 比较国产雷帕霉素洗脱支架(Firebird)和紫杉醇洗脱支架(Taxus)的长期临床效果.方法 回顾性分析从2004年4月至2005年4月阜外医院连续置入Firebird支架(F组:88例)和Taxus支架(T组226例)共314例患者.结果 基线上T组包括的复杂病变比率、病变狭窄程度、球囊预扩张的比率以及置入支架的长度均明显大于F组,两组介入成功率均为100%.主要心脏不良事件(MACE)发生率F组明显低于T组(8.O%、21.7%,P=0.005),其中心源性死亡、非致死性心肌梗死(MI)两组差异无统计学意义;(O%、1.8%)和(1.1%、3.5%);(P=0.580,P=0.453),靶血管重建率(TVR)F组明显低于T组(6.8%、16.4%,P=0.028).支架内血栓发生率两组差异无统计学意义(1.1%、3.5%,P=0.453),早、晚期和晚晚期支架内血栓发生率两组差异无统计学意义.造影随访F组支架内和血管段再狭窄率均明显低于T组(0%、21%;P=0.002和0%、24%,P=0.001).F组支架内和血管段的晚期丢失均明显小于T组[(0.11±0.07)mm、(0.53±0.38)mm,P=0.000和(0.05±0.03)mm、(0.38±0.19)mm,P=0.000)].结论 Taxas和Firebird支架有良好的长期临床效果,Firebird在降低再狭窄方面有优势.     

雷帕霉素洗脱支架治疗冠心病的临床应用

目的探讨雷帕霉素(Rapamycin)洗脱支架临床应用的安全性和有效性。方法对88例冠心病患者行雷帕霉素洗脱支架植入术，记录一般情况、术中支架植入情况以及随访结果。结果88例冠心病患者共植入雷帕霉素洗脱支架119枚，手术成功率100％，术中及术后无主要心血管事件发生。结论用雷帕霉素洗脱支架植入治疗冠心病是安全有效的，在防治经皮经腔冠状动脉血管成形术(PTCA)术后再狭窄方面有良好的应用前景。     

药物洗脱支架在冠心病超长病变择期经皮冠状动脉介入治疗中的应用

目的 评价药物洗脱支架应用于冠心病超长病变(≥50 mm)的安全性、有效性.方法 选取68例行经皮冠状动脉介入治疗(PCI)的冠心病超长病变患者置入Cypher支架、Firebird支架及Taxus支架,记录患者的治疗、在院期间和随访等情况.结果 68例患者PCI治疗均获成功,共置入Cypher支架84枚、Firebird支架42枚、Taxus支架69枚.1例合并糖尿病者术后出现支架内亚急性血栓,2例发生非Q波型心肌梗死,其他患者住院期间均无严重并发症发生.随访6～12个月,患者均未发生主要心脏不良事件,36例患者术后6～9个月行冠状动脉造影复查,其中3例发生支架内再狭窄并行外科搭桥术.结论 药物洗脱支架在冠心病超长病变PCI治疗中安全、有效,但需进一步评价.     

国产Firebird支架治疗冠心病194例临床观察

目的评价Firebird支架在冠心病患者中临床应用的近、远期疗效。方法对194例冠心病患者置入Firebird支架,术前、术后常规使用抗血小板药物及治疗冠心病药物,观察Firebird支架置入的手术成功率、术中并发症、住院期间及6个月临床随访期间的心血管事件和再狭窄发生率。结果支架置入成功率为100%,术中和住院期间死亡2例,心肌梗塞2例,住院期间主要心脏不良事件发生率为1.55%,192例患者随访6个月,2例患者死亡,均合并糖尿病。2例进行了靶血管重建,主要心脏不良事件发生率为2.06%。冠状动脉造影再狭窄率为4.35%,靶病变重建率为1.09%。结论国产Firebird支架是安全和有效的,其支架内再狭窄率低于普通金属支架。     

Comparison of home-made Firebird 2TM drug-eluting stent and imported Endeavor-Sprint drug-eluting stent

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.     

Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions

Background There are limited data on the efficacy of drug-eluting stents （DES） for treatment of chronic total occlusions （CTO）. The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent （BMS） implantation.
Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 （55.7%） who underwent DES and 524 （44.3%） who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events （MACE）. Long-term survival rates were estimated with the Kaplan-Meier method.
Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy （（7.4±2.5） months vs （1.7±0.8） months, P 〈0.001）. Average follow-up periods were （4.7±0.89） and （3.2±1.3） years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups （90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38）, but the 5-year target vessel revascularization （TVR）-free survival rate in the DES group was significantly higher than that in the BMS group （81.6% vs 73.5%, Log-rank P 〈0.001）. The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group （80.6% vs 71.5%, Log-rank P〈0.001）. The rates of readmission caused by cardiovascular disease （27.0% vs 37.8%, P 〈0.001） and the need for bypass surgery were significantly lower in the DES group （1.5% vs 3.4%, P 〈0.05）. By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients （HR： 0.492; 95% Cl 0.396-0.656, P 〈0.001）. Left ventricular ejection fraction 〈50% and elderly （〉65 years） were identified as independent predictors of long-term MACE during follow-up.
Conclusion This study demonstrates the long-term （up to 5 years） efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.     

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.     

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.     

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.

     

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。     

药物洗脱支架内再狭窄的介入治疗

目的评价药物洗脱支架(DES)内再狭窄患者中根据再狭窄模式选择介入治疗的远期预后。方法选择2006年6月—2009年12月因DES内再狭窄于上海交通大学附属胸科医院行再次介入治疗的冠状动脉性心脏病患者,根据再狭窄部位及类型选择介入治疗方案。对于累及DES节段的再狭窄者行再次植入DES术;对于狭窄部位局限于DES内的Ⅰ型病变者行高压球囊扩张术;对于狭窄部位局限于DES内的Ⅱ～Ⅳ型病变者先行球囊扩张,再根据扩张后的结果由术者决定是否再次植入DES。所有患者均前瞻性随访主要心血管不良事件(MACE),包括死亡、靶病变重建(TLR)和心肌梗死(MI)。结果共88例行介入治疗,其中42例行单纯球囊血管成形(POBA)术(POBA组),46例行再次植入DES(DES组)。两组间各靶病变部位及各种原植入DES的涂层药物类型构成比的差异均无统计学意义(P值均>0.05),两组间再狭窄病变部位及类型构成比的差异均有统计学意义(P值均<0.05)。POBA组、DES组的支架内再狭窄(ISR)的发生率分别为(72.5±11.9)%、(76.2±9.1)%,两组间的差异无统计学意义(P>0.05)。平均随访时间为(2.2±1.0)年,两组间MACE、TLR、MI的发生率及病死率的差异均无统计学意义(P值均>0.05)。结论根据DES内再狭窄部位及类型选择介入治疗方案是有效的。对于局灶型ISR可行POBA术,而对于非局灶型或节段内ISR病变则需要再次植入DES。     

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.     

Very late coronary aneurysm formation with subsequent stent thrombosis secondary to drug-eluting stent

Drug-eluting stents have changed the practice in interventional cardiology. With the widespread use of these stents important safety concerns regarding stent thrombosis and formation of coronary artery aneurysm have been expressed. While the majority of attention was focused on stent thrombosis, the formation of coronary aneurysm was only described in anecdotal reports. We report on a patient who suffered from very late stent thrombosis in association with coronary artery aneurysm formation secondary to drug-eluting stent but not to bare-metal stent.

     

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.