Four‐year clinical outcome of sirolimus‐ and paclitaxel‐eluting stents compared to bare‐metal stents for the percutaneous treatment of stable coronary artery disease

Background : There are limited data on the long‐term safety and efficacy profile of coronary stent implantation in patients with stable coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI). Objective : We aimed to assess the 4‐year clinical outcome in patients who received a bare‐metal stent (BMS), sirolimus‐eluting stent (SES), or a paclitaxel‐eluting stent (PES) for the percutaneous treatment of stable angina in our center during 2000–2005. Methods : In the study period, a total of 2,449 consecutive patients (BMS = 1,005; SES = 373; and PES = 1071) underwent a PCI as part of three historical PCI‐cohorts for stable angina and were routinely followed for the occurrence of major adverse cardiac events (MACE). Results : At 4 years follow‐up, 264 BMS patients (26.8%) had a MACE, compared to 75 SES patients (20.9%) and 199 PES patients (23.9%). Multivariate analysis showed that SES and PES were superior to BMS with respect to MACE [hazard ratio (HR) = 0.62, 95% confidence interval (CI): 0.47–0.81; HR = 0.67, 95% CI: 0.55–0.82, respectively]. The occurrence of MACE was significantly lower in the SES and PES population, primarily due to less target‐vessel revascularization (TVR) procedures (HR = 0.53, 95% CI: 0.37–0.75; HR = 0.71, 95% CI: 0.62–0.81, respectively). The occurrence of early, late, and very late stent thrombosis was equally rare with each stent type. There were no significant differences between SES and PES on death, myocardial infarction, TVR, and MACE. Conclusion : These findings suggest that SES and PES result in decreased TVR procedures and MACE compared to BMS at 4 years follow‐up. SES or PES implantation should be the preferred choice over BMS for patients with stable CAD undergoing PCI. © 2010 Wiley‐Liss, Inc.     

中国冠心病患者接受不同支架治疗预后的荟萃分析

目的比较中国冠心病患者置入药物洗脱支架(DES)和裸支架(BMS)或西罗莫司洗脱支架(SES)和紫杉醇洗脱支架(PES)之间,临床预后的差别。方法检索数据库,纳入随访时间≥6个月的、比较DES和BMS或SES和PES的临床研究。用STATA 10.0作荟萃分析,比较不同类型支架的临床预后,包括主要心血管不良事件(MACE)、靶病变血运重建(TLR)、靶血管血运重建(TVR)、支架内血栓形成和心肌梗死的发生情况。结果共纳入文献11篇(3780例),随访时间从6个月至3年。与BMS相比,DES可减少MACE(OR=0.471,95%CI0.336～0.662,P<0.001)、减少TVR(OR=0.250,95% CI0.148～0.422,P<0.001),但支架内血栓形成在两组间差异无统计学意义。而SES与PES相比,在MACE、TLR、TVR、支架内血栓、心肌梗死方面差异均无统计学意义。结论药物洗脱支架有效性、安全性高,药物支架中,西罗莫司支架和紫杉醇支架差异无统计学意义。     

Real World,Long‐Term Outcomes Comparison Between Paclitaxel‐Eluting and Sirolimus‐Eluting Stent Platforms

We compare real‐world, extended target vessel revascularization (TVR)‐free survival following percutaneous coronary intervention (PCI) for patients receiving either sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) following an index drug‐eluting stent (DES) supported procedure. We analyzed 2,363 consecutive patients having first DES‐supported PCI at receiving PES (n = 1,012) or SES (n = 1,332) from April 2004 to July 2006. Baseline clinical and procedural characteristics and in‐hospital outcomes were recorded during the time of the index procedure and extended clinical outcomes data were obtained thereafter. TVR and all cause mortality were identified during the study period. Adjusted Kaplan‐Meier and Cox's proportional hazard survival methods were performed. TVR‐free survival at 2.3 years was 91.3% for SES compared with 88.9% for PES (P = 0.06). Kaplan‐Meier survival curves did not significantly differ (adjusted hazard ratio ?1.39 [95% CI 0.99–1.97]) between the SES and PES patient cohorts. TVR was similar between the stent platforms at one (96.6% for SES [95% CI 95.3–97.6] vs. 95.7% for PES [95% CI 94.1–96.9]) and two (95.0%[95% CI 93.0–96.4] for SES vs. 93.7% for PES [95% CI 91.6–95.3]) years. Overall survival at 2 years was 96.2% for SES (95% CI 94.7–97.3) and 95.3% for PES (95% CI 93.7–96.5). SES and PES drug‐eluting stent platforms have good and similar extended outcomes in this real world registry of unselected patients having PCI. (J Interven Cardiol 2010;23:167‐175)     

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Backgrounds : Relative efficacy and safety of sirolimus‐eluting stents (SES) compared with paclitaxel‐eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. Objectives : The meta‐analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Methods : Five head‐to‐head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta‐analysis. Mean follow‐up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main‐branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Results : Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38–0.70, P < 0.001), main‐branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18–0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42–0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40–0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Conclusions : Compared with PES, SES reduced the incidence of TLR, main‐branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups. © 2011 Wiley Periodicals, Inc.     

Comparison of 2‐year clinical outcomes with sirolimus and paclitaxel‐eluting stents for patients with diabetes: Results of the Registro Regionale AngiopLastiche Emilia‐Romagna Registry

Background: Long‐term outcomes of percutaneous coronary interventions (PCI) with sirolimus‐eluting stents (SES) compared to paclitaxel‐eluting‐stents (PES) in unselected diabetics in routine practice is still debated. Objective: This study compared the 2‐year incidence of MACE (all‐cause mortality, nonfatal myocardial infarction and target vessel revascularization) of SES and PES in a real‐world setting of patients with diabetes. Design: Observational, multicenter, nonrandomized study. Setting: Prospective web‐based registry (REAL Registry; study period, 2002–2005) comprising all 13 hospitals performing PCI. Patients: Among the 945 eligible patients treated with either SES alone (n = 606) or PES alone (n = 339), 29% were insulin‐requiring, 72% had multivessel coronary disease, 26% had prior myocardial infarction and 10% had poor left ventricular function. Measurements: Unadjusted and propensity score‐adjusted 2‐year clinical outcome. Results: After propensity score adjustment, 2‐year MACE incidence in the SES and PES groups was equivalent (23.3% vs. 23.7%, HR 1.01, 95%CI 0.72–1.42, P = 0.96). Adjusted 2‐year angiographic stent thrombosis occurred in 1.1% of the SES patients versus 2.6% of the PES patients (P = 0.15). In this large, real‐world, diabetic population treated with DES, there was no difference in outcome between SES and PES. Further studies are needed to demonstrate the long‐term safety of different types of DES in patients with diabetes. © 2009 Wiley‐Liss, Inc.     

Everolimus‐Eluting Stents Versus Sirolimus‐ or Paclitaxel‐Eluting Stents: Two‐Year Results from the Guthrie Health Off‐Label Stent (GHOST) Registry

Objectives

We sought to compare the safety and effectiveness of everolimus‐eluting stents (EES) versus first generation drug‐eluting stents (FG‐DES; sirolimus‐eluting stent [SES] or paclitaxel‐eluting stent [PES]).

Methods

In 2,126 patients undergoing percutaneous coronary intervention (PCI), we compared the 2‐year incidence of stent thrombosis (ST) and target vessel revascularization (TVR) between the EES versus FG‐DES groups. Secondary end‐points included all‐cause death, myocardial infarction (MI), death or MI, and major adverse cardiovascular events (MACE, including death, MI, ST, or TVR). Further, we evaluated these end‐points in 2 propensity‐matched subgroups: EES versus SES; EES versus PES.

Results

Complete 2‐year follow‐up was available in 1,911 (90%) patients. Compared to FG‐DES, implantation of EES was associated with trends towards lower ST (0.9% vs. 2.8%, P = 0.068) and TVR (3.8% vs. 7.2%, P = 0.052), which persisted after adjustment for baseline differences (for ST, adjusted hazard ratio, HR 0.32; 95% confidence interval, 95% CI 0.10–1.02, P = 0.053; for TVR, HR 0.40; 95% CI 0.22–0.75, P = 0.004). Compared to SES, EES implantation was associated with lower TVR and a trend towards lower ST. Compared to PES, EES implantation was associated with less ST and TVR and trends towards lower death/MI and MACE. In the EES group, no ST was seen after the first 3 months.

Conclusions

The use of EES compared to FG‐DES appears to be associated with reductions in ST and TVR at 2‐year follow‐up. Improved outcomes with EES are observed in comparison with SES as well as PES. (J Interven Cardiol 2013;26:153–162)

     

Outcomes of diabetics receiving bare‐metal stents versus drug‐eluting stents

Objectives : We sought to determine if differences existed in in‐hospital outcomes, long‐term rates of target vessel revascularization (TVR), and/or long‐term mortality trends between patients with diabetes mellitus undergoing percutaneous coronary intervention (PCI) with either a drug‐eluting stent(s) (DES) or a bare metal stent(s) (BMS). Background : Short‐ and long‐term clinical outcomes of patients with diabetes mellitus undergoing PCI with DES versus BMS remain inconsistent between randomized‐controlled trials (RCTs) and observational studies. Methods : Data were collected prospectively on diabetics undergoing PCI with either DES or BMS from January 2000 to June 2008. Demographic information, medical histories, in‐hospital outcomes, and long‐term TVR and mortality trends were obtained for all patients. Results : A total of 1,319 patients were included in the study. Diabetics receiving DES had a significant reduction in index admission MACE compared to diabetics receiving BMS. Using multivariable adjustment, after a mean follow‐up of 2.5 years (maximum 5 years), diabetics who received DES had a 38% decreased risk of TVR compared to diabetics with BMS [HR 0.62 (95% CI: 0.43–0.90)]; diabetics with DES had an insignificant adjusted improvement in long‐term survival compared to diabetics with BMS [HR 0.72 (95% CI: 0.52–1.00)]. These long‐term survival and TVR rates were confirmed using propensity scoring. Conclusions : The use of DES when compared with BMS among diabetics undergoing PCI is associated with significant improvement in long‐term TVR, with an insignificant similar trend in all‐cause mortality. The long‐term results of this observational study are consistent with prior RCTs after adjusting for confounding variables. © 2010 Wiley‐Liss, Inc.     

Comparison between sirolimus‐ and paclitaxel‐eluting stents in complex patient and lesions subsets

Background : Sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) both significantly reduce the need for repeat intervention compared to bare metal stents. Studies comparing the clinical outcomes of these stents in noncomplex subsets of patients and lesions demonstrate a similar safety and efficacy profile. The data for more complex subsets of patients and lesions remains conflicting. This study aimed to compare SES with PES in a selected population with a broad range of complex features. Methods and Results : The patient population consisted of 1,591 consecutive patients with complex features undergoing drug‐eluting stent (DES) implantation. In the SES group there were 1,095 patients (1,653 lesions) and in the PES group 496 patients (802 lesions). In‐hospital, 30‐day, and 12‐month clinical outcomes were compared between groups. No discernable difference in major adverse cardiac events (MACE) between SES and PES was detected at intermediate and longer‐term follow‐up (SES 22.4% vs. PES 20.5% at 12 months; P = 0.407). A trend toward increased angiographically documented stent thrombosis was observed in the SES group at both 3 and 12 months (SES 2.2% vs. PES 0.8% at 12 months; P = 0.051). When adopting the more inclusive definition of probable stent thrombosis, this trend was no longer seen. After adjusting for baseline differences between the two groups, there still remained no difference in MACE between SES and PES (HR 1.051 [CI 0.826–1.339] P = 0.685). The trend toward increased angiographically documented stent thrombosis in the SES group remained after adjustment for baseline differences (HR 2.836 [CI 0.968–8.311] P = 0.057). Conclusions : In a selected population with complex disease the rate of MACE was comparable between SES and PES, with higher overall rates of thrombosis and MACE compared to a noncomplex population. Thus, the focus should be directed to prevent late complications in this complex subset regardless of stent type selection. © 2007 Wiley‐Liss, Inc.     

Comparison of three‐year clinical outcomes between sirolimus‐versus paclitaxel‐eluting stents in diabetic patients: Prospective randomized multicenter trial

Background : Three‐year follow‐up of major adverse cardiovascular event (MACE) (death, nonfatal myocardial infarction, target lesion revascularization) and the predictors of MACEs in diabetic patients after sirolimus‐eluting stent (SES) or paclitaxel‐eluting stent (PES) implantation have not been reported. Methods : Diabetic patients with de novo coronary lesions (169 patients with 190 lesions) were randomly assigned prospectively to either SES or PES. Results : Baseline characteristics were similar between the two groups. The rates of MACEs [5.9% (n = 5) in the SES vs. 9.5% (n = 8) in the PES Group, P = 0.374] and definite stent thrombosis [1.2% (n = 1) in the SES vs. 3.6% (n = 3) in the PES Group, P = 0.368] were similar in the two groups during the three‐year follow‐up. Multivariate logistic analysis showed that insulin treatment was the only independent predictor of MACE [odds ratio (OR) 8.60, 95% confidence interval (CI) 3.25–22.76, P < 0.001] and target vessel revascularization (TVR) (OR 9.50, 95% CI 3.07–29.44, P < 0.001) during the three‐year follow‐up. Conclusions : The rates of MACEs, TVR, and stent thrombosis during the three‐year follow‐up were similar in the SES and PES Groups. Insulin treatment was a main predictor of MACEs and TVR during the three‐year follow‐up after either SES or PES implantation. © 2009 Wiley‐Liss, Inc.     

Comparison of 2‐year clinical outcomes between zotarolimus‐, sirolimus‐, and paclitaxel‐eluting stents in real life clinical practice

Background : There are few studies comparing the long‐term efficacy and safety of the zotarolimus‐eluting stent (ZES) with sirolimus‐ (SES) and paclitaxel‐eluting stents (PES) in the unselected cohorts that were subject to real life clinical practice. Methods : Total 2,769 patient who underwent successful percutaneous coronary intervention (PCI) with the three drug‐eluting stents (DES) between April 2006 and July 2008 were analyzed retrospectively. A total of 1,152 patients were treated with SES, 810 with PES, and 807 with ZES. The primary analysis endpoint was cumulative rate of target‐lesion failure (TLF) at 24 months, defined as the composite of cardiac death, target‐vessel‐related myocardial infarction (MI), and target‐lesion revascularization (TLR). Results : At 24 months, the incidence of TLF was significantly lower in the SES group compared with the ZES (7.6% vs. 11.3%, HR = 0.66, CI = 0.49–0.88, P = 0.005) or the PES group (7.6% vs. 10.2%, HR = 0.74, CI = 0.55–0.99, P = 0.048), while similar between the PES and the ZES groups (HR = 0.89, CI = 0.66–1.20, P = 0.443). The difference was mostly driven by higher rate of TLR in the ZES and PES groups compared with the SES group, mostly within the first year post‐PCI. However, the rate of hard endpoints (cardiac death or nonfatal MI) was similar among the three groups. These results were reproduced in the propensity score‐matched cohort.Conclusions : This observational study shows that the use of SES is superior to PES or ZES for the TLF in the overall and matched analysis. © 2011 Wiley Periodicals, Inc.     

Long-term safety and effectiveness of drug-eluting stents compared to bare metal stents following successful PCI in non-ST-elevation myocardial infarction: findings from the Guthrie Health Off-Label StenT (GHOST) Registry

Background: The long‐term safety and effectiveness of drug‐eluting stents (DES) versus bare metal stents (BMS) in non‐ST‐segment elevation myocardial infarction (NSTEMI) beyond 2 years after percutaneous coronary intervention (PCI) is unknown. Methods: We studied 674 NSTEMI patients who underwent successful PCI with DES (n = 323) or BMS (n = 351). The primary study end‐points were time to occurrence of death or nonfatal recurrent myocardial infarction (MI), and stent thrombosis (ST). Secondary end‐points included time to occurrence of target vessel revascularization (TVR) and any major adverse cardiovascular event (MACE, defined as the composite of death, MI, ST, TVR). Results: The DES and BMS groups were well matched except that DES patients received dual antiplatelet therapy for a longer duration and had smaller final vessel diameter. In survival analysis, at a mean follow‐up of 1333 ± 659 days after PCI, the DES group had similar incidence of death/myocardial infarction (24% vs. 27%, log rank p = 0.23) and ST (4.0% vs. 2.6%, p = 0.18) as the BMS group. The DES patients had lower incidence of TVR (8.1% vs. 17%, p = 0.0018) but similar MACE (26% vs. 37%, p = 0.31). In multivariable analysis, DES vs. BMS implantation showed no significant impact on death/myocardial infarction [adjusted hazards ratio (HR) 1.0, 95% confidence intervals (CI) 0.7–1.4], ST (HR 1.7; CI 0.7 – 4.0), or MACE (HR 0.8; CI 0.6 – 1.1). However, TVR was lower in the DES group (HR 0.4; CI 0.3 – 0.7). Conclusion: In patients presenting with NSTEMI, DES implantation appears to be as safe as BMS implantation at long‐term follow‐up. In addition, DES are effective in reducing TVR compared to BMS. (J Interven Cardiol 2012;25:28–36)     

Prospective randomized comparison of sirolimus‐ versus paclitaxel‐eluting stents for the treatment of acute ST‐elevation myocardial infarction

Objective: The aim of this study was to compare effectiveness of the Sirolimus‐ (SES) and Paclitaxel‐eluting stent (PES) in primary angioplasty for acute ST‐elevation myocardial infarction (STEMI). Background: It has been reported that SES and PES have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there may be differences between these two drug‐eluting stents in terms of efficacy in the setting of acute STEMI. Methods: Acute STEMI patients (n = 308) undergoing primary angioplasty were randomly assigned to SES (n = 154) or PES (n = 154) deployment. The routine angiographic follow‐up was performed at 6 months and clinical follow‐up data was obtained at 12 months. The primary end point was major adverse cardiac events (MACE) including death, reinfarction, stent thrombosis, and target lesion revascularization (TLR) at 12 months. Results: The baseline clinical, angiographic, and procedural characteristics were similar between the 2 groups. Two patients (all from the PES group) experienced stent thrombosis (1 acute and 1 subacute). The SES group revealed lower in‐segment restenosis (5.9% vs. 14.8%, P = 0.03) and in‐segment late loss (0.09 ± 0.45 vs. 0.33 ± 0.68 mm, P = 0.002) than PES group on follow‐up angiography. Twelve‐month TLR rates (2.6% vs. 6.5%, P = 0.17) were similar between two groups. MACE rates were lower in the SES group than in the PES group, but it did not reach statistical significance (5.8% vs. 11.7%, P = 0.07). Conclusion: In the setting of primary angioplasty for STEMI, there were no statistically significant differences between the SES and the PES in terms of 12‐month MACE. However, binary angiographic in‐segment restenosis and in‐segment late loss were significantly lower in the SES group. © 2008 Wiley‐Liss, Inc.     

A comparative analysis of major clinical outcomes using drug‐eluting stents versus bare metal stents in diabetic versus nondiabetic patients

Objectives: We aim to explore the clinical outcome of drug‐eluting stents (DES) versus bare‐metal stents (BMS) implantation in diabetics versus nondiabetic patients. Background: Diabetic patients sustain worse long‐term clinical outcomes after percutaneous coronary interventions (PCI) when compared with nondiabetics. The use of DES decreases the rate of repeat revascularization in this population but data concerning long‐term clinical benefits, such as myocardial infarction (MI) or mortality is scant. Methods: We analyzed data from a comprehensive registry of 6,583 consecutive patients undergoing PCI at our center. A propensity score was used for analysis of outcomes and for matching (DES vs. BMS). Outcome parameters were total mortality, MI, repeat target vessel revascularization (TVR) rates, and risk‐adjusted event‐free survival. Within this cohort, we identified 2,571 nondiabetic patients and these were compared with 1,826 diabetic coronary patients. Results: Mean and median follow up time was 3 and 3.25 years, respectively. Overall, diabetics had higher rates of major‐adverse cardiovascular events (MACE) at 4 years compared with nondiabetics (23.03 vs. 31.96 P > 0.001). DES use was associated with lower rates of TVR in both groups [diabetics hazard ratio (HR) = 0.56, 95% confidence interval (CI): 0.42–0.76, P < 0.001, nondiabetics HR = 0.73, 95% CI: 0.55–0.97, P = 0.03] while sustained decreased rates of both mortality and MI were evident solely among diabetics (HR = 0.71, 95% CI: 0.56–0.89, P = 0.004 in diabetic vs. HR = 0.88, 95% CI: 0.69–1.13, P = 0.3). Conclusions: In a “real‐world,” unselected population and extended clinical use, DES in diabetics was associated with sustained decreased rates of MI, death, TVR, and MACE while this benefit was attenuated in the nondiabetic population. © 2011 Wiley‐Liss, Inc.     

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

Objectives and Background : First generation drug‐eluting stents have shown differential efficacy in high‐risk patient subsets at one year. It is unclear whether these differences endure over the medium‐ to long‐term. We compared the five‐year clinical efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in a population of high‐risk patients. Methods : The patient cohorts of the ISAR‐DESIRE, ISAR‐DIABETES, and ISAR‐SMART‐3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five‐year follow‐up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. Results : A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44–0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80–1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02–1.34; P = 0.12). Conclusions : In high‐risk patient subsets the lower rate of 12‐month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES. © 2011 Wiley‐Liss, Inc.     

Comparison of sirolimus‐eluting stent and paclitaxel‐eluting stent for long‐term cardiac adverse events in diabetic patients: The Korean multicenter angioplasty team (KOMATE) registry

Background: There is some controversy on long‐term cardiac outcomes between sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) in diabetes mellitus (DM). We compared cardiac adverse events after SES and PES implantation in patients with DM over a period of 3 year. Methods: A total of 634 patients with DM treated with SES (n = 428) or PES (n = 206) were consecutively enrolled in the KOMATE registry from 2003 to 2004. We assessed major adverse cardiac events (MACEs, cardiovascular death, nonfatal myocardial infarction, ischemia driven target vessel revascularization) and stent thrombosis (ST) according to the definitions set by the Academic Research Consortium. Results: Propensity score (PS) analysis was performed to adjust different baseline characteristics. The mean follow‐up duration was 38 ± 8 month (at least 36 month and up to 53 month). The 3‐year MACE rate did not show a significant difference between the two groups [52 (12.1%) in SES vs. 29 (14.1%) in PES, P = 0.496]. The definite and probable ST at 3 year were similar in both SES and PES [12 (2.8%) in SES vs. 7 (3.4%) in PES, P = 0.681]. There were no differences in hazard ratio for MACE and ST between two stents [MACE, crude: 0.844 (0.536–1.330) and adjusted for PS: 0.858 (0.530–1.389); ST, crude: 0.820 (0.323–2.083) and adjusted for PS: 0.960 (0.357–2.587)]. Conclusions: The present study demonstrated that long‐tem cardiac outcomes including ST were not significantly different between SES and PES in patients with DM. © 2008 Wiley‐Liss, Inc.     

The short‐ and long‐term outcomes of percutaneous intervention with drug‐eluting stent vs bare‐metal stent in saphenous vein graft disease: An updated meta‐analysis of all randomized clinical trials

The use of drug‐eluting stents (DES) vs bare‐metal stents (BMS) in saphenous vein graft (SVG) lesions remains controversial. We conducted a meta‐analysis of all randomized clinical trials comparing the outcomes of DES with BMS in SVG percutaneous coronary interventions. A search of PubMed, Embase, the Cochrane Register of Controlled Trials, and Clinicaltrials.gov was performed for all randomized clinical trials. We evaluated the short‐ and long‐term clinical outcomes of the following: all‐cause mortality, major adverse cardiovascular events (MACE), definite/probable stent thrombosis, target lesion revascularization (TLR), and target‐vessel revascularization (TVR). From a total of 1582 patients in 6 randomized clinical trials, 797 had DES and 785 had BMS. Patients with DES had lower short‐term MACE, TLR, and TVR in comparison with BMS (odds ratio [OR]: 0.56, 95% confidence interval [CI]: 0.35–0.91, P = 0.02; OR: 0.43, 95% CI: 0.19–0.99, P = 0.05; and OR: 0.45, 95% CI: 0.22–0.95, P = 0.04, respectively). However, there were no different outcomes for all‐cause mortality (P = 0.63) or stent thrombosis (P = 0.21). With long‐term follow‐up, there were no significant reductions of MACE (P = 0.20), TLR (P = 0.57), TVR (P = 0.07), all‐cause mortality (P = 0.29), and stent thrombosis (P = 0.76). The use of DES in SVG lesions was associated with lower short‐term MACE, TLR, and TVR in comparison with BMS. However, there were no significant differences with long‐term follow‐up.     

Comparison of Sirolimus‐ and Paclitaxel‐Eluting Stents in Patients Undergoing Primary Percutaneous Coronary Intervention for ST‐Elevation Myocardial Infarction: A Meta‐analysis of Randomized Trials

Background

It has been reported that sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) have been more effective than bare‐metal stents in reducing restenosis and cardiac events in a broad range of patients with coronary artery disease. However, it is unknown whether there might be differences between these two drug‐eluting stents in terms of efficacy and safety in the setting of acute ST‐segment elevation myocardial infarction (STEMI).

Hypothesis

The aim of the present study was to compare SES with PES in patients with acute STEMI undergoing primary percutaneous coronary intervention (PCI).

Methods

The published research was scanned by formal searches of electronic databases (PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials) from January 2001 to February 2010. Internet‐based sources of information on the results of clinical trials in cardiology were also searched.

Results

A total of 4 randomized trials were included in the present meta‐analysis, involving 1105 patients (550 in the SES group, 555 in the PES group). SES were significantly more effective in the reduction of angiographic binary (≥50%) restenosis (4.0% vs 9.6%, odds ratio 0.38, 95% confidence interval 0.19 to 0.74, P = 0.004) compared to PES. The differences between SES and PES were not statistically significant with respect to target vessel revascularization (TVR), stent thrombosis, cardiac death, and myocardial infarction.

Conclusions

SES are superior to PES in reducing the incidence of restenosis in patients undergoing primary PCI for STEMI, with nonsignificant differences in terms of TVR, cardiac death, myocardial infarction, and stent thrombosis. Copyright © 2010 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

Sirolimus-eluting stents in real-world patients with ST-segment elevation acute myocardial infarction

Recently, the use of sirolimus-eluting stents (SES) has been demonstrated to significantly reduce the rate of adverse events among selected patients with ST-segment elevation acute myocardial infarction (STEMI). We present real-world experience from a single center registry evaluating the safety and efficacy of primary percutaneous coronary intervention (PCI) in unselected patients with STEMI using SES. Clinical outcome at 300-day follow-up in two cohorts of 225 consecutive patients who underwent bare metal stent (BMS) (January 2004-February 2005, n = 123) or SES (March 2005-December 2006, n = 102) implantation was examined. The primary endpoint was a composite of major adverse cardiovascular events (MACE: death, nonfatal reinfarction, and target vessel revascularization [TVR]). The incidence of short-term MACE was similar between the SES group and BMS group (30-day rate of MACE: 4.9% versus 8.9%, P = 0.30). Angiographically documented stent thrombosis within 30 days after primary PCI was not diagnosed in any patient in the SES group and occurred in 1 patient treated with BMS (0 versus 0.8%, P = 1.0). At 300 days, SES implantation significantly reduced the incidence of MACE (7.8% versus 22.8%, hazard ratio [HR] 0.32 [95% confidence interval (CI) 0.15 to 0.71], P = 0.005), mainly due to a marked reduction in the risk of TVR (1.0% versus 17.1%, HR 0.05 [95% CI 0.01 to 0.39], P < 0.001). There was no new onset of documented stent thrombosis between 30 and 300 days in either group. Thus, this real-world registry confirmed the safety and efficacy of SES with remarkably lower rates of TVR and MACE in the setting of primary PCI for unselected patients with STEMI in a real-world scenario.     

Drug‐eluting stents in patients with end‐stage renal disease: Meta‐analysis and systematic review of the literature

Objective : The study sought to examine the total weight of evidence regarding the use of drug eluting (DES) and bare metal stents (BMS) in patients with end stage renal disease (ESRD). Background : The potential superiority of DES over BMS in reducing target lesion or vessel revascularization (TLR or TVR) in patients with ESRD on dialysis has not been established. Small studies comparing DES to BMS in this population have yielded inconclusive results mainly due to the small sample size. Methods : We searched MEDLINE, EMBASE, Science Citation Index, CINAHL, and the Cochrane CENTRAL database of controlled clinical trials (December 2009) for controlled trials comparing DES to BMS in ESRD patients. We conducted a fixed‐effects meta‐analysis across seven eligible studies (n = 869 patients). Results : Compared with BMS‐treated patients, DES‐treated patients had significantly lower TLR/TVR (OR 0.55 CI: 0.39–0.79) and major adverse cardiac events (MACE) (OR 0.54; CI: 0.40–0.73). The absolute risk reduction (ARR) with DES in TLR/TVR was ?0.09 (CI: ?0.14 to ?0.04; NNT 11) and in MACE was ?0.13 (CI: ?0.19 to ?0.07; NNT 8). A trend towards lower incidence of all cause mortality was also noted with DES (OR 0.68; CI: 0.45–1.01). No significant differences were noted between both groups in the relative or absolute risk of myocardial infarction. Conclusion : The use of DES in patients with ESRD is safe and yields significant reduction in the risk of TLR/TVR and MACE. Larger randomized studies are needed to confirm the results of this meta‐analysis and establish the appropriate stent choice in this high risk population. © 2010 Wiley‐Liss, Inc.     

Seven‐year safety and efficacy of the unrestricted use of drug‐eluting stents in saphenous vein bypass grafts

Objectives : The aim was to investigate the 7‐year clinical outcomes of patients treated with either drug‐eluting stents (DES) or bare‐metal stents (BMS) for saphenous vein graft disease (SVG). Background : Atherosclerotic disease in SVG has several peculiarities which make it difficult to extrapolate outcomes of the use of DES as compared to BMS, from outcomes observed in native coronary arteries. To date no long‐term safety and efficacy results for DES in SVG have been published. Methods : Between January, 2000 and December, 2005 a total of 250 consecutive patients with saphenous vein graft disease were sequentially treated with DES (either sirolimus‐ or paclitaxel‐eluting stents) or with BMS. Yearly follow‐up was performed. Results : At 87 months (7.25 years), a total of 101 patients died (58 [46%] in the BMS group and 43 [42%] in the DES group, P‐value= 0.4). There was no significant difference in the combined endpoint mortality or myocardial infarction. Cumulative target vessel revascularisation (TVR) was higher in the BMS group compared to the DES group (41% vs. 29%, respectively; adjusted hazard ratio [HR] 0.63, 95% confidence interval [CI]: 0.39–1.0). The cumulative incidence of major adverse cardiac events was 73% vs. 68% in the BMS and DES groups, respectively (adjusted HR 0.93, 95% CI: 0.67–1.3). Conclusions : In the present study, the unrestricted use of DES for SVG lesions appeared safe and effective up to 7.25 years‐ and the use of DES resulted in a clinically relevant lower rate of TVR. © 2011 Wiley Periodicals, Inc.