药物洗脱支架与金属裸支架置入术后对糖尿病患者远期死亡、心肌梗死和支架血栓发生情况的影响

目的本研究通过比较糖尿病患者置入金属裸支架(bare metal stents,BMS)vs药物洗脱支架(drug eluting stents,DES)后发生死亡、心肌梗死(myocardial infarction,MI)、再次血运重建和支架血栓的情况,以评价糖尿病患者置入DES后的远期安全性和有效性。方法本研究于2003年7月～2005年12月连续入选了834例因冠心病合并糖尿病在首都医科大学附属北京安贞医院心内科行经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的患者,按置入支架类型将患者分为DES组(n=583)和BMS组(n=251)。主要终点事件为24个月时全因病死率;次要终点事件为24个月时非致死性MI、再次血运重建以及主要不良心血管事件(major adverse cardiac events,MACE)的发生率。结果本研究结果经多因素回归分析显示,DES组明显降低了24个月时死亡[3.2%vs 5.1%,危险比(hazard ratio,HR)0.34,95%可信区间(confidential interval,CI)0.12～0.94,P=0.038]和心性死亡的风险(2.2%vs 4.4%,HR=0.29,95%CI:0.13～0.87,P=0.027),非致死性MI和心性死亡与非致死性MI复合终点发生风险比较差异无统计学意义;明确和可能的支架血栓的发生风险比较差异也没有统计学意义(1.9%vs 2.0%,HR=0.96,95%CI:0.51～2.17,P=0.351)。DES明显降低了再次血运重建的风险(10.5%vs 20.7%,HR=0.24,95%CI:0.11～0.78,P<0.001)和靶血管再次血运重建的风险(8.9%vs 17.1%,HR=0.33,95%CI:0.16～0.87,P<0.001);与BMS组比较DES组的MACE的风险也明显降低,差异有统计学意义(15.8%vs 27.9%,HR=0.19,95%CI:0.09～0.85,P<0.001);其主要与DES组患者的死亡和靶血管再次血运重建的风险降低有关。结论与BMS相比,DES可显著降低糖尿病患者的24个月时死亡、再次血运重建和MACE的风险,而未增加非致死性MI和支架血栓的风险。置入DES后死亡风险的降低原因,主要与DES降低再狭窄后的死亡和MI风险,获得更高的完全血运重建率以及未增加支架血栓的风险相关。     

Two-year clinical outcomes following elective drug-eluting versus bare-metal stent implantation: results from a large single-center database

Background In response to the increasing concern with the safety of the drug-eluting stent （DES）, the present study aimed to evaluate the long-term safety and efficacy of DES used for a Chinese patient population. Methods All patients, who underwent an index elective percutaneous coronary intervention with an implantation of either DES or bare-metal stent （BMS） in a single institution from April 2004 to December 2006, were included in the analysis. A propensity-score matching technique was applied to adjust and to minimize the impact of confounding factors. Results Overall, there were 1465 patients （20.2%） who had undergone an implantation of only BMS, and 5769 patients （79.8%） of only DES. The propensity-score matching technique set up 1321 pairs of patients for analysis. There were no significant differences between the rates of stent thrombosis （definite and probable） of the two groups （1.06% vs 1.21%, P=0.8580）. Although rates of mortality and myocardial infarction （MI） during the 2-year follow-up period had not differed significantly, rates of death/MI （3.0% vs 4.5%, P=0.0263）, target-lesion revascularization （TLR, 3.2% vs 8.5, P=0.0001）, target-vessel revascularization （TVR, 5.8% vs 9.5%, P 〈0.0001） and any revascularization （10.0% vs 13.3%, P=0.0066） were significantly lower for the DES group than for the BMS group. Among the patients in whom devices were implanted for off-label indications, the propensity-score matched rates of stent thrombosis, mortality, MI, and death/MI were not significantly different, while rates of TLR, TVR and any revascularization were significantly lower for the DES group than for the BMS group. Conclusions During the 2 years of follow-up post stenting, DES use is associated with lower rates of death/MI, TLR, TVR and any revascularization, compared with BMS, in propensity-score matched Chinese patient populations. In the setting of off-label usage, DES use is also associated with similar advantages.     

Two-year clinical outcome after successful implantation of drug-eluting and bare metal stents in diabetic patients: results from a real-world single center registry

Background Drug-eluting stents （DES） have revolutionized the field of interventional cardiology by dramatically improving clinical and angiographic outcomes. Patients with diabetes mellitus （DM） are associated with an increased risk of adverse clinical outcomes after a percutaneous coronary intervention （PCI）. Available information on the efficacy and safety of DES and bare metal stent （BMS） in diabetic patients remains scarce.
Methods From April 2004 to October 2006, 1565 patients with diabetes, who successfully underwent elective stenting at Fu Wai Hospital in Beijing, China, were enrolled in this study. All enrolled patients were assigned to a drug eluting stent group and a bare metal stent group. We obtained follow-up data： death, myocardial infarction （MI）, thrombus, target lesion revascularization （TLR）, and target vessel revascularization （TVR） at 30 days and 12 and 24 months, as defined by the Academic Research Consortium （ARC）. We calculated and compared all the unadjusted cumulative frequencies of the various adverse events in the two groups. Cox＇s proportional-hazards models adjusted with the propensity score were used to assess the relative risks of all the outcome measures at 24 months.
Results At 24 months, all ARC defined stent thrombosis in the two groups were similar; at 30 days, a more definite thrombosis was found in the BES group （0.08% vs 0.81%, P=0.016）. Patients treated with DES showed a significant lower risk of TLR （3.88% vs 10.89%; hazard ratio （HR） 0.159 （95% CI： 0.151-0.444）, P 〈0.001）, TVR （5.48%vs 11.69%; HR 0.383 （95% CI： 0.232-0.633）, P 〈0.001）, and any revascularization （12.47% vs 18.55%; HR 0.555 （95% CI： 0.370-0.831）, P=0.0004） at 24 months. No significant difference was apparent in terms of all-cause mortality, MI, and all-cause mortality/MI.
Conclusions In contemporary society＇s large, diabetic population, the use of DES is associated with long-term significant reductions in the risks of TLR, TVR, and any revascularization. There is no significant difference in all-cause mortality, MI, and thrombosis between DES and BMS in the patients with diabetes at 24-month follow-up.     

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.

     

Long-term effects of drug-eluting stents versus bare metal stents on patients with acute ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: outcomes of 3-year clinical follow-up

Background  The long-term safety and efficacy of drug-eluting stents (DES) versus bare metal stents (BMS) are unclear and controversial issues in patients with acute ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). The purpose of this study was to compare the long-term outcome of STEMI patients undergoing primary PCI with DES versus BMS implantation.  

Methods  A total of 191 patients with acute STEMI undergoing PCI from Jan. 2005 to Dec. 2007 were enrolled. Patients received DES (n=83) or BMS (n=108) implantation in the infarction related artery according to physician’s discretion. The primary outcome was the occurrence of major adverse cardiac events (MACE), which was defined as a composite of death, myocardial infarction (MI), target vessel revascularization (TVR) and stent thrombosis. The difference of MACE was observed between DES and BMS groups.

Results  The clinical follow-up duration was 3 years ((41.7±16.1) months). MACE occurred in 20 patients during three years follow-up. Logistic regression analysis showed that the left ventricular ejection fraction (LVEF) was an independent predictor for MACE in the follow-up period (P=0.0301). There was no significant difference in all-cause mortality (3.61% vs. 7.41%, P=0.2647), the incidence of myocardial infarction (0 vs. 0.93%, P=0.379) and stent thrombosis (1.20% vs. 1.85%, P=0.727) between the DES group and BMS group. The incidence of MACE was significantly lower in the DES group compared to the BMS group (4.82% vs. 14.81%, P=0.0253). The rate of TVR was also lower in the DES group (0 vs. 5.56%, P=0.029). In the DES group, there was no significant difference in the incidence of MACE between sirolimus eluting stents (SES, n=73) and paclitaxel-eluting stents (PES, n=10) subgroups (2.74% vs. 20.00%, P >0.05).

Conclusions  This finding suggested that drug-eluting stents significantly reduced the need for revascularization in patients with acute STEMI, without increasing the incidence of death or myocardial infarction. Use of DES significantly decreased the incidence of MACE compared with BMS during the 3-year follow-up.     

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.     

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.     

Clinical outcomes of serolimus-eluting stents versus bare metal stents in ST-segment elevation myocardial infarction patients: a meta-analysis

Background The benefits and safety of sirolimus-eluting stent （SES） have not been systematically quantified in different trials in ST-segment elevation myocardial infarction （STEMI） patients with primary or rescue percutaneous coronary intervention （PCI）. A meta-analysis of randomised trials comparing SES and bare-metal stent （BMS） was performed. Methods A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events （MACEs）. The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.
Results Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group （9.7% vs 20.3%, OR 2.45, 95% Cl 1.88-3.19, P 〈 0.00001）. No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group （5.1% vs 14.8%, OR 3.30, 95%CI 2.37-4.60, P 〈 0.00001）. No significant difference was found between the pooled rates of stent thrombosis （1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95%CI 0.79-3.26, P = 0.19）.
Conclusions SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.     

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.

     

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.     

Long-term outcomes of drug-eluting versus bare-metal stent implantation in patients with chronic total coronary artery occlusions

Background There are limited data on the efficacy of drug-eluting stents （DES） for treatment of chronic total occlusions （CTO）. The aim of the study was to evaluate the long-term clinical outcomes of DES implantation for CTO compared with bare-metal stent （BMS） implantation.
Methods Between June 1995 and December 2006, a total of 1184 patients with successful recanalization of at least one de novo CTO lesion were consecutively registered, including 660 （55.7%） who underwent DES and 524 （44.3%） who underwent BMS implantation. All patients were followed up for up to 5 years for occurrence of major adverse cardiac events （MACE）. Long-term survival rates were estimated with the Kaplan-Meier method.
Results Baseline clinical and angiographic characteristics were comparable between the two groups except that patients in the DES group received longer dual antiplatelet therapy （（7.4±2.5） months vs （1.7±0.8） months, P 〈0.001）. Average follow-up periods were （4.7±0.89） and （3.2±1.3） years for the BMS and DES groups, respectively. There was no significant difference in 5-year survival rates between the two groups （90.3% for DES group vs 89.6% for BMS group, Log-rank P=0.38）, but the 5-year target vessel revascularization （TVR）-free survival rate in the DES group was significantly higher than that in the BMS group （81.6% vs 73.5%, Log-rank P 〈0.001）. The cumulative MACE-free survival in the DES group was also significantly higher than that in the BMS group （80.6% vs 71.5%, Log-rank P〈0.001）. The rates of readmission caused by cardiovascular disease （27.0% vs 37.8%, P 〈0.001） and the need for bypass surgery were significantly lower in the DES group （1.5% vs 3.4%, P 〈0.05）. By multivariable analysis, DES implantation could significantly lower the long-term MACE risk of PCI for CTO patients （HR： 0.492; 95% Cl 0.396-0.656, P 〈0.001）. Left ventricular ejection fraction 〈50% and elderly （〉65 years） were identified as independent predictors of long-term MACE during follow-up.
Conclusion This study demonstrates the long-term （up to 5 years） efficacy of DES for treatment of CTO, which is superior to BMS implantation in reducing the rates of TVR and MACE, as well as the need of re-admission and bypass surgery.     

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.

     

西罗莫司洗脱支架对心绞痛患者血浆MCP-1的浓度及其受体CCR2表达的影响

目的比较成功植入冠状动脉支架后的再狭窄患者金属裸支架（BMs）与西罗莫司洗脱支架（SES）对单核细胞趋化蛋白-1（MCP-1）和趋化因子受体（CCR2）表达水平的影响。方法32例受试者随机分成BMS组与SES组,每组各16例,BMS组稳定型心绞痛患者成功植入冠状动脉BMS,SES组植入冠状动脉SES。结果BMS支架置人第14天和6个月后血浆MCP-1浓度显著上升,BMS支架置入后24h和48h单核细胞CCR2表达增加,SES组没有变化。支架置入后6个月内血浆中MCP-1（AMCP1）的变化与支架内管腔丢失明显相关。结论降低血浆MCP-1水平是降低管腔丢失的最好方法。通过植入SES减少MCP-1的生成,可能防止冠状动脉支架置入后再狭窄的发生。     

Long-term efficacy and safety of drug-eluting stent implantation for patients with multiple coronary chronic total occlusions

Background Data on the efficacy and safety of drug-eluting stent （DES） for treatment of multiple coronary chronic total occlusion （CTO） lesions are scanty. The aim of the present study was to compare the long-term outcomes of DES versus bare metal stent （BMS） implantation for multiple coronary CTO lesions.Methods We analyzed 188 patients who underwent coronary stenting for at least two de novo CTO lesions in our center from November 2000 to November 2006. Among them, 118 patients （62.8%） received DES and 70 patients （37.2%） received BMS implantation after the recanalization for CTO lesions. All patients were followed up for up to 5 years for the occurrence of major adverse cardiac events （MACE）. Long-term survival rates were estimated with the Kaplan-Meier method.Results There were no significant differences in baseline clinical characteristics and procedural success rate between DES group and BMS group. Compared with the BMS group, the DES group showed a significantly higher rate of long CTO （≥15 mm） （62.0% vs. 50.6%, P=0.023）. The number of stents per lesion （1.39±0.71 vs. 1.17±0.66, P=0.007） and the mean length of stents in the DES group were also higher than those in the BMS group （（40.8±11.4） mm vs. （23.4±8.7） mm, P〈0.001）. But the mean diameter of stents in the DES group was smaller than that in the BMS group （（3.1 ±0.2） mm vs. （3.3±0.5） mm, P〈0.001）. Average follow-up time was 4.8±0.7 （1.5-5.0） years in the BMS group and 4.3±0.5 （1.3-5.0） years in the DES group. Both the 5-year cumulative survival rates and the target vessel revascularization （TVR）-free survival rates of the DES group were significantly higher than those in the BMS group （83.1% vs. 72.9%, Log-rank P=0.044; 77.1% vs. 62.9%, Log-rank P=0.009）. The cumulative MACE-free survival rates in the DES group were significantly higher than those in the BMS group （71.2% vs. 51.4%, Log-rank P=0.001）. Multivariable Cox regression analysis demonstrated that DES implantation for multiple CTO lesions could significantly reduce the long-term MACE risk after percutaneous coronary intervention （PCI） （HR. 0.436; 95%C/ 0.327-0.665, P 〈0.001）. Age over 65 years （HR. 2.018; 95%CI1.491-3.127, P〈0.001） and left ventricular ejection fraction 〈50% （HR. 1.494; 95%CI1.125-2.376, P 〈0.001） were identified as the independent predictors of long-term MACE.Conclusion This study demonstrates the long-term （up to 5 years） efficacy and safety of DES for treatment of multiple coronary CTO lesions, and its superiority compared to BMS in reducing the rates of TVR and MACE.     

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     

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.     

Comparison of the Efficacy of Drug-eluting Stents Versus Bare-metal Stents for the Treatment of Left Main Coronary Artery Disease

Background:

Recent studies reported that percutaneous coronary intervention with stent implantation was safe and feasible for the treatment of left main coronary artery (LMCA) disease in select patients. However, it is unclear whether drug-eluting stents (DESs) have better outcomes in patients with LMCA disease compared with bare-metal stent (BMS) during long-term follow-up in Chinese populations.

Methods:

From a perspective multicenter registry, 1136 consecutive patients, who underwent BMS or DES implantation for unprotected LMCA stenosis, were divided into two groups: 1007 underwent DES implantation, and 129 underwent BMS implantation. The primary outcome was the rate of major adverse cardiac events (MACEs), including cardiovascular (CV) death, myocardial infarction (MI), and target lesion revascularization (TLR) at 5 years postimplantation.

Results:

Patients in the DES group were older and more likely to have hyperlipidemia and bifurcation lesions. They had smaller vessels and longer lesions than patients in the BMS group. In the adjusted cohort of patients, the DES group had significantly lower 5 years rates of MACE (19.4% vs. 31.8%, P = 0.022), CV death (7.0% vs. 14.7%, P = 0.045), and MI (5.4% vs. 12.4%, P = 0.049) than the BMS group. There were no significant differences in the rate of TLR (10.9% vs. 17.8%, P = 0.110) and stent thrombosis (4.7% vs. 3.9%, P = 0.758). The rates of MACE (80.6% vs. 68.2%, P = 0.023), CV death (93.0% vs. 85.3%, P = 0.045), TLR (84.5% vs. 72.1%, P = 0.014), and MI (89.9% vs. 80.6%, P = 0.029) free survival were significantly higher in the DES group than in the BMS group. When the propensity score was included as a covariate in the Cox model, the adjusted hazard ratios for the risk of CV death and MI were 0.41 (95% confidence interval [CI]: 0.21–0.63, P = 0.029) and 0.29 (95% CI: 0.08–0.92, P = 0.037), respectively.

Conclusions:

DES implantation was associated with more favorable clinical outcomes than BMS implantation for the treatment of LMCA disease even though there was no significant difference in the rate of TLR between the two groups.     

Comparison of drug eluting stent implantation with coronary artery bypass surgery in the treatment of patients with chronic total occlusion and multiple vessel disease

Background  In patients with chronic total occlusion (CTO) and multivessel coronary artery disease, the comparison of surgical and the percutaneous revascularization strategies has rarely been conducted. The aim of this study was to compare long term clinical outcomes of drug eluting stent (DES) implantation with coronary artery bypass surgery (CABG) in the patients with CTO and multivessel disease.

Methods  From a prospective registry of 6000 patients in our institution, we included patients with CTO and multivessel coronary artery disease who underwent either CABG (n=679) or DES (n=267) treatment. Their propensity risk score was used for adjusting baseline differences.

Results  At a median follow-up of three years, propensity score adjusted Cox regression analysis showed that the rate of major adverse cardiac cerebrovascular events (MACCE) was lower in CABG group (12.7% vs. 24.3%, hazard ratio (HR) 1.969, 95% CI 1.219–3.179, P=0.006) mainly due to lower rate of target vessel revascularization in CABG group than in DES group (3.1% vs. 17.2%, HR 16.14, 95% CI 5.739–45.391, P <0.001). The incidence of cardiac death or myocardial infarction (composite end point) was not significantly different between these two groups. On multivariate analysis, the significant predictors of MACCE were only the type of revascularization. Age, left ventricular ejection fraction (LVEF), and complete revascularization were identified as significant predictors of composite end points.

Conclusions  Our study shows that in patients with CTO and multivessel coronary disease, DES can offer comparable long term outcomes in cardiac death and myocardial infraction free survival in comparison with CABG. However, there is an increased rate of MACCE which results from more repeat revascularizations. Obtaining a complete revascularization is crucial for decreasing adverse cardiac events.

     

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。