植入金属裸支架治疗急性冠脉综合征患者的长期疗效与安全性随访研究

目的　探讨植入金属裸支架（BMS）治疗急性冠脉综合征（ACS）患者的长期疗效和安全性。方法　选择2000—2005年北华大学附属医院住院植入BMS随访资料完整的ACS患者491例为研究对象,均行经皮冠状动脉介入治疗植入BMS。经住院冠状动脉造影随访、门诊随访或电话随访,记录主要终点事件。结果　平均随访（95±39）个月,随访期间累积171例发生主要心脏不良事件（MACE）,MACE发生率为34.83%,年均MACE发生率为4.38%。死亡68例（13.85%）,靶病变血管重建71例（14.46%）,靶血管重建28例（5.70%）,晚期支架内血栓（LST）和极晚期支架内血栓（VLST）0例,心力衰竭2例（0.41%）,冠状动脉旁路移植2例（0.41%）。发生支架内再狭窄106例（21.59%）,支架节段内再狭窄60例（12.22%）,支架内再狭窄合并支架节段内再狭窄127例（25.87%）。结论　植入BMS治疗ACS患者,远期MACE、LST、VLST发生率较低,安全性较好。     

药物洗脱支架内再狭窄的介入治疗

目的评价药物洗脱支架(DES)内再狭窄患者中根据再狭窄模式选择介入治疗的远期预后。方法选择2006年6月—2009年12月因DES内再狭窄于上海交通大学附属胸科医院行再次介入治疗的冠状动脉性心脏病患者,根据再狭窄部位及类型选择介入治疗方案。对于累及DES节段的再狭窄者行再次植入DES术;对于狭窄部位局限于DES内的Ⅰ型病变者行高压球囊扩张术;对于狭窄部位局限于DES内的Ⅱ～Ⅳ型病变者先行球囊扩张,再根据扩张后的结果由术者决定是否再次植入DES。所有患者均前瞻性随访主要心血管不良事件(MACE),包括死亡、靶病变重建(TLR)和心肌梗死(MI)。结果共88例行介入治疗,其中42例行单纯球囊血管成形(POBA)术(POBA组),46例行再次植入DES(DES组)。两组间各靶病变部位及各种原植入DES的涂层药物类型构成比的差异均无统计学意义(P值均>0.05),两组间再狭窄病变部位及类型构成比的差异均有统计学意义(P值均<0.05)。POBA组、DES组的支架内再狭窄(ISR)的发生率分别为(72.5±11.9)%、(76.2±9.1)%,两组间的差异无统计学意义(P>0.05)。平均随访时间为(2.2±1.0)年,两组间MACE、TLR、MI的发生率及病死率的差异均无统计学意义(P值均>0.05)。结论根据DES内再狭窄部位及类型选择介入治疗方案是有效的。对于局灶型ISR可行POBA术,而对于非局灶型或节段内ISR病变则需要再次植入DES。     

Percutaneous intervention for in-stent restenosis after drug-eluting stent implantation

目的 评价药物洗脱支架(DES)内再狭窄患者中根据再狭窄模式选择介入治疗的远期预后.方法 选择2006年6月-2009年12月因DES内再狭窄于上海交通大学附属胸科医院行再次介入治疗的冠状动脉性心脏病患者,根据再狭窄部位及类型选择介入治疗方案.对于累及DES节段的再狭窄者行再次植入DES术;对于狭窄部位局限于DES内的I型病变者行高压球囊扩张术;对于狭窄部位局限于DES内的Ⅱ～Ⅳ型病变者先行球囊扩张,再根据扩张后的结果由术者决定是否再次植入DES.所有患者均前瞻性随访主要心血管不良事件( MACE),包括死亡、靶病变重建(TLR)和心肌梗死(MI).结果 共88例行介入治疗,其中42例行单纯球囊血管成形(POBA)术(POBA组),46例行再次植入DES( DES组).两组间各靶病变部位及各种原植入DES的涂层药物类型构成比的差异均无统计学意义(P值均＞0.05),两组间再狭窄病变部位及类型构成比的差异均有统计学意义(P值均＜0.05).POBA组、DES组的支架内再狭窄(ISR)的发生率分别为(72.5±11.9)％、(76.2±9.1)％,两组间的差异无统计学意义(P＞0.05).平均随访时间为(2.2±1.0)年,两组间MACE、TLR、MI的发生率及病死率的差异均无统计学意义(P值均＞0.05).结论 根据DES内再狭窄部位及类型选择介入治疗方案是有效的.对于局灶型ISR可行POBA术,而对于非局灶型或节段内ISR病变则需要再次植入DES.     

国产药物洗脱支架对急性ST段抬高型心肌梗死预后的影响

目的 探讨国产药物支架（DES）对急性ST段抬高型心肌梗死（STEMI）预后的影响.方法 对2004-03～2009-04共216例确诊为STEMI的患者分为两组,药物支架（DES）组（n=117）和裸支架（BMS）组（n=99）,术后长期随访,观察术后12个月随访终点时支架内再狭窄发生率（ISR）及主要心血管不良事件（包括死亡、急性心肌梗死、靶血管再成形等）发生率.结果 216例患者经皮冠状动脉介入（PCI）治疗均成功.介入治疗3～12个月后随访结果 显示,DES组再狭窄率明显低于BMS组（P〈0.05）,两组心血管不良事件发生率差异无统计学意义（P〉0.05）.结论 DES在STEMI患者中有较好的安全性及临床疗效,再狭窄率明显低于BMS（P〈0.05）.     

停用氯吡格雷后的晚期不良事件会降低植入药物洗脱支架患者的获益程度

药物洗脱支架（drug-eluting stent，DES）与金属裸支架（bare-metal stent,BMS）相比具有更好的疗效,主要体现在DES通过抑制内膜的过度增生使血管再狭窄率和靶病变血运重建率（target vessel revascularization，TVR）显著降低。而死亡和非致死性心肌梗死（myocardial infarction，MI）的发生率与BMS基本相同。     

药物洗脱性支架和裸金属支架植入治疗冠状动脉狭窄的临床随访观察

目的探讨药物洗脱性支架(DES)和裸金属支架(BMS)治疗冠状动脉狭窄的远期疗效。方法对成功进行DES植入术患者2734例和BMS植入患者216例术后6个月、1年进行随访,观察其支架内再狭窄(ISR)发生率、急性心肌梗死发生率、冠状动脉旁路移植(CABG)或再次经皮冠状动脉介入治疗(PCI)治疗率、病死率,分析术后再狭窄的独立危险因素。结果术后6个月、1年时DES组ISR发生率均低于BMS组(9.58%vs 18.98%,18.32%vs 31.94%),差异有统计学意义(P<0.05);随访6个月时,急性心肌梗死发生率、CABG或再次PCI治疗率和病死率方面比较差异无统计学意义(P>0.05),但是随访1年后,其差异有统计学意义(P<0.05);多因素分析发现,支架直径≤3 mm、吸烟和年龄是支架植入术后发生再狭窄的独立危险因素。结论在冠状动脉狭窄的治疗中,DES的远期疗效优于BMS,但临床应用还需要进一步的循证医学研究证据。     

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.     

冠状动脉支架后血栓形成的原因及防治进展

支架血栓形成（Stent Thrombosis，ST）是冠心病介入治疗的严重并发症，可对人体造成灾难性的后果。与普通金属支架（BMS）比较，药物洗脱支架（DES）可明显减少再狭窄率和靶病变的血运重建率。植入支架后可发生早期、晚期、极晚期支架血栓形成，其发生机制并不完全相同。抗血小板、抗凝、调脂治疗可能降低ST的发生率。个体化手术及个体化药物治疗，在解决冠脉血运重建的同时，可减少再狭窄率和降低ST的发生率。ST高危病人在植入支架后应该规律随访，加强对患者的健康教育。     

西罗莫司洗脱支架治疗糖尿病冠脉狭窄病变的临床研究

目的评价西罗莫司洗脱支架治疗糖尿病患者冠状动脉狭窄病变的安全性和临床疗效。方法 73例糖尿病合并冠心病患者入选研究,观察西罗莫司洗脱支架或紫杉醇涂层支架植入后12个月的主要心血管不良事件(MACE)及再狭窄率。结果接受两种支架植入的患者基本临床特征相似,均完成了12个月随访。西罗莫司洗脱支架组MACE事件发生率和再狭窄率分别为9.52%和4.76%,紫杉醇涂层支架组相应为9.67%和6.45%,两组比较差异无统计学意义(P>0.05)。结论西罗莫司洗脱支架治疗糖尿病冠状动脉狭窄病变同紫杉醇涂层支架一样安全有效,在降低MACE和再狭窄方面疗效满意。     

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。     

A single center investigation of bare-metal or drug-eluting stent restenosis from 1633 consecutive Chinese Han ethnic patients

Background Stents are widely used in China but the clinical impression is somehow that restenosis is less common because of the lower prevalence of coronary artery disease (CAD) and associated risk factors in Chinese populations. However, no large-sample published studies are available on angiographic stent restenosis including those of bare-metal stent (BMS) or drug-eluting stent (DES) in Chinese Han ethnic population.Mothods A total of 1633 consecutive patients with CAD who had undergone coronary stenting, quantitative coronary angiography (QCA) were retrospectively studied. At the time of stent implantation and at 7 months post-stenting 675 patients had a follow-up angiography. Statistical analysis was made with the chi-square test for categorical variables, unpaired t test for continuous variables, univariate or multivariate regression for baseline and angiographic characteristics and the Kaplan-Meier method for rate of target lesion revascularization (TLR).Results Stent restenosis was defined as ≥50% diameter stenosis in the dilated segment. A total of 675 patients with 1074 lesions were subjected to angiographic follow-up for 7 months on average. Of these lesions, 448 were implanted with BMS whereas 626 lesions with DES. At 7 months, bare-metal in-stent restenosis occured in 148 lesions (33.0%), and bare metal in-segment restenosis in 155 lesions (34.6%) in contrast to drug-eluting in-stent restenosis in 48 lesions (7.7%) and drug-eluting in-segment restenosis in 73 lesions (11.7%) (P&lt;0.001 compared with BMS respectively). Late loss in both in-stent and in segment was higher in BMS than in DES groups [(1.00±0.69) vs (0.28±0.52); (0.78±0.71) vs (0.21±0.52), P&lt;0.001 respectively]. Angulated lesion, lesion length, pre-procedural minimal luminal diameter (MLD), and BMS were independent predictors for TLR, (P&lt;0.01 respectively), whereas current smoker, ostial lesion, and stent overlapping, post-procedure in-stent MLD, lesion length, and stent types were independent predictors for in-segment restenosis (P&lt;0.01 respectively). Standard coronary risk factors such as hypertension, hyperlipidemia, diabetes, and history of CAD were not associated with a higher rate of restenosis caused by BMS or DES implantation in our Chinese Han ethnic population.Conclusions Coronary stenting including BMS or DES implantation in Chinese Han ethnic patients is associated with a restenosis rate comparable to that demonstrated in previous studies from the western countries, and predictors of stent restenosis are somehow different from those in the western population.     

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     

Comparison of drug eluting stents with bare metal stents in daily practice for bifurcation lesions in Chinese patients

Background Recently, numerous randomized and controlled trials have demonstrated great advantages of drug eluting stents (DES) with respect to significant reduction of restenosis and recurrence of symptoms and improvement of clinical outcomes after percutaneous coronary intervention (PCI). Little is known about the comparative effects between DES and bare metal stents (BMS) for bifurcation angioplasty in the Chinese population. We compared the inpatient and 7-month follow-up outcomes between DES and BMS for the treatment of bifurcation lesions. Methods From April 2004 to October 2005, 291 Chinese patients [85.9% male, mean age (57.8±10.4) years] underwent DES (387 lesions) and/or BMS (297 lesions) implantation for bifurcation lesions. Clinical and angiographic follow-up was performed at 7 months. Results Compared with BMS group, patients in DES group had significantly lower rates of restenosis at main branch (9.5% vs 28.7%, P < 0.001) or side branch (14.5% vs 37.0%, P < 0.001) and major adverse cardiac events (MACE) (14.0% vs 26.3%, P = 0.000). The occurrence rate of late in-stent thrombosis did not differ between the two groups in both main (0.8% vs 0, P = 0.224) and side branches (1.4% vs 0, P = 0.198). Target lesion revascularization (TLR) was less frequent in DES group for main branch (8.3% vs 21.3%, P < 0.001) and for side branch (7.6% vs 23.5%, P < 0.001). Multivariate regression analysis revealed that total stent length (OR = 1.029, P = 0.01), postprocedural in-stent minimum lumen diameter (OR = 0.476, P = 0.03) and stent type (OR = 3.988, P = 0.0001) were independent predictors of TLR for main branch. Prior history of coronary intervention (OR = 2.424, P = 0.041), angulated lesion (OR = 2.337, P = 0.033), postdilation (OR = 0.267, P = 0.035) and stent type (DES vs BMS, OR = 5.459, P = 0.000) were independent predictors of TLR for side branch. Conclusion The implantation of DES may be associated with greater reduction of restenosis and TLR than BMS in bifurcations angioplasty.     

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.

     

药物洗脱支架内再狭窄再次置人支架的远期疗效和安全性

目的探讨对药物洗脱支架(DES)置入后发生再狭窄(ISR)患者再次实施DES置入术的远期疗效和安全性。方法选择植入DES的冠心病患者,经冠状动脉造影检查证实发生再狭窄(ISR≥50%),并且再次置入DES治疗ISR介入手术成功的患者。985例DES-ISR患者根据狭窄类型分为局限性狭窄组130例(13.2%),弥漫性狭窄组699例(71.0%),闭塞性狭窄组156例(15.8%)。随访观察3组患者的远期(6个月、12个月)疗效及安全性。结果经过6个月的随访,局限性狭窄组患者主要不良心血管事件(MACE)的发生率为3.85%(5/130);弥漫性狭窄组患者MACE的发生率为2.72%(19/699);闭塞狭窄组患者MACE的发生率为3.21%(5/156),3组6个月的随访结果差异无统计学意义(P>0.05)。经过12个月的随访,局限性狭窄组患者MACE的发生率为13.08%(17/130);弥漫性狭窄组患者MACE的发生率为9.16%(64/699);闭塞狭窄组患者MACE的发生率为9.62%(15/156),3组12个月的随访结果差异亦无统计学意义(P>0.05)。结论目前对于DES-ISR患者来说,不论ISR的类型,再次置入DES都是一种有效的方法。     

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.

     

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.     

Long-term outcome of patients of over 85 years old with acute coronary syndrome undergoing percutaneous coronary stenting: a comparison of bare metal stent and drug eluting stent

Background Patients aged over 85 years have been under-represented in percutaneous coronary intervention （PCI） trials despite an increase in referrals for PCI. The long-term safety and efficacy of percutaneous coronary stenting in patients aged over 85 years with acute coronary syndrome （ACS） remain unclear. Moreover it is unknown whether there are differences between bare metal stent （BMS） and drug eluting stent iDES） in this special population.
Methods A total of 80 patients with ACS aged over 85 years undergoing stenting （BMS group n=21 vs DES group n=59） were retrospectively studied. In-hospital, one year and overall clinical follow-up （12-36 months） of major adverse cardiac events （MACEs） including cardiac deaths, myocardial infarction, target lesion revascutarization （TLR） and target vessel revascularization （TVR） as well as stroke and other major bleeding were compared between the two groups.
Results In the entire cohort, the procedure success rate was 93.8% with TIMI-3 coronary flow post-PCI in 93.8% of the vessels and the procedure related complication was 17.5%. The incidence of in-hospital MACEs in BMS group was higher （14.3% vs 6.8%, P=0.30）. The 1-year incidence of MACEs in DES group was 7.0% while there was no MACE in the BMS group. Clinical follow-up for 12-36 months showed that the overall survival free from MACE was 82.9% and the incidence of MACE in the BMS group was lower （5.3% vs 21.1%, P=0.20）. Multivariate regression analysis showed that the creatinine level （OR：. 1.013; 95%CI： 1.006-1.020; P=0.004） and hypertension （OR; 3.201; 95%CI： 1.000-10.663; P=0.04） are two major factors affecting the long-term MACE.
Conclusions Percutaneous coronary stenting in patients aged over 85 years is safe and provides good short and tona-term efficacy. Patients with renal dvsfunction and hvoertension may have a relatively hiah incidence of MACE.