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。     

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.     

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.     

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。     

Comparison of long-term clinical outcome after successful implantation of Firebird sirolimus- and Taxus paclitaxel-eluting stents in Chinese population: analysis of a large single center registry

Background Recent studies have shown that drug eluting stent （DES） implantation improved clinical outcome concerning efficacy compared with bare-metal stent （BMS） implantation, and sirolimus-eluting stent （SES） seemed superior to paclitaxel-eluting stent （PES） in improving the outcomes. Firebird SES is the most widely used SES in China. Long-term comparison of safety and efficacy between Firebird SES and Taxus PES in Chinese popuation is still not available. The aim of this research was to compare the safety and efficacy at 24 months after the successful implantation of Firebird SES and TAXUS PES in Chinese population.Methods From April 2004 to October 2006, 3110 consecutive patients who underwent successful DES （Firebird SES 2274; Taxus PES 836） implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. By outpatient clinic visit and telephone interview, we obtained 24-month clinical outcome including death, myocardial infarction （Ml）, thrombosis, target lesion revascularization （TLR）, target vessel revascularization （TVR）, and major adverse cardiac events （MACE, the composite of death, Ml, and TVR）. We used Cox＇s proportional-hazards models to assess relative risks of all the outcome measures before and after propensity match. Results Unadjusted clinical outcomes indicated that the patients treated with Firebird SES were associated with lower risk of TLR （HR0.38, 95%CI 0.26-0.54）, TVR （HR 0.51,95%CI 0.38-0.68） and MACE （HR 0.53, 95%CI 0.41-0.68）. The results after propensity match were consistent with that before matching, lower risk of TLR （HR 0.33, 95%CI 0.19-0.58）, TVR （HR 0.41, 95%CI 0.26-0.64）, MACE （HR 0.48, 95%CI 0.33-0.68） in Firebird group.Conclusion Compared with Taxus PES, the use of domestic Firebird SES may decrease the risk of TLR, TVR and MACE in daily practice.     

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.     

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.     

ST段抬高心肌梗死患者应用药物洗脱支架直接介入治疗的随访观察

目的 评估应用药物洗脱支架(DES)直接经皮冠状动脉介入(PCI)治疗ST段抬高心肌梗死(STEMI)的长期有效性和安全性.方法 入选2004年9月至2008年11月于北京安贞医院28病区行直接PCI的STEMI患者464例,比较不同DES[Cypher支架(西罗莫司洗脱支架)、Endeavor支架(磷酸胆碱涂层支架)、火鸟支架(西罗莫司洗脱支架)和吉威支架(西罗莫司洗脱支架)]间不良事件的差异.结果 各DES组间主要不良心脏事件(MACE,包括心性猝死、支架血栓、靶病变再次血运重建、靶血管再次血运重建、再次心肌梗死和外科冠状动脉搭桥术)、全因死亡、严重出血、抗血小板治疗和冠心病二级预防的差异均无统计学意义.累积MACE和支架血栓发生率分别为9.3%和1.1%,Cypher支架、Endeavor支架、火鸟支架和吉威支架MACE分别为9.4%、5.1%、5.9%、6.6%(P=0.483),血栓发生率分别为3.1%、0.0%、0.0%、0.0%(P=0.092).各DES组患者双重抗血小板治疗时间较长平均(16.2±6.7)个月,长期小剂量(100 mg)服用阿司匹林无严重出血.结论 不同DES应用于直接PCI具有同样的效果,在合理的抗血小板治疗策略和二级预防用药情况下长期安全、有效.     

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。     

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.

     

Firebird sirolimus eluting stent versus bare mental stent in patients with ST-segment elevation myocardial infarction

Background There are few evidences about the value of drug eluting stent in patients with ST-segment elevation myocardial infarction （STEMI）. We prospectively designed a randomized controlled trial to compare the safety and efficacy of Firebird sirolimus eluting stent （Firebird stent） and bare metal stent （BMS）. Methods Patients with STEMI enrolled during one year period were randomized to undergo implantation of Firebird stent or BMS, and clinical and angiographic follow-up. The primary endpoint of the present study was in-lesion late lumen loss （LLL） at 6 months, and secondary endpoint includes stent thrombosis and major adverse cardiac events （MACE） at 6 months. Results During one year period, 156 patients were randomized into the Firebird stent group （101 patients with an average age of 57.8 years） or the BMS group （55 patients with 59.7 years on average）. Six-month angiographic follow-up was available in 66.3% and 63.7% of patients assigned to Firebird stent and BMS, respectively. At 6-month follow-up, mortality, target vessel revascularization （TVR） and MACE were 2.0%, 6.9% and 9.9% in the Firebird stent group, while 3.6%, 30.9% and 36.4% in the BMS group （P〈0.05）. Subacute thrombosis occurred in 1 patient in both groups, respectively. The mean LLL was 0.18 mm in the Firebird stent group versus 0.72 mm in the BMS group. Conclusion Implantation of Firebird sirolimus eluting stent for STEMI may greatly reduce TVR and MACE at 6 months with low incidence of acute/subacute stent thrombosis compared with BMS.     

Long-term follow-up of crush versus no crush technique for coronary artery bifurcation lesions

Background Lesions at coronary bifurcations always are a big challenge for interventionists even with the advent of drug eluting stents （DES）. Even as more clinical trials are published, operators still can not confirm that one strategy is more efficient than another. Selection of patients and short term follow-up contribute to the difficulty in comparing strategies. Methods From April 2004 to April 2008, 505 consecutive Chinese patients underwent DES implantation for true bifurcation lesions; including 258 using crush strategy （213 male, （56.7＋10.8） years old） and 247 using no crush strategy （206 male, （58.1＋10.1） years old） were analyzed.
Results The follow-up period ranged from 237 to 1223 days, average （537＋340） days for the crush group and （538＋351） days for the no crush group. There was no significant difference of major adverse cardiac events （MACE） rate between the two groups （10.1% vs 12.1%; P=-0.481）, nor in cardiac death, nonfatal myocardial infarction （MI） or in the target vessel revascularization （TVR） （0.4% vs 1.6%; P=0.207, 2.7% vs 2.8; P=1.000 and 7.0% vs 7.7%; P=0.865）. The stent thrombosis rate was similar in the two groups （1.6% vs 2.0%; P=0.409）, late and very late stent thrombosis in both groups were very low （0.4% vs 0.4%; P=-1.000）. Seven-month angiographic follow-up showed no significant difference of the restenosis rate between the two groups （11.0% vs 13.5%; P=0.786）. During the follow-up, cardiac death, nonfatal MI, TVR and ST free survival rate showed no significant difference between the two groups. The only variant identified as a predictor of MACE was percutaneous coronary intervention （PCI） in the first two years, which accounted for 47% of patients of all cases in four years. Conclusion Crush technique showed similar long-term clinical effect compared with other two DES techniques for coronary bifurcation lesions, the surgeons＇ skills are very important for reducing clinical events.     

介入治疗冠状动脉左主干病变临床研究

目的研究经皮冠脉介入术（PCI）和冠脉旁路移植术（CABG）对冠状动脉左主干病变的疗效和安全性.方法回顾性收集2005年5月至2008年10月在昆明医学院附一院及云南省内部分医院心内科住院治疗的30例左冠状动脉主干病变行PCI治疗的患者为PCI组,另收集2007年3月至2008年10月在昆明医学院附一院心外科住院治疗的16例冠状动脉搭桥治疗左主干病变患者为CABG组.观察PCI组及CABG组患者的临床特征.并对上述两组患者进行随访,观察死亡、非致死性心肌梗死、靶血管血运重建术、脑血管事件等终点事件的发生情况及心绞痛复发情况.结果两组的临床特征基本相近.PCI组有5例（16.7%）左主干末端分叉病变达到Ⅲ级病变,而CABG组8例（50.0%）左主干末端分叉病变达到Ⅲ级病变,P=0.045,差异有统计学差异.PCI组中药物洗脱支架（DES）应用占绝对优势（97.0%）,左主干病变支架置入成功率为100%.两组在心绞痛复发率、再次心肌梗死、血运重建率、主要不良心脏事件（MACE）发生率、主要不良心脑事件（MACCE）发生率均无统计学意义.PCI组中急性冠脉综合症（ACS）与非ACS远期疗效比较在心绞痛复发率（29.4%VS0.0%,P〈0.05）及MACE发生率（41.2%VS7.6%,P〈0.05）差异有统计学意义.结论 （1）经选择无保护左主干病变PCI治疗的疗效与CABG治疗左主干病变比较PCI是可行和安全的,并取得较好的近远期疗效.（2）急性冠脉综合征可能是影响心绞痛复发率及MACE的因素之一.     

Efficacy of stenting for unprotected left main coronary artery disease in 297 patients

Background Angioplasty in the unprotected left main coronary artery （LMCA） has been controversial. This study aims to evaluate the safety and clinical effectiveness of stenting, including bare metal stent and drug eluting stent （DES）, for treatment of unprotected LMCA disease. Methods Between September 1997 and December 2005, a total of 297 consecutive patients underwent percutanous coronary intervention （PCI） on LMCA lesions in our hospital. Their in-hospital data and clinical follow-up outcomes were analyzed and those in pre-DES ＂＇era＂ （group I, from September 1997 to December 2002） were compared with those in DES ＂era＂ （group Ⅱ, from January 2003 to December 2004. Patients in 2005 for the time of follow-up less than one year were not included in this group）. Results Altogether 368 coronary stents were successfully deployed in 295 patients. Stents failed to be implanted after balloon predilation in two patients, who received coronary artery bypass graft （CABG） successfully. Bifurcation techniques for distal LMCA executed in 206 patients （69.4%, 2061297）, included crossover stenting in 156 （75.7%）, T stenting in 4 （1.9%）, provisional T stenting in 28 （13.6%）, kissing stenting in 5 （2.4%） and stent crushing in 13 （6.3%） patients. During their hospital stay, 5 （1.7%） patients died after PCI procedure, of which 4 died from cardiac origin and one of renal failure. The total in-hospital major adverse cardiac events （MACE） were 2.0% （6/297）. In the follow-up period, 19 patients （6.5%） died [15 （5.1%） of cardiac death and 4 of non-fatal myocardial infarction （MI）]. Besides, 2 （0.7%） developed subacute thrombosis （SAT） and 16 （5.4%） performed target lesion revascularization （TLR）. The total follow-up MACE was 14.5% （431297）. Further analysis also showed that, compared with patients in group I, those in group II apparently had more multi-vessel involvement （14.7% vs 81.9%, P〈0.001）, and more bifurcation lesions （32.4% vs 72.2%, P〈0.001）. After PCI, in-hospital MACE of group II was significantly lower than that in group I （1.1% vs 9.4%, P〈0.05）. And the incidences of MACE, TLR and angiographic restenosis in group II were all significantly lower than those in group I （all P〈0.05） after one year follow-up. Conclusions As new PCI strategies and intervention devices such as DES are developed, coronary stenting, which might have brought better in-hospital and long-term outcomes than CABG are proved to be technically successful and can be safely applied for the treatment of LMCA lesions in the experienced center for coronary intervention.     

Clinical outcomes of percutaneous coronary intervention for chronic total occlusion lesions in remote hospitals without on-site surgical support

Background The safety of percutaneous coronary intervention （PCI） for chronic total occlusion （CTO） lesions in remote hospitals without surgical facilities remains unknown. This study aimed to evaluate three-year outcomes after CTO for PCI in ten centers around China where no on-site coronary artery bypass grafting （CABG） support was available. Methods A total of 152 patients from 10 Chinese hospitals without on-site surgical facilities were prospectively studied. Intra-procedural and in-hospital events were assessed. Angiographic follow-up was indexed eight months after the initial procedure. Clinical follow-up was extended to three years. The primary outcome was the rate of major adverse cardiac events （MACE）, defined as cardiac death, myocardial infarction and target-vessel revascularization （TVR）. Results The incidence of CTO was 7.9% in patients who underwent PCI, Successful recanalization was achieved in 132 patients （86.8%）. Compared with patients in the PCI success group, patients with PCI procedural failure had longer lesion lengths （（42.32±22.08） mm vs （27.61±22.85） mm, P=0.023）, a higher rate of perforation （25.0% vs 0, P=0.014）, and a greater need for pericardial puncture. There were significant differences in MACE in-hospital and at one year and three years between the failure （10.0%, 30.0% and 35.0%） and the success （3.0%, 12.1% and 14.4%） groups （P=0.037, 0.034 and 0.040, respectively）. These led to a significant decrease in the MACE-free survival rate at one and three years in the failure group, compared with the success group （P=0.031 and 0.023, respectively）. Stump was the only predictor of recanalization success （HR 0.158, 95% Cl 0.041-0.612, P=0.008）, whereas procedural failure （OR 13.023, 95% CI 6.67-13.69, P=0.002）, incomplete revascularization （OR 9.71, 95% CI 2.93-5.59, P=0.005）, and total stent length （OR 6.02, 95% Cl 1.55-11.93, P=0.027） were three independent predictors of MACE. Conclusions PCI for CTO was unsafe in remote hospitals without CABG facilities. Paying attention to coronary perforation is important for successful procedures.     

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。     

Outcomes of Second Revascularization Procedures after Stent Implantation

Drug-eluting stents (DES) reduce subsequent revascularization procedures. Although randomized trials have compared DES to brachytherapy and balloon angioplasty (PTCA) for in-stent restenosis, few long-term comparisons have been made to bare metal stents (BMS) or bypass surgery (CABG), particularly following second procedures. We sought to assess the association between revascularization modality and long-term clinical outcomes of patients receiving a second procedure for coronary artery disease. Between January 2000 and July 2005, 4,666 consecutive patients underwent initial coronary stent implantation (DES or BMS). From this population we identified 569 patients undergoing a second target vessel revascularization (DES, BMS, PTCA or CABG). Outcomes were assessed at 6, 12, and 24 months after the second procedure, with follow-up through September 2006. Adjusted cumulative incidence rates were calculated using inverse probability weighted estimators. We found that at 24 months, there were no significant differences in death or myocardial infarction for PTCA, BMS, DES, and CABG (17.7%, 14.9%, 7.5%, and 10.2%, p = 0.26[3df]). DES patients had lower rates of death or myocardial infarction or third target vessel procedures than patients receiving PTCA (14.6% vs. 30.0%, p = 0.01) and BMS (14.6% vs. 42.2%, p < 0.01), but rates similar to CABG patients (14.6% vs. 14.6%, p = 0.99). For patients undergoing a second revascularization procedure, PTCA, BMS, DES, and CABG are associated with a similar risk of death or non-fatal myocardial infarction. DES and CABG are associated with lower rates of third revascularization procedures compared to PTCA and BMS. Further studies are needed to determine the optimum application for CABG vs. DES as a second or third revascularization procedure.     

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.     

西洛他唑联合氯吡格雷对冠状动脉药物涂层支架术后支架内再狭窄的影响

目的 探讨西洛他唑联合氯吡格雷抗血小板治疗对行冠状动脉(冠脉)药物涂层支架术患者支架内再狭窄(in-stent restenosis, ISR)的影响。方法 回顾性分析231例行冠脉药物涂层支架术且术后1年复查冠脉造影的冠心病患者的临床资料。根据不同的抗血小板治疗方案分为两组,其中214例术后1年内服用阿司匹林联合氯吡格雷(阿司匹林组),17例术后服用西洛他唑联合氯吡格雷(西洛他唑组),比较两组术后1年ISR的发生率及再次血运重建率。结果 两组患者的基线资料分析结果显示,西洛他唑组男性患者比例(88.2% vs 76.6%, P<0.001)及有消化道出血病史比例(35.3% vs 0.9%, P<0.001)明显高于阿司匹林组,其他临床资料差异无统计学意义(P>0.05)。支架术后1年,冠脉造影结果显示: 西洛他唑组与阿司匹林组ISR的发生率差异无统计学意义(29.4% vs 12.1%, P=0.06);西洛他唑组靶血管再次血运重建术与阿司匹林组无统计学差异(5.9% vs 6.1%, P=0.974);两组其他冠脉病变进展需行冠脉介入治疗(percutaneous coronary intervention, PCI)的患者比例亦无明显差异(17.6% vs 15.4%, P=0.734)。结论 对于行冠脉药物涂层支架术的患者,使用西洛他唑联合氯吡格雷抗血小板治疗与传统双联抗血小板治疗,预防ISR效果相当。对于消化道出血高风险或阿司匹林不耐受的人群,可考虑使用西洛他唑替代阿司匹林进行双联抗血小板治疗。     

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.