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.

     

Drug-eluting stents improve clinical outcomes in Chinese diabetic patients with de novo coronary artery disease

Diabetes mellitus （DM） has been regarded as an equivalent risk factor as coronary artery disease and is present in nearly 25% of patients who receive percutaneous coronary intervention （PCI）. DM is shown as an adverse predictor for major adverse cardiac events （MACE） after PCI in bare metal stent （BMS） era. Recently, clinical trials have demonstrated the favorable tendency of using drug-eluting stents （DES） in treating diabetic patients with coronary artery disease. This study compared the clinical outcomes between the diabetic patients receiving DES with those receiving BMS in China.     

药物洗脱支架治疗无保护左主干病变

目的 评价药物洗脱支架治疗冠状动脉无保护左主干(ULMCA)病变的安全性及疗效.方法 选择2002年10月～2007年11月我院收治经冠状动脉造影证实为无保护左主干病变患者44例;合并心功能不全(左室射血分数<40%)5例,肺功能减退2例,慢性肾功能不全5例;常规行冠状动脉造影及经皮冠状动脉介入治疗.分析其冠脉造影特征、手术成功率及临床随访结果 .结果 44例患者经皮冠状动脉介入治疗即刻成功率为100%,无严重术中并发症,手术住院期间的病死率、非致死性心肌梗死率及急诊常规行冠状动脉造影率均为0%.所有患者均植入药物洗脱支架.术后平均随访14.2～9.3月(6～65月),所有患者均未发生亚急性或延迟性支架内血栓形成;6例(13.6%)患者有心绞痛症状复发;1例患者在术后4个月困心力衰竭死亡;37例(84.1%)患者无严重不良心血管事件发生.35例(79.5%)患者进行了冠状动脉造影复查,其中冠状动脉造影复查提示发生再狭窄3例(8.6%):1例为左主干远端分叉病变,分叉处再狭窄转外科行常规行冠状动脉造影术;2例左主干末端分叉病变分支开口发生再狭窄,使用切割球囊再次经皮冠状动脉介入治疗后,症状缓解.结论 对选择性的冠状动脉左主干病变使用药物洗脱支架行介入治疗安全有效,近、远期疗效良好.     

雷帕霉素洗脱支架治疗冠心病的近期疗效研究

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。     

药物洗脱支架和金属裸支架对冠心病患者近远期疗效比较

目的对比观察药物洗脱支架(DES)和金属裸支架(BMS)治疗冠心病(CHD)患者近远期临床疗效的影响。方法收集我院2005年1月至2007年1月CHD患者305例,随机分为治疗组和对照组,其中治疗组接受DES治疗,对照组接受BMS治疗,于术后1、3、6、9和12个月进行电话或门诊随访,并于12个月做冠状动脉造影,观察不良心脏事件、支架内血栓及再狭窄的发生率,并评价两组不同因素对再狭窄的影响。结果治疗组置入支架成功率为98.7%,而对照组置入支架成功率为100%。在主要临床事件方面,治疗组主要心脏不良事件、支架内狭窄发生率明显低于对照组,二者相比有显著性差异(P<0.01);而近期血栓事件发生率为2.58%,与对照组相比无显著性差异(P>0.05)。亚组分析,治疗组中在弥漫病变、重叠支架、长支架时的再狭窄率小,与对照组相比,具有显著性差异(P<0.01)。结论在经皮冠状动脉介入治疗术支架置入中,DES具有较低的不良心脏事件、近期血栓及再狭窄的发生率,同BMS相比有显著的优势,近远期疗效是安全、可靠的。     

One-year clinical outcomes of Chinese sirolimus-eluting stent in the treatment of unselected patients with coronary artery disease

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,     

Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions

Background There are limited data on the efficacy of drug-eluting stents （DES） for treatment of chronic total occlusions （CTO）. The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent （BMS） implantation.
Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 （55.7%） who underwent DES and 524 （44.3%） who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events （MACE）. Long-term survival rates were estimated with the Kaplan-Meier method.
Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy （（7.4±2.5） months vs （1.7±0.8） months, P 〈0.001）. Average follow-up periods were （4.7±0.89） and （3.2±1.3） years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups （90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38）, but the 5-year target vessel revascularization （TVR）-free survival rate in the DES group was significantly higher than that in the BMS group （81.6% vs 73.5%, Log-rank P 〈0.001）. The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group （80.6% vs 71.5%, Log-rank P〈0.001）. The rates of readmission caused by cardiovascular disease （27.0% vs 37.8%, P 〈0.001） and the need for bypass surgery were significantly lower in the DES group （1.5% vs 3.4%, P 〈0.05）. By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients （HR： 0.492; 95% Cl 0.396-0.656, P 〈0.001）. Left ventricular ejection fraction 〈50% and elderly （〉65 years） were identified as independent predictors of long-term MACE during follow-up.
Conclusion This study demonstrates the long-term （up to 5 years） efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.     

The influence of diabetes mellitus on the procedural and in-hospital outcomes after elective percutaneous coronary intervention

Approximately 15% 20% of the patients undergoing percutaneous coronary intervention (PCI) procedure complicate with diabetes and this patient population continues to be a particular challenge for both the interventional cardiologist and the cardiac surgeon. It is well documented that diabetes is associated with more diffuse and severe coronary atherosclerosis.     

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.     

Long term clinical outcomes in patients with moderate renal insufficiency undergoing stent based percutaneous coronary intervention

Background Patients with end-stage renal disease have a high mortality from coronary artery disease, but the impact of moderate renal insufficiency on clinical outcomes after percutaneous coronary intervention （PCI） and the effect of drug-eluting stent implantation in these patients remain unclear. This study determined the long-term effect of moderate renal insufficiency on death and major adverse cardiac events （MACE） after stent based PCI and examined whether drug-eluting stent implantation could favourably influence clinical outcome. Methods Major adverse cardiac events and causes of mortality were determined for 1012 patients undergoing percutaneous intervention from January 1, 2002 to December 31, 2004 at Shanghai Ruijin Hospital. Based on estimated creatinine clearance levels, long term outcomes were compared between patients with estimated creatinine clearance 〈60 ml/min （renal insufficiency group; n=410） and those with estimated creatinine clearance ≥60 ml/min （control group; n=602）. Subgroup analysis was also made for patients with renal insufficiency between drug eluting stent （n=264） and bare metal stent implantation （n=146） during PCI. Results During follow-up （average 17 months） after successful PCI, all causes of death （7.1% vs 2.3%, P〈0.01） and cardiac death （3.4% vs 1.0%, all P〈0.01） were significantly higher in renal insufficiency group than in control group. For patients with moderate renal insufficiency, drug-eluting stent implantation reduced significantly all causes of death （5.3% vs 10.9%, P〈0.05） and occurrence of major cardiac adverse events （15.1% vs 24.6%, P〈0.05） compared with bare metal stents. Conclusions Moderate renal insufficiency is an important clinical factor influencing the mortality after PCI in patients with coronary artery disease and the use of drug-eluting stents should be the preferred therapy for the improvement of long-term outcomes in such patients.     

冠状动脉介入治疗对冠心病QT离散度的影响

目的:探讨经皮冠状动脉介入治疗对冠心病患者QT间期离散度(QTd)的影响。方法:对268例冠状动脉造影证实冠状动脉管腔狭窄≥75%而成功行支架置入术,术前、术后进行同步12导联心电图检查,测量QTd和校正QT间期离散度(QTcd);同期测量262例仅行冠状动脉造影术的患者术前、术后的QTd和QTcd。结果:冠状动脉造影组:冠状动脉造影后与冠状动脉造影前QTd和QTcd比较无显著性差异(P>0.05)。支架置入术组:支架置入术后与术前的QTd和QTcd比较明显缩短(P<0.01)。亚组分析表明:术前多支血管病变者的QTd及QTcd显著大于单支血管病变者(P<0.01),且治疗后多支血管病的QTd及QTcd的下降程度均较单支血管病变者更加明显(P<0.01)。结论:成功的支架置入术早期即可改善冠心病患者的QTd、QTcd,从而可能预防早期心血管事件的发生。     

紫杉醇洗脱支架治疗冠状动脉硬化性心脏病近期效果

目的评价紫杉醇洗脱支架（PES,商品名TAXUS）治疗冠状动脉硬化性心脏病患者的近期效果及安全性.方法对2003年7月至2004年11月在我院接受PES植入治疗的300例患者的即刻疗效和随访结果进行总结与分析.结果300例患者共处理350处病变,植入支架355枚,其中B2型以上复杂病变248处（70.9%）,小管径支架（2.50～2.75 mm）94处（26.5%）、长支架（＞20 mm）130处（36.6%）;术中未发生严重并发症,手术成功率100%.随访250例（83.3%）,平均随访6个月（1～15个月）,8例（2.7%）患者有心绞痛样发作,其中2例冠状动脉造影复查无支架再狭窄病变,1例于术后5个月发生心肌梗死,2例因非心源性因素死亡.结论PES治疗冠状动脉硬化性心脏病近期效果明显,且较为安全.     

紫杉醇洗脱支架治疗冠状动脉硬化性心脏病近期效果

目的 评价紫杉醇洗脱支架(PES,商品名TAXUS)治疗冠状动脉硬化性心脏病患者的近期效果及安全性。方法 对2003年7月至2004年11月在我院接受PES植入治疗的300例患者的即刻疗效和随访结果进行总结与分析。结果 300例患者共处理350处病变,植入支架355枚,其中B2型以上复杂病变248处(70.9%),小管径支架(2.50~2.75mm)94处(26.5%)、长支架(>20mm)130处(36.6%);术中未发生严重并发症,手术成功率100%。随访250例(83.3%),平均随访6个月(1~15个月),8例(2.7%)患者有心绞痛样发作,其中2例冠状动脉造影复查无支架再狭窄病变,1例于术后5个月发生心肌梗死,2例因非心源性因素死亡。结论 PES治疗冠状动脉硬化性心脏病近期效果明显,且较为安全。     

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     

雷帕霉素洗脱支架对吻术与单支架术对冠状动脉分叉病变疗效的影响

目的比较雷帕霉素洗脱支架对吻技术与单支架技术对真性分叉病变的近、远期疗效的影响。方法 200名分叉病变患者,随机分为对吻支架术和单支架术两组。随访1年,观察两组节段内再狭窄率、死亡率、非致死性心肌梗死率、靶病变再次血运重建率和支架内血栓形成率。结果术后1年,单支架组与对吻支架组相比,再狭窄率、死亡率、心肌梗死发生率、靶病变再次血运重建率、支架内血栓发生率及严重心血管不良事件发生率差异均无统计学意义（P〉0.05）;分支预扩张后,出现夹层的患者分析提示单支架与对吻支架组节段内再狭窄率、靶病变再次血运重建率及严重心血管不良事件发生率差异有统计学意义（P〈0.05）,而支架内血栓率、死亡率及心肌梗死率差异无统计学意义（P〉0.05）。结论对于直径较大的分叉病变患者,对吻支架技术的近、远期疗效与单支架术相近。预扩张后分支出现夹层应采用对吻支架术,没有夹层则应采用单支架植入。     

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.     

可降解涂层与永久性涂层药物洗脱支架治疗冠心病合并糖尿病患者的有效性及安全性研究

目的 比较可降解涂层与永久性涂层药物洗脱支架治疗冠心病合并糖尿病患者的远期疗效及安全性.方法 回顾性分析2008年1月至2012年12月我院确诊为冠心病合并糖尿病并行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者364例,男性261例,女性103例,145例植入可降解涂层药物洗脱支架,219例植入永久性涂层药物洗脱支架;对比术后两组患者主要不良心血管事件(main adverse cardiac events,MACE)的发生情况.结果 两组患者在临床一般基线资料、冠脉病变特征等方面均无统计学差异(P＞0.05).可降解涂层组与永久性涂层组相比,两组在心源性死亡(1.4％ vs 1.9％)、非致死性心肌梗死(0.7％ vs 0.9％)、支架内血栓(2.1％ vs2.3％)、靶血管血运重建(2.8％ vs 2.8％)方面差异均无统计学意义(P＞0.05).结论 永久性涂层药物洗脱支架和可降解涂层药物洗脱支架治疗冠心病合并糖尿病患者均有效,且两者安全性无明显差异.     

Retrieval of dislodged coronary stent from left renal artery by gooseneck snare

A rapamycin-eluting stent was dislodged during attempt of implantation at the proximal right coronary artery,which was found by fluoroscopy to have migrated into the anterior trunk of the left renal artery.We chose a 5 mm diameter Amplatz gooseneck snare and successfully retrieved the lost stent from the lodging vessel.     

糖尿病合并急性心肌梗死急诊介入治疗疗效

目的 评价糖尿病患者合并急性心肌梗死急诊介入治疗的疗效。方法 分析1997.2-1999.12中88例伴糖尿病与216例不伴糖尿病急性心肌梗死行急诊介入治疗患者的临床疗效。结果 糖尿病组伴心源性休克15例,死亡率为4.5％,成功率94.0％。78例成功介入治疗患者随访(11.7±7.8)月,主要不良心脏事件(MACE)发生率28.2％。不伴糖尿病组中有29例合并心源性休克,死亡率为1.9％,成功率97.1％,其中178例随访(12.6±8.3)月期间MACE发生率为18.0％。急诊介入治疗成功率两组相似,近期死亡率和中远期MACE发生率糖尿病组也无明显增高(P>0.05),女性患者的比例在糖尿病组明显增高(P=0.01)。结论 急诊介入治疗糖尿病合并急性心肌梗死安全可靠,效果佳。