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.     

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.     

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.     

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.     

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.     

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.     

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.     

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.     

Comparison of a polymer‐free rapamycin‐eluting stent (YUKON) with a polymer‐based paclitaxel‐eluting stent (TAXUS) in real‐world coronary artery lesions

Background : In selected patient cohorts the polymer‐free rapamycin‐eluting YUKON stent (A) has demonstrated noninferiority compared with the polymer‐based paclitaxel‐eluting TAXUS stent (B). To test for equivalency in unselected real‐world patients with coronary lesions of various complexities, we retrospectively compared both stent designs. Methods : A total of 410 patients with symptomatic CAD were successfully treated with A (n = 205) or with B (n = 205). Baseline clinical characteristics, coronary lesion location, lesion length, and the number of stents implanted per lesion were equally distributed between the treatment groups. All patients underwent QCA‐analysis at baseline. Clinical follow‐up with assessment of MACE and noncardiac deaths was obtained at 30 days and 6 months. Results : Nominal stent diameter was 2.96 ± 0.38 mm in Group A vs. 3.05 ± 0.42 mm in Group B (P = 0.2); nominal length of stented segmentwas 22.97 ±13.0 mm vs. 23.63 ± 10.0 (P = 0.56). Analysis of MACE after 6 months resulted in one angiographically documented stent thrombosis causing MI in B (0.2%) vs. none in A. No other MI or cardiac deaths occurred in either group, while two noncardiac deaths in A (1.0%) were reported. Fifteen target lesion revascularizations (7.3%) were performed in A vs. 7 (3.4%) in B. Differences in study endpoints at 6 months did not reach statistical significance (P > 0.05). Conclusions : Up to 6 months after PCI of real‐world coronary lesions, there were no statistically significant differences in MACE between patients treated with the polymer‐free rapamycin‐eluting YUKON stent and the polymer‐based paclitaxel‐eluting TAXUS stent. © 2008 Wiley‐Liss, Inc.     

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.     

Comparison of 2‐year outcomes between zotarolimus‐eluting and everolimus‐eluting new‐generation cobalt–chromium alloy stents in real‐world diabetic patients

Background : To date, it remains unknown whether different types of new‐generation drug‐eluting stents have a differential impact on long‐term outcomes in diabetic patients. Methods and Results : In this historical cohort study (two Italian centers), we analyzed 400 diabetic patients with 553 coronary lesions treated with new‐generation CoCr zotarolimus‐eluting stents (R‐ZES: 136 patients, 196 lesions) or everolimus‐eluting stents (EES: 264 patients, 357 lesions) between October 2006 and August 2012. Primary endpoint was the occurrence of major adverse cardiac events (MACE) over a 2‐year follow‐up period. MACE was defined as all‐cause mortality, any myocardial infarction (MI) and/or target lesion revascularization (TLR). Multivessel revascularization, intervention for restenotic lesion and use of intravascular ultrasound were significantly higher in the R‐ZES group, whereas small stent (≤2.5 mm) deployment was significantly higher in the EES group. At 2‐year follow‐up, there was no significant difference in occurrence of MACE (R‐ZES vs EES: 22.8% vs 18.9%, P = 0.39). Similarly, no significant differences were observed in the composite endpoint of all‐cause mortality/MI (10.0% vs 10.3%, P = 0.86) or TLR (12.4% vs 7.4%, P = 0.11). Adjustment for confounders and baseline propensity‐score matching did not alter the aforementioned associations. Conclusion : After 2 years of follow up similar outcomes (MACE, all‐cause mortality/MI, TLR) were observed in real‐world diabetic patients, including those with complex lesions and patient characteristics, treated with R‐ZES and EES. © 2015 Wiley Periodicals, Inc.     

Long-term outcomes of sirolimus-eluting stents vs. paclitaxel-eluting stents in unprotected left main coronary artery bifurcation lesions

Background:

The treatment of unprotected left main coronary artery (uLMCA) bifurcation lesions remains challenging.

Hypothesis:

We hypothesized that the type of drug‐eluting stent would correlate with clinical outcomes for the treatment of uLMCA bifurcation lesions.

Methods:

One hundred fifteen patients who underwent stent implantation using a provisional T‐stenting technique with sirolimus‐eluting stents (SES) or paclitaxel‐eluting stents (PES) for uLMCA bifurcation lesions were enrolled. A major adverse cardiac event (MACE) was defined as a composite of cardiac death, myocardial infarction, or target lesion revascularization.

Results:

Ninety‐four patients were treated with SES and 21 patients with PES. Baseline characteristics were similar between the 2 groups. Angiographic follow‐up was performed in 99 (86%) patients. Late loss in the LMCA to the left anterior descending coronary artery was significantly lower in the SES group than in the PES group (0.28 ± 0.54 mm vs 1.03 ± 0.45 mm, P<0.001). One case of stent thrombosis occurred in the SES group. During follow‐up with a median of 712 days, the SES group had a lower MACE compared with the PES group (10.6% vs 28.6%, P = 0.032). Cox proportional hazards models including age, sex, diabetes, acute coronary syndrome, true bifurcation, stenting strategy, and type of drug‐eluting stent used (SES vs PES) demonstrated that stent type was the only predictor of MACE (hazard ratio of PES vs SES: 3.88, 95% confidence interval: 1.29–11.67, P = 0.016).

Conclusions:

According to the results of the present study, SES may be associated with more favorable outcomes than PES for stenting of uLMCA bifurcation, which should be further studied by larger trials. © 2011 Wiley Periodicals, Inc. The authors have no funding, financial relationships, or conflicts of interest to disclose.     

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.     

Clinical and angiographic outcomes with an everolimus‐eluting stent in large coronary arteries: The SPIRIT III 4.0 mm registry

Objective : This study evaluates the safety and efficacy of the XIENCE V® 4.0 mm stent for the treatment of de novo native coronary artery lesions. Background : In the SPIRIT III trial, the XIENCE V® everolimus‐eluting stent (EES), compared with the TAXUS EXPRESS² paclitaxel‐eluting stent (PES) in 2.5–3.75 mm diameter coronary arteries, resulted in reduced angiographic late loss (LL), noninferior rates of target vessel failure (TVF), and fewer major adverse cardiac events (MACE). Methods : The SPIRIT III 4.0 mm registry was a concurrent arm of the SPIRIT III trial consisting of 69 nonrandomized patients with lesions ≤28 mm in length and reference vessel diameter 3.75–4.25 mm treated with a 4.0 mm EES. The primary endpoint was 8‐month in‐segment LL compared with the randomized PES arm. Results : In‐segment LL was 0.17 ± 0.38 mm in the 4.0 mm EES registry compared with 0.28 ± 0.48 mm in the PES arm (P < 0.0001 for noninferiority). The 1‐year rates of ischemia‐driven TVF (cardiac death, myocardial infarction [MI], or target vessel revascularization) and MACE (cardiac death, MI, or target lesion revascularization [TLR]) were numerically, but not statistically, lower in the 4.0 mm EES patients compared with the randomized PES patients (5.9 vs. 11.3%, P = 0.27 and 5.9 vs. 10.3%, P = 0.36, respectively). There was no difference in 8‐month LL or 1‐year TVF or MACE between the 4.0 mm EES and randomized EES patients. Conclusions : In large coronary arteries, the 4.0 mm EES results in low rates of LL at 8 months and adverse clinical events at 1 year. © 2009 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.     

Evaluation of the effects of everolimus‐eluting and paclitaxel‐eluting stents on target lesions with jailed side branches: 2‐year results from the SPIRIT III randomized trial

Objective: To evaluate whether an everolimus‐eluting stent (EES) with thinner stent struts and polymer results in less periprocedural myonecrosis and adverse outcomes. Background: Higher periprocedural myocardial infarction (MI) rates have been reported with the TAXUS® EXPRESS² paclitaxel‐eluting stent (PES) compared to the bare metal EXPRESS²® stent due to more frequent side branch compromise, presumably attributable to the thickness of the stent/polymer on the PES. Methods: In the SPIRIT III trial, we identified 113 patients in the XIENCE V® EES group and 63 patients in the TAXUS EXPRESS² PES group who met the criteria of having a lesion with a jailed side branch (<2 mm diameter, and <50% stenosis). Two‐year clinical outcomes were evaluated. Results: A periprocedural increase in Creatine Kinase‐MB >1× upper normal level occurred in 9.0% of EES compared to 29.7% of PES patients with jailed side branches, P = 0.01. Through 2 years, major adverse cardiac events (MACE; cardiac death, MI, or target lesion revascularization [TLR]) occurred in 6.8% of EES and 19.0% of PES jailed side branch patients (P = 0.03), with numerically lower rates of MI (2.9% vs. 10.3%, P = 0.07) and TLR (3.9% vs. 10.3%, P = 0.17) in the EES group, with comparable rates of cardiac death (1.9% vs. 1.7%, P = 1.00). Conclusions: In this post‐hoc analysis of the SPIRIT III RCT, patients undergoing stenting of target lesions with jailed side branches with the thin strut and polymer XIENCE V EES compared to the thicker strut TAXUS PES had lower rates of MACE through 2 years due to fewer MIs and TLRs. © 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.     

Sirolimus versus paclitaxel coronary stents in clinical practice

Objectives: We aimed at comparing the long term clinical outcome of SES and PES in routine clinical practice. Background: Although sirolimus‐eluting stents (SES) more effectively reduce neointimal hyperplasia than paclitaxel‐eluting stents (PES), uncertainty prevails whether this difference translates into differences in clinical outcomes outside randomized controlled trials with selected patient populations and protocol‐mandated angiographic follow‐up. Methods: Nine hundred and four consecutive patients who underwent implantation of a drug‐eluting stent between May 2004 and February 2005: 467 patients with 646 lesions received SES, 437 patients with 600 lesions received PES. Clinical follow‐up was obtained at 2 years without intervening routine angiographic follow‐up. The primary endpoint was a composite of death, myocardial infarction (MI), or target vessel revascularization (TVR). Results: At 2 years, the primary endpoint was less frequent with SES (12.9%) than PES (17.6%, HR = 0.70, 95% CI 0.50–0.98, P = 0.04). The difference in favor of SES was largely driven by a lower rate of target lesion revascularisation (TLR; 4.1% vs. 6.9%, P = 0.05), whereas rates of death (6.4% vs. 7.6%, P = 0.49), MI (1.9% vs. 3.2%, P = 0.21), or definite stent thrombosis (0.6% vs. 1.4%, P = 0.27) were similar for both stent types. The benefit regarding reduced rates of TLR was significant in nondiabetic (3.6% vs. 7.1%, P = 0.04) but not in diabetic patients (5.6% vs. 6.1%, P = 0.80). Conclusions: SES more effectively reduced the need for repeat revascularization procedures than PES when used in routine clinical practice. The beneficial effect is maintained up to 2 years and may be less pronounced in diabetic patients. © 2010 Wiley‐Liss, Inc.     

Comparison of zotarolimus‐ versus everolimus‐eluting stents in the treatment of coronary bifurcation lesions

Objectives : To compare zotarolimus‐eluting stent (Endeavor Sprint®; ZES‐S) and the everolimus‐eluting stent (Xience V®; EES) in the treatment of coronary bifurcation lesions Background : Both these stents have demonstrated good outcomes in the treatment of coronary lesions. However, the outcomes with respect to treatment of bifurcation lesions have yet to be conclusively demonstrated. Methods : In this single centered, nonrandomized, open label study, we treated, between August 2006 and December 2008, 110 bifurcations with ZES‐S and, in a second stage of the study, 129 bifurcations with EES. The primary end point was to compare the rate of major adverse cardiac events (MACE) (death, myocardial infarction, and new target lesion revascularization) in‐hospital and at 12 months of follow‐up. Provisional T stenting was the strategy used in the majority of cases. Angiographic follow‐up was performed only in patients who presented signs or symptoms suggestive of angina or ischemia. Results : There were no significant differences in in‐hospital MACE between the groups (ZES‐S: 8.1%; EES: 6.2%; P = 0.5). At 12 months, the ZES‐S group had significantly more MACE than the EES group (23.1% vs. 4.5%; P < 0.001) and an elevated index of new revascularization of the bifurcation (17.5% vs. 3.2%; P < 0.001). There were no significant differences in mortality (four patients in ZES‐S vs. one in EES; P = 0.14). Conclusion : The treatment of coronary bifurcation lesions using everolimus‐eluting stents results in better outcomes at 12 months of follow‐up than zotarolimus‐eluting stents. © 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.