国产药物洗脱支架在急性冠脉综合征介入治疗的应用

目的评价Excel在ACSPCI中的安全性和有效性。方法87例ACS患者,其中ST段抬高性心肌梗死39例,非ST段抬高性心肌梗死22例,不稳定型心绞痛26例,在行PCI过程中置入国产药物洗脱支架—Excel支架。结果所有患者均成功地完成了PCI,共置入Excel支架132枚,随访期间无严重心脏不良事件发生,17例患者术后6个月复查冠状动脉造影,仅1例直径狭窄50%。结论国产药物洗脱支架可安全、有效地应用于ACS患者。     

急性ST段抬高型心肌梗死直接PCI支架置入的必要性探讨

目的探讨急性ST段抬高型心肌梗死患者行直接PCI术时置入支架的时机.方法入选的90例急性ST段抬高型心肌梗死患者行直接PCI术时,有28例在球囊扩张后未置入支架,23例于两周后复查冠脉造影观察梗死相关动脉是否需要置入支架.结果本组病例约15.6%的患者不需要置入支架.结论急性ST段抬高型心肌梗死患者行直接PCI术时应采用必要性支架置入的治疗策略。     

不同药物洗脱支架植入对ST段抬高心肌梗死患者的疗效及预后研究

目的初步探讨ST段抬高心肌梗死患者在接受急诊PCI后,不同药物洗脱支架对患者的疗效,及血清标志物和ST段的恢复之间的关联。方法前瞻性连续入选ST段抬高型急性心肌梗死患者118人,分为雷帕霉素洗脱支架（66人）与紫杉醇洗脱支架组（52人）,统一测定心肌肌钙蛋白（cTnI）、肌酐激酶（CK-MB）、NT-pro-BNP水平、12导联心电图,并对所有入选患者进行12个月临床随访。结果应用两种支架植入100%获得手术成功,术后死亡、支架内血栓和靶病变血运重建等不良事件发生率差异无统计学意义,6-12个月造影随访雷帕霉素组、紫杉醇组再狭窄率分别为8.33%、10.52%。PCI前NT-pro-BNP水平较高的患者ST段不容易完全恢复。结论应用雷帕霉素药物洗脱支架和紫杉醇药物洗脱支架植入对ST段抬高心肌梗死患者的疗效并没有显著的差异。血浆NT-pro-BNP水平是一个能反映介入治疗后ST段恢复的新型独立预后指标。     

紫杉醇洗脱支架与裸金属支架在直接经皮冠状动脉介入治疗(PCI)中应用的比较

背景:已经证实,药物洗脱冠状动脉支架可降低再狭窄以及因此在经皮冠状动脉介入治疗(PCI)后需行额外手术的可能性。作者评价药物洗脱支架用于行PCI治疗ST段抬高型急性心肌梗死患者的疗效。     

两种国产雷帕霉素药物洗脱支架用于急诊经皮冠状动脉介入术治疗心肌梗死患者的效果比较

目的:比较两种国产雷帕霉素药物洗脱支架用于急诊经皮冠状动脉介入术(PCI)治疗心肌梗死患者的效果。方法:回顾性分析2017年1月至2019年1月该院收治的74例急性ST段抬高型心肌梗死患者的临床资料。所有患者行急诊PCI治疗,按照置入支架系统不同分为观察组和对照组,各37例。其中对照组Firebird2支架,观察组Nano无载体药物洗脱支架。比较两组手术前后的炎性因子水平以及术后1年的不良心血管事件发生率。结果:术后1 d,两组超敏C反应蛋白(hs-CRP)、白细胞介素-6(IL-6)水平比较,差异均无统计学意义(P>0.05);术后3个月,观察组hs-CRP、IL-6水平均明显低于对照组,差异有统计学意义(P<0.05);术后随访1年,观察组心血管不良事件发生率为2.70%,低于对照组的21.62%,差异有统计学意义(P<0.05)。结论:相比于Firebird2支架,置入Nano无载体药物洗脱支架可以有效抑制急性ST段抬高型心肌梗死患者PCI术后炎性因子的释放,减少心血管不良事件的发生风险,改善预后。     

国产雷帕霉素洗脱支架在多支病变中的疗效

目的分析国产雷帕霉素药物洗脱支架在多支血管病变介入治疗中的疗效。方法采用回顾性分析研究方法,在80例急性非ST段抬高急性冠脉综合征患者中置入国产雷帕霉素药物洗脱支架,随访住院及术后1年内主要心脏不良事件发生率。结果院内出现再发心绞痛4例。随访1年中,再发心肌梗死1例,脑梗死1例,再次冠状动脉内支架治疗9例。无死亡病例。结论国产雷帕霉素药物洗脱支架在多支血管病变介入治疗中疗效安全、有效,并发症少,再狭窄率低。     

非ST段抬高型心肌梗死急诊介入治疗的随访研究

目的：总结非ST段抬高性心肌梗死（NSTEMI）患者行急诊介入治疗（PCI）的临床疗效及随访结果.方法：2000年2月～2005年2月间,共收治142例NSTEMI患者,年龄36～82岁;其中6例行外科搭桥（CABG）治疗,136例行急诊PCI;发病到急诊PCI时间为1.5～11h.结果：136例行PCI者,131例成功,成功率96.3%.共治疗133处病变,置入支架177枚,4例患者仅行球囊扩张术.2例死亡,1例死于心源性休克,1例死于颅内出血.2例术后1周内支架内亚急性血栓形成.住院期间无其他严重心血管事件发生.129例患者门诊随访12个月,无不良心血管事件发生,86例PCI患者术后6～12个月行冠脉造影检查,再狭窄10例,8例金属裸支架者（16%）、2例药物洗脱支架者（5.6%）.结论：非ST段抬高型心肌梗死急诊介入治疗安全有效,能明显改善临床症状.药物洗脱支架可降低再狭窄发生率.     

雷帕霉素药物洗脱支架治疗急性ST段抬高性心肌梗死早期疗效观察

目的探讨雷帕霉素药物洗脱支架（Cypher^TM）在急性ST段抬高性心肌梗死（STEMI）经皮冠状动脉介入治疗（PCI）中的早期疗效。方法选择2004年1月至2005年6月的STEMI患者100例,随机分为两组：药物支架组50例和普通支架组50例,所有患者均于发病12 h内行急诊PCI治疗,一组置入Cypher^TM,另一组置入普通支架。比较两组支架置入情况及早期临床事件发生率。结果100例患者急诊PCI治疗均获得成功。药物支架组95支梗死相关血管（IRA）的99处病变置入98枚药物洗脱支架,普通支架组77支IRA的81处病变置入83枚普通支架。药物支架组1例介入治疗后第3天猝死。药物支架组和普通支架组相比较,手术成功率及PCI后造影结果和临床结果比较差异均无统计学意义。随后对99例病人进行了1-6个月随访,药物支架组有较低的再狭窄率和较少的心血管事件发生率（6.0%、16.0%和8.0%、14.0%,P〈0.01）。结论STEMI患者在PCI中应用Cypher^TM支架早期临床效果优于普通支架。     

急性心肌梗死急诊介入治疗的临床疗效安全性观察

目的:探讨急诊经皮冠状动脉介入治疗(急诊PCI)对ST段抬高型急性心肌梗死的近期临床疗效。方法:对276例ST段抬高型急性心肌梗死患者的罪犯血管行急诊PCI,共置入了289枚支架。观察术后TIMI血流、心电图抬高的ST段回落率和术后6个月内主要不良心血管事件(MACE)。结果:266例患者术后即刻恢复TIMI-3级血流,未发生与PCI相关的并发症,术后心电图24hST段回落率93.8%,术后6个月内发生猝死4例,其余患者未发生主要不良心血管事件。结论:急诊PCI治疗急性ST段抬高型心肌梗死安全,疗效显著。     

西罗莫司洗脱支架与裸金属支架在急性心肌梗死应用中的比较

背景:与裸金属支架相比,西罗莫司洗脱支架降低了再狭窄和再介入的发生率。关于应用这两种支架行直接经皮冠状动脉介入(PCI)治疗ST段抬高型急性心肌梗死的安全性和有效性的资料有限。方法:进行了一项单盲、多中心、前瞻性、随机化试验,以比较西罗莫司洗脱支架与裸金属支架用于对ST段抬高型急性心肌梗死患者行直接PCI的效果。     

Acute coronary syndrome is an independent risk factor for late incomplete stent apposition after sirolimus-eluting stent implantation

Background Late incomplete stent apposition （ISA） may occur after drug-eluting stent implantation, affecting long-term clinical outcomes. This study aimed to evaluate the impact of clinical presentations of coronary artery disease on late ISA after percutaneous coronary intervention （PCI） with sirolimus-eluting stents （SES） by means of three-dimensional volumetric intravascular ultrasound （IVUS） analyses. Methods One hundred and thirty-seven patients with coronary artery disease received SES implantation during PCI and had repeat angiography with IVUS examination. All patients were followed up one year after the procedure. Results In overall 219 treated lesions （137 patients）, late ISA was identified in 25 lesions （16 patients）. Clinical diagnosis of acute coronary syndrome （ACS） and use of long stents were more common in patients with than in those without late ISA. Patients with late ISA had greater external elastic membrane （EEM） area in stented segment （（15.34±5.44） vs （13.83±4.51） mm^2, P=0.026）, stented-to-reference segment EEM area ratio （1.13±0.22 vs 1.02±0.18, P 〈0.001）, and plaque and media area （（8.43±3.93） vs （7.01±2.93） mm^2, P =0.002） than in those without late ISA. Multivariate Logistic regression analysis showed that clinical diagnosis of ACS and use of long stents were independent risk factors for late ISA （OR 6.477, 95%CI 2.297-18.263, P 〈0.001; OR 3.680, 95%Cl 1.181-11.469, P =0.025; respectively）. During one-year follow-up after IVUS examination, the rate of very late stent thrombosis tended to be higher in patients with than in those without late ISA （18.7% vs 3.3%, P =0.051）. Conclusions The occurrence of late ISA after SES implantation may be related to clinical status, use of long stents, and marked positive vessel remodeling. Late ISA tended to increase the rate of very late stent thrombosis during follow-up, highlighting the importance of long-term dual antiplatelet therapy for these patients.     

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.     

氮氧化钛生物有效性支架与雷帕霉素药物洗脱支架临床应用比较

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.     

Long-term clinical outcomes after bioabsorbable polymer- and durable polymer-based sirolimus-eluting stents implantation: two-year follow-up results from a large single-center database

Background Several clinical trials have shown that sirolimus-eluting stents significantly reduce the risk of restenosis after percutaneous coronary intervention （PCI）. The FIREBIRD stent （coated with durable polymer） and the EXCEL stent （coated with bioabsorbable polymer） are two different types of sirolimus-eluting stents made in China; both have been approved for clinical use in China by the State Food and Drug Administration. The mid-term （6-month） angiographic and clinical results of both stents have been confirmed exciting perspective outcomes. However, it is unclear whether there are differences in the long-term safety and efficacy between the two types of stents in daily practice.
Methods All consecutive patients undergoing elective PCI with EXCEL or FIREBIRD stents between June 1,2006 and December 31, 2006 at Fu Wai Hospital in Beijing were included. Patients were classified from the index admission according to stent types （EXCEL or FIREBIRD） used. Clinical and procedural risk factors were collected prospectively. With propensity score matching without replacement, the frequency of major adverse cardiac events （MACE, a composite of death, myocardial infarction or target vessel revascularization） and stent thrombosis during a 2-year follow-up period were compared between the two groups.
Results A total of 474 patients were treated with EXCEL, and 640 were treated with FIREBIRD. Three hundred and ninety-seven EXCEL patients were matched to 397 FIREBIRD patients, 2-year risk-adjusted MACE rates were 6.1% in EXCEL group and 7.6% in FIREBIRD group （HR 0.84, 95%CI0.50-1.43）, whereas the respective rates for mortality, myocardial infarction and target-vessel revascularization were 2.3% vs 2.8% （HR 0.74, 95%CI0.30-0.85）, 1.8% vs 1.3% （HR 1.41,95%CI 0.45-4.43） and 2.5% vs 4.0% （HR 0.62, 95%CI0.28-0.37）, respectively. Cumulative incidence of stent thrombosis at 2 years was 1.8% in the EXCEL group vs 1.3% in the FIREBIRD group （P=0.5610）, whereas the rate of very late stent thrombosis was 0.5% vs 1.3% （P=0.2550）.
Conclusions Results from this long-term, relatively large size, single-center study showed that both of the EXCEL and the FIREBIRD sirolimus-eluting stent had similar and lower incidence of MACE after PCI in daily practice.     

可降解涂层雷帕霉素洗脱支架(Tivoli支架)治疗冠状动脉性心脏病的疗效

目的 评价国产可降解涂层雷帕霉素洗脱支架(Tivoli支架)用于冠状动脉性心脏病(CHD)患者介入治疗的安全性和近期疗效.方法 2010年9-11月于第二军医大学附属长海医院心血管内科单一植入Tivoli支架的CHD患者167例.术后接受双联抗血小板治疗9个月,观察主要心血管不良事件(MACE)的发生情况,并在术后12个月复查冠状动脉造影.结果 223处靶血管病变共使用Tivoli支架267枚,植入支架成 功率达100％.术后12个月冠状动脉造影随访结果显示,支架内再狭窄的发生率为1.9％(4/211),无1例发生MACE.结论 Tivoli支架治疗CHD是可行的,且具有良好的安全性和满意的近期临床效果.     

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.     

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.

     

雷帕霉素洗脱支架在冠心病合并2型糖尿病患者中的应用

目的 评估冠心病合并2型糖尿病患者冠状动脉内植入雷帕霉素洗脱支架的临床疗效。方法155例冠心病合并2型糖尿病患者接受冠状动脉内支架术，其中81例植入雷帕霉素洗脱支架（SES组），74例接受普通金属裸支架（BMS组），比较两组的临床一般情况、冠脉造影、支架植入术和远期综合心脏事件发生率。结果两组患者冠脉病变特点和支架植入术情况无统计学差异（P〉0．05），住院期间均无严重并发症发生。平均随访1年中，SES组远期心脏不良事件发生率显著低于BMS组（P〈0．001）。结论冠心病合并2型糖尿病患者植入雷帕霉素洗脱支架安全有效；与普通金属裸支架相比，雷帕霉素洗脱支架能显著降低心脏不良事件发生率。     

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。     

生物可降解涂层雷帕霉素洗脱支架在老年急诊冠状动脉介入术中的疗效观察

目的 评价生物可降解涂层雷帕霉素洗脱(Excel)支架在老年急性ST段抬高型心肌梗死(STEMI)急诊冠状动脉介入(PCI)治疗中的临床疗效.方法 回顾性分析90例年龄≥65岁STEMI靶病变血管行急诊PCI治疗患者,术后联合应用抗血小板药氯吡格雷和阿司匹林6个月,其后单用阿司匹林,观察术后12个月主要不良心脏事件及复查冠状动脉造影判定支架再狭窄(ISR)的发生率.结果 90例患者中有89例成功置入Excel支架.30 d内心源性死亡1例,脑出血死亡1例.对于存活的87例患者随访12个月,主要不良心脏事件发生率为11.2%(10/89),无再发心肌梗死、血栓事件发生.87例患者行冠状动脉造影复查,支架内病变再狭窄率为10.3%(9/87).结论 Excel支架在老年STEMI 急诊PCI 的应用中有较好的临床疗效,术后6个月的两联(氯吡格雷和阿司匹林)抗血小板治疗是安全的.