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。     

Can “Hybrid stent implantation” improve long-term safety without adversely affecting efficacy when treating multilesion coronary artery disease in the drug-eluting stent era?

Background  Though drug-eluting stent (DES) almost solved a problem of restenosis, safety issues related to stent thrombosis are still the major concern of DES. We hypothesized that hybrid stent implantation may decrease the use of DES, probably improving the long-term safety but not affecting efficacy adversely when treating multilesion coronary artery disease in the DES era.

Methods  From April 2004 to October 2006, 848 patients with multilesion disease underwent hybrid stent implantation. During the same period 5647 patients with multilesion coronary heart disease were treated by exclusive DES implantation in Fu Wai Hospital. According to propensity score matching, we chose 823 pairs of patients with multileison coronary artery disease for inclusion into our study. We obtained the 24-month clinical outcome including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR), and major adverse cardiac events (MACE, the composite of death, MI, and TVR). We used Cox’s proportional-hazard models to assess relative risks of all the outcome measures after propensity match.

Results  At 24 months, patients in the hybrid stent implantation group showed a significantly higher risk of TLR (8.39% vs. 3.28%, HR 2.38, 95% CI: 1.50–3.70), TVR (11.07% vs. 6.32%, HR 1.61, 95% CI: 1.15–2.27) and MACE (13.75% vs. 8.75%, HR 1.37, 95% CI: 1.02–1.85). No significant difference was apparent in terms of mortality (1.22% vs. 1.70%, HR 0.55, 95% CI: 0.24–1.25), MI (1.95% vs. 2.31%, HR 0.73, 95% CI: 0.37–1.42), or thrombosis (definite+probable) (0.73% vs. 1.58%, HR 0.40, 95% CI: 0.15–1.05).

Conclusions  In patients with multilesion coronary artery disease, the exclusive DES implantation was associated with significantly lower risks of TLR, TVR and MACE, and the hybrid stent implantation did not result in any significant improvements regarding safety issues. Prospective studies are needed to confirm our results.

     

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.

     

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.     

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.     

Comparison of long-term clinical outcome after successful implantation of FIREBIRD and CYPHER sirolimus-eluting stents in daily clinical practice: analysis of a large single-center registry

Background  Recent data have shown that sirolimus-eluting stents (SES) reduced not only the incidences of restenosis but also of target vessel revascularization (TVR). CYPHER and FIREBIRD stents are both widely used SES in China. However, comparative data concerning differences in long-term safety and efficacy regarding CYPHER and FIREBIRD stents in the Chinese population are still not available.

Methods  From April 2004 to October 2006, 3979 consecutive patients who underwent successful SES (FIREBIRD 2274; CYPHER 1705) implantation were prospectively enrolled into this study. All enrolled patients were divided into two groups based on stent type. Follow-up data, including death, myocardial infarction (MI), thrombosis, target lesion revascularization (TLR), TVR, and major adverse cardiac events (MACE, the composite of death, MI, and TVR) were obtained at 24 months. Cox’s proportional-hazards models were used to assess relative risks of all the outcome measures between the two groups before and after propensity match.

Results  Unadjusted clinical outcomes demonstrated higher TVR (hazard ratio (HR) 1.78, 95%CI 1.26–2.50) and MACE (HR 1.40, 95%CI 1.08–1.82) for patients treated with FIREBIRD SES. After propensity match, the results showed a non-significant trend towards superiority of the CYPHER stent in all the analyzed parameters, however, no significant differences were found for all events at 24 months between FIREBIRD and CYPHER groups, and all thrombosis rates by Academic Research Consortium (ARC) definition were comparable between the two groups.

Conclusions  In this large, real-world population, the use of domestic FIREBIRD SES in China was associated with nearly the same safety and efficacy versus the imported CYPHER SES. FIREBIRD SES can be taken as an alternative for CYPHER SES in daily practice.

     

Clinical outcomes and cost-utility after sirolimus-eluting versus bare metal stent implantation

Background Randomized studies have shown beneficial effects of drug-eluting stent （DES） in reducing the risk of repeated revascularization. Other studies have shown higher proportion of death, myocardial infarction （MI） and increased cost concerning DES. However the long term safety and effectiveness of DES have been questioned recently.Methods To compare long term clinical outcomes, health-related quality of life （HRQOL） and cost-utility after sirolimus-eluting stent （SES） and bare metal stent （BMS） implantation in angina patients in China, 1241 patients undergoing percutaneous coronary revascularization （PCl） with either SES （n=632） or BMS （n=609） were enrolled continuously in this prospective, nonrandomized, multi-center registry study.Results Totally 1570 stents were implanted for 1334 lesions. Follow-up was completed in 1205 （97.1%） patients at 12 months. Rates of MI, all causes of death were similar between the two groups. Significant differences were found at rate of cardiovascular re-hospitalization （136 （22.4%） in BMS group vs. 68 （10.8%） in SES group, P=0.001） and recurrent angina （149 （24.5%） vs. 71 （11.3%）, P=0.001）. Dramatic difference was observed when compared the baseline and 9-month HRQOL scores intra-group （P 〈0.001）. However no significant difference was found inter-group either in baseline or follow-up HRQOL. Compared with SES, the total cost in BMS was significantly lower on discharge （62 546.0 vs. 78 245.0 Yuan, P=0.001）. And follow-up expenditure was remarkably higher in the BMS group than that in the SES group （13 412.0 vs. 8 812.0 Yuan, P=0.0001）.Conclusions There were no significant differences on death, in-stent thrombosis, MI irrespective of stent type. SES was superior to BMS on improvement of life quality. SES was with higher cost-utility compared to BMS.     

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.     

冠状动脉植入金属裸支架适应证的研究

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

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

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

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.     

Comparison of paclitaxal vs. sirolimus eluting stents with bio-degradable polymer for the treatment of coronary bifurcation lesions: subgroup analysis from DKCRUSH-I and DKCRUSH-II studies

Background  The difference in clinical outcome between paclitaxal-eluting stents (PES) and sirolimus-eluting stents with bio-degradable polymer (SES-BDP) for bifurcation lesions remains unclear. The present study aimed to investigate the one-year clinical outcome after DK crush stenting using PES (Taxus^TM) vs. SES-BDP (Excel^TM) from our database.

Methods  A total of 275 patients (90 from the DKCRUSH-I and 185 from the DKCRUSH-II study) were studied. The primary endpoint was the occurrence of major adverse cardiac events (MACE) at 12 months; including cardiac death, myocardial infarction (MI), or target vessel revascularization (TVR). The rate of binary restenosis and stent thrombosis served as secondary endpoints.

Results  At follow-up, minimal luminal diameter (MLD) in the Taxus group was (2.11±0.66) mm, with resultant increased target lesion revascularization (TLR) 12.2% and TVR 14.4%, significantly different from the Excel group; (2.47±0.56) mm, P <0.001, 3.2%, P=0.006, 4.9%, P=0.019, respectively. As a result there was a significant difference in MACE between the Taxus (20.0%) and Excel (10.3%, P=0.038) groups. Overall stent thrombosis was monitored in 11 patients (4.0%), with five in the Excel group (2.7%) and six in the Taxus group (6.7%). All stent thrombosis in the Excel group was classified as early, and all were defined as late in the Taxus group.

Conclusion  The Excel stent had lower rate of stent thrombosis, TLR, TVR, and composite MACE at 12-month after an indexed stenting procedure, compared to the Taxus stent.

     

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.     

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.     

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.     

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.     

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.     

Meta-analysis of stent thrombosis after drug-eluting stent implantation: 4-year follow-up

Background Drug-eluting stents （DES） are the most common device used in percutaneous treatment of coronary artery disease. Recently, there has been an increased concern regarding their safety profile, in particular the late and very late stent thrombosis rate compared to bare metal stents （BMS）. The aim of the study was to compare the reported incidence of late and very late stent thrombosis of DES and BMS in patients from published clinical studies with an extended follow-up period to four years.Methods A search strategy was developed to identify publications reporting on late or very late thrombosis of BMS and DES available through MEDLINE and Cochrane Library databases. Two independent reviewers appraised eligible studies and extracted data. Odds ratios （OR） were calculated for each outcome and presented with 95% confidence intervals （CI）.Results Fourteen randomized controlled trials, which were at least single blinded, were identified. There was no difference in the incidence of late and very late stent thrombosis in patients treated with DES compared with patients treated with BMS （late OR 0.55, 95%Cl 0.23-1.31 and late/very late OR=1.08, 95%CI 0.61-1.91）.Conclusions The safety profile of DES was similar to BMS in terms of stent thrombosis. We found no evidence of increased risk of late and very late thrombosis for DES.     

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

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

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

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

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

     

Clinical outcome after management of unprotected left main in-stent restenosis after bare metal or drug-eluting stents

Background Implantation of either bare metal stent （BMS） or drug-eluting stent （DES） has been used in every day practice for patients with unprotected left main stenosis （UPLMS）. There are still a lack of data regading the subsequent results of UPLMS in-stent restenosis （ISR）. The present study aimed at determing the clinical outcome of UPLMS ISR patients after implantation of either BMS or DES.Methods Patients with UPLMS ISR after stenting were included. The primary endpoint was the cumulative major adverse cardiac events （MACE）, including cardiac death, myocardial infarction （Ml）, and target vessel revascularization （TVR）.Results UPLMS ISR rate was 14.8% （n=73, 15.7% after BMS, 14.5% for DES） after average of （3.89±2.01） years （range from 1 to 10.5 years） follow-up. Angiographic follow-up between 6-8 months was available in 85.3%. Of these,repeat percutaneous coronary intervention （PCI） was used in 62 （84.9%） patients, with medicine only in 9 （12.4%） and coronary artery bypass graft （CABG） in 2 （2.7%）. Most repeat PCI patients were with unstable angina （87.0%）, and had decreased left ventricular ejection fraction （（42.58±5.12）%）, fewer focal/ostial left circumflex branch （LCX） lesions, in relative to medicine only group. After （31.9±23.3） months, the MACE, Ml, TVR and cardiac death were 31.5%, 1.4%, 24.1% and 8.2%, respectively. Definite and possible stent thrombosis occurred in 1 （1.4%） patient.Conclusions Medical therapy for asymptomatic isolated ostial LCX was safe. Repeat PCI for UPLMS ISR was associated with acceptable early and short-term clinical outcome. Further study was needed to elucidate the role of CABG in treating UPLMS ISR.