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     

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。     

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.

     

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.     

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial

Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.     

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.     

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.

     

A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients

Background Stents are widely used in China but the clinical impression is somehow that restenosis is less common because of the lower prevalence of coronary artery disease (CAD) and associated risk factors in Chinese populations. However, no large-sample published studies are available on angiographic stent restenosis including those of bare-metal stent (BMS) or drug-eluting stent (DES) in Chinese Han ethnic population.Mothods A total of 1633 consecutive patients with CAD who had undergone coronary stenting, quantitative coronary angiography (QCA) were retrospectively studied. At the time of stent implantation and at 7 months post-stenting 675 patients had a follow-up angiography. Statistical analysis was made with the chi-square test for categorical variables, unpaired t test for continuous variables, univariate or multivariate regression for baseline and angiographic characteristics and the Kaplan-Meier method for rate of target lesion revascularization (TLR).Results Stent restenosis was defined as ≥50% diameter stenosis in the dilated segment. A total of 675 patients with 1074 lesions were subjected to angiographic follow-up for 7 months on average. Of these lesions, 448 were implanted with BMS whereas 626 lesions with DES. At 7 months, bare-metal in-stent restenosis occured in 148 lesions (33.0%), and bare metal in-segment restenosis in 155 lesions (34.6%) in contrast to drug-eluting in-stent restenosis in 48 lesions (7.7%) and drug-eluting in-segment restenosis in 73 lesions (11.7%) (P&lt;0.001 compared with BMS respectively). Late loss in both in-stent and in segment was higher in BMS than in DES groups [(1.00±0.69) vs (0.28±0.52); (0.78±0.71) vs (0.21±0.52), P&lt;0.001 respectively]. Angulated lesion, lesion length, pre-procedural minimal luminal diameter (MLD), and BMS were independent predictors for TLR, (P&lt;0.01 respectively), whereas current smoker, ostial lesion, and stent overlapping, post-procedure in-stent MLD, lesion length, and stent types were independent predictors for in-segment restenosis (P&lt;0.01 respectively). Standard coronary risk factors such as hypertension, hyperlipidemia, diabetes, and history of CAD were not associated with a higher rate of restenosis caused by BMS or DES implantation in our Chinese Han ethnic population.Conclusions Coronary stenting including BMS or DES implantation in Chinese Han ethnic patients is associated with a restenosis rate comparable to that demonstrated in previous studies from the western countries, and predictors of stent restenosis are somehow different from those in the western population.     

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.

     

药物洗脱支架术后支架内亚急性血栓的发生和原因分析

目的分析冠状动脉药物洗脱支架（drug—eluting stent,DES）置入术后支架内亚急性血栓形成的因素及治疗措施。方法回顾性分析2004年12月至2008年4月我院心内科冠心病患者行药物洗脱支架置入术后11例患者发生支架内亚急性血栓的好发时间、部位及相关危险因素。结果2004年12月至2008年4月,我院共完成PCI术596例,其中DES置入术455例,术后发生支架内亚急性血栓11例,发生率为2．42％,血栓形成时间为3—15d,平均（6．9±4．1）d。其中冠脉3支病变患者5例,2支血管病变4例;左前降支病变6例;置入多支架8例;支架贴壁不良2例。支架置入术后突然出现无其他原因可以解释的明显胸痛者7例;心衰低血压状态2例;以心脏骤停发病者2例,均院外死亡。心电图提示支架段血管支配区域心肌缺血加重或急性心梗2例,造影复查证实原支架内闭塞伴血栓影像7例,术后突然出现无其他原因可以解释死亡2例。4例因停用氯吡格雷而致血栓形成;2例可能支架贴壁不良。经单纯球囊扩张,冠脉内注入血小板GPⅡb／Ⅲa受体拮抗剂等治疗,7例患者存活出院,4例患者死亡（病死率36．4％）。结论亚急性支架内血栓形成与患者临床病变特点、介入操作因素和支架本身、抗凝治疗等有关,多发生在AMI、合并糖尿病或心功能不全、多支血管病变、前降支病变、B／C型复杂病变等患者。急诊再次介入治疗是治疗支架内血栓的首选。     

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。     

Efficacy and safety of FIREHAWK(r) abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort

Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure.The purpose of this study was to evaluate the efficacy and the safety ...     

Smoking control hindered by realities in China

Background Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents （SES） for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.Mothods A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group （n=-264） and calcification group （n=-189）. Lesions treated with SES were subjected to quantitative coronary angiography （QCA） immediately and 8 months following stenting. Results Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; instent restenosis： 3.8% vs 4.2%; P=0.081; in-segment restenosis： 8.7% vs 10.6%, P=0.503. The target lesion revascularization （TLR） was also not significantly different between the two groups; 4.9% vs 6.9%, P=0.378. In addition, the in-stent late loss was similar in both groups; （0.16±0.40） mm vs （0.17±0.33） mm, P〉0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P〉0.05. Conclusion Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.     

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.     

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.     

Age-based clinical and angiographic outcomes after sirolimus-eluting stent implantation in patients with coronary artery disease

Background Advanced age independently predicts early and late mortality and major adverse cardiac events （MACE） after percutaneous coronary intervention （PCI）. Randomized clinical trials indicate that siroUmus-eluting stent （SES） implantation reduces target lesion revascularization （TLR）, but there are limited data on the impact of age on outcomes following SES implantation in patients with coronary artery disease （CAD） in real-world practice. Methods A total of 333 CAD patients with 453 lesions were enrolled in this study. Subjects were divided into two groups according to age： a young group （〈65 years old, 244 patients with 369 lesions） and elderly group （≥65 years old, 89 patients with 113 lesions）. Clinical follow-up and quantitative coronary angiography （QCA） were performed seven months after PCh Results Baseline clinical, demographic, angiographic, and procedural chararcteristics were similar in both groups, except that there were more female patients in the elderly group （21.3% vs 9.8%, P=-0.006）. Primary success rate was similar in both groups （96.5% in young group vs 95.7% in elderly group, P〉0.05）. During angiographic follow-up at 7 months, binary in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups （4.7% vs 1.8%; 9.7% vs 8.8%, P〉0.05 respectively）. Both sub-acute and late thrombosis rates were similar in the two groups （0.3% vs 0.9% and 1.2% vs 0.9%, P〉0.05 respectively. TLFI was not significantly different between the two groups （6.5% vs 3.5%;P=-0.246）. The rates of bleeding, stroke, angina rehospitalization during the, follow-up period were also similar in both groups （P〉0.05 respectively）. Conclusion Despite a high-risk clinical profile, coronary SES implantation can be safely and effectively performed in elderly patients with a similar procedural success rate, a low complication rate, and excellent 7-month outcomes.     

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。     

冠状动脉植入金属裸支架适应证的研究

背景　目前国内植入金属裸支架（BMS）的比例不足5%,远低于美国和欧洲国家的30%~40%。其原因是对植入BMS适应证研究报道较少,BMS的认识还停留在初级阶段。BMS的适应证、效果和安全性受到质疑。目的　探讨急性冠脉综合征（ACS）患者植入BMS的适应证、长期效果和安全性。方法　选取2001—2010年在北华大学附属医院心脏中心住院植入BMS和药物洗脱支架（DES）随访资料完整的ACS患者1 203例为研究对象,其中BMS组491例和DES组712例。患者均住院行冠状动脉造影（CAG）或门诊行CT血管造影（CTA）随访,随访时间为12~175个月,平均随访（71.4±36.4）个月。比较两组不同病变类型（A、B1、B2、C型病变）患者随访终点事件及再狭窄发生率的差异。结果　BMS组与DES组患者心力衰竭、靶血管重建（TVR）、冠状动脉旁路移植术（CABG）发生率比较,差异均无统计学意义（P>0.05）;BMS组患者全因死亡、总主要不良心血管事件（MACE）、靶病变血管重建（TLR）发生率高于DES组,再发非致命性心肌梗死、支架内血栓形成（ST）发生率低于DES组（P<0.05）。两组A型病变患者全因死亡、总MACE、再发非致命性心肌梗死、心力衰竭、TLR、TVR、ST发生率比较,差异均无统计学意义（P>0.05）。BMS组B1型、B2型、C型病变患者全因死亡、总MACE、TLR发生率高于DES组（P<0.05）。两组A型、B1型病变患者支架内再狭窄、节段内再狭窄、支架内再狭窄和/或节段内再狭窄发生率比较,差异均无统计学意义（P>0.05）。两组B2型、C型病变患者节段内再狭窄发生率比较,差异均无统计学意义（P>0.05）;BMS组B2型、C型病变患者支架内再狭窄、支架内再狭窄和/或节段内再狭窄发生率高于DES组（P<0.05）。结论　A型病变ACS患者植入BMS长期全因死亡、总MACE、TLR发生率和再狭窄发生率与DES无差异,远期效果好,安全性高,故可把A型病变ACS作为植入BMS的适应证。     

Clinical outcomes and cost-utility after sirolimus-eluting versus bare metal stent implantation

Background Randomized studies have shown beneficial effects of drug-eluting stent （DES） in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction （MI） and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently.Methods To compare long term clinical outcomes, health-related quality of life （HRQOL） and cost-utility after sirolimus-eluting stent （SES） and bare metal stent （BMS） implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization （PCl） with either SES （n=632） or BMS （n=609） were enrolled continuously in this prospective, nonrandomized, multi-center registry study.Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 （97.1%） patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization （136 （22.4%） in BMS group vs. 68 （10.8%） in SES group, P=0.001） and recurrent angina （149 （24.5%） vs. 71 （11.3%）, P=0.001）. Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group （P 〈0.001）. However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge （62 546.0 vs. 78 245.0 Yuan, P=0.001）. And follow-up expenditure was remarkably higher in the BMS group than that in the SES group （13 412.0 vs. 8 812.0 Yuan, P=0.0001）.Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS.     

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.