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1.
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.  相似文献   

2.

Background  The Firebird 2TM 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 2TM 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.

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3.
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  相似文献   

4.
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.  相似文献   

5.
The application of drug-eluting stent (DES), either sirolimus-eluting stent (Cypher, Cordis, USA) or paclitaxel-eluting stent (Taxus, Boston Scientific, USA), in treatment of patients with coronary artery disease (CAD) has achieved great success. The high cost of imported DES (either Cypher or Taxus) gave the birth to a China-made, polymer-based, sirolimus-eluting stent (Firebird, Microport Company,  相似文献   

6.
7.
《中华医学杂志(英文版)》2012,125(19):3393-3397
Background  Since permanent polymer is implicated in adverse events associated with delayed vessel healing after drug eluting stents (DES) implantation, great efforts have been made to develop more biocompatible DES with biodegradable polymer or without polymer. The present study aimed to evaluate the safety and efficacy of polymer free paclitaxel-eluting stents (PF-PES) in comparison with permanent polymer sirolimus-eluting stents (PP-SES) in patients with acute ST-segment elevation myocardial infarction (STEMI).
Methods  Patients with STEMI were randomly assigned to receive PP-SES (n=55), and PF-PES (n=50). The 6-month angiographic and 1-year clinical outcomes were compared between the two groups. Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction (Re-MI), or target lesion revascularization (TLR).
Results  Follow-up angiography at six months was performed in 72.7% of the PP-SES group and 70.0% of the PF-PES group (P=0.757). The two groups had comparable angiographic outcomes including minimal luminal diameter, diameter stenosis, late loss and binary restenosis. All patients were clinically followed up to one year. The two groups had similar clinical outcomes with relatively low rates of target lesion failure (10.9% PP-SES vs. 12.0% PF-PES, P=0.861) and definite or probable stent thrombosis (1.8% PP-SES vs. 2.0% PF-PES, P=1.000) at one year.
Conclusions  The present study suggests that the safety and efficacy of PF-PES in the setting of STEMI are comparable to PP-SES. Further randomized trials with larger study populations are needed to get definite conclusions.
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8.
张孝忠  张晋  张军  王红  原新茹 《医学争鸣》2009,30(23):2835-2837
目的:对比研究氮氧化钛生物有效性支架(Titan2-BAS)与雷帕霉素药物洗脱支架(sirolimus-eluting stent,SES)在冠状动脉血运重建方面的临床疗效.方法:141例冠心病患者,根据植入的支架不同分为A组(Titan2-BAS)87例,B组(SES)54例,均采用经桡动脉或尺动脉途径冠脉血运重建.A组阿司匹林与氯吡格雷治疗1~3 mo,B组至少12 mo.计算A,B两组支架病变的通过率、早期支架内血栓发生率及随访MACE发生率(指死亡、急性心肌梗死、靶血管重建等).结果:①A组病变内径(3.1±0.4)mm,长度为(24±3)mm,B组病变内径(3.0±0.5)mm,长度为(22±4)mm,两组无显著差异(P〉0.05).②A组146处〉75%狭窄病变共植入Ti-tan2-BAS 168枚,1枚支架未能通过病变(RCA),通过率99.3%;B组86处病变共植入SES94枚,通过率100%,两组无显著差异(P〉0.05).③随访1~17 mo,平均5.8 mo.两组均无死亡病例;A组无急、晚期血栓.B组1例术后2 d出现支架内血栓;A组1例术后3 mo行靶血管重建,B组无靶血管重建;两组MACE发生率无显著差异(P〉0.05).结论:在本研究样品量情况下,Titan2-BAS与SES在冠脉血运重建方面的近期及远期疗效相近,Titan2不增加MACE发生率.  相似文献   

9.

Background  Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease. 

Methods  A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤40 mm, reference vessel diameter 2.25–4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

Results  Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25±0.33) mm vs. (0.57±0.55) mm, diff (95% CI) –0.23 (–0.32, –0.14), P <0.0001; in-segment (0.25±0.33) mm vs. (0.42±0.55) mm, diff (95% CI) –0.13 (–0.23, –0.02), P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).

Conclusions  TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

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10.
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 ...  相似文献   

11.
Li JJ  Xu B  Yang YJ  Ma WH  Chen JL  Qiao SB  Qin XW  Yao M  Liu HB  Wu YJ  Yuan JQ  Chen J  You SJ  Dai J  Xia R  Gao RL 《中华医学杂志(英文版)》2006,119(13):1059-1064
Background In-stent restenosis (ISR) remains a challenge for interventional cardiologists. Some data suggest that drug-eluting stents (DES) represent a promising new option for the treatment of patients with ISR. Currently, 2 DES platforms are available [sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) ], but the superiority of either approach for treating ISR has not been convincingly demonstrated. The aim of the present study was to retrospectively compare angiographic and clinical outcomes after treatment of ISR with SES or PES in a series of consecutive patients with ISR.  相似文献   

12.
目的评价冠心病患者接受雷帕霉素洗脱支架(SES)的近斯安全性及有效性。方法对160例接受雷帕霉素洗脱支架植入术患者实施即刻疗效和临床随访。结果160例中共处理病变210处,植入支架216枚。其中B2型以上复杂病变145处(69.0%),小管径支架(2.5mm~2.75mm)44例(27.5%),长支架58例(36.3%),术中无严重并发症发生,手术成功率100%。130例(81.3%)随访1~17个月,6例患者类似胸痛发作,其中3例复查了冠状动脉造影,无支架及节段内再狭窄,未发生心肌梗死及死亡。结论雷帕霉素洗脱支架治疗冠心病患者近期疗效安全有效。  相似文献   

13.
Background  Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.
Methods  From April 2004 to October 2006, 3979 consecutive patients who underwent successful SES (FIREBIRD 2274; CYPHER 1705) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. Follow-up data, including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), TVR, and major adverse cardiac events (MACE, the composite of death, MI, and TVR) were obtained at 24 months. Cox’s proportional-hazards models were used to assess relative risks of all the outcome measures between the two groups before and after propensity match.
Results  Unadjusted clinical outcomes demonstrated higher TVR (hazard ratio (HR) 1.78, 95%CI 1.26–2.50) and MACE (HR 1.40, 95%CI 1.08–1.82) for patients treated with FIREBIRD SES. After propensity match, the results showed a non-significant trend towards superiority of the CYPHER stent in all the analyzed parameters, however, no significant differences were found for all events at 24 months between FIREBIRD and CYPHER groups, and all thrombosis rates by Academic Research Consortium (ARC) definition were comparable between the two groups.
Conclusions  In this large, real-world population, the use of domestic FIREBIRD SES in China was associated with nearly the same safety and efficacy versus the imported CYPHER SES. FIREBIRD SES can be taken as an alternative for CYPHER SES in daily practice.
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14.
Recent clinical trials with rapamycin-eluting stents have shown very low restenosis rates.1-4 However, the higher penetration of drug eluting stent (DES) in China is being limited by the high costs of these imported devices, especially when considering multiple stenting.  相似文献   

15.
Recent clinical trials with rapamycin-eluting stents ,have shown very low restenosis rates.However, the higher penetration of drug eluting stent (DES) in China is being limited by the high costs of these imported devices, especially when considering multiple stenting. Firebird (Microport Co. Ltd., China) is a rapamycin (Huadong Pharmaceutical, China) polymer-based eluting stent with reasonable cost. The objective of this study was to evaluate the safety and efficacy of using Firebird stents in routine interventional practice.  相似文献   

16.
李平  姚光  陈坚  王正东  甘剑挺  梁祥文 《广东医学》2012,33(12):1726-1728
目的对比研究国产Firebird 2TM雷帕霉素药物洗脱钴基合金支架与进口Endeavor-Sprint药物洗脱支架临床应用的安全性及疗效。方法对100例冠心病患者进行介入治疗,随机分为Firebird组和Endeavor组,每组50例,比较两组支架植入后效果。结果两组患者血管病变单支、双支、三支、分叉、慢性闭塞、左主干数比较差异无统计学意义(P>0.05),平均血管直径和平均靶病变长度比较差异无统计学意义(P>0.05);两组手术成功率为100%。Firebird组无血栓形成事件发生,Endeavor组发生1例亚急性血栓形成事件,且进行血运重建。Firebird组28例复查冠状动脉造影,1例再狭窄;Endeavor组19例复查冠状动脉造影,2例有再狭窄,两组比较差异无统计学意义(P>0.05)。结论 Firebird 2TM雷帕霉素药物洗脱钴基合金支架具有良好的安全性和满意的近、中期疗效。其与进口Endeavor-Sprint药物洗脱支架比较无明显差别。  相似文献   

17.

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.

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18.
刘志东 《四川医学》2009,30(12):1904-1905
目的比较雷帕霉素和紫杉醇两种药物洗脱支架(DES)在冠状动脉长病变中的临床疗效分析。方法选择2007年1月-2008年7月期间分别接受雷帕霉素DES和紫杉醇DES的冠脉长病变患者各35例和32例,观察6个月的主要心脏事件(MACE)。结果雷帕霉素DES和紫杉醇DES两组患者支架置入成功率均为100%,随访6个月其心脏不良事件发生率分别为8.57%和9.37%,差异无统计学意义(P〉0.05)。结论雷帕霉素DES治疗冠状动脉长病变的疗效和安全性与紫杉醇DES相似,更长期的临床疗效比较尚有待于进一步随访观察。  相似文献   

19.
Influence of insulin resistance on long-term outcomes in patients   总被引:2,自引:0,他引:2  
Background Insulin resistance(IR)is significantly associated with coronary artery disease and cardiovascular events in patients with or without type 2 diabetes mellitus.This study aimed to evaluate the influence of IR on long-term outcomes of patients undergoing percutaneous coronary intervention(PCI)with sirolimus-eluting stent(SES)implantation.Methods A total of 467 consecutive patients undergoing SES-based PCI were divided into lR group(n=104)and non-IR group(n=363).The patients were followed up for one year.The rate of major adverse cardiac events(MACEs) including death, non-fatal myocardial infarction and recurrent angina pectoris was compared by the log-rank test,and the independent risk factors were identified by the Cox regression analysis.Results MACEs occurred more frequently,and cumulative survival rate was lower in the IR group than in the non-IR group during the follow-up (all P〈0.05).IR was an independent risk factor for the occurrence of cardiac death and non-fatal myocardial infarction(OR=2176,95% CI=1.35-5.47,P=0.034).Old age,diabetes,and multi-vessel disease were determinants for recurrent angina pectoris after PCI(P〈0.05).Subgroup analysis revealed that IR(OR=3.35,95% CI=1.07-13.59,P=0.013)and multi-vessel disease(OR=2.19,95%CI=1.01-5.14,P=0.044)were independent risk predictors for recurrent angina pectoris in patients with diabetes after PCI.Conclusions IR is associated with reduced MACE-free survival and remains an independent predictor for recurrent angina pectoris after PCI with SES implantation.  相似文献   

20.
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.  相似文献   

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