Use and long-term outcome of bare metal stent implantation in the drug-eluting stent era

BACKGROUND: Although drug-eluting stents (DES) are widely used today, bare metal stents (BMS) are still frequently employed. We investigated the utilization and clinical outcomes of BMS implantation since we first began using DES. METHODS: The clinical course following percutaneous intervention with de novo implantation of BMS was studied beginning in July 2004, when sirolimus-eluting stents (SES) were first used in our hospital, to August 2006. Outcomes following BMS and SES implantation were compared. RESULTS: BMS implantation was carried out in 160 lesions and SES implantation in 242 lesions. Follow-up coronary angiography was performed for 208 lesions (78 lesions in which BMS were implanted and 130 lesions in which SES were implanted) within 1 year. There were no significant differences in patient characteristics between the SES and BMS groups. Regardless of the reason for BMS implantation, the rates of in-stent restenosis and target lesion revascularization were higher in the BMS group than in the SES group. However, the rate of in-stent restenosis and target lesion revascularization of BMS in lesions with a diameter of 4.0mm or greater was 0%. CONCLUSIONS: In order to reduce the risk of in-stent restenosis and target lesion revascularization, we recommend implantation of BMS with a diameter of 4.0 mm or greater or SES unless it is contraindicated.     

Comparison of drug-eluting stents with bare metal stents in unselected patients with acute myocardial infarction.

OBJECTIVES: The aim of this study was to compare the procedural characteristics and outcomes of patients with acute myocardial infarction treated with drug-eluting stents (DES) vs. bare metal stents (BMS). BACKGROUND: DES have been shown to reduce the incidence of restenosis and target vessel revascularization (TVR) in clinical randomized studies when compared with BMS in patients undergoing elective percutaneous intervention. Limited data are available with the use of DES in patients with acute ST-segment elevation myocardial infarction. METHODS: Two hundred and sixty-one consecutive patients who presented with myocardial infarction between 7/2001 and 8/2005 were studied. The procedural characteristics, 30-day and 12-month outcomes of 131 patients treated with DES were compared with 130 patients treated with BMS. RESULTS: At 12-months follow-up DES therapy was associated with a substantial decrease in major adverse cardiovascular events (MACE) (HR 0.33; P =0.002), TVR (HR 0.19; P =0.002), and recurrent myocardial infarction (HR 0.23; P =0.051) vs. BMS therapy. Coronary interventions utilizing DES were characterized by a marked increase in the number of stent per target vessel (DES: 1.9 +/- 0.9 vs. BMS: 1.38 +/- 0.6, P < 0.0001), treatment of bifurcation (DES: 21% vs. BMS: 5%, P =0.0004), and multivessel intervention (DES: 22% vs. BMS: 8%, P =0.003). CONCLUSION: The routine use of DES in acute myocardial infarction is associated with reduced rates of MACE at 12 months vs BMS, despite a higher rate of complex procedures in the DES treated patients. In addition to its anti-restenosis effect, the improved outcome of patients treated with DES may be linked to a more complete revascularization in association with prolonged clopidogrel therapy.     

药物洗脱支架在急性心肌梗死急诊冠脉介入治疗中的应用

目的探讨药物洗脱支架在急性心肌梗死(AMI)急诊冠脉介入治疗中应用的安全性和有效性。方法选择2002-11~2004-11在深圳市人民医院心内科收治的77例AMI患者,均在起病12h内给予急诊经皮冠状动脉介入治疗(PCI),按介入治疗时使用的支架不同分为两组:雷帕霉素药物洗脱支架组(38例)和普通支架组(39例)。结果所有77例病人PCI均获得成功。雷帕霉素药物洗脱支架组38支梗死相关血管的38处病变置入了38个支架;普通支架组39支梗死相关血管的39处病变置入了39个支架。两组病人的PCI后造影情况、临床情况差异无显著性。结论CypherTM雷帕霉素药物洗脱支架应用于急性心肌梗死血栓性病变是安全的和有效的。     

Predictors of sub-acute stent thrombosis in acute myocardial infarction patients following primary coronary stenting with bare metal stent.

BACKGROUND: The aim of the present study was to identify the relationship between sub-acute stent thrombosis (SAT) and acute-phase inflammatory reactants, such as high-sensitivity C-reactive protein (hs-CRP) and serum amyloid-A protein (SAA), in patients with acute myocardial infarction (AMI) successfully treated with primary coronary stenting. METHODS AND RESULTS: The 381 consecutive AMI subjects were reperfused by primary coronary stenting within 24 h of onset. SAT was confirmed angiographically in 10 patients (2.6%). There were no significant differences between the patients with or without SAT in terms of patient characteristics, Killip classification on admission, or stent diameter, nor were there significant differences between the 2 groups in terms of left ventricular function soon after stenting (left ventricular ejection fraction) or end-diastolic volume index. The plasma levels of both hs-CRP and SAA were significantly higher in the SAT patients than in the others (hs-CRP: 6.7+/-6.7 mg/dl vs 3.3+/-3.8 mg/dl, p=0.007; SAA: 699+/-812 mug/dl vs 208+/-273 mug/dl, p<0.0001). Multivariate analysis identified SAA as an independent predictor of SAT (risk ratio: 4.9, 95% confidence interval: 1.7-14.9, p<0.05). CONCLUSION: In patients with AMI who are treated with primary coronary stenting, inflammation may be closely related to SAT, for which SAA is a useful predictor.     

Improved survival with drug-eluting stent implantation in comparison with bare metal stent in patients with severe left ventricular dysfunction.

OBJECTIVE: We examined the efficacy of drug-eluting stent (DES) implantation (Sirolimus or Paclitaxel) in patients with ischemic cardiomyopathy and severe left ventricular (LV) dysfunction and compared the outcome with a similar group of patients undergoing bare metal stent (BMS) implantation. BACKGROUND: Patients with severe LV dysfunction are a high risk group. DES may improve the long term outcomes compared with BMS. METHODS: One hundred and ninety one patients (23% women) with severe LV dysfunction (LV ejection fraction < or =35%) underwent coronary stent implantation between May 2002 and May 2005 and were available for follow-up. One hundred and twenty eight patients received DES (Sirolimus in 72 and Paclitaxel in 54) and 63 patients had BMS. Patients with acute S-T elevation myocardial infarction (STEMI) were excluded. The primary endpoint was cardiovascular mortality. A composite endpoint of major adverse cardiac events (MACE) including cardiovascular mortality, myocardial infarction (MI), and target vessel revascularization (TVR) was the secondary endpoint. RESULTS: Mean follow-up was 420 +/- 271 days. No differences were noted in age (69 +/- 10 years vs. 70 +/- 10 years, P = NS), number of vessel disease (2.3 +/- 0.7 vs. 2.2 +/- 0.8, P = NS), history of congestive heart failure (47% vs. 46%, P = NS), MI (60% vs. 61%, P = NS), or number of treated vessels (1.3 +/- 0.5 vs. 1.3 +/- 0.6, P = NS) for the DES and BMS group, respectively. Diabetes was more common among DES patients (45% vs. 25%, P = 0.01). The left ventricular ejection fraction (LVEF) was similar between the two groups (28% +/- 6% vs. 26% +/- 8%, P = NS for the DES and BMS, respectively). During the follow-up, there were a total of 25 deaths of which two were cancer related (2 in DES group). There were 23 cardiac deaths, 8/126 (6%) which occurred in the DES group and 15/63 (24%) in the BMS group (P = 0.05 by log-rank test). MACE rate was 10% for the DES group and 41% for the BMS group (P = 0.003). NYHA class improved in both groups (from 2.5 +/- 0.8 to 1.7 +/- 0.8 in DES and from 2 +/- 0.8 to 1.4 +/- 0.7 in the BMS, P = NS). CONCLUSION: Compared with bare-metal stents, DES implantation reduces mortality and MACE in high risk patients with severe left ventricular dysfunction.     

金属裸支架内迟发晚期血栓介入治疗后再发支架内血栓一例

患者男,63岁.2000年2月1日因胸闷胸痛5 h至我院急诊,心电图示V1～V3呈rS型伴sT段抬高0.2 mV,拟诊"急性前壁心肌梗死"行急诊冠状动脉造影,术中见前降支近段完全闭塞,2.5 mm×20.0 mm球囊607.95 kPa(6个大气压)扩张20 s后置入3.5 mm×15.0 mm金属裸支架,1013.25 kPa(10个大气压)扩张15 s,复查造影完全覆盖病变,无残余狭窄,远段血流TIMI 3级;术中曾发生含碘造影剂过敏反应,静脉推注地塞米松后症状消失.     

ST段抬高的急性心肌梗死急诊置入药物洗脱支架与普通金属裸支架的比较

目的对比观察雷帕霉素药物洗脱支架（Cypher）与普通金属支架（Bx-sonic）在急性ST段抬高心肌梗死（STEAMI）急诊冠脉介入（PCI）治疗中应用的安全性和临床疗效。方法选择我院急诊住院的82例STEAMI患者,在发病时间12h内急诊行直接PCI治疗,其中50例于梗死相关血管的靶病变植入Cypher支架（Cypher支架组）,32例植入Bx-sonic支架（普通支架组）。并对其临床资料,病变特征,术后住院期间及随访期间再梗死、死亡、靶血管再成形等心脏不良事件发生率进行分析。结果两组支架术患者住院期间心脏不良事件发生率无显著差异。平均随访（6.2±2.3）个月,Cypher支架组心绞痛发生率较普通支架组显著减低（5%vs21%,P<0.01）。Cy-pher支架组无心脏事件生存率显著高于普通支架组（95%vs78%,P<0.01）。普通支架组支架内再狭窄率较Cy-pher支架组高。再梗死、心源性死亡、中风等不良事件发生率无显著差异。结论雷帕霉素药物洗脱支架与普通支架一样在STEAMI急诊PCI中是安全有效的。     

药物洗脱支架与单纯球囊扩张术在急性心肌梗死小血管罪犯病变中应用的对照研究

目的探讨药物洗脱支架在急性心肌梗死小血管罪犯病变介入治疗中的安全性与有效性。方法共入选1 364例罪犯血管为小血管病变（靶血管直径≤2.5 mm）的急性心肌梗死并接受成功PCI治疗患者,根据治疗方案分为药物洗脱支架组（支架组,n=683）,单纯球囊扩张组（球囊扩张组,n=681）,对比两组患者随访8个月时的主要不良心脏事件的发生情况。结果支架组与球囊扩张组相比,总病死率显著减低（P=0.049）,其他不良心脏事件发生率两组间比较无统计学差异。结论急性心肌梗死小血管病变患者即使闭塞血管已再通,置入药物洗脱支架也是必要的。     

Promising efficacy of the sirolimus-eluting stent in patients with acute myocardial infarction

OBJECTIVES: This study investigated the safety and efficacy of sirolimus-eluting stents (SESs) on early and late outcomes in patients with acute myocardial infarction. METHODS: A series of 100 consecutive patients (September 2004 to November 2005)with acute myocardial infarction undergoing primary stenting using SES ptember 24 hr) was compared with 100 consecutive patients (September 2003 to August 2004) treated with bare metal stent (BMS). The frequency of major adverse cardiac events (MACE) and stent thrombosis, and status of ticlopidine administration were assessed at 270 days. RESULTS: The rates of premature discontinuation of ticlopidine (SES group <3 months: 11%, BMS group <1 month: 11%, p = NS) and stent thrombosis (SES group: 1%, BMS group: 0%, p = NS) were similar in the two groups. At follow-up, restenosis rate and target vessel revascularization rate were lower in the SES group(4% vs 19%, p < 0.001 and 4% vs 10%, p = 0.149, respectively). Furthermore, the occurrence of MACE at 270 days was significantly less frequent in the SES group compared with the BMS group (6% vs. 17%, p = 0.038). Multivariate analysis showed SES use tended to predict 270-day MACE (hazard ratio 0.37, 95% confidence interval 0.14-1.02, p = 0.055). Culprit lesion located in the left main trunk was identified as an independent predictor of 270-day MACE (hazard ratio 5.43, 95% confidence interval 1.07-27.59, p = 0.041). CONCLUSIONS: The use of a SES was not associated with increased risk of stent thrombosis compared with a BMS. With lower rates of restenosis and subsequent target vessel revascularization, SES placement could provide superior outcomes in patients with acute myocardial infarction.     

Comparison of outcomes for patients receiving drug-eluting versus bare metal stents for non-ST-segment elevation myocardial infarction

The outcomes for patients undergoing percutaneous coronary interventions (PCI) with drug-eluting stents (DESs) and bare metal stents (BMSs) have been compared in many studies for patients with ST-segment elevation myocardial infarction. However, little is known about the relative outcomes for patients with non-ST-segment elevation myocardial infarction (NSTEMI). The aim of the present study was to compare the NSTEMI outcomes for PCI with DESs and BMSs. New York's PCI registry was used to propensity-match 4,776 pairs of patients with NSTEMI who had received DESs and BMSs from January 1, 2003 to December 31, 2007. These patients were followed up through December 31, 2008 to test for differences in mortality, target vessel revascularization, and total repeat revascularization. The outcomes were also compared for various patient subsets. At a median follow-up period of 3.68 years, the patients receiving DESs had significantly lower mortality (16.58% vs 14.52%, difference 2.06%, p<0.001), target vessel revascularization (13.08% vs 11.04%, p=0.009), and total repeat revascularization (22.16% vs 18.77%, p<0.001). The patients receiving paclitaxel-eluting and sirolimus-eluting stents both experienced superior outcomes compared to patients receiving BMSs. The patients receiving DESs had significantly lower mortality rates than their propensity-matched counterparts receiving BMSs when they were ≥65 years (difference 2.29%, p=0.01) and male (difference 2.77%, p=0.003). In conclusion, patients with NSTEMI undergoing PCI experienced lower 4-year mortality, target vessel revascularization, and repeat revascularization rates when they had received DESs than when they had received BMSs, and patients who were >65 years old, and men received notable benefits.     

药物洗脱支架血栓形成并发急性ST段抬高型心肌梗死的预后研究

目的 分析药物洗脱支架(DES)血栓形成引起急性ST段抬高型心肌梗死(STEMI)的临床和直接冠状动脉介入治疗(PCI)特征及预后.方法 31例因DES血栓形成引起STEMI(ST组)和93例由原发冠状动脉病变所致STEMI患者(对照组)接受直接PCI治疗.记录各例临床和PCI特征及1年随访结果.研究主要终点为院内及1年累积主要心脏不良事件(MACE),包括死亡、非致命性再梗死及靶血管再次血运重建(TVR).结果 与对照组比较,ST组年龄较大(69.9±11.4岁比63.7±13.6岁,P=0.01),糖尿病(41.9%比22.6%,P=0.04)和既往心肌梗死史(29.0%比11.8%,P=0.02)明显增多;直接PCI后冠状动脉TIMI 3级血流显著降低(45.2%比92.5%,P＜0.001).ST组院内死亡率(16.1%比3.2%,P=0.01)和MACE发生率(25.8%比7.5%,P:0.007)显著增高,术后1年总生存率及无MACE生存率显著降低(分别为77.4%比92.5%,P=0.016;59.4%比85.1%,P=0.001).结论 DES血栓形成引起STEMI患者即使接受直接PCI治疗,其院内死亡及MACE发生率仍显著高于由原发冠状动脉病变所致的心肌梗死患者.     

Comparison of one-year cardiac events with drug-eluting versus bare metal stent implantation in rescue coronary angioplasty

Rescue percutaneous coronary intervention (PCI) with bare metal stent (BMS) implantation is useful in patients with acute myocardial infarction (AMI) and failed thrombolysis. Drug-eluting stent (DESs) are more effective in reducing restenosis compared to BMS. No data are available comparing the clinical outcomes between the 2 types of stents nor has information ever been provided about the predictors of events in patients treated with rescue PCI in the current era. The aims of the present study were to evaluate the outcomes of patients undergoing rescue PCI with DES implantation compared to BMS implantation and to determine the independent predictors of events during 1 year of follow-up. The study population consisted of 311 consecutive patients with ST-segment elevation AMI and evidence of failed fibrinolysis undergoing successful revascularization with DES (n = 134) or BMS (n = 177) implantation. The end point of the present study was the incidence of major adverse cardiac events (MACE) defined as death, recurrent AMI, and target vessel revascularization. No differences were found in the number of MACE at 1 year of follow-up between the DES and BMS groups (n = 10 and 19, respectively, p = 0.29). The Cox proportional hazards model identified cardiogenic shock (adjusted hazard ratio 7.05, 95% confidence interval 2.08 to 23.9, p = 0.001), age (hazard ratio 1.51, 95% CI 1.09 to 2.08, p = 0.011), and final minimal lumen diameter (hazard ratio 0.42, 95% confidence interval 0.21 to 0.83, p = 0.013) as independent predictors of MACE at 1 year of follow-up. After propensity score adjustments, the predictors did not change. In conclusion, we found no differences between DESs and BMSs with respect to MACE at 1 year of follow-up in patients with AMI treated with rescue PCI. Cardiogenic shock, age, and final minimal luminal diameter were identified as predictors of MACE.     

Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death

In clinical trials of highly selected patients, drug-eluting stents (DESs) decreased restenosis but not the rate of acute myocardial infarction (AMI) or death. Whether DES use has an affect on the rate of AMI or death in unselected patients is uncertain. Bare metal stents (BMSs) were placed in 1,164 consecutive patients in the year before the introduction of DESs. DESs were subsequently placed in 1,285 consecutive comparable patients at Wake Forest Baptist Medical Center. Early and late clinical outcomes were compared. Propensity score analysis was used to adjust outcomes for baseline differences. Patient and procedural characteristics of the 2 groups were similar, with an overall incidence of 72% for acute coronary syndromes (p = NS). At 9 months, target vessel revascularization (2.8% vs 8.6%, p <0.001), AMI (3.7% vs 4.7%, p = 0.257), and death (4.9% vs 7.1%, p = 0.030) were lower in the DES group than in the BMS group. Propensity score-adjusted Cox proportional hazard ratios for DES versus BMS at 9 months were 0.71 (95% confidence interval 0.42 to 1.19) for AMI, 0.56 (95% confidence interval 0.36 to 0.87) for death, and 0.60 (95% confidence interval 0.42 to 0.86) for the combined end point of AMI or death. In conclusion, in this single-center observational study, use of DESs in consecutive unselected patients, most of whom would not have been eligible for inclusion in the randomized trials of DES versus BMS, was associated with lower AMI and death rates than in a comparable group of patients treated with BMSs in mid-term (9-month) follow-up.     

Intravascular ultrasound-guided primary percutaneous coronary intervention with drug-eluting stent implantation in patients with ST-segment elevation myocardial infarction

Background:

Studies investigating the clinical outcome of intravascular ultrasound (IVUS)‐guided primary percutaneous coronary intervention (PPCI) in patients with ST‐segment elevation myocardial infarction (STEMI) show conflicting results. The aim of our study was to evaluate whether IVUS‐guidedPPCI with drug‐eluting stents (DESs) in STEMI patients improves clinical outcome.

Hypothesis:

IVUS‐guided PPCI is superior to angio‐guided PPCI.

Methods:

Three hundred forty‐one patients who underwent PPCI for STEMI and survived the hospitalization were enrolled in this study. Two hundred sixteen (63.3%) patients were treated with angio‐guided PPCI and 125 (36.7%) patients were treated with IVUS‐guided PPCI. The primary endpoint was defined as the composite of death, myocardial infarction, target vessel revascularization, and target lesion revascularization at the 3‐year follow‐up visit.

Results:

Male gender, dyslipidemia, and smoking were frequent in the IVUS‐guided PPCI group. These patients had a higher rate of radial approach, adjunctive ballooning, thrombectomy, and the use of a glycoprotein IIb/IIIa inhibitor. The number and length of implanted stents were higher in the IVUS‐guided PPCI group. The primary end point (18.1% vs 12.8%, P = 0.22) and stent thrombosis (2.8% vs 2.4%, P = 1.00) was not different between the groups.

Conclusions:

In our observational study, IVUS‐guided PPCI with DESs in patients with STEMI did not improve clinical outcome or stent thrombosis. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Direct versus conventional stent implantation in patients with acute coronary syndrome just before the era of drug-eluting stents

BACKGROUND: Direct stent implantation in patients, who undergo elective percutaneous coronary intervention (PCI) can be performed with a high success rate and clinical results that are comparable to those after predilatation. It was the aim of this prospective study to compare clinical, angiographic and procedural parameter of direct stent implantation (DS) and conventional stent implantation (CS) in patients with acute coronary syndrome (ACS). PATIENTS AND METHODS: We analysed 194 patients with ACS (ST-elevation myocardial infarction 66%, non-ST-elevation myocardial infarction 18%, unstable angina 16%), in whom primary PCI was performed between January and December 2002. In 156 (80%) patients glycoprotein IIb/IIIa inhibitors were administered during the procedure. In 73 patients (38%) direct stent implantation could be performed successfully. In 12 patients (6%) direct stent implantation failed due to the inability to pass the stenosis. In 121 patients (62%) the stent was implanted after predilatation. RESULTS: The clinical parameters were comparable in both groups. Reference luminal diameter before stent implantation did not differ in both groups (DS 3.01+/-0.54 vs. CS 2.84+/-0.43 mm). The final minimal luminal diameter was significantly higher in the DS group (DS 2.95+/-0.45 vs. CS 2.77+/-0.47 mm, p=0.01). The procedural time (DS 41.0+/-14.1 vs. CS 46.8+/-16.9 min, p=0.02), radiation exposure time (DS 7.3+/-4.6 vs. CS 8.9+/-4.6 min, p=0.002) and the amount of contrast agent (DS 216+/-90 vs. CS 235+/-79 ml, p=0.03) could be decreased by the technique of direct stent implantation. The incidence of major adverse cardiac events (death, myocardial infarction, CABG) during hospitalization was 4.1% in the DS group and 11.5% in the CS group (p=0.11). CONCLUSIONS: Direct stent implantation is safe and feasible in patients with acute coronary syndromes. The procedural time, radiation exposure time and the amount of contrast agent can be significantly decreased using the technique of direct stent implantation. The incidence of major adverse cardiac events was not significantly different in this subset of patients.