可降解涂层与永久性涂层药物洗脱支架治疗冠心病合并糖尿病患者的有效性及安全性研究

目的 比较可降解涂层与永久性涂层药物洗脱支架治疗冠心病合并糖尿病患者的远期疗效及安全性.方法 回顾性分析2008年1月至2012年12月我院确诊为冠心病合并糖尿病并行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者364例,男性261例,女性103例,145例植入可降解涂层药物洗脱支架,219例植入永久性涂层药物洗脱支架;对比术后两组患者主要不良心血管事件(main adverse cardiac events,MACE)的发生情况.结果 两组患者在临床一般基线资料、冠脉病变特征等方面均无统计学差异(P＞0.05).可降解涂层组与永久性涂层组相比,两组在心源性死亡(1.4％ vs 1.9％)、非致死性心肌梗死(0.7％ vs 0.9％)、支架内血栓(2.1％ vs2.3％)、靶血管血运重建(2.8％ vs 2.8％)方面差异均无统计学意义(P＞0.05).结论 永久性涂层药物洗脱支架和可降解涂层药物洗脱支架治疗冠心病合并糖尿病患者均有效,且两者安全性无明显差异.     

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.     

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     

Coronary aneurysm and very late stent thrombosis formation associated with sirolimus-eluting stent implantation

Since drug-eluting stents （DES） can significantly reduce the risk of instant restenosis compared with bare-metal stents, they have been widely used in interventional therapy for coronary heart disease. With bare-metal stents being rapidly replaced by DES there is a great concern about the safety of DES due to stent thrombosis.Very late stent thrombosis （VLST） has been categorized as occurring beyond 1 year.3 Coronary aneurysm formation induced stent malapposition is a rare but potentially fatal cause of VLST. We report a case of coronary aneurysm with VLST formation 35 months after sirolimus-eluting stent （SES） 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.     

Morphologic characteristics of late stent malapposition after drug-eluting stents implantation by optical coherence tomography follow-up

Background Late stent malapposition was frequently observed after DES implantation, which has been associated with the occurrence of late stent thrombosis due to poor neointimal coverage. This study was designed to evaluate the frequency of late stent malapposition at least 1 year after different DESs implantation by optical coherence tomography （OCT）. Methods Angiographic and OCT examinations were given to 68 patients who had received total 126 various DESs implantation for at least 1 year to detect late stent malapposition. Malapposed strut distance （MSD）, malapposed strut area （MSA）, reference lumen area （RLA） and reference stent area （RSA） were checked with off-line OCT analysis. Results Totally 26 Cypher Select stents, 15 Taxus Liberte stents, 51 Partner stents and 34 Firebird I stents were examined. Among 68 patients who underwent DES implantation, 7 patients （10.3%） had late malapposition. Average RSA, MSA and MSD were （7.9=6？..8） mm2,（2.0＋1.6） mm2 and （590_＋_270） pm respectively. According to the MSA/RSA ratio 4 patients had slight malapposition, 2 patients had moderate malapposition and 1 patient had severe malapposition. Conclusions Late stent malapposition is detected frequently after implantation of DES, but if this predisposes to late stent thrombosis and requires any specific therapy needs to be further elucidated.     

Six-month clinical outcomes of Firebird 2TM sirolimus-eluting stent implantation in real-world patients with coronary artery diseases

Background  The Firebird 2^TM sirolimus-eluting stent (Firebird 2 stent) is a second-generation sirolimus-eluting stent which has a cobalt-chromium alloy stent platform, a brand new bracket structure, and two layers of styrene-butylenes-styrene polymer coatings with better biocompatibility. The Firebird 2^TM cObalt-Chromium alloy sirolimus-elUting Stent registry (FOCUS registry) aimed to evaluate the safety and efficacy of the Firebird 2 stent in patients with coronary artery disease in daily practice.

Methods  The FOCUS registry is a prospective, non-randomized, international multi-center, single-arm clinical registry. Between March 2009 and February 2010, 5084 patients receiving at least 1 Firebird 2 stent during daily clinical practice at 83 medical centers were enrolled.

Results  Of the 5084 patients enrolled in the registry, 5077 and 5058 were respectively available for 30 days and 6 months follow-up. The 30-day rate of major adverse cardiac events (MACE) was 1.20%, including 13 cardiac deaths, 46 non-fatal myocardial infarction (MI), and 6 target vessel revascularization (TVR). At 6 months follow-up, the rate of MACE was 1.80%. There were 32 cardiac deaths, 48 non-fatal MI, and 15 TVR. According to the Academic Research Consortium definition, definite/probable stent thrombosis (ST) occurred in 0.43% (22/5058) of patients, including 8 cases of acute ST, 11 subacute ST, and 3 late ST.

Conclusion  The Firebird 2 stent showed the promising efficacy and safety at 30 days and 6 months in a real-world population of patients with coronary artery diseases.

     

Gender difference on five-year outcomes of EXCEL biodegradable polymer-coated sirolimus-eluting stents implantation: results from the CREATE study

Background The gender difference on long-term outcome in unselected patients after percutaneous coronary intervention (PCI) has not yet been fully investigated.This study aimed to evaluate the gender d...     

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.     

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 ...     

雷帕霉素洗脱支架治疗冠心病的近期疗效研究

目的评价冠心病患者接受雷帕霉素洗脱支架(SES)的近斯安全性及有效性。方法对160例接受雷帕霉素洗脱支架植入术患者实施即刻疗效和临床随访。结果160例中共处理病变210处,植入支架216枚。其中B2型以上复杂病变145处(69.0%),小管径支架(2.5mm~2.75mm)44例(27.5%),长支架58例(36.3%),术中无严重并发症发生,手术成功率100%。130例(81.3%)随访1~17个月,6例患者类似胸痛发作,其中3例复查了冠状动脉造影,无支架及节段内再狭窄,未发生心肌梗死及死亡。结论雷帕霉素洗脱支架治疗冠心病患者近期疗效安全有效。     

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.     

涂层可降解与不可降解药物洗脱支架在冠状动脉疾病治疗中的对比研究

目的：比较涂层可降解药物洗脱支架（Excel）与涂层不可降解药物洗脱支架（Partner）在冠状动脉疾病治疗中的近期疗效及安全性。方法：将1315例接受药物洗脱支架治疗的冠心病患者纳入此回顾性对照研究,其中Excel组498例,Partner组817例．观察术后1年内两组患者主要不良心脏事件（MACE）及支架内血栓事件发生情况。结果：两组患者在基线资料、冠脉病变特征等方面均无统计学差异（P〉0．05）;两组患者平均置入支架直径[（2．97±0．39）mm vs（3．03±0．46）mm]及置入支架长度[（25．37±7．39）mm vs（24．57±7．11）mm]比较,差异均有统计学意义（P〈0．05）。尽管Excel组患者平均置入支架直径较小且支架长度偏长,但随访结果显示两组患者1年内主要不良心脏事件及支架内血栓事件发生情况差异均无统计学意义（2．41％vs2．69％,P〉0．05;0．60％vs0．86％,P〉0．05）。结论：涂层可降解与不可降解药物洗脱支架在冠状动脉疾病治疗中的近期疗效及安全性相似。     

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.     

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.     

非顺应球囊后扩张对置入药物洗脱支架预后的影响

目的评估使用非顺应性球囊后扩张对经置入药物洗脱支架冠状动脉粥样硬化性心脏病(以下简称冠心病)患者的疗效。方法回顾性分析2011年1月至2011年5月共356例行药物洗脱支架植入且使用非顺应性球囊后扩张的患者,采用倾向性评分抽取同期356例行药物洗脱支架植入术而未后扩张的患者与之1∶1匹配。结果 2组在年龄、性别、临床表现、主要危险因素及冠状动脉病变特征方面比较,差异无统计学意义(P>0.05),具有可比性。平均随访时间18个月,后扩张组主要不良心血管事件(major adverse cardiac events,MACE)明显低于未后扩张组(10.1%vs 15.7%,P=0.020),主要是靶血管重建(6.2%vs10.7%,P=0.010)、支架内血栓(1.1%vs 3.7%,P=0.030)发生率比较,差异有统计学意义(P<0.05),而心肌梗死(3.9%vs4.6%,P=0.700)、死亡(1.1%vs 1.7%,P=0.760)比较,差异没有统计学意义。结论冠心病患者置入药物洗脱支架后使用非顺应性球囊后扩张安全,可改善患者的临床预后。     

阿托伐他汀序贯疗法对冠状动脉支架置入术后患者预后的影响

目的 探讨阿托伐他汀序贯疗法对冠状动脉支架置入术后患者再狭窄和临床远期疗效的影响.方法 将确诊冠心病并行支架置入术治疗的125例患者分为观察组和对照组;观察组术前阿托伐他汀80 mg顿服,术后改40 mg/次,1次/d,30 d后再改为20 mg/次,1次/d;对照组维持20 mg/次,1次/d.观察治疗后6个月血脂、管腔造影情况、心血管事件发生率等指标的变化.结果 观察组LDL、HDL、最小管腔直径和狭窄百分比等指标与对照组相比有明显改善,差异有统计学意义(P＜0.05).观察组心血管事件的发生率明显少于对照组(P＜0.05).结论 阿托伐他汀序贯疗法能够有效地减少支架置入术后再狭窄,降低术后心血管事件的发生率,改善患者预后.     

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.

     

Nine-month angiographic and two-year clinical follow-up of polymer-free sirolimus-eluting stent versus durable-polymer sirolimus-eluting stent for coronary artery disease: the Nano randomized trial

Background First generation drug-eluting stents （DES） were associated with a high incidence of late stent thrombosis （ST）,mainly due to delayed healing and re-endothelization by the durable polymer coating.This study sought to assess the safety and efficacy of the Nano polymer-free sirolimus-eluting stent （SES） in the treatment of patients with de novo coronary artery lesions.Methods The Nano trial is the first randomized trial designed to compare the safety and efficacy of the Nano polymer-free SES and Partner durable-polymer SES （Lepu Medical Technology,Beijing,China） in the treatment of patients with de novo native coronary lesions.The primary endpoint was in-stent late lumen loss （LLL） at 9-month follow-up.The secondary endpoint was major adverse cardiac events （MACE）,a composite of cardiac death,myocardial infarction or target lesion revascularization.Results A total of 291 patients （Nano group：n=143,Partner group：n=148） were enrolled in this trial from 19 Chinese centers.The Nano polymer-free SES was non-inferior to the Partner durable-polymer DES at the primary endpoint of 9 months （P 〈0.001）.The 9-month in-segment LLL of the polymer-free Nano SES was comparable to the Partner SES （0.34±0.42） mm vs.（0.30±0.48） mm,P=0.21）.The incidence of MACE in the Nano group were 7.6% compared to the Partner group of 5.9% （P=0.75） at 2 years follow-up.The frequency of cardiac death and stent thrombosis was low for both Nano and Partner SES （0.8% vs.0.7%,0.8% vs.1.5%,both P=1.00）.Conclusions In this multicenter randomized Nano trial,the Nano polymer-free SES showed similar safety and efficacy compared with the Partner SES in the treatment of patients with de novo coronary artery lesions.Trials in patients with complex lesions and longer term follow-up are necessary to confirm the clinical performance of this novel Nano polymer-free SES.     

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.