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.     

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)

     

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 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.     

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)     

Impact of renal insufficiency on safety and efficacy of drug‐eluting stents compared to bare‐metal stents at 6 years

Background : There is few information on the long‐term efficacy and safety of sirolimus‐eluting stents (SES) and paclitaxel‐eluting stents (PES) compared to bare metal stents (BMS) in all‐comer percutaneous coronary intervention (PCI)—patients complicated by renal insufficiency (RI). Objective : Our aim was to assess the 6‐year clinical outcome of PCI‐patients with RI treated exclusively with BMS, SES, or PES in our academic hospital. Methods: A total of 1382 patients, included in three cohorts of consecutive PCI‐patients (BMS = 392; SES = 498; PES = 492), were categorized by creatinine clearance calculated by the Cockroft–Gault formula (normal kidney function ≥ 90; mild RI = 60–89; moderate RI < 60) and systematically followed for the occurrence of major adverse cardiac events (MACE). Results : Mortality rates were significantly higher for patients with moderate RI compared to mild RI and normal kidney function at 6 years (Kaplan–Meier estimate: moderate RI (34%) vs. mild RI (12%), P < 0.001; moderate RI (34%) vs. normal kidney function (8%), P < 0.001). After multivariate Cox‐regression analysis, SES and PES decreased the occurrence of target‐vessel revascularization (TVR) and MACE at 6 years in patients with a normal creatinine clearance compared to BMS [adjusted hazard ratio (aHR) = 0.48, 95% CI: 0.28–0.84; aHR = 0.75, 95% CI: 0.57–0.97, respectively] with no significant effect on mortality. Safety‐ and efficacy end points were comparable for the three stent types in patients with mild‐ and moderate renal function. Conclusion : Patients with a normal creatinine clearance had significant improvement in TVR and MACE rates after SES‐ or PES implantation compared to BMS at 6 years. However, there was no superiority of both drug‐eluting stents over BMS in safety and efficacy end points for patients with impaired renal function. © 2012 Wiley Periodicals, Inc.     

Decreased risk of stent fracture‐related restenosis between paclitaxel‐eluting stents and sirolimus eluting stents: Results of long‐term follow‐up

Objective: To compare the outcomes between paclitaxel‐eluting stents (PES) and sirolimus‐eluting stents (SES) for the treatment of drug‐eluting stent (DES) fracture. Background: DES fracture is considered as an important predictor of in‐stent restenosis (ISR). However, little data are available evaluating the optimal treatment for this complication of coronary stenting. Methods: From January 1, 2004 to December 31, 2008, patients with DES ISR treated with a second DES were identified and evaluated for stent fracture. Stent fracture was defined by the presence of strut separation in multiple angiographic projections, assessed by two independent reviewers. Target lesion revascularization (TLR) at 6 and 12 months were the primary end points. Results: Of 131 lesions with DES ISR treated with a second DES, we found 24 patients (24 lesions, 18.2%) with angiographically confirmed stent fracture. Of these, 20 patients (20 lesions) treated with either PES (n = 11/55%) or SES (n = 9/45%) were included in the study. TLR at 6 months occurred in 9% of patients treated with PES and 22% of those treated with SES (P = 0.41). After 12 months, TLR was 9% and 55.5%, respectively (P = 0.024). Conclusions: This study demonstrates a high incidence of stent fracture in patients presenting with DES ISR in need of further treatment with another DES. The suggested association between treatment of stent fracture‐associated DES ISR with PES as compared with SES, and better long‐term outcomes, is in need of confirmation by larger prospective registries and randomized trials. © 2011 Wiley Periodicals, 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 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.     

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.     

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.     

Treatment of coronary bifurcation lesions with drug-eluting stents: insights from the first phase of the prospective multicenter german drug-eluting stent registry

Background: Controversy exists about the impact of treating bifurcations on overall outcome of coronary interventions using drug‐eluting stents (DES). We sought to investigate 1‐year outcome of the treatment of bifurcation lesions using DES in a large “real‐world” cohort. Methods and Results: Among 5,126 patients enrolled in phase I of the multicenter German Drug‐Eluting Stent Registry, 814 (16%) were treated for a bifurcation lesion. Patients with bifurcations were compared to those without bifurcations in terms of baseline characteristics, major adverse cardiac and cerebrovascular events (MACCE) and target vessel revascularization (TVR) at 1 year. Usage of sirolimus‐eluting stents (SES) versus paclitaxel‐eluting stents (PES) was also evaluated. In total, 1,021 and 5,189 stents were implanted in the bifurcation (1.25 stents/patient) and nonbifurcation (1.2 stents/patient) group, respectively, but 64.5% of bifurcation lesions were treated with a single stent. More complex lesion and procedural characteristics were observed in the bifurcation group. However, there was no difference in 1‐year MACCE rates (a composite of death, myocardial infarction, and stroke) between the bifurcation group and nonbifurcation group (8.1% vs. 8.3%, P = 0.85). Rates of TVR (11.2% vs. 10.8%, P = 0.75) and Academic Research Consoritum‐defined definite stent thrombosis (0.9% vs. 0.8%, P = 0.67) were also comparable. MACCE and TVR rates remained similar after adjustment for differences in baseline characteristics. MACCE and TVR in SES patients were 7.2% and 12.6% versus 8.7% and 10.2% in PES patients (P = 0.46 and P = 0.30, respectively). Conclusion: In this large multicenter registry, treatment of bifurcation lesions with DES appears effective and safe. The presence of bifurcations did not affect 1‐year outcomes after DES implantation. The outcomes for SES and PES were similar. (J Interven Cardiol 2012;25:344–352)     

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‐ 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 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.     

Difference of neointimal growth patterns in bifurcation lesions among four kinds of drug‐eluting stents

Aim: Neointimal proliferation of bifurcation lesions after implantation of drug‐eluting stents (DES) has not been well evaluated. Thus, we compared neointimal proliferation of bifurcation lesions among four DES using optical coherence tomography (OCT). Methods: 8‐month follow‐up OCT was performed in 68 bifurcation lesions treated by 15 sirolimus‐eluting stents (SES) and 17 paclitaxel‐eluting stents (PES) as first‐generation DES, and by 17 zotarolimus‐eluting stents (ZES) and 19 everolimus‐eluting stents (EES) as second‐generation DES. Cross‐sectional images of the bifurcation lesion using OCT were analyzed every 450 µm. All images were divided into three areas: inner wall of the bifurcation (IB), outer wall of the bifurcation (OB), and ostium of the side branch (SB). We compared the incidence of uncovered struts (IUS) among three areas and the averaged neointimal thickness (NIH) between IB and OB in each stent and also compared these OCT parameters among all DES. Results: There were no significant differences of IUS between IB and OB in second‐generation DES, while in first‐generation DES, IUS of IB and OB showed significant differences. The IUS of SES in both areas was significantly higher than in the other DES (all P < 0.001). PES had a significantly higher IUS in SB than the others (all P < 0.001). NIH of OB was significantly higher than that of IB in PES, ZES, and EES, but in SES the NIH was similar in the two areas. Conclusions: OCT revealed different neointimal growth patterns among SES, PES, ZES, and EES in bifurcation lesions. © 2014 Wiley Periodicals, Inc.     

Comparison between sirolimus- and paclitaxel-eluting stents for the treatment of older patients affected by coronary artery disease: results from a single-center allcomers registry

The treatment of elderly patients with coronary artery disease (CAD) is challenging because this population is complex and greatly expanding. Drug-eluting stents (DES) generally improve the outcome in high-risk cases. We evaluated the clinical impact of different first-generation DES, i.e., sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), in this context. A prospective, nonrandomized, single-center, allcomers registry consecutively enrolling all patients aged ≥75 years eligible for percutaneous coronary intervention (PCI) with DES was carried out. Only one type of DES was implanted per protocol for each patient. Two groups were identified according to the type of implanted stent, i.e., SES and PES. The primary end point encompassed major adverse cardiac events (MACE), including death, myocardial infarction, and target lesion revascularization (TLR). The secondary end point encompassed the rate of definite/probable stent thrombosis and target vessel revascularization (TVR). From June 2004 to May 2008, 151 patients were enrolled. Among them, 112 (74.2%) received SES and 39 (25.8%) received PES. Baseline clinical characteristics were similar, while few angiographic features (ostial location, stent diameter, proximal reference vessel diameter) showed minor differences. At the median follow-up of 22.6 months, primary and secondary end points did not significantly differ in terms of MACE (SES 12.5% vs PES 20.5%, P = 0.3), death (SES 5.4% vs PES 7.7%, P = 0.7), myocardial infarction (SES 4.5% vs PES 10.3%, P = 0.2), TLR (SES 2.7% vs PES 2.6%, P = 1.0), stent thrombosis (SES 1.8% vs PES 5.1%, P = 0.3), and TVR (SES 1.8% vs PES 0%, P = 0.6). In this real-world population of elderly patients treated by DES–PCI for CAD, the overall efficacy and safety have been excellent in both DES, and the choice between SES and PES did not influence the clinical outcome.     

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.     

Multivessel drug‐eluting stenting and impact of diabetes mellitus—A report from the EVENT registry

Objectives: To compare clinical outcomes in patients with and without diabetes after multivessel percutaneous coronary intervention (PCI). Background: Diabetes is associated with significantly worse outcomes after multivessel PCI and coronary bypass surgery is recommended as the preferred option for these patients. Methods and Results: The Evaluation of Drug Eluting Stents and Ischemic Events registry is a multicenter evaluation of acute and 1 year outcomes in unselected patients undergoing PCI since approval of drug‐eluting stents (DES). Major adverse cardiac events (MACE) were defined as all cause mortality, myocardial infarction, or repeat revascularization and rate was estimated by Kaplan‐Meier method and compared using log‐rank. The independent correlates of MACE were determined using Cox proportional hazards regression. Of 4,819 nonemergency native coronary DES procedures, 1,595 (33.1%) were in patients with diabetes and 722 (11.7%) involved >1 vessel. Of patients undergoing multivessel procedures, diabetes was present in 256 (35.5%). One year after multivessel PCI, MACE was similar for patients with or without diabetes (22.3% versus 21.2%, log‐rank test P = 0.85). The independent correlates of 1 year MACE were female sex (Hazard ratio [HR], 1.58, 95% CI 1.14–2.20), ejection fraction (HR 0.74 per group [<25%, 26–35%, 36–50%, and >50%], 95%CI 0.59–0.94) and number of stents (HR 1.20 per stent, 95%CI 1.04–1.38) but not diabetes (HR 1.00, 95% CI 0.71–1.39). Conclusions: Multivessel DES is performed commonly in patients with diabetes with outcomes at 1 year similar to patients without diabetes. Longer follow‐up is required to more fully evaluate the safety and effectiveness of this strategy. © 2009 Wiley‐Liss, Inc.