雷帕霉素和紫杉醇药物洗脱支架在冠状动脉长病变中的临床应用分析

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。     

雷帕霉素和紫杉醇药物洗脱支架在冠心病复杂病变中的临床近远期疗效的比较

目的比较雷帕霉素（CYPHER）和紫杉醇（TAXUS）药物洗脱支架（DES）在冠心病复杂病变中的临床近、远期疗效。方法本研究选自2002年4月～2004年6月期间接受CYPHER和TAXUSDES治疗的患者各为611例和450例，两组的临床情况和入选的病变类型具有可比性。结果CYPHER和TAXUSDES置入成功率分别为99．2％和98．8％，住院期间心脏事件（死亡，AMI，靶病变重建，MACE）发生率各为0．65％和1．3％（P〉0．05），6～8个月随访率各为97．5％和96．2％，随访期间MACE发生率分别为2．3％和3．2％（P〉0．05），再狭窄发生率分别为7．3％和14％（P〉0．05）。结论研究结果提示，对于冠心病复杂性病变CYPHER和TAXUSDES均有良好的临床近、远期疗效，在再狭窄发生率上CYPHER支架有优于TAXUS支架的趋势。     

雷帕霉素和紫杉醇药物洗脱支架在冠心病复杂病变中的临床近远期疗效的比较

目的比较雷帕霉素(CYPHER)和紫杉醇(TAXUS)药物洗脱支架(DES)在冠心病复杂病变中的临床近、远期疗效。方法本研究选自2002年4月～2004年6月期间接受 CYPHER 和 TAXUS DES 治疗的患者各为611例和450例,两组的临床情况和入选的病变类型具有可比性。结果 CYPHER 和 TAXUS DES 置入成功率分别为99.2%和98.8%,住院期间心脏事件(死亡,AMI,靶病变重建,MACE)发生率各为0.65%和1.3%(P>0.05),6～8个月随访率各为97.5%和96.2%,随访期间 MACE 发生率分别为2.3%和3.2%(P>0.05),再狭窄发生率分别为7.3%和14%(P>0.05)。结论研究结果提示,对于冠心病复杂性病变 CYPHER 和 TAXUS DES 均有良好的临床近、远期疗效,在再狭窄发生率上 CYPHER 支架有优于 TAXUS支架的趋势。     

Comparison of drug-eluting stents with bare metal stents implantation for the treatment of acute ST-elevation myocardial infarction: 2-year clinical outcomes from single-center registry

Background  Some larger scale, randomized studies have demonstrated the superiority of drug-eluting stents (DES) over bare metal stents (BMS) for the treatment of acute myocardial infarction (AMI). This study aimed to investigate the impact of DES, in comparison with BMS, on the 2-year clinical outcomes in patients with ST-elevation myocardial infarction (STEMI).

Methods  From January 2002 to December 2008, a total of 1301 consecutive STEMI patients treated with coronary stenting in Shenyang Northern Hospital were prospectively registered. Patients received BMS (n=868) or DES (n=435) implantation in the infarction related artery according to physician’s discretion. A propensity score analysis was performed and two well matched subgroups were selected (BMS, n=288; DES, n=288) to evaluate the 2-year clinical outcomes. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of all-cause death, myocardial infarction (MI), or target vessel revascularization (TVR).

Results  Survival salvage analysis showed that 2-year cumulative hazards were not significantly different between the two groups with respect to TVR (2.8% vs. 3.1%, log-rank P=0.780), stent thrombosis (1.7% vs. 4.2%, log-rank P=0.079) and MACE (8% vs. 10.8%, log-rank P=0.236). Multivariate analysis showed that DES was an independent protective factor of MI (HR: 0.211, 95% CI: 0.049 to 0.908) and stent thrombosis (HR: 0.327, 95% CI: 0.107 to 0.994).

Conclusion  DES was associated with similar 2-year clinical outcomes to those of BMS for the treatment of STEMI in daily practice.

     

多个药物支架植入安全性和可行性的临床研究

目的 评估多药物支架植入术的近期疗效及安全性.方法 对我院从2004年6月到2005年12月共34例多个药物支架(≥3枚)植入术进行回顾性分析,对照组为单个支架植入组(n=64)和两支架植入组(n=53),随访术后6月冠状动脉内急性及亚急性血栓形成的发生率、再狭窄和心血管事件的发生率.结果 151例患者PCI治疗均成功.介入治疗1个月随访结果显示,多支架组、两支架组及单支架组均没有发生冠状动脉内血栓形成(P＞0.05),介入治疗6个月随访结果显示,再狭窄及心血管事件发生率均无统计学差异(P＞0.05).结论 多个药物支架植入治疗,并不增加近期血栓形成和心血管事件的发生率.     

雷帕霉素药物洗脱支架的早中期安全性及有效性评价

目的评价雷帕霉素药物洗脱支架（drug—elutingstent,DES）在冠脉病变介入治疗后的安全性与有效性。方法从2009年1月1日-2011年11月1日期间在我院心血管内科行冠状动脉造影并置入雷帕霉素药物洗脱支架的患者中随机筛选500例,按随访时间将其分为术后1年随访组（130例）、术后3年随访组（139例）2组。采用电话随访或门诊检查,必要时复查冠脉造影观察在支架置入后不良心血管事件发生情况及靶血管复查造影情况。结果两组不良心血管事件总体发生率有统计学差异（3．25％VS13．28％,P=0．04）,其中靶病变血运重建发生率（2．44％VS8．59％,P=0．03）有统计学意义,而心源性死亡发生率f0．81％vs2．34％,P=0．64）和非致死性心肌梗死发生率（0．00％阳2．34％,P=0．26）无统计学差异;两组造影复查支架再狭窄率（4．88％瑚14．84％,P=0．008）有统计学意义。结论支架置入术术后3年与术后1年相比有较高的靶血管血运重建率及支架再狭窄率。     

A comparison of angiographic and clinical outcomes after sirolimus-eluting versus paclitaxel-eluting stents for the treatment of in-stent restenosis

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.     

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.     

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     

叶酸对冠脉药物涂层支架植入术患者再狭窄的预防作用

目的研究叶酸对药物涂层支架（DES）内再狭窄（ISR）的预防作用。方法 DES支架术后患者随机分为叶酸（FA）组和对照组,叶酸组加服叶酸5mg/d。检测并对比两组支架术后即刻、术后6个月、术后1年血FA和同型半胱氨酸（Hcy）。两组患者于术后即刻和1年后行冠脉造影检查以测定并对比最小病变血管内径。结果两组患者大部分基线指标差异无统计学意义。叶酸组患者腰围较对照组高（P〈0.01）,低密度脂蛋白（LDL-C）较对照组低（P〈0.05）。两组间术后即刻叶酸浓度、tHcy浓度和最小病变血管直径无统计学意义（P〉0.05）。术后6个月和术后1年叶酸组患者叶酸浓度较对照组升高（P〈0.05）,tHcy浓度较对照组降低（P〈0.05）。术后1年叶酸组最小病变血管直径较对照组大（P〈0.05）。结论叶酸可以预防药物涂层支架内再狭窄。     

Comparison of a five-year clinical outcome between Chinese women and men with de novo coronary disease treated with implantation of a drug-eluting stent: a three-center, prospective, registry study

Background  The gender-based differences in adverse events after drug-eluting stent (DES) implantation between Chinese women and men have not been fully studied. The present study aimed to compare the 5-year clinical outcome after DES implantation in Chinese women and men.

Methods  Chinese women (n=298) and men (n=698) with newly diagnosed de novo coronary lesions were studied after DES implantation. The primary endpoint was the occurrence of major adverse cardiac events (MACEs) over a 5-year follow-up, including myocardial infarction (MI), cardiac death, and target vessel revascularization (TVR). Propensity score matching (PSM) was used to compare the adjusted MACE rates between sexes.

Results  Women differed in body habitus and had increased fasting cholesterol. Fewer women presented with MI, and they had better cardiac function with less complex disease. The unadjusted rate of MI at 3 years (2.1%) and 5 years (5.0%) and MACE (25.2%) at 5 years in men was significantly higher than that of women (0.3%, 1.0% and 17.8%, P=0.050, P=0.032, and P=0.011, respectively). After PSM, the adjusted adverse events between sexes were similar. The stent thrombosis rate rapidly increased after 2 years in men.

Conclusions  There were significant gender-based differences in baseline characteristics. Chinese men had equivalent outcomes to women after DES after adjustment by PSM. The increased rate of MI in men was attributed to an increased unadjusted rate of MACE.

     

术前强化他汀治疗对高龄冠心病患者冠脉介入治疗预后的影响

目的观察术前应用不同负荷剂量阿托伐他汀钙对高龄冠心病患者经皮冠状动脉介入治疗（PCI）预后的影响。方法将
120例≥80岁的择期PCI冠心病患者随机分为20 mg他汀组（40例）、40 mg他汀组（40例）和60 mg他汀组（40例）,在入院后48~
72 h 内接受PCI。分别于PCI 术前使用阿托伐他汀钙20、40、60 mg/d,观察3 组患者术后心脏生化标志物肌酸激酶同工酶
（CKMB）、肌钙蛋白I（cTNI）及高敏C反应蛋白（hsCRP）等指标变化及术后1个月内主要不良心脏事件（MACE,包括心源性死
亡、心肌梗死和靶血管血运重建）的发生率。结果最终20 mg他汀组有34例患者、40 mg他汀组有40例患者、60 mg他汀组有
38例患者完成本课题研究,20、40、60 mg他汀组PCI术后12 h、术后24 h hs-CRP与术前对比显著升高（P<0.05）,60 mg他汀组术
后24 h CKMB、cTNI、hs-CRP显著低于20 mg他汀组（P<0.05）。60 mg他汀组PCI术后30 d内总MACE事件显著低于20 mg他
汀组（2.6%比26.5%, P=0.003）,主要原因是60 mg他汀组与PCI 相关的心肌梗死显著低于20 mg他汀组（2.6%比20.6%, P=
0.016）。三组药物不良反应无统计学差异（P>0.05）。结论高龄冠心病患者择期PCI术前强化阿托伐他汀钙60 mg/d可以显著
减少与PCI相关的心肌梗死,并且安全性良好。
     

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion lesions in remote hospitals without on-site surgical support

Background The safety of percutaneous coronary intervention （PCI） for chronic total occlusion （CTO） lesions in remote hospitals without surgical facilities remains unknown. This study aimed to evaluate three-year outcomes after CTO for PCI in ten centers around China where no on-site coronary artery bypass grafting （CABG） support was available. Methods A total of 152 patients from 10 Chinese hospitals without on-site surgical facilities were prospectively studied. Intra-procedural and in-hospital events were assessed. Angiographic follow-up was indexed eight months after the initial procedure. Clinical follow-up was extended to three years. The primary outcome was the rate of major adverse cardiac events （MACE）, defined as cardiac death, myocardial infarction and target-vessel revascularization （TVR）. Results The incidence of CTO was 7.9% in patients who underwent PCI, Successful recanalization was achieved in 132 patients （86.8%）. Compared with patients in the PCI success group, patients with PCI procedural failure had longer lesion lengths （（42.32±22.08） mm vs （27.61±22.85） mm, P=0.023）, a higher rate of perforation （25.0% vs 0, P=0.014）, and a greater need for pericardial puncture. There were significant differences in MACE in-hospital and at one year and three years between the failure （10.0%, 30.0% and 35.0%） and the success （3.0%, 12.1% and 14.4%） groups （P=0.037, 0.034 and 0.040, respectively）. These led to a significant decrease in the MACE-free survival rate at one and three years in the failure group, compared with the success group （P=0.031 and 0.023, respectively）. Stump was the only predictor of recanalization success （HR 0.158, 95% Cl 0.041-0.612, P=0.008）, whereas procedural failure （OR 13.023, 95% CI 6.67-13.69, P=0.002）, incomplete revascularization （OR 9.71, 95% CI 2.93-5.59, P=0.005）, and total stent length （OR 6.02, 95% Cl 1.55-11.93, P=0.027） were three independent predictors of MACE. Conclusions PCI for CTO was unsafe in remote hospitals without CABG facilities. Paying attention to coronary perforation is important for successful procedures.     

无保护左主干病变应用药物洗脱支架介入治疗的预后及影响因素分析

目的评价无保护左主干病变应用药物洗脱支架介入治疗的预后及影响因素。方法 45例无保护左主干病变患者接受经皮冠状动脉介入治疗（PCI）,根据病变是否累及左主干远端分叉分组,开口或体部病变为非分叉组（26例）,累及左主干远端或前降支、回旋支开口者为分叉组（19例）。15例患者术中应用血管内超声指导,13例在术后（9.5±6.3）个月进行了冠状动脉造影复查。结果 45例患者经治疗后均达到操作成功标准。术后42例患者获得随访,随访时间13～48个月。分叉组随访期间再发心绞痛率明显高于非分叉组（P〈0.05）,但两组主要心脏不良事件（MACE）发生率比较差异无统计学意义（P〉0.05）。对MACE单因素分析发现,术中血管内超声指导患者MACE发生率明显低于未应用血管内超声指导患者（P〈0.05）。13例术后复查患者4例发生支架内再狭窄,均发生在分叉组,且双支架术再狭窄率明显高于单支架（P〈0.01）。结论经选择的无保护左主干病变药物洗脱支架治疗是可行和安全的,可取得较好的近远期效果,术中应用血管内超声指导可明显减少MACE的发生。     

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.

     

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.     

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,     

冠心病合并糖尿病患者药物洗脱支架置入术后远期疗效观察

目的分析冠心病合并糖尿病患者药物洗脱支架（drug-eluting stent,DES）置入后远期有效性及安全性。方法在本院心内科2005年1月-2008年12月间行冠状动脉造影确诊为冠心病并行DES支架置入的646例患者根据有无合并糖尿病分为DES糖尿病组192例（随访183例,95.3%）与DES非糖尿病组454例（随访428例,94.3%）,随访患者在DES置入后远期不良心血管事件（major adverse cardiac events,MACE）发生情况。结果糖尿病组合并高血压（75.4%vs 60.5%,P=0.00）及冠状动脉三支病变（47.0%vs 37.6%,P=0.05）、女性（26.2%vs 16.6%,P=0.01）比例高于非糖尿病组,单支病变（24.0%vs32.0%,P=0.05）比例及平均年龄小于非糖尿病组（60.08±11.58 vs 64.01±10.79,P=0.00）。两组MACE发生率比较差异无统计学意义,但随着术后时间延长,两组MACE率均呈递增趋势。两组支架内血栓发生率差异有统计学意义（2.7%vs 0.2%,P=0.02）。结论冠心病合并糖尿病患者较单纯冠心病患者多支病变比例及PCI术后确定的支架内血栓发生率高。DES术后两组MACE发生率均呈递增趋势,糖尿病组在极远期（〉5年）增长更快。     

高维持剂量氯吡格雷在冠脉分叉病变双药物洗脱支架植入术后有效性和安全性对照研究

目的评价150 mg高维持剂量氯吡格雷在冠脉分叉病变患者植入双药物洗脱支架(drug eluting stents,DES)的疗效和安全性。方法 2007-06～2009-12入选146例冠脉真分叉病变采用双DES植入患者。所有入选患者术后在服用阿司匹林基础上随机分为两组,每日75 mg(对照组,n=71)或150 mg(实验组,n=75)维持剂量的氯吡格雷治疗30 d,30 d后所有患者接受每日75 mg的氯吡格雷治疗直至术后12个月。观察两组患者临床特征、冠脉病变特点以及支架植入特征,并进行随访(12-24个月)主要心血管事件、支架内血栓和出血事件。结果实验组心梗及再次血运重建发生率均显著低于对照组(8.0%vs 15.5%,P=0.042;6.67%vs 12.68%,P=0.048)。两组间全因病死率差异无统计学意义(1.33%vs 2.82%,P=0.873)。实验组主要终点事件绝对风险较对照组降低8.99%(P=0.037)。实验组近期、远期支架内血栓事件发生率显著低于对照组(0 vs 2.82%,P=0.049;1.33%vs 4.23%,P=0.042);两组间严重出血(1.33%vs 0,P=0.343)、轻微出血(2.67%vs2.82%,P=0.873)风险无统计学差异。结论 150 mg高维持量氯吡格雷可降低冠脉分叉病变双DES植入的患者术后发生主要不良心血管事件、支架内血栓形成的风险,并且不增加出血事件的发生。