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.     

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.     

Comparison of in-hospital and long-term outcomes between a Cypher stent and a Taxus stent in Chinese diabetic patients with coronary artery disease

Background  The sirolimus and paclitaxel distribution patterns and tissue residence time may be modified in atherosclerotic lesions for patients with diabetes, and the biological mechanisms of action for these agents differ significantly. Previous clinical trials have yielded discrepant results of major adverse cardiac events and restenosis between a sirolimus-eluting stent and a paclitaxel-eluting stent in coronary artery disease. Therefore, this study was conduced to compare in-hospital and long-term clinical outcomes between patients receiving sirolimus-eluting stent (Cypher or Cypher Select stent) and paclitaxel-eluting stent (Taxus Express stent) after percutaneous intervention (PCI) in Chinese patients with diabetes.
Methods  One hundred and sixty-four consecutive diabetic patients underwent PCI in Fuwai Hospital from April 2004 to December 2004. Of them, 101 patients received Cypher or Cypher Select stents (Cypher group, 145 stents) and 63 patients received Taxus Express stents (Taxus group, 129 stents). Repeat coronary angiography was performed at 6-month and clinical outcomes were evaluated at 1- and 3-year follow-up. Stent thrombosis was classified according to Academic Research Consortium (ARC).
Results  The two groups did not differ significantly with respect to cardiac death, recurrent myocardial infarction (re-MI), target vessel revascularization (TVR) and occurrence of major adverse cardiac events (MACE). And the MACE-free cumulative survival at 1- and 3-year follow-up and early, late and very late thrombosis rates were also similar in the two groups (all P>0.05). There was a trend favoring PES over SES with regard to reducing cardiac death (0 vs 2.0%, P=0.524), re-MI (0 vs 2.0%, P=0.524), the composite of the cardiac death and re-MI (0 vs 4.0%, P=0.299) and very late thrombosis (0 vs 3.0%, P=0.295) between 1-year and 3-year follow-up.
Conclusion  The study indicates that PCI with either Cypher or Taxus stents is associated with similar efficacy and safety in the small population of Chinese diabetic patients during long-term follow-up.

     

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.     

COMPARISON OF SHORT- AND LONG-TERM OUTCOMES BETWEEN CYPHER AND TAXUS DRUG-ELUTING STENTS FOR IN-STENT RESTENOSIS

IN-STENT restenosis (ISR) is the overriding factorthat influences therapeutic effect of interventionaltherapy.Although balloon dilation, especially for thecutting balloon, showed some effects on ISR lesions, therestenosis rate after balloon dilation remai…     

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-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     

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     

Comparison of long-term clinical outcome after successful implantation of Firebird sirolimus- and Taxus paclitaxel-eluting stents in Chinese population: analysis of a large single center registry

Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.Methods From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird group.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.     

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.     

冠状动脉药物支架再狭窄形式分析

目的:分析冠状动脉支架置入后造影复查的影像资料,寻找不同药物支架再狭窄的特点。方法:收集冠状动脉介入治疗后造影复查再狭窄患者121例,共159处病变,进行再狭窄形式分析。结果:裸支架(BMS)和药物支架(DES)后再狭窄病变局限性再狭窄分别占39.80%和70.49%(P<0.001);弥漫性再狭窄病变分别占60.20%和29.51%(P<0.001);三种不同类型DES(Cypher,Taxus和Firebird)再狭窄形式没有差异,局限性再狭窄分别为83.33%,55.56%和75.00%(P=0.070);弥漫性再狭窄分别占16.67%,44.44%和25.00%,(P=0.070)。结论:①DES改变了以往BMS再狭窄模式,由弥漫型转为局限型;②不同种类的药物支架再狭窄形式没有差异。     

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.

     

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.     

A case of stent thrombosis occurred at 5 years after sirolimus-eluting stent implantation

Drug-eluting stents (DES) have reduced the rate of repeated revascularization of target lesions. For this reason, DES are considered to be superior to bare-metal stents in reducing the restenosis rate. However, some problems have been reported after implantation of DES. One of them, stent thrombosis, has arisen as a fatal complication. Dual antiplatelet therapy is recommended for at least 12 months after implantation of DES to prevent stent thrombosis. Here, we report a case of very late stent thrombosis that occurred 1 week after discontinuation of clopidogrel at 5 years (1832 days) after implantation of a sirolimus-eluting stent.     

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)

     

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 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.     

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。     

Long-term outcomes following drug-eluting stent implantation in unprotected left main bifurcation lesions

Background The safety and efficacy of drug-eluting stents （DES） implantation in unprotected left main （LM） bifurcation lesions has yet to be determined. The aim of the present report was to evaluate the long-term outcome following implantation of DES in unprotected LM bifurcation lesions. Methods We identified 70 consecutive patients treated with DES in unprotected LM bifurcation lesions from April 2003 to January 2005. Of them, 42 patients were treated with sirolimus-eluting stent （SES） and 28 patients were treated with paclitaxel-eluting stent （PES）. Results Stents to the left anterior descending and to the circumflex were implanted in 62 patients. During 1-year follow-up, 3 （4.3%） patients died of cardiac causes. One of them had myocardial infarction and adjudicated as possibly due to stent thrombosis. Angiographic follow-up was available in 80% of patients. The per lesion restenosis rate was 13.4% in the entire cohort, of which 10.7% occurred in lesions treated with SES and 16.1% in those treated with PES （P=0.58）. All restenosis was focal and occurred in the lesions treated with a stent with stent size to post-procedural reference vessel diameter ratio 〈1.0 （17.6% vs 0, P=0.04）. The per patient target lesion revascularization rate at 1 year was 17.1%. One year survival free from major adverse cardiac events was 77.1%. Conclusions Treatment of LM bifurcation lesions using DES is a safe and feasible way with a low one-year mortality. The need for revascularization in 17% of patients demands for improvement.     

Short-term safety and effects of a novel fully bioabsorable poly-L-lactic acid sirolimus-eluting stents in porcine coronary arteries

The role of drug-eluting stent (DES),which prevents acute or subacute recoil and elutes drugs to prevent smooth muscle cell proliferation,is temporary and limited within a few weeks after its implantation.Beyond that,there is no utility or advantages but only limitations just like foreign materials in patients' body.All of these problems can be solved with the use of fully bioabsorbable stent (BAS),which will disappear from the vessel wall after complete degradation and leave a "clean" vessel.Numerous BASs are currently undergoing pre-clinical and clinical trials.1'2 The purpose of the present study was to assess the short-term effects of a novel,fully bioabsorbable poly-L-lactic acid (PLLA)sirolimus-eluting stent (SES) made in China compared with a metallic durable polymer-coated sirolimus-eluting Cypher stent in healthy porcine coronary arteries.