药物洗脱支架与血管内放射治疗在支架内再狭窄中运用的Meta分析

目的 比较药物洗脱支架与血管内放射治疗在支架内再狭窄治疗中的疗效及安全性.方法 利用文献检索方法收集国内外治疗支架内再狭窄的对比研究,对符合入选条件的文献采用RevMan 5.1软件进行Meta分析.结果 入选13篇文献,共纳入病例2 312例,其中药物洗脱支架组1 259例,血管内放射治疗组1 053例.Meta分析显示:药物洗脱支架组再发支架内狭窄(P ＜0.000 01)、晚期管腔丢失(P ＜0.000 01)、靶血管血运重建(P=0.03)和主要不良心血管事件(P=0.004)均明显低于血管内放射治疗组.药物洗脱支架组晚期支架血栓发生率和死亡率与血管内放射治疗组相比差异均无统计学意义.结论 Meta分析显示,药物洗脱支架治疗支架内再狭窄在降低支架再次狭窄、减少晚期管腔丢失、靶血管血运重建方面明显优于血管内放射治疗,但不能减少晚期支架血栓形成及降低患者的死亡率.     

非顺应性球囊高压后扩张在冠心病药物洗脱支架植入术中的应用

目的探讨非顺应性球囊高压后扩张在冠心病药物洗脱支架植入术中的应用效果。方法 150例冠心病患者,随机分为观察组和对照组各75例,对照组采用药物洗脱支架(DES)植入术进行治疗,观察组在此基础上行非顺应性球囊高压后扩张。分析手术过程中患者临床特征、植入DES数量、血管病变情况、管腔狭窄程、血栓形成情况以及术中并发症等,并做好记录。结果观察者患者支架植入后管腔最小直径、绝对内径分别为(3.31±0.34)、2.63±0.47)mm,明显高于对照组(2.74±0.32)、(2.25±0.40)mm的指数,(P0.05);观察者患者亚急性支架内血栓发生率、晚期支架内血栓发生率、心脏不良事件发生率以及支架内再狭窄发生率分别为1.33%、1.33%、2.67%、2.67%明显低于对照组5.33%、6.67%、8.00%、9.33%的发生率(P0.05)观察组患者管腔内绝对内径丢失、管腔狭窄程度均优于对照组(P0.05);两组患者植入DES数量、血管病变情况、管腔狭窄程及并发症等之间没有显著的差异(P0.05)。结论非顺应性球囊高压后扩张在冠心病DES植入术中能够有效降低患者心脏不良事件发生率和支架内再狭窄发生率,减少患者绝对内径的丢失等,具有较好的治疗效果。     

国产可降解涂层西罗莫司洗脱支架在冠状动脉长病变中的应用

目的 初步评价国产可降解涂层西罗莫司洗脱支架(Tivoli支架)治疗冠状动脉长病变的可行性、安全性及有效性.方法 2007年8月-2008年2月共有55例原位冠状动脉长病变的患者分别接受Tivoli支架(Tivoli组,28例)和进口左他莫司洗脱支架(Endeavor组,27例)治疗,观察两组患者的手术即刻成功率、术后8个月冠状动脉造影结果、术后270 d时的主要不良心脏事件(MACE)及支架内血栓事件的发生率.结果 治疗前,Tivoli组既往有心肌梗死者占50.0%(14/28),显著高于Endeavor组的11.1%(3/27,P=0.002);左心室射血分数为(0.600±0.044),显著低于Endeavor组的(0.659±0.060)(P=0.003);平均病变长度为(29.5±12.5)mm,显著高于Endeavor组的(22.19±9.43)mm(P=0.006).两组支架植入的成功率均为100%.术后8个月,Tivoli组和Endeavor组的造影随访率分别为92.9%(26/28)和92.6%(25/27),支架内再狭窄的发生率分别为10.5%(4/26)和3.3%(1/25)(P=0.370),支架内晚期管腔丢失分别为(0.37±0.47)和(0.59±0.49)mm(P=0.108);术后270 d的随访率为100%,两组均无死亡、心肌梗死和血栓事件发生,MACE的发生率分别为10.7%(3/28)和7.4%(2/27,P=1.000),均为靶病变血运重建.结论 Tivoli支架在冠状动脉长病变中应用的中期疗效及安全性与进口左他莫司洗脱支架相似,初步表明其用于冠状动脉长病变的治疗是可行的.     

直接置入国产药物洗脱支架治疗急性心肌梗死的可行性研究

目的 评价无球囊预扩张直接置入国产药物洗脱支架治疗急性心肌梗死(acute myocardial infarction,AMI)的安全性和有效性.方法 将100例ST段抬高型AMI患者随机分为无球囊预扩张直接置入国产药物洗脱支架组(直接支架组)和球囊预扩张后置入冠状动脉内支架组(预扩张组),应用心肌梗死溶栓治疗试验(thrombolysis in myocardial infarction,TIMI) 血流分级、心肌呈色分级(myocardial blush grading,MBG)两种方法评价AMI患者的心肌灌注情况,并对主要不良心脏事件(major adverse cardiac events,MACE)及冠脉造影随访6个月.结果 虽然两组术后即刻TIMI 3级血流分级差异无统计学意义(94% vs 90%,P>0.05),但直接支架组与预扩张组比较,术后即刻MBG分级2～3级明显增高(90% vs 74%,P<0.05),无复流(no-reflow,NR)发生率明显降低(10% vs 26%,P<0.05).两组6个月MACE差异无统计学意义(6% vs 10%,P>0.05),冠脉造影再狭窄发生率及支架内最小管腔直径、节段内最小管腔直径、支架内晚期管腔丢失、节段内晚期管腔丢失差异均无统计学意义[分别为5.5% vs 7.7%,(2.91±0.25) mm vs(2.94±0.35) mm、(2.87±0.18) mm vs(2.84±0.25) mm、(0.12±0.09) mm vs(0.12±0.08) mm、(0.14±0.12) mm vs(0.13±0.10)mm,P值均>0.05].结论 无球囊预扩张直接置入国产药物洗脱支架治疗AMI安全可行,可降低AMI血管再通后心肌无复流的发生.     

国产药物洗脱支架在急性冠脉综合征中的应用

目的：探讨国产药物洗脱支架（Firebird支架）在急性冠脉综合征急诊介入治疗中应用的安全性和有效性.方法：2004年10月～2005年7月间治疗急性冠脉综合征患者86例,所有患者均于发病12h内行急诊经皮冠状动脉介入治疗（PCI）.治疗时随机置入Firebird支架或Cypher支架.Firebird支架组46例,Cypher支架组40例.结果：86例患者急诊PCI治疗均获得成功.Firebird组46支罪犯血管置入53枚Firebird支架,Cypher组40支罪犯血管置入49枚Cypher支架.其中1例置入Cypher支架者术后出现脑出血而死亡.Firebird支架组和Cypher支架组比较,PCI术后TIMI3级率和并发症发生率无显著性差异.对85例患者进行了3～6个月的随访,两组患者均未发生任何心血管事件,术后6个月Firebird支架组有20例（43%）行冠状动脉造影检查,无一例发生支架内再狭窄;Gypher支架组有19例（49%）行冠状动脉造影检查,1例发生支架内再狭窄,两组再狭窄率无显著性差异.结论：Firebird支架在急性冠脉综合征急诊介入治疗中应用有较好的安全性和有效性.     

国产和进口雷帕霉素洗脱支架治疗急性心肌梗死的疗效比较

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)中应用的安全性和近、远期疗效。方法选择我院心内科2005年3月￣2006年6月收治的STEMI且在发病12h内接受急诊置入雷帕霉素药物洗脱支架的患者105例,分为Cypher组(33例)和Firebird组(72例)。比较2组住院期间和随访10个月时心脏事件(MACE)的发生率。结果Cypher组33例梗死相关血管的33处病变置入42枚Cypher支架,Firebird组72处梗死相关病变置入113枚Firebird支架。支架置入成功率为100%。无再流现象:Cypher1例,Firebird组2例(P=1.000)。Cypher组心脏破裂死亡1例,Firebird组亚急性支架内血栓形成死亡1例。住院期间MACE发生率Firebird组为1.4%(1/72),Cypher组3.0%(1/33)(P>0.1),临床PCI成功率91.4%(96/105)。对86例患者进行了平均[10.2±4.2(6￣20)]个月随访,Cypher组28例和Firebird组58例;再发心绞痛3例,Cypher组1例和Firebird组2例;Firebird组术后3个月心衰死亡1例;随访时MACE发生率:Firebird组3.4%(2/59),Cypher组3.4%(1/29)(P=1.000)。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,近、远期疗效与Cypher支架相近。     

药物支架和切割球囊在药物洗脱支架植入术后再狭窄中治疗效果比较

目的比较药物支架再植入和切割球囊2种方法,在药物洗脱支架植入术后再狭窄病人中的治疗效果。方法回顾分析124例药物洗脱支架内再狭窄病人,经切割球囊或药物支架再次植入治疗即刻和术后随访结果。并于治疗时及术后(6.0±1.4)个月行冠脉造影检查。结果 2组病人的年龄、性别、既往病史及介入治疗前支架内再狭窄情况比较,差异无统计学意义(P>0.05)。介入治疗即刻切割球囊组与药物支架组:最小管腔直径[(2.54±0.45)mm vs(2.67±0.48)mm]及直径狭窄率(23.5%±10.3%vs 21.8%±9.4%)比较,差异无统计学意义(P>0.05)。术后6个月药物支架组的最小管腔直径(1.86±0.63)mm明显高于切割球囊组(1.34±0.71)mm(P<0.01),且直径狭窄率显著低于切割球囊组(39.2%vs 47.8%,P<0.05)。药物支架组复发再狭窄和晚期管腔丢失量均低于切割球囊组[4.1%vs 9.8%,(0.52±0.48)mm vs(0.74±0.53)mm],差异有统计学意义(P<0.01)。结论药物支架再植入相比于切割球囊治疗药物洗脱支架术后再狭窄,6个月后支架内再狭窄率低于切割球囊组。     

药物洗脱支架和金属裸支架对冠心病合并2型糖尿病患者安全性和疗效比较

目的 对比药物洗脱支架和金属裸支架对冠心痛合并2型糖尿病患者安全性和疗效.方法 2009年5～12月我院接受经皮冠状动脉介入治疗的冠心痛合并有2型糖尿病患者共67例,其中药物洗脱支架组31例,金属裸支架组36例.支架术后6个月左右接受冠状动脉造影随访.结果 药物洗脱支架组支架内再狭窄率显著低于金属裸支架组(17.6%比41.9%,P=0.01),但药物洗脱支架组局限性支架内再狭窄率却显著高于金属裸支架组(50.0%比10.0%,P=0.035).两组病变在晚期支架内血栓形成上差异无统计学意义(5.9%比2.3%,P=0.735).随访期间药物洗脱支架组靶病变血管重建率显著低于金属裸支架组(11. 8%比30.2%,P=0.026).结论 药物洗脱支架能显著降低冠心痛合并2型糖尿病患者支架内再狭窄率和靶病变血管重建率,具有良好的安全性和疗效.     

49例冠状动脉介入治疗再狭窄高危患者药物洗脱支架的临床应用

目的:分析经皮冠状动脉介入治疗(PCI)后再狭窄高危患者应用两种药物洗脱支架的临床疗效.方法:在17个月期间对49例再狭窄高危患者行雷帕霉素(Cypher)和/或紫杉醇(Taxus)药物洗脱支架置入术.24例患者接受Cypher支架置入术;25例患者接受Taxus支架置入术.结果:24例患者26支血管的27处病变共置入27个Cypher支架;25例患者36支血管的42处病变共置入42个Taxus支架.对49例患者平均随访7.3个月(1个月～17个月),没有1例发生术后再狭窄或进行靶血管重建或靶病变重建,但有2例在PCI后5 d(Cypher支架)和45 d(Taxus支架)分别发生了亚急性支架内血栓形成.结论:药物洗脱支架置入术即刻成功率高,在再狭窄高危患者的术后近期再狭窄发生率很低,但是术后亚急性支架内血栓形成是一个需要引起特别关注的问题.     

Zotarolimus洗脱支架与雷帕霉素洗脱支架临床应用比较

目的 对比研究Zotarolimus洗脱支架和进口雷帕霉素洗脱支架(Cypher支架)临床应用疗效.方法 129例符合冠脉介入手术指征的冠脉病变患者被随机分为两组,Zotarolimus洗脱支架植入组和Cypher支架植入组,其中Cypher支架组65例,Zotarolimus洗脱支架组64例.植入Cypher支架83枚,植入Zotarolimus支架80枚.结果 两组患者平均靶病变长度和置入支架长度Cypher支架组对比Zotarolimus洗脱支架组分别为:(18.72±5.96)mm比(19.42±6.21)mm,(24.67±7.81)mm比(25.56±6.98)mm,差异无显著性(P>0.05).临床随访观察,再发心肌梗死及死亡,再发心绞痛、再次血运重建和主要心血管事件对比,均差异无显著性.但Cypher支架组支架内亚急性及迟发性血栓形成率显著高于Zotarolimus洗脱支架组,为3.1%比0.结论 与Cypher支架相比,Zotarolimus洗脱支架在预防再狭窄、减少近期心血管事件方面疗效相似,但具有更低支架内亚急性血栓及迟发性发生率.     

Firebird and Cypher sirolimus-eluting stents and bare metal stents in treatment of very long coronary lesions

Background As a kind of sirolimus-eluting stent （SES） made in China, Firebird SES is more effective than bare metal stent （BMS） and not inferior to Cypher SES for short coronary lesions in terms of reduction of restenosis and revascularization. However, Firebird SES does not show any benefits in patients with a very long coronary lesion （VLCL）. The present study was undertaken to evaluate the safety and efficacy of Firebird SES for VLCL by comparison of Cypher SES and BMS. Methods In this prospective, nonrandomized and comparative study, eligible patients with de novo coronary lesion （≥ 30 mm） between January 2005 and June 2006 were allocated into Firebird SES group, Cypher SES group or BMS group. They were subjected to an angiographic follow-up of 6 months and a clinical follow-up of 12 months. The primary endpoints constitute the in-stent and in-segment restenosis rates at 6 months. The secondary endpoint was defined as a major adverse cardiovascular event （MACE） that was a 12-month combined endpoint of all-cause deaths, reinfarction or in-stent thrombosis, and target-lesion revascularization. The 12-month in-stent thrombosis was also evaluated to address the safety of Firebird SES implantation exceptionally. Results A total of 468 patients were assessed for eligibility. Of 113 patients who were finally included according to the prior inclusion and exclusion criteria, 39 （41 lesions） were treated with Firebird SES, 37 （39 lesions） with Cypher SES, and 37 （37 lesions） with BMS. There were no significant differences in the baseline characteristics between the three groups; but there were longer lesions, more frequent use of overlapping stent in the Firebird SES group and the Cypher SES group. Angiographic follow-up showed that the rates of binary stenosis were similar between the Firebird SES group and the Cypher SES group （in-segment： 14.6% vs 12.8%, relative risk （RR）1.14, P=0.81; in-stent： 9.8% vs 10.3%, RR 0.95, P=0.94）, and significantly lower than those in the B     

非限制性外支架对兔移植静脉血小板源性生长因子表达的影响

目的 探讨非限制性外支架防治移植静脉再狭窄的可能作用机制. 方法新西兰白兔随机分为支架组和对照组,每组18只.均实施颈外静脉-颈总动脉移植术,支架组在移植静脉外套以外支架(直径6 mm的人造涤纶血管),对照组无外支架.术后7、14、28 d每组各6只兔手术取出移植静脉,分别进行血小板源性生长因子B链(PDGF-B)免疫组织化学染色,计算PDGF-B阳性率;以RT-PCR方法检测PDGF-B mRNA的表达量. 结果支架组移植静脉内膜PDGF-B阳性率术后14、28 d均明显低于对照组(15.2%±3.6%vs 21.6%±4.6%,6.5%±2.6%vs 12.5%±4.4%,均P＜0.05);中膜阳性率术后7、14、28 d均明显低于对照组(13.8%±4.6%vs 25.4%±6.2%,21.3%±4.4%vs 35.7%±7.3%,7.2%±3.2%vs 19.2%±5.4%,均P＜0.01);外膜阳性率术后28 d达高峰,而对照组在术后14 d达高峰,28 d时支架组阳性率明显高于对照组.RT-PCR检测显示术后7、14、28 d 2组移植静脉均可见PDGF-B特异条带(457 bp),各时间点支架组PDGF-B mRNA的表达均明显低于对照组(31.2%±6.5%vs 45.4%±8.4%,P＜0.05;42.3%±6.2%vs 65.2%±11.5%,P＜0.01;21.3%±5.6%vs 36.2%±9.4%,P＜0.01). 结论抑制移植静脉PDGF合成、改变PDGF分布规律可能是非限制性外支架防治移植静脉再狭窄的作用机制之一.     

A comparison of clinical and angiographic outcomes after Excel bioabsorbable polymer versus Firebird durable polymer rapamycin-eluting stent for the treatment of coronary artery disease in a “real world” setting: six-month follow-up results

Background Several clinical trials have shown that rapamycin-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention (PCI). The Firebird stent and the Excel stent (coated with bioabsorbable polymer) are two different types of rapamycin-eluting stents made in China, both have been recently approved for clinical use in China by State Food and Drug Administration. However, it is unclear whether there are differences in safety and efficacy between the two types of stents in daily practice. Methods In the month of June 2006, a total of 190 consecutive patients were treated exclusively with Firebird stents (n=93, Firebird group) or Excel stents (n=97, Excel group) in our center and were included in this study. The frequency of major adverse cardiac events (MACE, a composite of death, myocardial infarction or target lesion revascularization), binary restenosis, and late lumen loss and stent thrombosis during a six-month follow-up period were compared between the two groups.Results Patient and lesion characteristics were comparable between the groups. Major adverse cardiac event rates were low in hospital and at 6 months (2.1% in the Excel group and 0% in the Firebird group, P﹥0.05). The 6-month angiographic in-stent restenosis rate was 0% in both groups, with an associated late loss of (0.15 ± 0.21) mm versus (0.14 ± 0.20) mm (P=0.858) and the in-segment restenosis rate was also 0% for the Excel group and the Firebird group. There was no definite stent thrombosis identified in either group during the six-month follow-up period and only one patient in the Excel group had probable stent thrombosis in hospital. Conclusions Results from this mid-term, single-center study showed that both of the Firebird and the Excel rapamycin eluting stent had similar effects on reducing the incidence of MACE and the risk of restenosis (both in-stent and in-segment binary restenosis) after PCI in daily practice.     

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.

     

Comparison of the incidence of late stent thrombosis after implantation of different drug-eluting stents in the real world coronary heart disease patients: three-year follow-up results

Background Late stent thrombosis （LST） is still concerned by interventions cardiologists in daily clinical practice. This study aimed to compare the incidence of LST after implantation of different drug-eluting stents （DES） in coronary heart disease （CHD） patients in the real world.Methods From December 2001 to February 2009, a total of 11 875 consecutive CHD patients undergone DES implantation were enrolled in this single-center registery study. Patients with acute ST-segment elevation myocardial infarction, mixed DES implantation, restenosis lesions, and patients who could not take dual antiplatlet medication and those who were contraindicated for coronary interventional treatment were excluded. All patients were treated with completed dual antiplatelet medications for at least 9 months after DES deployment. The follow-up was completed by outpatient visits, letter correspondence, phone calls and coronary angiography. Definite LST was diagnosed auording to the Academic Research Consortium （ARC） definition.Results Cypher or Cypher Select stents were implanted in 4104 cases, Taxus or Taxus Liberty stents in 2271 cases and Firebird stents （Chinese rapamycin-eluting stents） in 5500 cases. One-year follow-up was completed in 9693 patients, including 3346 cases with Cypher or Cypher Select stents, 1529 cases with Taxus or Taxus Liberty stents and 4818 cases with Firebird stents. Two- and three-year follow-up results were obtained in 7133 and 4353 patients, respectively, including 2410 and 1760 cases with Cypher or Cypher Select stents, 1285 and 900 cases with Taxus or Taxus Liberty stents as well as 3438 and 1693 cases with Firebird stents. One-year follow-up results showed that the incidence of LST was 1.08% in patients with Cypher or Cypher Select stents, 1.24% in those with Taxus or Taxus Liberty stents and 0.71% in those with Firebird stents; there was no significant difference between those with Cypher or Cypher Select and Firebird stents, but there was significant difference between those with Taxus or Taxus Liberty and Firebird stents （P=0.044）. The incidence of LST at the 2- and 3-year follow-up was 1.33% and 1.70% in those with Cypher or Cypher Select stents, 1.40% and 1.70% in those with Taxus or Taxus Liberty stents, and 0.83% and 0.95% in those with Firebird stents, respectively. There were no significant differences among the three groups.Conclusions This study indicates that first-generation DES are acceptable to treat complex coronary lesions, and there is no significant difference of LST for three different DES.     

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.     

Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction

Background There are few evidences about the value of drug eluting stent in patients with ST-segment elevation myocardial infarction （STEMI）. We prospectively designed a randomized controlled trial to compare the safety and efficacy of Firebird sirolimus eluting stent （Firebird stent） and bare metal stent （BMS）. Methods Patients with STEMI enrolled during one year period were randomized to undergo implantation of Firebird stent or BMS, and clinical and angiographic follow-up. The primary endpoint of the present study was in-lesion late lumen loss （LLL） at 6 months, and secondary endpoint includes stent thrombosis and major adverse cardiac events （MACE） at 6 months. Results During one year period, 156 patients were randomized into the Firebird stent group （101 patients with an average age of 57.8 years） or the BMS group （55 patients with 59.7 years on average）. Six-month angiographic follow-up was available in 66.3% and 63.7% of patients assigned to Firebird stent and BMS, respectively. At 6-month follow-up, mortality, target vessel revascularization （TVR） and MACE were 2.0%, 6.9% and 9.9% in the Firebird stent group, while 3.6%, 30.9% and 36.4% in the BMS group （P〈0.05）. Subacute thrombosis occurred in 1 patient in both groups, respectively. The mean LLL was 0.18 mm in the Firebird stent group versus 0.72 mm in the BMS group. Conclusion Implantation of Firebird sirolimus eluting stent for STEMI may greatly reduce TVR and MACE at 6 months with low incidence of acute/subacute stent thrombosis compared with BMS.     

Morphologic characteristics of late stent malapposition after drug-eluting stents implantation by optical coherence tomography follow-up

Background Late stent malapposition was frequently observed after DES implantation, which has been associated with the occurrence of late stent thrombosis due to poor neointimal coverage. This study was designed to evaluate the frequency of late stent malapposition at least 1 year after different DESs implantation by optical coherence tomography （OCT）. Methods Angiographic and OCT examinations were given to 68 patients who had received total 126 various DESs implantation for at least 1 year to detect late stent malapposition. Malapposed strut distance （MSD）, malapposed strut area （MSA）, reference lumen area （RLA） and reference stent area （RSA） were checked with off-line OCT analysis. Results Totally 26 Cypher Select stents, 15 Taxus Liberte stents, 51 Partner stents and 34 Firebird I stents were examined. Among 68 patients who underwent DES implantation, 7 patients （10.3%） had late malapposition. Average RSA, MSA and MSD were （7.9=6？..8） mm2,（2.0＋1.6） mm2 and （590_＋_270） pm respectively. According to the MSA/RSA ratio 4 patients had slight malapposition, 2 patients had moderate malapposition and 1 patient had severe malapposition. Conclusions Late stent malapposition is detected frequently after implantation of DES, but if this predisposes to late stent thrombosis and requires any specific therapy needs to be further elucidated.     

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)

     

Drug-eluting stent for the treatment of small coronary lesion: comparison between sirolimus- and paclitaxel-eluting stent

Background  Patients with small coronary lesions are at increased risk for repeat interventions after coronary angioplasty and stenting. The efficacy of drug-eluting stents (DES) has been demonstrated to improve the outcomes of these patients and is a focus of interest. Currently, two platforms of DES are available (sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES)). However, it has less been known that DES, SES vs PES, is superior for the treatment of small coronary lesions.
Methods  In this retrospective study, 87 consecutive patients with 151 lesions underwent implantation of coronary SES (n=68) and PES (n=83). Quantitative coronary angiography (QCA) was performed at the time of stent implantation and subsequently at 8 months post-stenting. Small vessel disease was defined as lesions in vessels with diameter 2.5 mm measured by QCA. Major adverse cardiac events (MACE) including death, thrombosis, nonfatal myocardial infarction and target lesion revascularization (TLR) were compared between the two groups.
Results  Baseline clinical characteristics and angiographic parameters were similar between the two groups. At clinical and angiographic follow-up, overall thrombosis rates were similar in both groups (0 vs 1.2%, P>0.05). The TLR and in-segment restenosis were not significantly different (19.1% vs 25.3%; 10.3% vs 10.8%, P=0.365 and P=0.913 respectively) between the two groups. The in-stent restenosis rate, however, was significantly higher in the PES group (4.4% vs 21.7%; P=0.002). Similarly, the late loss was significantly higher in the PES group ((0.140.38) mm vs (0.490.61) mm; P<0.001).
Conclusions  In this small sample-size, non-randomized study, the data indicated that implantation of SES for the treatment of patients with small coronary lesion showed more favorable results in respect of restenosis compared with PES implantation.