Everolimus-eluting Stent Group Research Articles

2925Four-year clinical outcome following randomised use of zotarolimus-eluting stents versus everolimus-eluting stents in all-comers: insights from the DUTCH PEERS trial

Background: The DUTCH PEERS (TWENTE II) trial (clinicaltrials.gov NCT01331707) is a randomised, multicenter, single-blinded, investigator initiated all-comers trial. All coronary syndromes were permitted with no limit for lesion length, reference size, or number of lesions or diseased vessels to be treated. In total, 1811 patients were 1:1 randomised to cobalt chromium-based zotarolimuseluting stents (ZES) versus platinum chromium-based everolimus-eluting stents (EES). These durable polymer-based drug-eluting stents (DES) were developed to facilitate device deliverability and to improve stent apposition to the vessel wall. Purpose: We assessed the 4-year clinical outcome of the DUTCH PEERS trial in terms of safety and efficacy. Methods: Clinical outcome was assessed by means of follow-up data of the trial participants. The primary endpoint target vessel failure (TVF) is a composite of cardiac death, target vessel-related myocardial infarction (MI) or target vessel revascularization. Secondary endpoints included the individual components of the TVF and the incidence of definite-or-probable stent thrombosis. Endpoints were analyzed by the logrank test by comparing the time to the endpoint, using the Kaplan-Meier method. Independent contract research organizations performed the study monitoring and clinical event adjudication. Results: The 4-year clinical follow-up data were available in 1802 patients (99.5%; 4 patients were lost to follow-up and 5 withdrew consent). The ZES and EES groups showed favourable outcomes with a similar incidence of TVF (12.1% vs. 12.1%; Logrank p=0.95). The rates of the individual components of TVF were also similar for both stent arms: cardiac death (3.9% vs. 3.7%; Logrank p=0.78); target vessel-related MI (3.2% vs. 2.5%; Logrank p=0.38); and target vessel revascularization (6.8% vs. 7.5%; Logrank p=0.55), respectively. In addition, the incidence of definite-or-probable stent thrombosis was similar for patients treated with ZES versus EES (1.5% vs. 1.2%; Logrank p=0.67). Conclusion: At 4-year follow-up, ZES and EES showed similar and sustained results in terms of safety and efficacy for treating all-comer patients.

Abstract 148: Difference in Neointimal Coverage Pattern Between Zotarolimus Eluting Stents and Everolimus Eluting Stents Using Optical Coherence Tomography: A Meta-Analysis

Background: Late stent thrombosis in drug eluting stents (DES) is attributed to poor endothelialization of struts. Second generation DES have shown superior safety profile and efficacy in comparison to first generation DES. We conducted a meta-analysis to compare the neointimal coverage patterns between Zotarolimus eluting stents (ZES) and Everolimus eluting stents (EES) using optical coherence tomography (OCT). Methods: We searched online databases for studies comparing the neointimal thickness (NIT), %malapposed strut per stent (MSS) or % uncovered strut per stent (USS) between ZES and EES using OCT. Studies included inte mmeta-analysis, OCT was performed >6 months after stent deployment. A calculation of weighted standardized mean difference (SMD) in NIT, MSS and USS between ZES and EES groups was calculated. Residual maximum likelihood (REML) metaregression was performed on smokers, diabetes mellitus (DM), hypertension, (HTN) dyslipidemia (DLD), and age and sex covariates. Results: A total of 6 studies enrolling 327 patients which met inclusion criteria were included in the meta-analysis. 400 stents including 184 ZES and 216 EES were analyzed by OCT. The median of mean age in years, male sex, smokers, DM, HTN and DLD in the ZES group was 60.7(59.5 - 60.9), 76.7% (71.4 - 77.3), 38.7% (18.2 - 45.8), 36.4% (23.3 - 37.5), 63.6% (60 - 66.6), 66.7% (47.9 - 68.4) versus 62.6(59.8 - 65.3), 63.9% (63.6 - 82.1), 30% (17.2 - 47.2), 31.8% (25 - 36.1), 69.4% (59.1 - 75.9), 70% (48.9 - 70.7) in the EES group respectively. The unweighted median NIT, MSS and USS in the ZES group are 127.5 μm (108.8 - 152.2), 0.7% (0.7 - 0.9), 1.8% (0.2 - 3.5) vs 117.4 μm (108.5 - 128.5), 0.3% (0.2 - 1.3), 2.3% (0.9 - 3.5) in the EES group respectively. The weighted SMD of NIT, MSS and USS in the ZES vs EES groups are -0.22 (95%CI -1.12; 0.67) P = 0.63, -0.51(95% CI -1.78; 0.77), P = 0.44, -1.26 (95%CI -2.83; 0.31). None of the above mentioned covariates accounted for statistical insignificance except age for NIT. As age increases, the SMD increases for NIT and was not significant for MSS and USS. Conclusion: No significant difference was noted in the NIT, MSS and USS between both groups. This suggests that the neointimal coverage patterns are similar in ZES and EES groups.

Bioresorbable scaffolds compared with everolimus-eluting stents for the treatment of chronic coronary total occlusion

Data on bioresorbable vascular scaffolds for recanalization of chronic total occlusions (CTOs) are limited. We compared the bioresorbable scaffold Absorb with everolimus-eluting stents for the treatment of true CTO. After recanalization of CTO, 15 lesions treated with the bioresorbable scaffold Absorb were matched with 15 lesions receiving everolimus-eluting stent (EES) (http://www.clinicaltrials.gov NCT02162082). Match criteria were presence of diabetes mellitus, total device length and maximal device diameter. Angiographic follow-up was scheduled after 9 months and clinical follow-up after 12 months. Dual antiplatelet therapy was administered for 12 months. Quantitative coronary analysis was carried out before and after implantation and at angiographic follow-up. All lesions were predilated. The Absorb scaffolds and drug-eluting stents were carefully placed and postdilatated with high-pressure balloons. Patients received dual antiplatelet therapy for 12 months. The baseline characteristics were similar between both the groups. The mean scaffold length was 81.7±29.1 versus 79.3±27.4 mm for the mean stent length (P=0.82). In-device late lumen loss at the 9-month follow-up was 0.38±0.47 versus 0.46±0.60 mm (P=0.69). The device-oriented composite endpoint was similar in both groups, with 6.7% in the Absorb-group versus 13.3% in the EES group because of target lesion revascularization (P=0.54). In CTOs, the use of a bioresorbable scaffold Absorb after recanalization showed similar 9-month angiographic and 12-month clinical results compared with an EES with 12 months of dual antiplatelet therapy.

Randomized Multicenter Trial Investigating Angiographic Outcomes of Hybrid Sirolimus-Eluting Stents With Biodegradable Polymer Compared With Everolimus-Eluting Stents With Durable Polymer in Chronic Total Occlusions: The PRISON IV Trial

ObjectivesThe aim of this study was to investigate the efficacy and safety of the hybrid ultrathin-strut sirolimus-eluting stent (SES) with biodegradable polymer compared with the thin-strut everolimus-eluting stent (EES) with durable polymer in successfully recanalized chronic total occlusions (CTOs). BackgroundThe introduction of drug-eluting stents revolutionized the treatment of CTOs. However, limited data are available on new-generation drug-eluting stents with biodegradable polymer in CTOs. MethodsIn this multicenter trial, patients were randomized, after successful CTO recanalization, to either SES or EES. The primary noninferiority endpoint was in-segment late lumen loss (noninferiority margin 0.2 mm). Secondary endpoints included in-stent late lumen loss and clinical endpoints. ResultsOverall, 330 patients were included. At 9 months, angiography was available in 281 patients (85%). Duration of occlusion ≥3 months was 92.5%, with mean stent length of 52.4 ± 28.1 mm versus 52.3 ± 26.5 mm in the SES and EES groups. The primary noninferiority endpoint, in-segment late lumen loss, was not met for SES versus EES (0.13 ± 0.63 mm vs. 0.02 ± 0.47 mm; p = 0.08, 2-sided; difference 0.11 mm; 95% confidence interval: −0.01 to 0.25 mm; pnoninferiority = 0.11, 1-sided). In-stent late lumen loss was comparable between SES and EES (0.12 ± 0.59 mm vs. 0.07 ± 0.46 mm; p = 0.52). The incidence of in-stent and in-segment binary restenosis was significantly higher with SES compared with EES (8.0% vs. 2.1%; p = 0.028), with comparable rates of reocclusions (2.2% vs. 1.4%; p = 0.68). Clinically indicated target lesion and target vessel revascularization (9.2% vs. 4.0% [p = 0.08] and 9.2% vs. 6.0% [p = 0.33]), target vessel failure (9.9% vs. 6.6%; p = 0.35), and definite or probable stent thrombosis (0.7% vs. 0.7%; p = 1.00) were comparable between the SES and EES groups. ConclusionsThis randomized trial failed to show noninferiority of hybrid SES relative to EES in terms of in-segment late lumen loss in successfully recanalized CTOs. Furthermore, a statistically significantly higher rate of binary restenosis was found with SES.

Efficacy of everolimus-eluting stent implantation in patients with small coronary arteries (≤2.5 mm): outcomes of 3-year clinical follow-up

Previous studies have demonstrated that patients with small coronary artery lesions are at increased risk for late cardiac events after percutaneous coronary intervention. It remains uncertain whether second-generation drug-eluting stents have an advantage over first-generation drug-eluting stents in patients with small vessel lesions. Our aim was to compare in the 3-year clinical impact between second-generation everolimus-eluting stents (EES) and first-generation sirolimus-eluting stents (SES) in small vessel lesions. Four-hundred forty-four patients with small vessel lesions defined as reference diameter <2.5mm were treated with EES (237 patients, 265 lesions) or SES (207 patients, 220 lesions) and completed 3-year follow-up. We compared the major adverse clinical events (MACE) between the two groups. EES had no significant impact on the MACE rate compared with SES (4.6 vs. 7.2%, p=0.14). No significant differences were observed in the individual components of cardiac death (1.7 vs. 1.9%, p=0.78), myocardial infarction (1.3 vs. 3.4%, p=0.12), and ischemia-driven target lesion revascularization (2.3 vs. 4.6%, p=0.13) in EES and SES, respectively. Stent thrombosis, however, was significantly less in the EES group than in the SES group (0.7 vs. 3.4%, HR: 0.53, 95% CI 0.38-0.88, p<0.05). EES implantation did not significantly impact 3-year MACE rates compared to SES implantation in small vessel lesions. A significant reduction in the overall rate of stent thrombosis was observed in recipients of EES. While the SES group showed increasing rates of late and very late thrombosis, the EES group did not. EES offers a safe and effective treatment for small vessel lesions.

Prospective randomized comparison of clinical and angiographic outcomes between everolimus-eluting vs. zotarolimus-eluting stents for treatment of coronary restenosis in drug-eluting stents: intravascular ultrasound volumetric analysis (RESTENT-ISR trial).

At present no proven standard treatment for drug-eluting stent (DES) restenosis is available, and the efficacy and safety of everolimus-eluting stent (EES) and zotarolimus-eluting stent (ZES) for DES restenosis are limited. The purpose of this prospective, randomized 9-month intracoronary ultrasound (IVUS) and 3-year clinical follow-up study was to compare the effects of EESs and ZESs on neointima volume and major adverse cardiovascular events (MACEs) such as death, myocardial infarction (MI), target lesion revascularization (TLR) and stent thrombosis in DES restenosis patients. Patients were eligible for this study if they were between 40 and 75 years old with in-stent restenosis >50% by quantitative coronary angiographic analysis in DES or within 5 mm of the stent edges with signs of ischaemia. Eligible patients (n = 304, 146 women and 158 men) were randomly assigned to receive either EES (158 patients) or ZES (146 patients). The primary endpoint of the study was to compare neointima volume between the EES and ZES groups at the 9-month follow-up IVUS. MACEs, including death, non-fatal MI, stent thrombosis and the need for repeated TLR within 3 years, were noted. The 9-month angiographic and IVUS follow-up showed no significant differences in late lumen loss (0.40 ± 0.56 vs. 0.45 ± 0.61 mm, P = 0.57, respectively) and neointima volume (0.51 ± 0.48 vs. 0.56 ± 0.54 mm3/1 mm, P = 0.47, respectively) in the EES and the ZES groups. Composite MACEs such as death, MI, stent thrombosis and TLR during 3-year follow-up were comparable between the two groups [15.8% (n = 25) in the EES group and 22.6% (n = 33) in the ZES group, P = 0.276], independent of de novo DES type, sex, age, body mass index, presence of diabetes, hypertension and dyslipidaemia. Patients with first- and second-generation DES restenosis, both EES and ZES implantation were effective and safe in reducing neointima volume and late loss with a comparable rate of MACEs independent of cardiovascular risk factors.

State of the art in coronary revascularization: Everolimus eluting stents versus multiple arterial grafting

BackgroundContemporary comparisons on coronary revascularization should take into account the state of the art percutaneous coronary intervention (PCI) with new generation everolimus-eluting stents (EESs) and coronary artery bypass grafting (CABG) with multiple arterial grafts (MAGs). We aimed to compare early outcomes and late survival after EES versus MAG in patients with multivessel coronary artery disease using a single centre institutional database. MethodsIn an observational registry study, we identified 3787 patients with multivessel coronary disease. Of these 696 (18.3%) underwent PCI with EES and 3091 (81.7%) CABG with MAG. With the use of propensity-score matching, we identified 483 pairs for final comparison (C-statistic: 0.91). ResultsThe two groups were comparable for 30-day mortality (1.6% versus 0.8% in the EES and MAG group respectively, P=0.38). Stroke was not observed in the EES group and it was 0.8% in the MAG group (P=0.13). After a mean follow-up of 3.1years, PCI with EES was associated with a higher risk of late death (HR 2.2; 95% CI 1.18–4.16; P=0.01). ConclusionsIn patients with multivessel coronary disease, CABG with multiple arterial grafts when compared with PCI with new generation drug eluting stent, was associated with significantly improved long-term survival. Further randomized studies are warranted to identify the best revascularization strategies in the current era.

The Impact of Post-Procedural Asymmetry, Expansion, and Eccentricity of Bioresorbable Everolimus-Eluting Scaffold and Metallic Everolimus-Eluting Stent on Clinical Outcomes in the ABSORB II Trial

The study sought to investigate the relationship between post-procedural asymmetry, expansion, and eccentricity indices of metallic everolimus-eluting stent (EES) and bioresorbable vascular scaffold (BVS) and their respective impact on clinical events at 1-year follow-up. Mechanical properties of a fully BVS are inherently different from those of permanent metallic stent. The ABSORB II (A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions) trial compared the BVS and metallic EES in the treatment of a de novo coronary artery stenosis. Protocol-mandated intravascular ultrasound imaging was performed pre- and post-procedure in 470 patients (162 metallic EES and 308 BVS). Asymmetry index (AI) was calculated per lesion as: (1- minimum scaffold/stent diameter/maximum scaffold/stent diameter). Expansion index and optimal scaffold/stent expansion followed the definition of the MUSIC (Multicenter Ultrasound Stenting in Coronaries) study. Eccentricity index (EI) was calculated as the ratio of minimum and maximum scaffold/stent diameter per cross section. The incidence of device-oriented composite endpoint (DoCE) was collected. Post-procedure, the metallic EES group was more symmetric and concentric than the BVS group. Only 8.0% of the BVS arm and 20.0% of the metallic EES arm achieved optimal scaffold/stent expansion (p< 0.001). At 1 year, there was no difference in the DoCE between both devices (BVS 5.2% vs. EES 3.1%; p= 0.29). Post-procedural devices asymmetry and eccentricity were related to higher event rates while there was no relevance to the expansion status. Subsequent multivariate analysis identified that post-procedural AI >0.30 is an independent predictor of DoCE (hazardratio: 3.43; 95% confidence interval: 1.08 to 10.92; p= 0.037). BVS implantation is more frequently associated with post-procedural asymmetric and eccentric morphology compared to metallic EES. Post-procedural devices asymmetry were independently associated with DoCE following percutaneous coronary intervention. However, this approach should be viewed as hypothesis generating duetolow event rates. (ABSORB II Randomized Controlled Trial [ABSORB II]; NCT01425281).

Biodegradable-Polymer Biolimus-Eluting Stents versus Durable-Polymer Everolimus-Eluting Stents at One-Year Follow-Up: A Registry-Based Cohort Study.

We compared outcomes of percutaneous coronary intervention patients who received biodegradable-polymer biolimus-eluting stents with those who received durable-polymer everolimus-eluting stents. At Tehran Heart Center, we performed a retrospective analysis of the data from January 2007 through December 2011 on 3,270 consecutive patients with coronary artery disease who underwent percutaneous coronary intervention with the biodegradable-polymer biolimus-eluting stent or the durable-polymer everolimus-eluting stent. We excluded patients with histories of coronary artery bypass grafting or percutaneous coronary intervention, acute ST-segment-elevation myocardial infarction, or the implantation of 2 different stent types. Patients were monitored for 12 months. The primary endpoint was a major adverse cardiac event, defined as a composite of death, nonfatal myocardial infarction, and target-vessel and target-lesion revascularization. Durable-polymer everolimus-eluting stents were implanted in 2,648 (81%) and biodegradable-polymer biolimus-eluting stents in 622 (19%) of the study population. There was no significant difference between the 2 groups (2.7% vs 2.7%; P=0.984) in the incidence of major adverse cardiac events. The cumulative adjusted probability of major adverse cardiac events in the biodegradable-polymer biolimus-eluting stent group did not differ from that of such events in the durable-polymer everolimus-eluting stent group (hazard ratio=0.768; 95% confidence interval, 0.421-1.44; P=0.388). We conclude that in our patients the biodegradable-polymer biolimus-eluting stent was as effective and safe, during the 12-month follow-up period, as was the durable-polymer everolimus-eluting stent.

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up.

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3%, p<0.05; TVR 2.5 vs. 9.4%, p<0.05; recurrent MI 1.0 vs. 4.1%, p<0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3%, p<0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9%, p=0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes-specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2years.

Clinical outcomes in patients with ST-segment elevation myocardial infarction treated with everolimus-eluting stents versus bare-metal stents (EXAMINATION): 5-year results of a randomised trial

Data for the safety and efficacy of new-generation drug-eluting stents at long-term follow-up, and specifically in patients with ST-segment elevation myocardial infarction, are scarce. In the EXAMINATION trial, we compared everolimus-eluting stents (EES) with bare-metal stents (BMS) in an all-comer population with ST-segment elevation myocardial infarction. In this study, we assessed the 5-year outcomes of the population in the EXAMINATION trial. In the multicentre EXAMINATION trial, done in Italy, Spain, and the Netherlands, patients with ST-segment elevation myocardial infarction were randomly assigned in a 1:1 ratio to receive EES or BMS. The random allocation schedule was computer-generated and central randomisation (by telephone) was used to allocate patients in blocks of four or six, stratified by centre. Patients were masked to treatment assignment. At 5 years, we assessed the combined patient-oriented outcome of all-cause death, any myocardial infarction, or any revascularisation. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00828087. 1498 patients were randomly assigned to receive either EES (n=751) or BMS (n=747). At 5 years, complete clinical follow-up data were obtained for 731 patients treated with EES and 727 treated with BMS (97% of both groups). The patient-oriented endpoint occurred in 159 (21%) patients in the EES group versus 192 (26%) in the BMS group (hazard ratio 0·80, 95% CI 0·65-0·98; p=0·033). This difference was mainly driven by a reduced rate of all-cause mortality (65 [9%] vs 88 [12%]; 0·72, 0·52-0·10; p=0·047). Our findings should be taken as a point of reference for the assessment of new bioresorbable polymer-based metallic stents or bioresorbable scaffolds in patients with ST-segment elevation myocardial infarction. Spanish Heart Foundation.

Paclitaxel-Eluting versus Everolimus-Eluting Coronary Stents in Diabetes

BackgroundThe choice of drug-eluting stent in the treatment of patients with diabetes mellitus and coronary artery disease who are undergoing percutaneous coronary intervention (PCI) has been debated. Previous studies comparing paclitaxel-eluting stents with stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) have produced contradictory results, ranging from equivalence between stent types to superiority of everolimus-eluting stents.MethodsWe randomly assigned 1830 patients with diabetes mellitus and coronary artery disease who were undergoing PCI to receive either a paclitaxel-eluting stent or an everolimus-eluting stent. We used a noninferiority trial design with a noninferiority margin of 4 percentage points for the upper boundary of the 95% confidence interval of the risk difference. The primary end point was target-vessel failure, which was defined as a composite of cardiac death, target-vessel myocardial infarction, or ischemia-driven target-vessel revascularization at the 1-year follow-up.ResultsAt 1 year, paclitaxel-eluting stents did not meet the criterion for noninferiority to everolimus-eluting stents with respect to the primary end point (rate of target-vessel failure, 5.6% vs. 2.9%; risk difference, 2.7 percentage points [95% confidence interval, 0.8 to 4.5]; relative risk, 1.89 [95% confidence interval, 1.20 to 2.99]; P=0.38 for noninferiority). There was a significantly higher 1-year rate in the paclitaxel-eluting stent group than in the everolimus-eluting stent group of target-vessel failure (P=0.005), spontaneous myocardial infarction (3.2% vs. 1.2%, P=0.004), stent thrombosis (2.1% vs. 0.4%, P=0.002), target-vessel revascularization (3.4% vs. 1.2%, P=0.002), and target-lesion revascularization (3.4% vs. 1.2%, P=0.002).ConclusionsIn patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO–India Clinical Trials Registry–India number, CTRI/2011/06/001830).

Incidence and Characteristics of Late Catch‐Up Phenomenon Between Sirolimus‐Eluting Stent and Everolimus‐Eluting Stent: A Propensity Matched Study

We evaluated and compared the incidence and characteristics of late catch-up phenomenon (LCU) between everolimus-eluting stent (EES) and sirolimus-eluting stent (SES) implantations. Late catch-up phenomenon after everolimus-eluting stent (EES) implantation has not yet been evaluated sufficiently. Between April 2007 and May 2011, 1,234 patients with coronary artery disease were treated with SES and 502 patients with EES. Following propensity score matching, we evaluated 495 SES-treated patients and 495 ESS-treated patients. The incidences of LCU (i.e., late target lesion revascularization [TLR] [1-3 years]) were compared. The cumulative incidence of TLR at 3 years was 11.9% in the SES group and 6.1% in the EES group (P = 0.001). The incidence of late TLR was 7.5% in the SES group and 3.4% in the EES group (P = 0.004). Even though not statistically significant, intravascular ultrasound showed a higher tendency of stent fracture (SF) in late restenosis lesions in the SES group than in the EES group (37.0% vs 7.7%; P = 0.052). Moreover, the SF rate tended to increase in late restenosis compared with early restenosis (within 1 year) in the SES group compared with the EES group (SES: 37.0% vs 22.2%; P = 0.293, EES: 7.7% vs 10.0%; P = 0.846), although the increase was not significantly different. EES was superior to SES in terms of LCU. SF may be associated with LCU after SES implantation.

Two-year clinical outcome in patients with small coronary artery disease treated with everolimus- versus paclitaxel-eluting stenting

BackgroundPercutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the 2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. MethodsFrom the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. ResultsThe 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p=0.01) and target vessel revascularization (8.0% vs. 13.9%, p=0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p=0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p>0.99). ConclusionEES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.

Differences in Vessel Healing Between Sirolimus- and Everolimus-Eluting Stent Implantation for Bifurcation Lesions: The J-REVERSE Optical Coherence Tomography Substudy

BackgroundWe aimed to clarify the differences in vessel healing after stenting of bifurcation lesions using sirolimus-eluting stents (SESs) or everolimus-eluting stents (EESs). MethodsJapanese Registry Study in Comparison Between Everolimus-Eluting Stent and Sirolimus-Eluting Stent for the Bifurcation Lesion (J-REVERSE) is a prospective multicentre registry of 303 bifurcation lesions that were treated with provisional SES or EES with or without final kissing inflation. The first 115 lesions at selected study sites were predefined for inclusion in the optical coherence tomography (OCT) substudy, and 9-month follow-up OCT was conducted in 64 lesions (SES, n = 18; EES, n = 46). In addition to standard OCT parameters, stent eccentricity index (SEI; minimum divided by the maximum stent diameter), neointimal unevenness score (NUS; maximum neointimal thickness in the cross-section [CS] divided by the average neointimal thickness [NIT] of the same CS; uniformity of the neointima suppression) were averaged for each segment (proximal, bifurcation, and distal segments). ResultsOverall, the average stent and luminal area, NIT, and frequency of uncovered struts were similar. The frequency of malapposed struts and SEI were significantly lower in the EES group than in the SES group. The EES group had a significantly smaller NUS in the proximal and distal segments. ConclusionsEESs offer homogeneous vessel healing with less malapposition in the treatment of bifurcation lesions.

Clinical outcomes in low risk coronary artery disease patients treated with different limus-based drug-eluting stents--a nationwide retrospective cohort study using insurance claims database.

The clinical outcomes of different limus-based drug-eluting stents (DES) in a real-world setting have not been well defined. The aim of this study was to investigate the clinical outcomes of three different limus-based DES, namely sirolimus-eluting stent (SES), Endeavor zotarolimus-eluting stent (E-ZES) and everolimus-eluting stent (EES), using a national insurance claims database. We identified all patients who received implantation of single SES, E-ZES or EES between January 1, 2007 and December 31, 2009 from the National Health Insurance claims database, Taiwan. Follow-up was through December 31, 2011 for all selected clinical outcomes. The primary end-point was all-cause mortality. Secondary end-points included acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. Cox regression model adjusting for baseline characteristics was used to compare the relative risks of different outcomes among the three different limus-based DES. Totally, 6584 patients were evaluated (n=2142 for SES, n=3445 for E-ZES, and n=997 for EES). After adjusting for baseline characteristics, we found no statistically significant difference in the risk of all-cause mortality in three DES groups (adjusted hazard ratio [HR]: 1.14, 95% confidence interval [CI]: 0.94-1.38, p=0.20 in E-ZES group compared with SES group; adjusted HR: 0.77, 95% CI: 0.54-1.10, p=0.15 in EES group compared with SES group). Similarly, we found no difference in the three stent groups in risks of acute coronary events, heart failure needing hospitalization, and cerebrovascular disease. In conclusion, we observed no difference in all-cause mortality, acute coronary events, heart failure needing hospitalization, and cerebrovascular disease in patients treated with SES, E-ZES, and EES in a real-world population-based setting in Taiwan.

Clinical outcomes of chronic kidney disease patients treated with everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES)

BackgroundThe target lesion revascularization of paclitaxel-eluting stents (PES) has been reported to be lower than that of sirolimus-eluting stents in patients on hemodialysis (HD). However, the comparison of PES and second generation drug-eluting stents in CKD patients has not been fully investigated. We compared clinical outcomes of everolimus-eluting stents (EES) and PES in CKD patients. MethodsHundred and forty seven CKD patients (eGFR<60mLmin−11.73m−2) treated with PES (n=74, from May 2007 to December 2009) and EES (n=73, from January 2010 to January 2013) were enrolled in the study. Major adverse cardiac events (MACEs) were defined as death, non-fatal myocardial infarction, and ischemia driven target lesion revascularization. ResultsThe incidence of 36-month MACE was significantly lower in EES, non-HD group compared to PES, non HD group (0% in EES group and 13.5% in PES group, respectively, P<0.01). There was no significant difference in MACE between EES and PES in HD patients (5.4% in PES group and 5.5% in EES group, P=0.98). In multivariate analysis, PES group and PES ISR were independent factors for worse incidence of MACE. ConclusionsIn CKD patients, PES was associated with worse clinical outcomes in non-HD patients as compared with EES.

Comparisons of everolimus and Paclitaxel-eluting stents in patients with acute myocardial infarction.

It has been established that the newer-generation drug-eluting stent (DES) everolimus-eluting stent (EES) is superior to the first-generation DES paclitaxel-eluting stent (PES). However, the advantages of EES over PES in the setting of acute myocardial infarction (AMI) need to be fully elucidated. The present analysis enrolled 2,911 AMI patients receiving PES (n = 1,210) or EES (n = 1,701) in a large-scale, prospective, multicenter Korea Acute Myocardial Infarction Registry (KAMIR). Propensity score matching was used to adjust for baseline biases in clinical and angiographic characteristics, yielding a total of 2,398 patients (1,199 receiving PES and 1,199 receiving EES). Various clinical outcomes at 1 year were compared between the two propensity score matched groups. Target lesion failure (TLF) was defined as the composite of cardiac death, recurrent nonfatal myocardial infarction (Re-MI), or target lesion revascularization (TLR). Baseline clinical and angiographic characteristics were comparable between the two groups after propensity score matching. Clinical outcomes of the propensity score matched patients showed that the rates of in-hospital and 1-year cardiac and all-cause death were similar between the two groups. But patients in the EES group had significantly lower incidences of Re-MI (1.4% vs 2.8%, P = 0.002), TLR (1.2% vs 3.1%, P = 0.001), TLF (6.4% vs 10.2%, P = 0.001), and probable or definite stent thrombosis (0.3% vs 1.8%, P < 0.001) than did those in the PES group. The present propensity matched analysis suggests that the use of EES in the setting of AMI appears to be superior to PES in reducing TLF, and stent thrombosis.

Serial Randomized Comparison of Strut Coverage of Everolimus- and First-Generation Sirolimus-Eluting Stents

BackgroundThere has not been sufficient data to evaluate the serial vascular healing pattern after everolimus-eluting stent (EES) implantation. Using optical coherence tomography, we compared serial changes in strut coverage of the EES and the first-generation sirolimus-eluting stent (SES). MethodsSixty patients were randomly assigned to receive either EES (n = 30) or first-generation SES (n = 30) for coronary artery disease. Serial optical coherence tomography evaluation immediately after the procedure, and 3- and 12-month follow-ups were performed in 50 patients with 54 stents (25 patients with 28 EES vs 25 patients with 26 SES). The percentage of uncovered struts was defined as the ratio of uncovered struts to total struts. The primary end point was the percentage of uncovered struts at 12-month follow-up. The secondary primary end point was the percentage of uncovered struts at the 3-month follow-up and the comparative percentage change (Δ) of uncovered struts at 3- and 12-month follow-ups of EES vs SES. ResultsThe percentage of uncovered struts was significantly lower in the EES group compared with the SES group (median value, 6.9%; interquartile range [IQR], 3.9-10.6% vs 11.1%; IQR, 5.5-29.4%, respectively) at the 3-month follow-up (P = 0.03), and at the 12-month follow-up (median value, 1.3%; IQR, 0.3-3.5% vs 3.6%; IQR, 1.0-9.4%; P = 0.02). The percentage Δ of uncovered struts from the 3- to the 12-month follow-up was similar (−7.0 ± 6.9% in EES vs −10.5 ± 13.6% in SES; P = 0.24). ConclusionsThe EES group showed more favourable stent strut coverage than the first-generation SES group at the early and late periods after stent implantation. These findings suggest that EES have a more beneficial effect for vascular healing.

Abstract 11911: Comparison of Late Catch-Up Phenomenon Between Sirolimus-Eluting Stent and Everolimus-Eluting Stent During 3 Years Follow-Up - a Propensity Matched Study -

Background: Recent studies have suggested the possibility of late catch-up phenomenon after implantation of sirolimus-eluting stent (SES) for coronary artery disease (CAD) compared to bare metal stent. However, little is known about the incidence of late catch-up phenomenon after implantation of everolimus-eluting stent (EES). Methods: Between April 2007 and May 2011, 1234 patients with CAD were treated with SES and 502 patients were treated with EES in our institution. We used a propensity score matching method with 1:1 matching, including 495 patients treated with SES and 495 patients treated with EES. Late catch-up phenomenon which was defined as target lesion restenosis (1 year to 3 years) were compared between the 2 groups. Results: After the propensity matching, no difference was seen in baseline characteristics between the 2 groups. Cumulative incidence of TLR at 3 years was 7.1% in EES group and 13.5% in SES group (P=0.001, log-rank test). Incidence of late catch-up phenomenon was 4.2% in EES group and 7.8% in SES group (P=0.020, log-rank test). Multivariate Cox’s proportional hazard analysis revealed that sirolimus eluting stent usage (HR 4.7, 95%CI 2.8-7.9, P&lt;0.001), hemodialysis (HR 2.7, 95%CI 1.5-4.9, P=0.001), 2 stent use for bifurcation (HR 2.1, 95%CI 1.1-4.1, P=0.028), IVUS usage (HR 0.41, 95%CI 0.27-0.62, P&lt;0.001), and ACS (HR 1.9, 95%CI 1.0-3.4, P=0.038) were independent predictors of late catch up phenomenon. Conclusions: EES was significantly superior to SES in the incidence of late catch-up phenomenon.