Extended follow‐up safety and effectiveness of the Endeavor zotarolimus‐eluting stent in real‐world clinical practice: Two‐year follow‐up from the E‐Five Registry

Objectives: To present data from the cohort of patients in the all‐comers Endeavor zotarolimus‐eluting stent (ZES) registry (E‐Five) who underwent 2‐year follow‐up. Background: The Endeavor ZES has been shown to be safe and efficacious for treatment of single, de novo lesions in patients with stable coronary artery disease. E‐Five evaluated the ZES in over 8,000 real‐world patients, at 188 sites followed to 1 year. A subset of sites continued follow‐up through 2 years to evaluate late‐term safety and effectiveness of the ZES in this population with diverse clinical and lesion characteristics. Methods: E‐Five, a prospective, multicenter, nonrandomized global registry, collected 2‐year outcomes for 2,116 patients from 26 centers. Sites were selected for participation based on patient accrual rates and the ability to continue follow‐up activities for an additional year. Complete data was available for 2,054 patients. To observe whether or not a sustained benefit was achieved, data for all patients from the selected sites were included in the analysis. Results: The outcomes in the 2‐year cohort tracked with the results of randomized controlled trials using the Endeavor ZES. One year results were MACE 7.5%, TLR 4.5%, and ARC definite/probable stent thrombosis 0.6%. Outcomes at 2 years for MACE, TLR, and ARC definite/probable stent thrombosis were 8.5, 5.1, and 0.7%, respectively. Conclusions: Long‐term efficacy and safety outcomes were maintained between 1 and 2 years for the 2‐year patient cohort, with only a small number of additional MACE, TLR, and very late stent thrombosis events. © 2010 Wiley‐Liss, Inc.     

Efficacy of everolimus eluting stent implantation in patients with calcified coronary culprit lesions: Two‐year angiographic and three‐year clinical results from the SPIRIT II study

Background : Little is known about the impact of treatment with drug‐eluting stents (DES) on calcified coronary lesions. This analysis sought to assess the safety and efficacy of the XIENCE V everolimus‐eluting stent (EES) in patients with calcified or noncalcified culprit lesions. Methods : The study population consisted of 212 patients with 247 lesions, who were treated with EES alone. Target lesions were angiographically classified as none/mild, moderate, or severe grades of calcification. The population was divided into two groups: those with at least one target lesion moderately or severely calcified (the calcified group: 68 patients with 75 calcified lesions) and those with all target lesions having mild or no calcification (the noncalcified group: 144 patients). Six‐month and 2‐year angiographic follow‐up and clinical follow‐up up to 3 years were completed. Results : The baseline characteristics were not significantly different between both groups. When compared with the noncalcified group, the calcified group had significantly higher rates of 6‐month in‐stent angiographic binary restenosis (ABR, 4.3% vs. 0%, P = 0.03) and ischemia‐driven target lesion revascularization (ID‐TLR, 5.9% vs. 0%, P = 0.01), resulting in numerically higher major cardiac adverse events (MACE, 5.9% vs. 1.4%, P = 0.09). At 2 years, when compared with the noncalcified group, the calcified group presented higher in‐stent ABR (7.4% vs. 0%, P = 0.08) and ID‐TLR (7.8% vs. 1.5%, P = 0.03), resulting in numerically higher MACE (10.9% vs. 4.4%, P = 0.12). At 3 years, ID‐TLR tended to be higher in the calcified group than in the noncalcified group (8.6% vs. 2.4%, P = 0.11), resulting in numerically higher MACE (12.1% vs. 4.7%, P = 0.12). Conclusions: The MACE rates in patients treated with EES for calcified lesions were higher than in those for noncalcified lesions, but remained lower than the results of previously reported stent studies. EES implantation in patients with calcified culprit lesions was safe and associated with favorable reduction of restenosis and repeat revascularization. © 2010 Wiley‐Liss, Inc.     

慢性肾功能不全患者经皮冠状动脉介入治疗的疗效观察

目的 探讨冠心病合并慢性肾功能不全(CRI)患者经皮冠状动脉介入治疗(PCI)的临床特点和预后.方法 分析1160例CRI、1200例肾功能正常冠心病患者的临床特点和PCI治疗情况.结果 CRI组急性心肌梗死、高血压、糖尿病比例、平均住院天数、B2/C型病变比例、院内血栓事件发生率和再次血运重建率均明显高于对照组(P＜0.01).尽管CKI组造影剂用量(180 ml±80 ml)明显少于对照组(230 ml±60 ml,P＜0.05),但CRI组造影剂肾病的发生率显著高于对照组(27.5%比10.3%,P＜0.01).     

Impact of severity of renal dysfunction on determinants of in‐hospital mortality among patients undergoing percutaneous coronary intervention

Background : Chronic kidney disease (CKD) is a known prognostic indicator of poor outcomes following percutaneous coronary intervention (PCI) for coronary artery disease. However, it is unclear whether other predictors of mortality differ among patients with varying degrees of renal impairment. Thus, we aimed to identify determinants of in‐hospital mortality which are specific to patients with preserved renal function, moderate CKD, or end stage renal disease (ESRD) on dialysis, undergoing PCI. Methods : The study population included 25,018 patients who underwent PCI between January 1, 2004, and December 31, 2007, at four New York State hospitals. The primary endpoint of the study was in‐hospital mortality. Results : A total of 474 (1.9%) patients had ESRD on dialysis, 6,596 (26.4%) had moderate CKD (GFR<60 ml/min/1.73m²), and 17,948 (71.7%) had preserved renal function (GFR>60 ml/min/1.73m²). Patients with ESRD and moderate CKD were older, more often male, and had higher rates of prior coronary revascularization, peripheral vascular disease, congestive heart failure, prior stroke, and diabetes than those with preserved function. All‐cause in‐hospital mortality rates were significantly higher in patients with ESRD and moderate CKD compared to patients with GFR >60ml/min/1.73m² (2.1% and 1.3%, respectively vs. 0.3%, p < 0.001). In multivariable analysis, ESRD (OR: 3.68, 95% CI 1.62–8.36) and moderate CKD (OR: 2.92, 95% CI 1.91–4.46) were independently associated with higher rates of in‐hospital mortality. Independent predictors of mortality were markedly distinct in each group and included female gender and myocardial infarction within the past 72 hr in the ESRD group, versus left ventricular ejection fraction, peripheral vascular disease, congestive heart failure, emergency PCI, and absence of prior PCI in the moderate CKD group and age, prior bypass graft surgery, congestive heart failure, emergency PCI, and absence of prior myocardial infarction in patients with preserved renal function Conclusions : Patients with moderate CKD or ESRD undergoing PCI have an approximately threefold increase in the risk of in‐hospital mortality compared with patients with preserved renal function, with radically different mortality predictors existing for varying levels of renal function. © 2012 Wiley Periodicals, Inc.     

Five‐year clinical follow‐up after implantation of the endeavor zotarolimus‐eluting stent: ENDEAVOR I,first‐in‐human study

Objective : To evaluate the 5‐year clinical outcomes of patients treated with the Endeavor zotarolimus‐eluting stent (ZES) in the ENDEAVOR I first‐in‐human study. Background : ENDEAVOR I was a prospective, nonrandomized, multicenter study of the Endeavor ZES in 100 consecutive patients with symptomatic coronary artery disease (CAD) due to de novo, stenotic lesions in native coronary arteries. Methods : Patients with single or multivessel CAD were eligible to participate, but only one lesion per patient was treated. The lesion had to have ≥50% stenosis, be ≤15 mm in length, and located in a vessel with a reference diameter of 3.0–3.5 mm. Major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel failure (TVF), and stent thrombosis were evaluated 5 years after stent implantation. Results : The cumulative incidence of MACE was 2.0% at 1 year, 3.0% at 2 years, 6.1% at 3 years, 7.2% at 4 years, and 7.2% at 5 years. At 5 years, there were seven patients who had eight events; four noncardiac (cancer) deaths, three cases of TLR, of which one presented as a non‐Q‐wave MI because of a stent thrombosis at 10 days after the index procedure. There were no late or very late stent thromboses by any definition. TVF at 5 years was 5.2%. Conclusions : Use of the Endeavor ZES to treat symptomatic CAD due to de novo lesions in native coronary arteries resulted in sustained clinical benefits to 5 years, with low rates of MACE, TLR, TVF, and stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Three‐year outcome of drug‐eluting stent implantation for coronary artery bifurcation lesions

Objectives: To compare the very long‐term clinical outcomes of bifurcation lesions using the crush and the simultaneous kissing stent (SKS) techniques. Background: A variety of two‐stent techniques have been used to treat coronary artery bifurcation lesions in the drug‐eluting stent era, but the long‐term clinical outcome of these approaches is not known. Methods: A total of 74 consecutive patients underwent bifurcation stenting using either the crush or SKS techniques. Mean patient age was 66.91 ± 11.3 years; 26% were diabetic, and the left anterior descending/diagonal bifurcation was the most frequently treated lesion (68%). Results: In‐hospital outcomes were not significantly different between groups. Over a median follow‐up of 3.3 years, 1 patient in the SKS group and 3 patients in the crush group died (P = ns). Probable stent thrombosis leading to death according to the Academic Research Consortium definition occurred in 1 patient in the crush group. Mortality in the remaining 3 patients was noncardiac. Target lesion revascularization (TLR) occurred in 14 patients (40%) in the SKS group and 5 patients (12.8%) in the crush group (P = 0.015). Survival free from major adverse cardiac events (MACE) was significantly less in the SKS group and predominantly driven by TLR (60 vs. 88%, P = 0.001). Conclusions: In conclusion, over a median of 3.3 years of follow‐up, TLR and MACE are significantly lower in bifurcation lesions treated with the crush technique when compared with the SKS technique. Definite or probable stent thrombosis is rare with either technique. © 2009 Wiley‐Liss, Inc.     

肾动脉狭窄并冠状动脉多支病变患者部分或完全冠状动脉血运重建对比分析

目的 探讨在肾动脉狭窄合并冠状动脉粥样硬化性心脏病（冠心病）的患者中进行冠状动脉介入治疗时,选择部分或完全冠状动脉血运重建方法的临床效果差异.方法 收集2006年1月至2011年1月在广东省人民医院进行肾动脉及冠状动脉介入治疗的肾动脉狭窄合并冠心病患者共287例,其中177例进行了冠状动脉完全血运重建（complete revascularization,CR）,110例为部分冠状动脉血运重建（incomplete revascularization,ICR）.然后进行术后2年的随访调查,比较两种介入治疗策略的临床疗效以及其远期预后的差异.结果 两种治疗策略的整体住院病死率比较,差异无统计学意义（Х^2=0.474,P=0.491）.术后CR组的收缩压及舒张压较基线降低,差异有统计学意义（P均＜0.01）;而ICR组收缩压及舒张压与基线相比,差异无统计学意义（P＞0.05）.两组术前和术后肾功能、心功能改善的情况及住院时间比较,差异无统计学意义（P均＞0.05）.两组2年随访病死率及主要心血管事件发生率比较,差异无统计学意义（P均＞0.05）.结论 肾动脉狭窄患者在进行肾动脉及冠状动脉介入治疗时,进行冠状动脉完全血运重建和部分冠状动脉血运重建术效果相近,但完全血运重建有助于血压的控制.     

Results of percutaneous drug‐eluting stent implantation for unprotected left main coronary disease according to left ventricular systolic function

Objectives: We aimed to appraise the early and long‐term outcome after percutaneous coronary intervention (PCI) with drug‐eluting stents (DES) in patients with unprotected left main disease (ULM) and left ventricular systolic dysfunction (LVD). Background: PCI with DES has being performed with increasing frequency in subjects with ULM and LVD, but few specific data are available. Setting and Patients: We identified patients undergoing PCI with DES for ULM at our Center and distinguished those with ejection fraction (EF) >50% from those with 40% <EF ≤50% and those with EF ≤40%. The primary end‐point was the rate of major adverse cerebro‐cardiovascular events (MACCE, ie death, myocardial infarction [MI], stroke, repeat PCI or bypass surgery). Results: A total of 197 patients were included, 57.4% with EF >50%, 32.0% with 40% <EF ≤50%, and 10.6% with EF ≤40%. In‐hospital mortality was significantly higher in those with EF ≤40% (9.5% vs. 0 and 3.2%, P < 0.001). A total of 96% patients were followed for 23 ± 14 months, yielding a MACCE rate of 44.2% (41.6% in those with EF >50%, 41.6% in those with 40% <EF ≤50%, and 61.9% in those with EF ≤40%, P = 0.4). Specifically, death occurred in 2.7%, 7.9%, and 28.6% (P < 0.001), cardiac death in 1.8%, 4.8%, and 23.8% (P = 0.001), MI in 8.0%, 7.9% and 0 (P = 0.4), and TVR in 15.9%, 11.1% and 33.3% (P = 0.6). Conclusion: Systolic ventricular dysfunction is highly correlated with in‐hospital and long term death rates in patients undergoing PCI with DES for ULM disease. However it does not confer an increased risk of nonfatal adverse events or stent thrombosis. © 2009 Wiley‐Liss, Inc.     

Comparison of sirolimus‐eluting stent,paclitaxel‐eluting stent,and bare metal stent in the treatment of long coronary lesions

Objective: This study compared the efficacy of the sirolimus‐eluting stent (SES), the paclitaxel‐eluting stent (PES), and the bare metal stent (BMS) for long coronary lesions. Background: The outcome of drug‐eluting stent (DES) implantation in long coronary lesions remains unclear. Methods: The study involved 527 patients with de novo long coronary lesions (≥24 mm), which were treated with long (≥28 mm) SESs (223 lesions), PESs (194 lesions), or BMSs (201 lesions). Results: Lesions in the SES (36.0 ± 14.9 mm, P < 0.001) and PES (36.3 ± 14.5 mm, P < 0.001) groups were longer than those in the BMS group (32.0 ± 12.3 mm), meaning the two DES groups had longer stented segments than did the BMS group. Six‐month angiographic follow‐up showed the SES (9.3%, P < 0.001) and PES (21.3%, P < 0.001) groups had lower in‐segment restenosis rates than that of the BMS group (42.5%). The rate of major adverse cardiac events (MACE) including death, myocardial infarction, and target lesion revascularization at 9 months was higher in the BMS group (26.6%) than that in the SES (13.0%, P < 0.001) and PES (15.7%, P < 0.001) groups. Posthoc analysis of the two DES groups showed that the in‐segment restenosis rate was lower for the SES than that for the PES group (P = 0.002), while the MACE rate was similar. Conclusions: The use of DESs for long coronary lesions appears to be safe and more effective than the use of BMSs in terms of restenosis and adverse clinical events. SES use was associated with lower late luminal loss and a lower angiographic restenosis rate compared with PES use. © 2006 Wiley‐Liss, Inc.