冠状动脉植入金属裸支架适应证的研究

背景　目前国内植入金属裸支架（BMS）的比例不足5%,远低于美国和欧洲国家的30%~40%。其原因是对植入BMS适应证研究报道较少,BMS的认识还停留在初级阶段。BMS的适应证、效果和安全性受到质疑。目的　探讨急性冠脉综合征（ACS）患者植入BMS的适应证、长期效果和安全性。方法　选取2001—2010年在北华大学附属医院心脏中心住院植入BMS和药物洗脱支架（DES）随访资料完整的ACS患者1 203例为研究对象,其中BMS组491例和DES组712例。患者均住院行冠状动脉造影（CAG）或门诊行CT血管造影（CTA）随访,随访时间为12~175个月,平均随访（71.4±36.4）个月。比较两组不同病变类型（A、B1、B2、C型病变）患者随访终点事件及再狭窄发生率的差异。结果　BMS组与DES组患者心力衰竭、靶血管重建（TVR）、冠状动脉旁路移植术（CABG）发生率比较,差异均无统计学意义（P>0.05）;BMS组患者全因死亡、总主要不良心血管事件（MACE）、靶病变血管重建（TLR）发生率高于DES组,再发非致命性心肌梗死、支架内血栓形成（ST）发生率低于DES组（P<0.05）。两组A型病变患者全因死亡、总MACE、再发非致命性心肌梗死、心力衰竭、TLR、TVR、ST发生率比较,差异均无统计学意义（P>0.05）。BMS组B1型、B2型、C型病变患者全因死亡、总MACE、TLR发生率高于DES组（P<0.05）。两组A型、B1型病变患者支架内再狭窄、节段内再狭窄、支架内再狭窄和/或节段内再狭窄发生率比较,差异均无统计学意义（P>0.05）。两组B2型、C型病变患者节段内再狭窄发生率比较,差异均无统计学意义（P>0.05）;BMS组B2型、C型病变患者支架内再狭窄、支架内再狭窄和/或节段内再狭窄发生率高于DES组（P<0.05）。结论　A型病变ACS患者植入BMS长期全因死亡、总MACE、TLR发生率和再狭窄发生率与DES无差异,远期效果好,安全性高,故可把A型病变ACS作为植入BMS的适应证。     

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.     

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.

     

Efficacy and safety of Firebird sirolimus-eluting stent in treatment of complex coronary lesions in Chinese patients: one-year clinical and eight-month angiographic outcomes from the FIREMAN registry

Background  Off-label application of drug-eluting stents (DES) during percutaneous coronary intervention (PCI) was not uncommon in daily practice, however DES in treating Chinese patients with complex lesion subset was under-investigated. The primary objective of the FIREMAN registry was to evaluate the long term efficacy and safety of the Firebird sirolimus-eluting stent (SES) in treating patients with complex coronary lesions. Here we report the mid-term of one-year clinical outcomes and eight-month angiographic follow-up results of FIREMAN registry. 

Methods  The FIREMAN registry was a prospective multi-center registry, which included 1029 consecutive patients undergoing PCI with Firebird SES implantation between September 2006 and July 2007 in 45 centers in China. The clinical follow-up was designed to be performed at 1, 6, 12, 18, 24, 30 and 36 months post index procedure, and non-mandatory angiographic follow-up at 8 months was planned. One hundred percent site monitoring was conducted.

Results  Long lesions (59.2%), multi-vessel disease (50.4%), and small vessel disease (31.6%) were mostly found in angiography. Major adverse cardiac events (MACE) occurred in 51 (5.1%) patients at 1 year clinical follow-up, including cardiac mortality in 6 (0.6%), non-fatal myocardial infarction in 11 (1.1%), and target lesion revascularization in 36 (3.5%) of the patients. Definite and probable stent thrombosis (ST) by Academic Research Consortium (ARC) definition occurred in 12 (1.36%) patients at one-year clinical follow-up. The 8-month binary restenosis rate was 5.7% in-segment and 4.3% in-stent, respectively. Late lumen loss was (0.21±0.40) mm in-segment and (0.23±0.36) mm in-stent, respectively. Furthermore, Cox regression analysis revealed that diabetes, small vessel diameter, and chronic total occlusion were independent predictors of ST.

Conclusions  The results showed that the Firebird SES was effective and safe in treating Chinese patients with complex coronary lesions and occurrence of ST rate at one-year clinical follow-up was acceptable, however further long-term follow-up was still necessary. (NCT00552656)

     

紫杉醇药物涂层支架治疗左前降支病变临床研究

目的：探讨紫杉醇药物涂层支架（PES）治疗冠状动脉左前降支（LAD）病变的即刻疗效及预后。方法：2003年2月～2005年3月在本院造影证实连续LAD单支病变患者94例,共107处病变,按常规行经皮冠状动脉成形术加支架置入术,分析患者临床、X线影像学特征及手术成功率,并行随访。结果：94例患者中,29例置入PES,65例置入金属裸支架（BMS）,手术成功率100％。病变弥漫性30例（31．9％）,位于近段52例（55．3％）,中段12例（12．8％）。全部患者均完成术后6个月的随访并行造影复查。PES组术后6个月时造影复查2例（6,9％）发生再狭窄;BMS组1例1个月内因急性前壁心梗死亡,6个月时造影复查21例（32．3％）发生再狭窄。结论：PES置入治疗冠状动脉LAD病变安全有效,术后心源性猝死及非Q波性心肌梗死发生率与置入BMS者相似,支架内再狭窄发生率明显降低,因再狭窄需冠脉搭桥率也显著降低,术后6个月再狭窄率与文献报道冠脉搭桥术相近。     

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     

Efficacy and safety of FIREHAWK(r) abluminal groove filled biodegradable polymer sirolimus-eluting stents for the treatment of long coronary lesions: nine-month angiographic and one-year clinical results from TARGET I trial long cohort

Background Previous studies indicated that long coronary lesions are one of the key predictors of drug-eluting stent (DES) failure.The purpose of this study was to evaluate the efficacy and the safety ...     

Drug-eluting coronary stents--a note of caution

There are two types of coronary stents: bare-metal stents (BMS) that cost about $800 each, and drug-eluting stents (DES) that cost about $3,300 each. DES reduce the rate of restenosis but have a higher incidence of late stent thrombosis, particularly if dual antiplatelet therapy with aspirin and clopidogrel is interrupted. Stent thrombosis has a myocardial infarction rate of 70% and a mortality rate of 31%-45%. Randomised studies of BMS versus DES show no increase in myocardial infarction or death with DES in simple coronary lesions, but in clinical practice, DES are mainly used in complex coronary disease where the rate of stent thrombosis is higher. Registry data suggest an increased rate of death and myocardial infarction of 0.5%-1.0% per annum with DES. Clinicians need to be aware of the risks associated with prematurely ceasing dual antiplatelet therapy in patients with DES.     

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。     

Smoking control hindered by realities in China

Background Calcified coronary lesions carry the risk of suboptimal stent expansion, subsequently leading to restenosis. The effectiveness of sirolimus-eluting stents （SES） for the treatment of calcified lesion has not been fully investigated. In the present study, therefore, we evaluated the effectiveness of SES implantation for the treatment of calcified coronary lesions.Mothods A total of 333 consecutive patients with 453 lesions were enrolled in this study. They were divided into two groups according to whether the lesion treated with SES was calcified or not; no calcification group （n=-264） and calcification group （n=-189）. Lesions treated with SES were subjected to quantitative coronary angiography （QCA） immediately and 8 months following stenting. Results Baseline clinical, demographic or angiographic characteristics were well balanced in both groups. Angiographic follow-up at 8 months, the in-stent restenosis and in-segment restenosis rates were not significantly different between the two groups; instent restenosis： 3.8% vs 4.2%; P=0.081; in-segment restenosis： 8.7% vs 10.6%, P=0.503. The target lesion revascularization （TLR） was also not significantly different between the two groups; 4.9% vs 6.9%, P=0.378. In addition, the in-stent late loss was similar in both groups; （0.16±0.40） mm vs （0.17±0.33） mm, P〉0.05. Meantime, overall thrombosis rates were also similar in both groups; 1.6% vs 1.6%, P〉0.05. Conclusion Although calcified coronary lesion was hard to stent, successful percutaneous coronary intervention with SES stenting for calcified lesions was conferred by the similar favorable results that were seen when comparing non-calcified and calcified coronary lesions.     

Drug-eluting stent: where is the way out?

Since the first Palmaz-Schatz bare-metal stent (BMS)was implanted in human body in 1985,coronary stenting successfully resolved problem of the high restenosis rate in balloon dilatation era and soon became the primary means of clinical treatment of coronary artery disease.In order to meet the requirement of further reduction of the restenosis rate,drug-eluting stent (DES)was developed more than a decade later.With the excellent clinical efficacy,DESs established a milestone in the field of percutaneous coronary intervention (PCI).However,since the "stent thrombosis (ST) storm"triggered in 2006,the late ST after DES implantation quickly became a challenging problem.1.2 To solve this problem,a lot of advances have been achieved.Among them,biodegradable polymers and abluminal coating are two new technologies with bright future.     

Is adjunctive balloon postdilatation necessary with drug-eluting stents? One center experience in Chinese patients

Background With the advent of drug-eluting stents （DES） and much lower rates of target vessel revascularization （TVR）, whether adjunctive balloon postdilatation can further optimize outcome is still unknown. The present study was to compare the outcomes of postdilatation with un-postdilatation following deployment of DES. Methods From April 2004 to September 2006, 6479 consecutive Chinese patients who underwent DES implantation, including 1769 with postdilatation （1454 male, （57.9 ± 10.8） years old） and 4710 without postdilatation （3819 male, （57.9 ± 10.6） years old） were analyzed. Clinical and angiographic follow-up was performed at 7 months. Results Compared with the un-postdilatation group, the postdilatation group had more complex lesions and larger relevant vessel diameter （RVD）. In the postdilatation group, in-stent residual restenosis was significantly improved right after the procedure （（16.80±5.88）% vs （19.60±6.07）%; P=0.000）. There was no statistical difference in the major adverse cardiac events （MACE） rate between the groups （2.9% vs 3.3%; P=0.420）, and there were also no statistical differences in death, acute myocardial infarction （AMI） and target lesion revascularization （TLR） rates in the two groups （0.1% vs 0.4%, P=0.127; 1.7% vs 1.3%, P=0.229; and 1.5% vs 2.0%, P=0.206, respectively）. The in-stent thrombosis rate was almost the same in both groups （0.5% vs 0.5%; P=1.000）. Seven months angiographic follow-up results showed that both in-stent and in-segment restenosis rates were lower in the postdilatation group （8.8% vs 15.6%, P=0.000; and 10.5% vs 17.3%, P=0.000）, and so were instent and in-segment late loss （（0.32±0.12） mm vs （0.49±0.13） mm, P=0.000; and （0.24±0.08） mm vs （0.36±0.09） mm, P=0.001 ）. Conclusion Postdilatation after DES deployment was safe and could reduce the restenosis rate, especially for more complex lesions.     

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.

     

药物洗脱支架对首诊心内科患者转行冠状动脉搭桥治疗的影响

目的了解药物洗脱支架（DES）对首诊于心内科的冠心病患者转诊行冠状动脉搭桥术（CABG）的影响。方法入选2001年7月1日至2002年6月30日（BMS时代）以及2003年7月1日至2004年6月30日（DES时代）首诊于北京安贞医院心内科并接受经皮冠状动脉介入（PCI）或冠状动脉搭桥（CABG）的2598例患者,分析BMS时代与DES时代患者转行CABG术的临床及冠状动脉病变特征,评价DES对转诊CABG治疗的影响。结果DES时代1333例（80．1％）患者接受PCI治疗,331例（19．9％）患者转行CABG术,BMS时代721例（77．2％）患者接受PCI治疗,213例（22．8％）患者转行CABG术,转诊率下降约12．7％。与BMS时代相比,DES时代左主干病变（1．4％比3．2％,P=0．025）前降支近端（39．8％比44．2％,P=0．047）与弥漫长病变患者（11．2％比19．7％,P=0．021）接受PCI治疗的比例明显增加,但无论是否置入DES,左主干病变、慢性闭塞病变、前降支近段病变以及开口病变的患者仍是接受CABG治疗的最常见冠状动脉病变类型。DES时代接受PCI治疗的患者再次血管重建率明显低于BMS时代（12．7％比7．1％,P〈0．001）。多变量Logistic分析显示,病变血管支数、左主干病变、慢性闭塞病变以及前降支近端病变是选择CABG的主要预测因素。结论DES对冠心病患者血管重建方式及策略产生了一定的影响,在非DES时代需要转诊行CABG治疗的冠状动脉病变,在DES时代接受PCI治疗置入DES。     

冠脉内置入药物涂层支架与金属裸支架对血浆C反应蛋白水平影响的对比观察

目的:PCI术后的炎症过程的激活对血管内皮的增生与再狭窄起着重要作用,多项研究表明药物涂层支架(DES)可减少血管内再狭窄的发生,我们对冠脉内置入DES和金属裸支架(BMS)的冠心病患者的血浆CRP(C反应蛋白)水平进行比较,旨在探讨PCI术后再狭窄的发生机制。方法:置入了单个支架的冠心病稳定型心绞痛患者83例入选本研究(男54例,女29例,年龄55±14岁)DES组43例,BMS组40例,另选同期住院行冠脉造影检查显示冠状动脉不同程度的狭窄,而未行PCI的冠心病的患者35例做对照组(男24例,女11例,年龄60±12岁),分别于术前和术后48、72小时和2周后取静脉血2ml,测定血浆C反应蛋白水平,术前三组患者临床特征及冠脉造影显示的病变特征相似具有可比性,术前血浆CRP水平无显著差别。结果:术后48、72小时PCI患者较单纯进行冠脉造影的冠心病患者血浆C反应蛋白水平显著升高分别为(13.4±14.7比5.9±4.9mg/L,P<0.01);(16.7±19.8比5.4±3.9mg/L,P<0.01),亚组分析显示:DES组血浆C反应蛋白水平较BMS组显著升高,分别为(6.26±4.36比21.02±15.46mg/L,P<0.01);(4.83±3.50比15.03±9.79mg/L,P<0.01)。结论:冠脉内支架置入可显著升高血浆CRP水平,但DES与BMS相比,可明显降低血浆CRP水平,表明DES可明显抑制PCI术后诱发的急性炎症反应。     

A prospective multicenter parallel-controlled trial of TIVOLI biodegradable-polymer-based sirolimus-eluting stent compared to ENDEAVOR zotarolimus-eluting stent for the treatment of coronary artery disease: 8-month angiographic and 2-year clinical follow-up results

Background  Available drug-eluting stents (DES) have achieved great success in reducing restenosis rates. Recently, investigators have demonstrated that the durable polymer carrier plays a significant role in DES-related hypersensitive reaction and delays vessel healing. TIVOLI stent is a novel sirolimus-eluting coronary stent with biodegradable coating containing sirolimus and polylactic-co-glycolic acid (PLGA) polymer. The present study sought to evaluate the effectiveness and safety of the TIVOLI biodegradable-polymer-based sirolimus-eluting stent in treating patients with coronary artery disease. 

Methods  A prospective, multicenter clinical trial comparing TIVOLI biodegradable coated sirolimus-eluting stent with ENDEAVOR zotarolimus-eluting stent was conducted in 324 patients (TIVOLI group: 168 patients; ENDEAVOR group: 156 patients) at 12 centers in China to demonstrate the non-inferiority of in-stent late loss with TIVOLI stent compared to ENDEAVOR stent in subjects with a maximum of two de novo native coronary artery lesions (lesion length ≤40 mm, reference vessel diameter 2.25–4.00 mm). The primary end point was angiographic in-stent late loss at 8-month. The secondary end points were clinical outcomes at 2 years, including major adverse cardiac events (cardiac death, myocardial infarction, or target-lesion revascularization) and stent thrombosis.

Results  Angiographic late lumen loss at 8 months in the TIVOLI group was superior to the ENDEAVOR group (in-stent (0.25±0.33) mm vs. (0.57±0.55) mm, diff (95% CI) –0.23 (–0.32, –0.14), P <0.0001; in-segment (0.25±0.33) mm vs. (0.42±0.55) mm, diff (95% CI) –0.13 (–0.23, –0.02), P=0.0083). The rate of in-stent binary restenosis at 8 months was reduced from 8.6% in the ENDEAVOR group to 2.9% in the TIVOLI group (P=0.0229). Compared to ENDEAVOR stent, TIVOLI stent resulted in a significant reduction in target-lesion revascularization (4.2% vs. 9.6%, P=0.0495) at 2 years. The two-year major adverse cardiac events (MACE) rate was lower for the TIVOLI group, but not significantly different (6.6% vs. 10.9%, P=0.1630).

Conclusions  TIVOLI was superior to ENDEAVOR stent with respect to late lumen loss at 8 months, and it yielded both lower rates of angiographic binary restenosis at 8 months and target lesion revascularization (TLR) at 2 years. The MACE rate at 2 years was comparable in both groups.

     

冠心病介入治疗的进展

经皮冠状动脉介入治疗(PCI)是冠心病重要的治疗方法,迄今已走过30余年,目前已成为与药物治疗、外科冠状动脉旁路移植手术并驾齐驱的治疗手段。经皮冠状动脉腔内成形术、裸金属支架置入技术、药物洗脱支架置入技术成为冠心病介入治疗的三个里程碑。特别是近期药物洗脱支架的应用拓宽了PCI的适应证,看到了战胜支架内再狭窄的曙光。     

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.     

Firebird药物洗脱支架联合国产替罗非班治疗急性冠脉综合征的安全性及疗效

目的 评估Firebird药物洗脱支架(DES)加替罗非班与Cypher支架加替罗非班治疗急性冠脉综合征(ACS)病人的安全性和有效性.方法 2005年7月至2007年7月323例ACS病人,其中接受Firebird支架(Firebird组)161例,接受Cypher支架(Cypher组)162例.两组同时加用替罗非班.首先给予负荷量10μg·kg-1,3 min内静注完毕,之后以0.15 μg·kg-1·min-1的速度微量泵持续静点36 h.比较两组支架植入后即刻到近期的有效性和安全性,并于30 d内进行随访,比较有效性和主要不良心脏事件的发生率.结果 Firebird组与Cypher组比较,术前左室射血分数、靶病变的部位、血小板计数、血红蛋白、红细胞压积差异均无统计学意义.两组手术成功率均为100%,术后出血并发症、血小板计数、血红蛋白、红细胞压积差异均无统计学意义,两组各有2例发生支架内急性血栓(1.2% vs 1.2%,P＞0.05).均无亚急性血栓发生、非致死性心肌梗死各2例(1.3% vs 1.3%)、靶血管再次重建分别为1例(0.6%),2例(1.3%)、再住院分别为2例(1.3%)1例(0.6%)差异均无统计学意义(均P＞0.05).30 d随访均未见支架内再狭窄.结论 Firebird药物洗脱支架加用冠替罗非班治疗ACS均有较好的安全性和有效性,具有与Cypher支架相似的临床疗效.     

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.