药物洗脱支架置入后长期临床预后与氯吡格雷应用的关系

背景：近来关于冠状动脉内药物洗脱支架（DES）的研究表明目前的抗血小板方案不足以预防晚期支架内血栓形成。目的：评估冠心病患者接受DES和裸金属支架（BMS）置入后长期临床预后与氯吡格雷应用的关系。设计、地点和患者：对2000年1月1日至2005年7月31日间在Duke心脏中心接受冠状动脉支架置入术的连续患者进行观察研究。分别在6个月、12个月、24个月时进行随访，直至2006年9月7日。研究对象为4666例接受首次PCI支架置入的患者，其中3165例接受BMS，1501例接受DES。[第一段]     

非顺应性球囊高压后扩张在冠心病药物洗脱支架植入术中的应用

目的探讨非顺应性球囊高压后扩张在冠心病药物洗脱支架植入术中的应用效果。方法 150例冠心病患者,随机分为观察组和对照组各75例,对照组采用药物洗脱支架(DES)植入术进行治疗,观察组在此基础上行非顺应性球囊高压后扩张。分析手术过程中患者临床特征、植入DES数量、血管病变情况、管腔狭窄程、血栓形成情况以及术中并发症等,并做好记录。结果观察者患者支架植入后管腔最小直径、绝对内径分别为(3.31±0.34)、2.63±0.47)mm,明显高于对照组(2.74±0.32)、(2.25±0.40)mm的指数,(P0.05);观察者患者亚急性支架内血栓发生率、晚期支架内血栓发生率、心脏不良事件发生率以及支架内再狭窄发生率分别为1.33%、1.33%、2.67%、2.67%明显低于对照组5.33%、6.67%、8.00%、9.33%的发生率(P0.05)观察组患者管腔内绝对内径丢失、管腔狭窄程度均优于对照组(P0.05);两组患者植入DES数量、血管病变情况、管腔狭窄程及并发症等之间没有显著的差异(P0.05)。结论非顺应性球囊高压后扩张在冠心病DES植入术中能够有效降低患者心脏不良事件发生率和支架内再狭窄发生率,减少患者绝对内径的丢失等,具有较好的治疗效果。     

药物涂层球囊与药物洗脱支架对冠状动脉支架再狭窄的治疗效果

目的 探讨药物涂层球囊与药物洗脱支架对冠状动脉支架再狭窄的治疗效果.方法 选取2018年2月-2019年3月我院收治的54例冠状动脉支架再狭窄患者,按随机数字表法分为药物涂层球囊组(A组)和药物洗脱支架组(B组).比较两组靶病变管腔直径面积变化、不良心血管事件、再狭窄及死亡率.结果 治疗后B组最小管腔直径、面积优于A组...     

药物支架和切割球囊在药物洗脱支架植入术后再狭窄中治疗效果比较

目的比较药物支架再植入和切割球囊2种方法,在药物洗脱支架植入术后再狭窄病人中的治疗效果。方法回顾分析124例药物洗脱支架内再狭窄病人,经切割球囊或药物支架再次植入治疗即刻和术后随访结果。并于治疗时及术后(6.0±1.4)个月行冠脉造影检查。结果 2组病人的年龄、性别、既往病史及介入治疗前支架内再狭窄情况比较,差异无统计学意义(P>0.05)。介入治疗即刻切割球囊组与药物支架组:最小管腔直径[(2.54±0.45)mm vs(2.67±0.48)mm]及直径狭窄率(23.5%±10.3%vs 21.8%±9.4%)比较,差异无统计学意义(P>0.05)。术后6个月药物支架组的最小管腔直径(1.86±0.63)mm明显高于切割球囊组(1.34±0.71)mm(P<0.01),且直径狭窄率显著低于切割球囊组(39.2%vs 47.8%,P<0.05)。药物支架组复发再狭窄和晚期管腔丢失量均低于切割球囊组[4.1%vs 9.8%,(0.52±0.48)mm vs(0.74±0.53)mm],差异有统计学意义(P<0.01)。结论药物支架再植入相比于切割球囊治疗药物洗脱支架术后再狭窄,6个月后支架内再狭窄率低于切割球囊组。     

国产雷帕霉素药物洗脱支架的临床应用观察

目的评价国产雷帕霉素药物洗脱支架的安全性和有效性。方法对32例冠心病患者,予以置入56个国产雷帕霉素药物洗脱支架(Firebird)治疗,并进行6个月以上随访。结果即刻成功率为100%。6个月以上随访,无重要心脏不良事件,无病变靶血管重建术,再狭窄率为0%。结论Firebird能有效预防冠脉支架术后再狭窄,并具有很高的安全性。     

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。     

药物洗脱支架治疗冠状动脉支架内再狭窄的临床观察

目的观察药物洗脱支架治疗冠脉支架内再狭窄的临床疗效。方法对入选的患者行药物洗脱支架治疗,术后观察心脏不良反应事件的发生情况。结果 44例患者中发生不良反应事件22例,其中胸痛复发19例,TVR7例,ISR处原支架的类型是影响术后疗效的重要因素,本研究认为DES术后ISR的疗效好于BMS术后ISR（P=0.002）。而患者的年龄、性别、病变血管的直径和病变部位、病变的严重程度以及DES涂层材料的不同与治疗效果无明显的相关性。结论药物洗脱支架是治疗冠状动脉支架内再狭窄的有效手段。     

药物洗脱支架治疗冠状动脉支架内再狭窄的临床观察

目的观察药物洗脱支架治疗冠脉支架内再狭窄的临床疗效。方法对入选的患者行药物洗脱支架治疗,术后观察心脏不良反应事件的发生情况。结果 44例患者中发生不良反应事件22例,其中胸痛复发19例,TVR7例,ISR处原支架的类型是影响术后疗效的重要因素,本研究认为DES术后ISR的疗效好于BMS术后ISR(P=0.002)。而患者的年龄、性别、病变血管的直径和病变部位、病变的严重程度以及DES涂层材料的不同与治疗效果无明显的相关性。结论药物洗脱支架是治疗冠状动脉支架内再狭窄的有效手段。     

药物洗脱支架治疗无保护左主干病变临床研究

目的 评价药物洗脱支架(DES)置入与冠脉旁路移植术(CABG)对冠脉无保护左主干病变患者的近远期疗效.方法 对2003年2月至2008年6月接受治疗的冠脉无保护左主干病变的病人进行评估,其中113例置入了药物洗脱支架(DES组),96例病人接受了冠脉旁路移植术(CABG组).记录患者围手术期,术后6月及3 a不良心脑血管事件(MACCES)发生率.结果 (1)两组患者一般临床特征比较无统计学意义;(2)DES组与CABG组术后12月的MACCES发生率分别为11%及10.6%,P＞0.05; (3)平均随访18个月,DES组与CABG组无MACCES生存率比较差异无统计学意义(P＞0.05); (4)冠脉造影随访DES组再狭窄率高于CABG组(7.69%比 0%,P＜0.05).结论 冠脉无保护左主干病变DES治疗手术成功率高,有较理想的近远期疗效.     

Zotarolimus洗脱支架和雷帕霉素洗脱支架的临床疗效对比观察

目的 对比研究Zotarolimus洗脱支架和进口雷帕霉素洗脱支架（Cypher支架）临床应用疗效。方法 129例符合冠脉介入手术指征的冠脉病变患者被随机分为两组,Zotarolimus洗脱支架植入术组和Cypher支架植入术组,其中Cypher支架组65例,Zotarolimus洗脱支架64例。植入Cypher支架83枚,植入Zotarolimus支架80枚。结果 两组患者平均靶病变长度和置入支架长度Cypher支架组对比Zotarolimus洗脱支架组分别为：(18.72+5.96)mm比(19.42+6.21)mm,(24.67+7.81)mm比(25.56+6.98)mm,显著无差异性（P >0.05）。临床随访观察,再发心肌梗死及死亡,再发心绞痛、再次血运重建和主要心血管事件对比,均P>0.05,统计学无差异性。但Cypher支架组支架内亚急性及迟发性血栓形成率高于Zotarolimus洗脱支架组,为3.1%比0,P ＜0.05,结论 与Cypher支架相比,Zotarolimus洗脱支架在预防再狭窄,减少近期心血管事件方面疗效相似,但具有更低支架内亚急性血栓及迟发性发生率。     

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.     

Sirolimus-eluting stents for treatment of drug-eluting versus bare-metal stents restenosis: 42-month clinical outcomes from a Chinese single center

Background  Restenosis of bare-metal stents (BMS) and drug-eluting stents (DES) has been increasingly treated with sirolimus-eluting stents (SES), but the long-term outcomes are unknown.

Methods  In our study, 388 consecutive patients (144 DES restenosis and 244 BMS restenosis) with 400 lesions (147 DES restenosis and 253 BMS restenosis) treated with SES were included. The rates of target lesion revascularization (TLR) and major adverse cardiac events (MACE) at 42 months were analyzed.

Results  At the mean follow-up of 42 months, the rates of death (3.5% vs. 3.3%, P=1.000) and myocardial infarction (2.8% vs. 1.2%, P=0.431) in the DES group and BMS group were comparable. Compared with the BMS group, ischemia-driven TLR occurred with a higher frequency in the DES group (18.8% vs.10.7%, P=0.024). This translated into an increased rate of MACE in the DES group (22.2% vs. 14.0%, P=0.034). Stent thrombosis occurred with a similar frequency in both groups (2.8% vs. 1.6%, P=0.475). Multivariate analysis showed that DES restenosis (OR=1.907, 95% CI 1.108–3.285, P=0.020) and smoking (OR=2.069; 95% CI 1.188–3.605; P=0.010) were independent predictors of MACE.

Conclusions  Although SES implantation appears to be safe and effective, it was associated with higher TLR recurrence for DES than BMS restenosis.

     

Domestic coronary drug-eluting stents on a new horizon

Supported by growing evidence from randomized clinical trials and observational or registry studies,percutaneous coronary intervention (PCI) with implantation of drug-eluting stents (DES) has become the standard of care for coronary artery disease,because of reduced repeat intervention and improved clinical outcomes in comparison with bare metal stent.1-3Currently,majority of coronary artery disease patients with complicated lesion subsets or clinical conditions can be successfully treated with DES-based PCI with favorable results.4-6 In 2011,around 300000 PCI procedures have been performed in China,with the penetration rate of DES reaching beyond 90％ in most of the centers.     

Comparison of the safety and efficacy of biodegradable polymer drug-eluting stents versus durable polymer drug-eluting stents: a meta-analysis

Background

A meta-analysis was conducted to assess the safety and efficacy of biodegradable polymer drug-eluting stents (BP-DESs).

Methods

PubMed, Science Direct, China National Knowledge Infrastructure, and Chongqing VIP databases were searched for randomized controlled trials comparing the safety and efficacy of BP-DESs versus durable polymer drug-eluting stents (DP-DESs). Efficacy included the prevalence of target lesion revascularization (TLR), target vessel revascularization (TVR), and late lumen loss (LLL), and safety of these stents at the end of follow-up for the selected research studies were compared.

Results

A total of 16 qualified original studies that addressed a total of 22,211 patients were included in this meta-analysis. In regard to efficacy, no statistically significant difference in TLR (odds ratio (OR) = 0.94, P = 0.30) or TVR (OR 1.01, P = 0.86) was observed between patients treated with BP-DESs and those with DP-DESs. However, there were significant differences in in-stent LLL (weighted mean difference [WMD] = −0.07, P = 0.005) and in-segment LLL (WMD = −0.03, P = 0.05) between patients treated with BP-DESs and with DP-DESs. In terms of safety, there was no significant difference in overall mortality (OR 0.97, P = 0.67), cardiac death (OR 0.99, P = 0.90), early stent thrombosis (ST) and late ST (OR 0.94, P = 0.76; OR 0.96, P = 0.73), or myocardial infarction (MI) (OR 0.99, P = 0.88) between patients treated with BP-DESs and with DP-DESs. However, there was a statistically significant difference in very late ST (OR 0.69, P = 0.007) between these two groups. In addition, the general trend of the rates of TVR and TLR of BP-DESs groups was lower than DP-DESs groups after a 1-year follow-up.

Conclusion

BP-DESs are safe, efficient, and exhibit superior performance to DP-DESs with respect to reducing the occurrence of very late ST and LLL. The general trend of the rates of TVR and TLR of BP-DESs groups was lower than DP-DESs groups after a 1-year follow-up.     

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.     

药物洗脱支架的社会经济学分析

目的：对于目前国内药物洗脱支架（DES）在临床普遍使用的现象进行社会经济学分析,为我国DES和金属裸支架（BMS）的科学合理使用提供依据.方法：运用成本效果分析方法分析比较了唐都医院心内科冠心病患者在经皮冠状动脉介入治疗（PCI）中植入DES相对于BMS的相关医疗成本开支的成本效果,以2006年国家统计局公布的我国居民人均年收入为标准,初步估测中国居民个人支付相关医疗费用的情况.结果：随着植入支架个数（1根或2根）和中国各地居民所享受的医保制度不同,植入DES较BMS增加的医疗费用相当于2006年中国城镇居民人均年可支配收入的0.80~1.32倍,2006年中国农民年纯收入的7.03~12.20倍.按照DES减少靶血管血运重建（TVR）率不同,植入1根或2根支架时,为避免一次TVR事件,中国城镇居民和农民需额外支付的医疗费用为人民币9720~59 500元和38 000~205 833元.结论：就中国医疗保障体系和国民的个人支付能力而言,BMS可能不应该过早地退出心血管介入领域.     

老年冠心病患者临床特征及PCI术后远期疗效观察

目的 评价老年冠心病患者临床特征及经皮冠状动脉介入术（percutaneous coronary intervention,PCI）后远期安全性及有效性。方法 随机选取2007年1月-2009年1月在解放军总医院心血管内科行冠状动脉支架置入患者632例,将患者分为老年组（≥65岁）和非老年组（〈65岁）,于2012年3月采用电话随访、门诊检查、冠脉造影等随访方式观察患者冠状动脉支架置入后远期不良心血管事件（major adverse cardiac events,MACE）发生情况。结果 老年组与非老年组在女性（24.5%vs 16.8%,P=0.02）、高血压（72.4%vs 59.5%,P=0.001）、吸烟（27.2%vs 53.6%,P=0.001）比例上的差异有统计学意义;PCI术前冠脉造影特征老年组三支病变比例高（44.4%vs 37.3%,P=0.08）;两组MACE发生率差异无统计学意义（12.8%vs 9.1%,P=0.15）,其他不良事件全因死亡率差异有统计学意义（5.5%vs 1.3%,P=0.004）;冠脉造影三支病变中,老年组与非老年组MACE发生率差异无统计学意义（14%vs 8.6%,P=0.23）。结论 老年冠心病患者应当积极控制血压,加强老年女性患者冠心病的筛查。老年冠心病患者冠状动脉支架置入术后远期是安全、有效的。     

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.     

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.

     

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。