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。     

国产药物洗脱支架治疗冠心病35例临床疗效观察

目的观察国产药物洗脱支架在冠心病介入治疗中的安全性和有效性。方法选择2005年5月-2006年7月期间冠心病介入治疗的患者35例,置入国产Firebird药物洗脱支架56枚。观察即刻成功率、术中并发症发生率、住院期间和临床随访期间心脏不良事件发生率。结果35例患者中即刻手术成功率100%,住院期间及临床随访7个月～22个月均无心脏不良事件发生,35例患者全部完成冠状动脉造影术后6个月复查,均无支架内再狭窄。结论国产药物支架能够有效预防冠脉介入治疗术后血管再狭窄,治疗冠心病是安全和有效的。     

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.     

147例国产雷帕霉素洗脱支架Firebird治疗冠心病疗效观察

目的：评价应用国产药物洗脱支架Firebird的临床疗效.方法：选择2004年9月～2007年3月147例置入Firebird支架治疗的冠心病患者进行临床观察,随访1～30个月,11例复查冠状动脉造影.结果：147例患者共置入Firebird支架279枚,手术即刻成功率100%,住院病死率0.6‰,靶病变血管重建术为0,心脏不良事件发生率为1.3%.随访中未发现与Firebird支架相关的再狭窄依据,其中11例患者经冠脉造影证实无再狭窄.结论：上述观察显示Firebird支架能有效治疗冠脉狭窄,减少冠脉支架术后再狭窄,具有很高的安全性及应用前景.     

国产药物洗脱支架在急性心肌梗死的应用及冠状动脉造影随访观察

目的评价国产药物洗脱支架(Firebird支架,上海微创公司)治疗急性心肌梗死的安全性及近中期疗效。方法65例急性心肌梗死患者行急诊介入术时接受了Firebird支架治疗,65处靶病变共置入82枚Firebird支架。观察手术成功率、并发症、随访期间心脏不良事件发生率、再狭窄率及晚期管腔丢失等。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。临床随访6~14个月,所有患者均未发生任何心脏不良事件,无一例死亡。30例患者术后6~12个月复查了冠状动脉造影。结论Firebird支架治疗急性心肌梗死是安全可行的,其近期及术后9个月内的疗效是满意的,它能显著降低9个月内的支架内再狭窄率及再次血运重建率。     

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.     

国产药物洗脱支架在急，陛心肌梗死的应用及冠状动脉造影随访观察

目的评价国产药物洗脱支架（Firebird支架，上海微创公司）治疗急性心肌梗死的安全性及近中期疗效。方法65例急性心肌梗死患者行急诊介入术时接受了Firebird支架治疗，65处靶病变共置入82枚Firebird支架。观察手术成功率、并发症、随访期间心脏不良事件发生率、再狭窄率及晚期管腔丢失等。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。临床随访6～14个月，所有患者均未发生任何心脏不良事件，无一例死亡。30例患者术后6～12个月复查了冠状动脉造影。结论Firebird支架治疗急性心肌梗死是安全可行的，其近期及术后9个月内的疗效是满意的，它能显著降低9个月内的支架内再狭窄率及再次血运重建率。     

国产Firebird支架治疗2型糖尿病合并冠心病患者的临床疗效观察

目的:观察国产Firebird支架在2型糖尿合并冠心病患者中的临床疗效.方法:纳入我院2005年3月至2006年12月行冠状动脉介入治疗(Percutaneous coronary intervention,PCI)的2型糖尿合并冠心病患者共90例,其中Firebird支架组47例,普通支架组43例,术前术后除常规使用阿司匹林和波立维外,同时给予严格的内科强化治疗,术后进行随访,观察2组的临床疗效.结果:冠状动脉造影显示2支以上血管病变占71.11%,一共植入Firebird支架74枚,普通支架55枚,所有患者均获得成功.平均随访(10.2±3.3)月,其中药物支架组复发心绞痛3例(6.4%),主要心脏不良事件2例(4.2%);普通支架组复发心绞痛13例(30.2%),主要心脏不良事件13例(30.2%).国产Firebird支架组心绞痛复发率以及主要心脏不良事件发生率均低于普通支架组,差异显著(6.4%比30.2%,P相似文献   

Firebird药物洗脱支架在冠心病介入治疗中应用的临床观察

目的：研究国产雷帕霉素药物洗脱支架（Firebird）在冠心病介入治疗中应用的安全性及疗效。方法：26例冠心病患者接受Firebird支架置入术，观察支架置入术即刻及近期结果。结果：26例患者置入支架56枚，手术即刻成功率100％。严重心脏不良事件（MACE）1例（发生率3．8％）；其余25例患者术后随访1—12月，无再发心绞痛和MACE。结论：Firebird药物洗脱支架用于冠心病介入治疗即刻手术成功率高，安全有效。     

Incidence of thrombosis after implantation of drug-eluting stents in patients with coronary artery disease

Background Randomized clinical trials have demonstrated equivalent safety to bare-metal stents after drug-eluting stents （DES） implantation. However, the DES thrombosis in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. This study sought to assess the incidence of DES thrombosis after implantation of DES in patients with real world coronary artery disease （CAD） in China.
Methods From December 2001 to April 2007, 8190 consecutive patients received the treatment with DES, 5412 patients completed one year follow-up： 2210 with sirolimus-eluting stent Cypher, 1238 with paclitaxel-eluting stent Taxus and 1964 with Chinese sirolimus-eluting stent Firebird, After two years of follow-up, there were 2176 patients （1245 Cypher, 558 Taxus and 373 Firebird）. All patients were treated with aspirin and clopidogrel over at least 9 months.
Results Among 8190 patients, 17 patients had acute stent thrombosis （0.24%）： 7 in the Cypher group, 4 Taxus and 6 Firebird; 23 patients had subacute stent thrombosis： 8 Cypher, 6 Taxus and 9 Firebird. The incidence of acute and subacute thrombosis was 0.49%： 0.50% Cypher, 0.63% Taxus and 0.41% Firebird. The incidence of late thrombosis at one year followup was 0.63%： 0.63% Cypher, 0.88% Taxus and 0.46% Firebird; at two year follow-up the incidence was 0.74%： 0.72% Cypher, 0.90% Taxus and 0.54% Firebird. There was no significant difference among three groups at 1 year and 2 years follow-up.
Conclusion The first generation DES in the treatment of complex lesions are safe and effective if patients are aggressively treated with dual antiplatelet agents.     

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.

     

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.     

Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result A prospective, historically controlled, multi-center clinical study

Background  The emergence of drug-eluting stents (DES) has dramatically reduced the incidence of in-stent restenosis. This study was conducted to evaluate the safety and efficacy of sirolimus-eluting cobalt-chrome stents (Firebird 2) for treating patients with coronary artery disease.
Methods  Sixty-seven patients with de novo or non-stented restenostic coronary lesions were chosen to receive the Firebird 2 stent as the final treatment (Firebird 2 group). Another 49 consecutive patients were implanted with bare cobalt alloyed stents (Driver, Medtronic) within the previous six months and served as historical controls (control group). Baseline clinical characteristics, angiographic features, procedural results, 30-day, 6-month and 12-month clinical follow-up regarding the occurrence of major adverse cardiac events (MACE), as well as the primary endpoint of late lumen loss at 6-month angiographic follow-up were compared between the two groups.
Results  The demographic characteristics were similar between the two groups despite more patients in the Firebird 2 group who underwent previous percutaneous coronary intervention (22.4% vs 8.2%, P=0.0418) and who had diabetes mellitus (29.9% vs 12.2%, P=0.0253). In the Firebird 2 group, the mean diameter of the reference vessel was smaller ((2.79±0.46) mm vs (2.98±0.49) mm, P=0.0175) and more stents were implanted for each lesion (1.28±0.52 vs 1.10±0.30, P=0.0060). Other angiographic, procedural results and the device success rate were similar between the two groups. The MACE rate at 30-day and 3-month was the same, but significantly fewer MACE occurred in the Firebird 2 group at 6- and 12-month follow-up (1.5% vs 12.2% at 6 month, P=0.0168; 1.5% vs 26.5% at 12 month, P<0.0001). The primary endpoint of late lumen loss at 6-month angiographic follow-up was significantly reduced in the Firebird 2 group (in-stent: (0.05±0.09) mm vs (0.98±0.61) mm; in-segment: (0.05±0.18) mm vs (0.72±0.59) mm; P<0.0001) than the control group. One patient in the Firebird 2 group had in-segment restenosis (1.3%) while the rate in the control group (38.1%) was significantly higher, P<0.0001. Intravascular ultrasound examination was performed in 70.1% of patients in the Firebird 2 group and revealed that the percentage of volumetric obstruction was (1.26±1.05) %. No stent thrombosis was observed in either group at 12-month follow-up.
Conclusion  The Firebird 2 sirolimus-eluting cobalt alloyed stent is safe and feasible in treating patients with coronary artery disease.

     

Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

Background  Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry. 

Methods  The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.

Results  Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21±0.40) mm in-segment and (0.23±0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.

Conclusions  The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

     

药物洗脱支架在糖尿病冠状动脉长病变中的应用研究

目的探讨依维莫司洗脱支架在糖尿患者冠状动脉长病变中的临床疗效。方法选择河南大学第一附属医院2010年1月至2011年12月就诊的冠状动脉长病变患者56例,其中伴糖尿病患者18例为伴糖尿病组,其余38例为不伴糖尿病组。比较两组依维莫司洗脱支架植入术的成功率,随访6个月至1年,观察主要不良心血管事件发生率、靶血管血运重建率、再发心绞痛率、最终管腔丢失指数、平均最小管径等指标。结果糖尿病组随访6个月和1年的主要不良心血管事件发生率、靶血管血运重建率、再发心绞痛率高于不伴糖尿病组,差异有统计学意义(P<0.05);糖尿病组术前靶血管平均直径、随访1年时平均最小管径小于不伴糖尿病组,差异有统计学意义(P<0.05),糖尿病组随访1年的管腔直径狭窄率高于不伴糖尿病组,差异有统计学意义(P<0.05)。结论依维莫司洗脱支架对糖尿病合并冠状动脉狭窄长病变患者疗效确切,安全性好,值得临床推广。     

Sirolimus-eluting cobalt-chromium stents: two-year clinical results

Background Drug-eluting stents （DES） have been shown to significantly reduce clinical events and angiographic restenosis in the treatment of coronary artery disease （CAD）. This study was conducted to assess the long-term efficacy and safety of the polymer-based sirolimus-eluting cobalt-chromium Firebird 2TM stents in the treatment of patients with CAD. Methods This first-in-man study using the Firebird 2TM stent is a prospective, historically-controlled multicenter clinical study, which enrolled 67 patients with CAD who were treated with the sirolimus-eluting cobalt-chromium stent （Firebird 2TM, Microport Shanghai, Firebird 2 group）, compared to another 49 patients treated with a bare cobalt alloy stent （Driver, Medtronic, control group）. Continued 2-year clinical follow-up was performed after getting the initial 6-month angiographic and 1-year clinical follow-up. The incidence of major adverse cardiac events （MACE） including cardiac death, reinfarction and target lesion revascularization （TLR） and stent thrombosis were compared between the two groups. Results All patients in the Firebird 2 group （100.0%） and 48 patients in the control group （98.0%） completed the 2-year clinical follow-up. At the 1-year follow-up the use of the Firebird 2 stent was highly effective, resulting in a significant 94% decrease of TLR （26.5% in the control group and 1.5% in the Firebird 2 group, P〈0.0001）. A significant difference in TLR was maintained at 2-year follow-up, Firebird 2 group 1.5% and the control group 31.3% （P〈0.0001）. Between 1- and 2-year post-stenting, no more TLR occurred in the Firebird 2 group compared with two cases in the control group （P〉0.05）. There was a 1.5% incidence of MACE at 1- and 2-year follow-up in the Firebird 2 group, compared with 26.5% and 33.3% in the control group, respectively （all P〈0.0001）. The cumulative 1- and 2-year MACE free survival rates were 98.5% in the Firebird 2 group vs 73.5% and 66.7% in the control group （log rank P〈0.000     

Comparison of drug eluting stent implantation with coronary artery bypass surgery in the treatment of patients with chronic total occlusion and multiple vessel disease

Background  In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG) in the patients with CTO and multivessel disease.

Methods  From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.

Results  At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% CI 1.219–3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739–45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.

Conclusions  Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.

     

Long term efficacy and safety of Chinese made sirolimus eluting stents: results, including off label usage, from two centres over three years

Background Multiple randomized clinical trials have demonstrated that drug eluting stents can significantly reduce the rates of restenosis and subsequent adverse events across lesion and patient. We investigated the medium term clinical efficacy and safety of Firebird sirolimus eluting stent （SES） in coronary artery disease. Methods The sample was 509 consecutive patients with coronary artery disease （CAD） who were treated by Firebird SES and finished three-year clinical follow-up. The occurrences of major adverse cardiac events （MACE） and Academic Research Consortium defined stent thrombosis （ST） were evaluated in patients with and without diabetes mellitus. Results Three hundred and thirty three patients （65. 4%） were treated by Firebird SES by off label indications. Angiographic success was achieved in 98.3% of the lesions. MACE and target vessel revascularization rates at 6-month, 1 year＇s and 3 years＇ clinical follow-up were 2.4% and 1.4%, 4.1% and 2.8%, 7.9% and 5.1%, respectively. The cumulative 3-year MACE free survival rate was 92.1%. After 3 years, DM patients had significantly higher rates of MACE （13.7% vs 6.4%, P 〈0.05） and TVR （9.8% vs 4.0%, P 〈0.05） and the cumulative MACE free survival rate was very significantly lower in the DM group （86.4% vs 93;6%, P 〈0.05）. ST occurred in 7 patients （1.4%） at the end of 3 years＇ follow-up, 5 of them had definite ST with 4 cases presenting with myocardial reinfarction and 1 with unstable angina, the other 2 with probable ST had reinfarction in the stented coronary territory without angiographic follow-up. There was no difference in occurrence of ST between off label （1.5%） and on label groups （1.1%, P=-0.07）. Conclusions In daily practice, about 2/3 of patients were treated by Firebird SES by off label indications. Medium term clinical follow-up of 3 years indicated CAD patients treated by Firebird SES had a low MACE and acceptable ST rate. DM patients had higher rates of adverse events and than non DM.     

无保护左主干病变不同治疗策略远期临床效果

目的观察无保护左主干(ULM)冠状动脉病变不同治疗策略远期临床效果。方法比较211例冠状动脉内药物洗脱支架置入术(DES)(DES组)和176例冠状动脉搭桥术(CABG)(CABG组)治疗ULM病变后远期主要心脑血管事件(MACCE)发生率。结果 DES组远期再次血运重建率明显高于CABG组,心源性病死率明显低于CABG组(P<0.05)。采用倾向性得分法分析,血运重建方式与远期MACCE、总病死、心源性病死、心肌梗死和脑卒中发生率未见明显相关(P>0.05);DES与远期再次血运重建率明显相关,风险比为3.050,95%可信区间(1.289,7.217),P<0.05。结论与DES比较,CABG治疗的ULM病变患者临床状态更复杂,冠状动脉病变更严重。DES是接受血运重建的ULM病变患者远期再次血运重建的独立预测因子。