Long-term outcomes of drug-eluting stents versus bare-metal stents in large coronary arteries

Background

Long-term (> 3 years) outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in large coronary arteries were not conclusive. In addition, large coronary vessels were defined using a wide size range (≥ 3.0 mm) in previous studies. The aim of this study was to assess the long-term efficacy of DES versus BMS in subgroups of different vessel sizes.

Methods

A total of 1096 patients (1342 lesions) who underwent either DES or BMS implantation in large coronary vessels was followed for a mean duration of 4.5 years. Patients were divided into 4 subgroups by the reference vessel diameters (Q1: 3.0–3.25 mm, Q2: 3.26–3.50 mm, Q3: 3.51–3.75 mm, and Q4: 3.76–4.50 mm). The primary endpoint was major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target vessel revascularization, and stent thrombosis. The propensity score-adjusted Cox regression method was applied.

Results

In the 3 subgroups with smaller vessel sizes, the adjusted risk of MACE in DES recipients was reduced by 82% in Q1 (hazard ratio [HR]: 0.18, 95% confidence interval [CI]: 0.09–0.38), 49% in Q2 (HR: 0.51, 95% CI: 0.26–0.98), and 67% in Q3 (HR: 0.33, 95% CI: 0.15–0.73). However, in the largest vessel subgroup (> 3.75 mm), all clinical outcomes were not significantly different irrespective of the stent type used.

Conclusions

The incidence of MACE in 3.0–3.75 mm vessels was significantly reduced by the use of DES than by the use of BMS during a long-term follow-up. However, DES lost its benefit in > 3.75 mm vessels.     

药物支架和裸支架治疗急性ST段抬高心肌梗死患者的随访研究

Objective To evaluate the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) on clinical outcomes in patients with acute ST-segment elevation myocardial infarction (ASTEMI) receiving primary percutaneous coronary intervention (PPCI). Methods The 217patients with ASTEMI receiving PPCI from Jan. 2005 to Dec. 2007 were enrolled in this study. And they were divided into two groups: DES group (n=92) and BMS group (n=125). The baseline characteristics including age, gender, angiographic characteristics, stents characteristics, Killip classification, cardiac troponin I(CTnI)levels, left ventricular ejection fraction(LVEF), hemoglobin levels, hypertension, diabetes, hyperlipidemia, obesity and smoking of the two groups were collected.Clinical follow-up end point were major adverse cardiac event(MACE)including death, acute myocardial infarction, stent thrombosis and stent restenosis. Clinical follow-up duration was(16.8±11.3) months (6-38 months). Results The average age (years), rate of Killip classification (class 2, 3, 4), average diameter (mm) of stent were significantly higher in BMS group than in DES group(64.6±11.9 vs. 61.2±11.8, t=2.09, P=0.037;25.9% vs. 12.2%, χ2=5.53, P=0.019;3.07±0.38 vs. 2.91±0. 40, t=2.78, P=0.006). And the average LVEF (%) was significantly lower in BMS group than in DES group (55.4±11.9 vs. 60.3±12.8, t= -2.57, P=0.011). The average length (mm) of stent, rate of stent post dilatation and diabetes were significantly higher in DES group than inBMSgroup (32.8±16.2 vs. 26.2±11.2, t=-3.54, P=0.001;45.7% vs. 21.6%, χ2=13.85, P=0. 000;28.2% vs. 16.0%, χ2=4.77, P=0.030). MACE occurred in 36 patients during clinical follow-up, 6 in DES group and 30 in BMS group. Incidence of MACE was significantly lower in DES group than in BMS group(6.5% vs. 24.0%, χ2=11.70, P＜0.01). Conclusions Using DES in ASTEMI patients is safe and may improve clinical outcomes by reducing incidence of MACE compared with BMS.     

药物支架和裸支架治疗急性ST段抬高心肌梗死患者的随访研究

Objective To evaluate the effects of drug-eluting stents (DES) versus bare-metal stents (BMS) on clinical outcomes in patients with acute ST-segment elevation myocardial infarction (ASTEMI) receiving primary percutaneous coronary intervention (PPCI). Methods The 217patients with ASTEMI receiving PPCI from Jan. 2005 to Dec. 2007 were enrolled in this study. And they were divided into two groups: DES group (n=92) and BMS group (n=125). The baseline characteristics including age, gender, angiographic characteristics, stents characteristics, Killip classification, cardiac troponin I(CTnI)levels, left ventricular ejection fraction(LVEF), hemoglobin levels, hypertension, diabetes, hyperlipidemia, obesity and smoking of the two groups were collected.Clinical follow-up end point were major adverse cardiac event(MACE)including death, acute myocardial infarction, stent thrombosis and stent restenosis. Clinical follow-up duration was(16.8±11.3) months (6-38 months). Results The average age (years), rate of Killip classification (class 2, 3, 4), average diameter (mm) of stent were significantly higher in BMS group than in DES group(64.6±11.9 vs. 61.2±11.8, t=2.09, P=0.037;25.9% vs. 12.2%, χ2=5.53, P=0.019;3.07±0.38 vs. 2.91±0. 40, t=2.78, P=0.006). And the average LVEF (%) was significantly lower in BMS group than in DES group (55.4±11.9 vs. 60.3±12.8, t= -2.57, P=0.011). The average length (mm) of stent, rate of stent post dilatation and diabetes were significantly higher in DES group than inBMSgroup (32.8±16.2 vs. 26.2±11.2, t=-3.54, P=0.001;45.7% vs. 21.6%, χ2=13.85, P=0. 000;28.2% vs. 16.0%, χ2=4.77, P=0.030). MACE occurred in 36 patients during clinical follow-up, 6 in DES group and 30 in BMS group. Incidence of MACE was significantly lower in DES group than in BMS group(6.5% vs. 24.0%, χ2=11.70, P＜0.01). Conclusions Using DES in ASTEMI patients is safe and may improve clinical outcomes by reducing incidence of MACE compared with BMS.     

药物支架和裸支架治疗急性ST段抬高心肌梗死患者的随访研究

目的 评价药物支架和裸支架治疗急性ST段抬高心肌梗死患者疗效和预后方法217例接受了急诊经皮冠状动脉介入治疗急性ST段抬高心肌梗死患者纳入本研究,药物支架组92例、裸支架组125例,收集基线资料并随访6～38个月.结果 裸支架组的平均年龄(64.6±11.9)岁、Killip分级(2、3、4级)为25.9%和支架平均直径为(3.07±0.38)mm,均高于药物支架组(61.2±11.8)岁、12.2%和(2.91±0.40),差异有统计学意义(t=2.09,P=0.037;χ2=5.53,P=0.019;t=2.78,P=0.006),裸支架组平均左心室射血分数(55.4±11.9)%低于药物支架组(60.3±12.8)%,差异有统计学意义(t=-2.57,P=0.011).支架长度[(32.8±16.2)mm、(26.2±11.2)mm]、支架后扩张(45.7%、21.6%)、糖尿病(28.2%、16.0%)药物支架组高于裸支架组(t=-3.54,P=0.001;χ2=13.85,P=0.0002;χ2=4.77,P=0.030).随访期间,主要不良心脏事件(MACE)发生36例,药物支架组6例(6.5%),裸支架组30例(24.0%)(χ2=11.70,P＜0.01).结论 急性ST段抬高心肌梗死急诊介入治疗是安全有效的,同裸支架相比药物支架明显降低随访期MACE发生率而改善预后.     

Outcomes of stenting with overlapping drug-eluting stents versus overlapping drug-eluting and bare-metal stents for the treatment of diffuse coronary lesions

Introduction

We investigated the outcomes of stenting with overlapping drug-eluting stents (DES) versus overlapping stenting with a combination of drug-eluting and bare metal stents (BMS) in very long ≥(≥ 25 mm).

Methods and Results

Fifty-two patients treated with either overlapping DES-DES (n = 22) or DES-BMS (n = 30) were selected from a registry of 588 patients with very long coronary lesions. Patients with acute myocardial infarction (MI) within the preceding 48 hours were excluded. The DES-DES combination was more frequently used for longer lesions compared with the DES-BMS group (47.95 ± 9.25 vs 39.98 ± 9.15 mm, p = 0.003). Left anterior descending artery lesions were also more frequently treated with the DES-DES combination (95.5 vs 66.7%, p = 0.02). In four patients in the DES-BMS group, overlapping stents were used for the coverage of dissections. Peri-procedural non-Q-wave MI occurred in one patient in the DES-BMS group. On follow up, only one case of non-fatal MI occurred in a patient with overlapping DES-DES.

Conclusion

Overlapping a BMS in the proximal part of a long DES instead of exclusive deployment of two or more overlapped DES seems to be a safe and feasible therapeutic strategy in our practice.     

Comparison of coronary drug-eluting stents versus coronary artery bypass grafting in patients with diabetes mellitus

We compared 1-year outcome after drug-eluting stent (DES) implantation with off-pump bypass grafing (OPCABG) in patients with type 2 diabetes mellitus and multivessel coronary artery disease involving the proximal segment of the left anterior descending coronary artery. All consecutive diabetic patients treated by DES (DES group) or OPCABG (CABG group) in our institution from April 2002 to December 2004 because of de novo coronary lesions were included. Patients in the CABG group (n = 149) were older and had a higher rate of 3-vessel disease than those in the DES group (n = 69). At 12 months, major adverse cardiac and cerebrovascular events occurred in 29% of the DES group and 20.5% of the CABG group (unadjusted analysis, odds ratio 1.20, 95% confidence interval [CI] 0.93 to 1.54, p = 0.17). After propensity score analysis, adjusting for baseline differences between the 2 cohorts, DESs increased the risk of 12-month major adverse cardiac and cerebrovascular events (hazard ratio 1.88, 95% CI 1.09 to 3.02, p = 0.020). This was due to the higher rate for repeat revascularization in the DES group (19% vs 5%, odds ratio 2.05, 95% CI 1.12 to 3.75, p = 0.001). In contrast, there was no difference in the rate of the composite end points of death, myocardial infarction, and stroke (DES group 13%, CABG group 12%; adjusted analysis, hazard ratio 0.80, 95% CI 0.80 to 1.35, p = 0.40). In conclusion, at 1 year in diabetic patients with multivessel coronary artery disease involving the proximal left anterior descending coronary artery, the advantage of OPCABG over DES implantation seems to be limited at a lower rate of repeat revascularization. No difference seems to exist in the rate of death, stroke, and myocardial infarction.     

Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents.

OBJECTIVES: We sought to define the incidence of late clinical events and late stent thrombosis in patients treated with drug-eluting (DES) versus bare-metal stents (BMS) after the discontinuation of clopidogrel as well as their timing and outcome. BACKGROUND: There is growing concern that delayed endothelialization after DES implantation may lead to late stent thrombosis and related myocardial infarction (MI) or death. However, event rates and outcomes after clopidogrel discontinuation versus BMS are unknown. METHODS: A consecutive series of 746 nonselected patients with 1,133 stented lesions surviving 6 months without major events were followed for 1 year after the discontinuation of clopidogrel. Patients were assigned randomly 2:1 to DES versus BMS in BASKET (Basel Stent Kosten Effektivit?ts Trial). The primary focus of this observation was cardiac death/MI. RESULTS: Rates of 18-month cardiac death/MI were not different between DES and BMS patients. However, after the discontinuation of clopidogrel (between months 7 and 18), these events occurred in 4.9% after DES versus 1.3% after BMS implantation. Target vessel revascularization remained lower after DES, resulting in similar rates of all clinical events for this time period (DES 9.3%, BMS 7.9%). Documented late stent thrombosis and related death/target vessel MI were twice as frequent after DES versus BMS (2.6% vs. 1.3%). Thrombosis-related events occurred between 15 and 362 days after the discontinuation of clopidogrel, presenting as MI or death in 88%. CONCLUSIONS: After the discontinuation of clopidogrel, the benefit of DES in reducing target vessel revascularization is maintained but has to be balanced against an increase in late cardiac death or nonfatal MI, possibly related to late stent thrombosis.     

Meta-analysis of long-term outcomes for drug-eluting stents versus bare-metal stents in primary percutaneous coronary interventions for ST-segment elevation myocardial infarction

The use of drug-eluting stents (DESs) in primary percutaneous coronary intervention (PPCI) has shown early benefit over bare-metal stents (BMSs) in decreasing adverse cardiac events. However, there are concerns regarding the increased risk of late and very late stent thrombosis (ST) after DES use. With the paucity of ST events individual trials may have been underpowered to detect significant differences. We sought to perform a meta-analysis to evaluate the available literature examining the outcomes of DESs and BMSs in PPCI after ≥3 years of follow-up. We analyzed 8 randomized clinical trials (RCTs) and 5 observational studies comparing DESs to BMSs in PPCI. Clinical end-point data were analyzed for RCTs and observational studies separately using random-effect models. RCTs included 5,797 patients in whom first-generation DESs (sirolimus- or paclitaxel-eluting stents) were compared to BMS control arms. Patients receiving DESs had a significantly lower risk of target lesion revascularization (odds ratio [OR] 0.48, confidence interval [CI] 0.37 to 0.61), target vessel revascularization (OR 0.53, CI 0.42 to 0.66), and accordingly major adverse cardiac events (OR 0.69; CI 0.56 to 0.84). Incidence of ST was not different between groups (OR 1.02, CI 0.76 to 1.37). There was no significant difference in mortality (OR 0.88, CI 0.68 to 1.12) or recurrent myocardial infarction (OR 0.97; CI 0.61 to 1.54). Among observational studies (n = 4,650) fewer studies reported on target lesion revascularization and target vessel revascularization, but the trend remained in favor of DESs. A small but statistically significant increase in ST was noted with DES use (OR 1.62, CI 1.18 to 2.21) at ≥3 years of follow up, without evidence of recurrent myocardial infarction. Those receiving DESs had a significantly lower mortality compared to those receiving BMSs (OR, 0.65, 95% CI 0.53 to 0.80, p <0.001). In conclusion, this meta-analysis of RCTs examining the long-term outcomes of first-generation DESs versus BMSs in PPCI, DES use resulted in decreased repeat revascularization with no increase in ST, mortality, or recurrent myocardial infarction.