Efficacy Of Everolimus-eluting Stents Research Articles

Impact of chronic kidney disease on long-term clinical outcomes of everolimus-eluting stent implantation: A subanalysis of the Tokyo-MD PCI registry.

The aim of the study was to investigate the impact of chronic kidney disease (CKD) on the 5-year clinical outcomes of everolimus-eluting stent (EES) implantation. Recent studies have demonstrated the safety and efficacy of EES. However, limited information exists on the long-term clinical outcomes associated with CKD. The Tokyo-MD PCI study is a multi-center observational study designed to describe the clinical outcomes of unselected patients after EES implantation. In this subanalysis, patients on maintenance hemodialysis were excluded, and patients with (n = 316) or without (n = 1,424) CKD were evaluated for their 5-year incidence rates of major adverse cardiac events (MACEs), defined as death, non-fatal myocardial infarction, ischemia driven target lesion revascularization (ID-TLR), and stent thrombosis (ST). The mean and median follow-up duration were 1,391 ± 557 days and 1,769 days (interquartile range, 1,012-1,800 days), respectively. Although the incidence of ID-TLR and ST was similar between patients with and without CKD (4.9% vs. 3.7%, P = 0.26, 0.5% vs. 1.0%, P = 0.20, respectively), cardiac death and MACE were significantly higher in patients with CKD than in those without CKD (6.5% vs. 2.9%, P = 0.007, 26.9% vs. 14.0%, P < 0.001, respectively). In multivariate analysis, CKD was an independent predictor of MACE (hazard ratio 1.22 [95% confidence interval 1.04-1.43], P = 0.01). Patients with CKD had similar ID-TLR and ST rates as those without CKD at 5 years after EES implantation. The risk of long-term MACEs appeared to be associated with CKD.

Favorable early vessel healing after everolimus-eluting stent implantation: 3-, 6-, and 12-month follow-up of optical coherence tomography

BackgroundAlthough a prospective randomized control study revealed that 3-month dual anti-platelet therapy (DAPT) is safe and does not compromise the efficacy of everolimus-eluting stent (EES) in selected patients, detailed vessel healing at early phase after EES implantation has yet to be investigated in Japanese patients. Methods and resultsA total of 27 lesions in 19 patients treated with EES were serially evaluated by using optical coherence tomography (OCT) at 3, 6, and 12 months after stent implantation. In addition to standard quantitative OCT parameters, the percentage of stents with peri-strut low-intensity area (PLIA, a region around stent struts homogenously showing lesser intensity than the surrounding tissue, suggesting fibrin deposition or impaired neointima maturation) and that with in-stent thrombi were evaluated.There was a significant, but small increase in neointimal thickness (63±17μm; 83±30μm; and 111±44μm, respectively; p=0.006) and small decrease in average lumen area (6.80±2.57mm2, 6.62±2.58mm2, 6.33±2.58mm2, p=0.038) from the 3- to the 12-month follow-up. The incidences of uncovered and malapposed struts were low at 3 months and did not significantly change at 6 months and 12 months (3.01±4.43; 2.45±3.75; and 1.47±3.16, p=0.143, and 0.75±0.65; 0.63±0.73; and 0.58±1.42, p=0.162, respectively). Also, frequency of struts with PLIA was already low at three months and significantly decreased during the follow-up (6.4±6.5; 4.6±5.4; and 2.3±3.3, respectively; p=0.001). ConclusionFavorable vessel healing was achieved at 3 months after EES implantation without neointimal hyperplasia which was persistently suppressed up to 12 months.

Initial and late efficacy of everolimus-eluting stents for small and non-small coronary lesions from evaluating delayed late loss study.

The aim of the present study was to evaluate the long-term outcomes at 2years in patients in whom everolimus-eluting stents (EESs) were implanted in small and non-small vessels. A small vessel is an important risk factor for restenosis with BMSs, even in the first generation DESs. The 690 patients with 690 lesions implanted with an EES were enrolled and divided into two groups by vessel reference diameter (RD): >2.5mm for non-small vessels (Non-S-group) and ≤2.5mm for small vessels (S-group). Two years later, the 365 patients with no restenosis at 8months who underwent angiography were enrolled into the late catch-up study. At the initial 8-month follow-up, the rates of restenosis and target lesion revascularization (TLR) of both groups were not significantly different (restenosis 3.9 vs 6.5%, p=0.17; TLR 3.9 vs 6.5%, p=0.17). At the late 2-year follow-up, there were no significant differences in the late loss (0.36±0.66 vs 0.34±0.50mm, p=0.14), net gain (1.50±0.75 vs 1.26±0.60mm, p=0.39), late catch-up restenosis rate (5.1 vs 3.4%, p=0.38), TLR (4.9 vs 2.7%, p=0.40), and delayed late loss (0.14±0.58 vs 0.15±0.49mm, p=0.10) between both groups. There is no correlation between delayed late loss and RD in all patients(r=-0.009) and in AMI patients (r=-0.004). These results demonstrate that the initial and late catch-up restenosis rates of small coronary vessels with EES placement were excellent, the same as for non-small coronary vessels. We suggest that involvement of small coronary arteries may not be a risk factor for restenosis and results of stenting for small coronary arteries with EES placement were excellent.

Comparison of the Efficacy of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With In-Stent Restenosis (from the RIBS IV and V Randomized Clinical Trials)

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p <0.0001). At follow-up, patients treated with EESs had larger in-segment minimal lumen diameter (primary end point 2.16 ± 0.7 vs 1.88 ± 0.6 mm, p <0.0001; absolute mean difference 0.28 mm; 95% confidence interval [CI] 0.16 to 0.40) and net lumen gain (1.33 ± 0.6 vs 1.00 ± 0.7 mm, p <0.0001) and had lower %diameter stenosis (19 ± 21% vs 28 ± 22%, p <0.0001) and binary restenosis rate (8.7% vs 15.7%, p = 0.02). Consistent results were observed in the in-lesion analysis. No interactions were found between the underlying stent type and treatment effects. At 1-year clinical follow-up, the composite of cardiac death, myocardial infarction, and target vessel revascularization was significantly reduced in the EES arm (8.8% vs 14.5%, p = 0.03; hazard ratio 0.59, 95% CI 0.31 to 0.94) mainly driven by a lower need for target vessel revascularization (6% vs 12.4%, p = 0.01, hazard ratio 0.46, 95% CI 0.25 to 0.86). This pooled analysis of the RIBS IV and RIBS V randomized trials demonstrates the superiority of EES over DEB in the treatment of patients with ISR.

Safety and efficacy of everolimus-eluting stent versus zotarolimus-eluting stent: A meta-analysis of randomized controlled clinical trials and observational studies

BackgroundThe safety and efficacy of everolimus-eluting stent (EES) versus zotarolimus-eluting stent (ZES) are controversial both in randomized controlled clinical trials (RCTs) and observational studies. The aim of this study was to assess the safety and efficacy of EES versus ZES. MethodsPubmed, Embase, Cochrane database and www.clinicaltrials.gov updated to Mar 2014 with safety [major adverse cardiac events (MACE)], all-cause mortality, non-fatal myocardial infarction (MI), stent thrombosis (ST) and efficacy [target vessel revascularization (TVR), target lesion revascularization (TLR), target vessel failure (TVF), target lesion failure (TLF)] endpoints and follow-up of ≥12months were identified. ResultsData from 11,778 patients in 8 RCTs and 34,850 patients in 26 observational studies were included. In RCT studies, no evidence indicating that EES was safer or more efficacious than ZES. In observational studies, EES associated with a significantly lower risk for MACE (RR: 0.56, 95% CI: 0.46–0.69), ST (RR: 0.59, 95% CI: 0.45–0.78), TVR (RR: 0.61, 95% CI: 0.47–0.79), TLR (RR: 0.57, 95% CI: 0.38–0.83) and TLF (RR: 0.69, 95% CI: 0.50–0.93). The pooled data of RCTs and observational studies showed that compared to ZES, EES associated with a significant lower risk for MACE (RR: 0.65, 95% CI: 0.54–0.78), ST (RR: 0.66, 95% CI: 0.52–0.83), TVR (RR: 0.72, 95% CI: 0.58–0.89), TLR (RR: 0.63, 95% CI: 0.49–0.82) and TLF (RR: 078, 95% CI: 0.62–1.00). ConclusionsIn RCTs, EES and ZES showed comparable safety and efficacy, while in observational studies or pooled data, EES was safer and more efficacious than ZES.

Long‐term safety and efficacy of second‐generation everolimus‐eluting stents compared to other limus‐eluting stents and bare metal stents in patients with acute coronary syndrome

This study aimed to investigate the long-term safety and efficacy of everolimus-eluting stents (EES) compared with other limus-eluting stents and bare metal stents (BMS) in ACS patients. There have been concerns about the long-term safety of drug-eluting stents in the setting of acute coronary syndrome. The study cohort included 1,612 patients presenting with acute coronary syndrome who underwent BMS, SES, E-ZES, or EES implantation. End points included probable or definite stent thrombosis and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, Q-wave myocardial infarction, and target lesion revascularization up to 3 years. The overall MACE rates were significantly higher for both BMS and SES, but not E-ZES, when compared with EES (EES vs. BMS: HR 2.68, 95% CI 1.91-3.78, P <0.001; EES vs. SES: HR 1.75, 95% CI 1.24-2.47, P = 0.001 and EES vs. HR 1.08, 95% CI 0.65-1.77, P = 0.72). Stent thrombosis rates were similar for EES, E-ZES, and BMS but higher for SES throughout the 3-year follow-up (EES vs. BMS: HR 1.02, 95% CI: 0.31-3.35, P = 0.973; EES vs. SES: HR 4.90, 95% CI: 1.75-13.69, P = 0.002 and EES vs. HR 1.63, 95% CI 0.37-7.31, P = 0.449). There was an improvement in the long-term outcome for MACE with EES when compared to earlier-generation stents, but this was comparable with the 2nd-generation E-ZES. There was no additional risk of early or late stent thrombosis in EES when compared with BMS.

Everolimus-eluting versus sirolimus-eluting coronary stents in patients with and without diabetes mellitus

Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status. Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI. Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.

TCTAP A-009 The Efficacy of Everolimus-eluting Stent (EES) Implantation in Patients with ST-elevation Myocardial Infarction: Outcomes of 2-year Clinical Follow-up

TCTAP A-009 The Efficacy of Everolimus-eluting Stent (EES) Implantation in Patients with ST-elevation Myocardial Infarction: Outcomes of 2-year Clinical Follow-up

5-Year Results of a Randomized Comparison of XIENCE V Everolimus-Eluting and TAXUS Paclitaxel-Eluting Stents: Final Results From the SPIRIT III Trial (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions)

This study sought to evaluate the long-term safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in patients with obstructive coronary artery disease. The use of EES compared to PES has been shown to result in improved clinical outcomes in patients undergoing PCI. However, there have been concerns regarding the durability of these benefits over longer-term follow-up. SPIRIT III was a prospective, multicenter trial in which 1,002 patients were randomized 2:1 to EES versus PES. Endpoints included ischemia-driven target vessel failure (TVF) (death, myocardial infarction (MI), or ischemia-driven target vessel revascularization [TVR]), the pre-specified primary endpoint), target lesion failure (TLF) (cardiac death, target-vessel MI, or ischemia-driven target lesion revascularization [TLR]), major adverse cardiac events (MACE) (cardiac death, MI, or ischemia-driven TLR), their individual components and stent thrombosis. Five-year follow-up was available in 91.9% of patients. Treatment with EES versus PES resulted in lower 5-year Kaplan-Meier rates of TVF (19.3% vs. 24.5%, p = 0.05), TLF (12.7% vs. 19.0%, p= 0.008), and MACE (13.2% vs. 20.7%, p = 0.007). EES also resulted in reduced rates of all-cause death (5.9% vs. 10.1%, p = 0.02), with nonsignificantly different rates of MI, stent thrombosis, and TLR, and no evidence of late catch-up of TLR over time. At 5 years after treatment, EES compared to PES resulted in durable benefits in composite safety and efficacy measures as well as all-cause mortality. Additionally, the absolute difference in TLR between devices remained stable over time without deterioration of effect during late follow-up.

TCT-179 Safety and Efficacy of Everolimus-Eluting Stents Versus Zotarolimus-Eluting Stents for 3-year of Follow-Up in Real-World Practice

TCT-179 Safety and Efficacy of Everolimus-Eluting Stents Versus Zotarolimus-Eluting Stents for 3-year of Follow-Up in Real-World Practice

Second‐Generation Everolimus‐Eluting Stents Compared to First‐Generation Drug‐Eluting Stents in Patients Treated for Multivessel Disease

This study aimed to compare the safety and efficacy of everolimus-eluting stents (EES) to first-generation drug-eluting stents (DES) in multivessel disease (MVD). Second-generation EES have demonstrated superiority over first-generation DES for single-vessel disease, although the merits of EES in MVD are less established. A cohort of 1,285 patients (3,124 lesions) with ≥ 2 diseased vessels were treated with either first-generation DES (n = 1,002) or EES (n = 283). The rates of death, myocardial infarction, target lesion revascularization, target vessel revascularization, definite stent thrombosis, and major adverse cardiac events (MACE), defined as the combined incidence of target vessel revascularization, death, and non-fatal myocardial infarction, were compared at 1 year. Baseline characteristics were similar except for a lower left ventricular ejection fraction and a lower incidence of stable angina pectoris in the first-generation DES group (P = 0.001 and 0.013, respectively). At 1 year, the MACE rate was lower in the EES group (9.5P% vs. 15.7%; P = 0.01). Multivariable analysis demonstrated that EES use predicted a higher chance of freedom from MACE at 1 year (hazard ratio 0.58 [0.38-0.87]; P = 0.009; 95% confidence interval). The use of EES in patients with MVD is safe with signals for improved effectiveness compared to first-generation DES. Randomized trials comparing new-generation DES to coronary artery bypass grafting surgery are warranted.

Two-Year Follow-Up of Outcomes of Second-Generation Everolimus-Eluting Stents Versus First-Generation Drug-Eluting Stents for Stenosis of Saphenous Vein Grafts Used as Aortocoronary Conduits

Second-generation everolimus-eluting stents (EESs) have demonstrated superiority in efficacy and safety compared with first-generation drug-eluting stents (DESs) in the treatment of native coronary artery lesions. The present study evaluated and compared the safety and efficacy of EESs and first-generation DESs in saphenous vein graft lesions. The EES group consisted of 88 patients with 96 lesions, and the first-generation DES group consisted of 243 patients with 317 lesions (sirolimus-eluting stents, n = 212; paclitaxel-eluting stents, n = 105). The end points included target lesion revascularization, target vessel revascularization, major adverse cardiovascular events (composite of all-cause death, myocardial infarction, and target vessel revascularization), and definite stent thrombosis at 2 years. The groups had similar baseline characteristics and graft ages (128.1 ± 77.5 vs 132.4 ± 90.8 months, p = 0.686). The EES group had more type C lesions and less embolic protection device use. The peak postprocedure values of creatinine kinase-MB and troponin I were similar between the 2 groups. Overall, major adverse cardiovascular events occurred in 18.2% of EES patients and 35.0% of first-generation DES patients (p = 0.003), mainly driven by a lower target vessel revascularization rate (6.8% vs 24.5%, p <0.001). The target lesion revascularization rate was lower in the EES group (1.1% vs 11.6%, p = 0.005). Stent thrombosis was low and similar between the 2 groups (0% vs 0.8%, p = 1.000). On multivariate analysis, the type of DES implanted and graft age were the only independent predictors of major adverse cardiovascular events. In conclusion, the superiority of EESs compared with first-generation DESs shown in native artery lesions has been extended to saphenous vein graft lesions and should be considered as the DES of choice for this lesion type.

The Efficacy of Everolimus-eluting Stent(EES) Implantation in Patients with Acute Coronary Syndrome: Outcomes of 2-year Clinical Follow-up

The Efficacy of Everolimus-eluting Stent(EES) Implantation in Patients with Acute Coronary Syndrome: Outcomes of 2-year Clinical Follow-up

EVEROLIMUS–ELUTING VERSUS SIROLIMUS–ELUTING CORONARY STENTS IN PATIENTS WITH AND WITHOUT DIABETES MELLITUS

AIMS Patients with diabetes mellitus have a higher risk of adverse events after percutaneous coronary intervention (PCI). This study aimed to elucidate the relative efficacy of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) according to diabetic status. METHODS AND RESULTS Data from the EXCELLENT randomised trial and registry were pooled in a per protocol analysis manner. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel-related myocardial infarction, or target vessel revascularisation. Among a total of 6,524 patients, 2,404 (36.8%) had diabetes mellitus. Patients with diabetes were shown to have a higher rate of TLF after PCI, which was mainly driven by differences in cardiac death and myocardial infarction, while the rate of repeat revascularisation and stent thrombosis did not differ significantly. TLF occurred at a similar rate between patients treated with EES versus SES in each subgroup stratified by diabetic status (interaction p=0.384). In addition, no significant interactions were present with regard to any pre-specified clinical endpoints. The results were corroborated by analysis with inverse probability of treatment weighting (interaction p=0.329). We also found that insulin-dependent diabetes imposed an even greater risk of TLF on patients treated with PCI. CONCLUSIONS Despite the recent advances in drug-eluting stent technology, diabetic patients are still at higher risk of adverse clinical events after PCI than those without diabetes mellitus. Whether a patient was treated with EES or SES had no significant interaction with diabetic status in terms of clinical outcome after PCI.

Five-year long-term clinical follow-up of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery disease: the SPIRIT II trial

To assess the safety and performance of the XIENCE V everolimus-eluting stent (EES) versus the TAXUS paclitaxel-eluting stent (PES) in the treatment of patients with de novo coronary artery lesions after a five-year follow-up period. Second-generation drug-eluting stents (DES) were developed with the aim of improving the safety profile of DES, after reports of stent thrombosis (ST) with first-generation devices. However, long-term follow-up data are scarce. SPIRIT II was a multicentre, prospective, single-blind, clinical trial, randomising 300 patients with up to two de novo coronary artery lesions in a ratio of 3:1 to either a EES or a PES. The five-year clinical follow-up was completed in 244 patients (81%). At five-year follow-up, 19.5% of patients were on thienopyridine in the EES arm, while 30.5% were on the same therapy in the PES arm. Cardiac mortality was significantly lower in EES than in PES (1.5% vs. 7.3%, p=0.015). There was a trend towards lower cardiac death and MI (4.8% vs. 11.4%) and lower ID-TLR (4.7% vs. 9.4%) in EES than in PES. As a result, there was a consistent reduction in ID-MACE for EES vs. PES (ID-MACE 8.0% vs. 18.1%, p=0.018). In addition, the ARC-defined stent thrombosis rate was numerically lower in EES compared to PES (0.9% vs. 2.8%). No definite stent thrombosis events were observed after two years in the EES arm. Five-year clinical follow-up of the SPIRIT II trial demonstrated the continuing long-term safety and efficacy of EES.

Stent Thrombosis

Drug-eluting stents (DES) were introduced to address the major limitation of bare metal stents (BMS), namely exuberant neointimal hyperplasia leading to clinical restenosis, which occurred in up to 30% of patients. Sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES)—referred to as early generation DES—by means of controlled release of antiproliferative drugs had a major impact on restenosis, reducing the risk of repeat revascularization by 50% to 70% compared with BMS at 1 year.1 Although large-scale clinical trials and meta-analyses failed to show any difference in terms of death or myocardial infarction (MI) between DES and BMS, long-term follow-up of patients treated with early generation DES raised safety concerns because of a continuous risk of stent thrombosis (ST) during the very late phase (>1 year).2 This phenomenon was linked to delayed vascular healing of the stented segment, with evidence of inflammatory infiltrates, delayed reendothelization, and positive coronary remodeling.3 Therefore, a new generation of DES was developed to improve outcomes by reducing strut thickness; using more biocompatible, durable, or biodegradable polymer coatings; and reducing the drug load. Articles see p 357, 365 The everolimus-eluting stent (EES) is the device with the largest amount of clinical information among newer-generation DES to date. Indeed, the safety and efficacy of EES has been compared with early generation devices in several randomized trials and registries.4–9 The superiority of EES over PES has been consistently shown as evidenced by a reduced risk of repeat revascularization, ST, and MI in favor of EES.4,5 Conversely, all individual trials directly comparing EES with SES failed to show any difference in clinical outcomes up to 2 years of follow-up.4–8 In this issue of Circulation: Cardiovascular Interventions , 2 new studies shed additional light on the impact of EES on …

Randomized study comparing everolimus‐ and sirolimus‐eluting stents in patients with bifurcation lesions treated by provisional side‐branch stenting

To compare the efficacy of sirolimus- and everolimus-eluting stents in patients with bifurcation lesions treated with provisional side-branch stenting. The efficacy of everolimus-eluting stents in bifurcation lesions has been poorly tested. Patients with all types of Medina bifurcation lesions were randomly assigned to treatment with either a sirolimus- (n = 145) or everolimus-eluting stent (n = 148). We included patients with main vessel diameter over 2.5 mm and side branches over 2.25 mm. Patients with diffuse side-branch stenosis were excluded. There were no significant differences between patients from the sirolimus and everolimus groups in terms of age, risk factors, clinical status, location of the bifurcation lesions or angiographic variables. Immediate results and in-hospital outcome were also similar in both groups of patients. In-hospital death occurred in two patients, one from each group. Target lesion revascularization was required in nine patients: four patients (2.7%) from the sirolimus group and five patients (3.4%) from the everolimus group. Late cardiac mortality occurred in two patients from the sirolimus group and in one patient from the everolimus group. Major cardiac event rates at 1 year were similar in both groups: nine patients (6.2%) in the sirolimus group and nine patients (6.1%) from the everolimus group (p: ns). In patients with bifurcation lesions, no significant differences in clinical outcome at 1-year follow-up were observed between sirolimus- and everolimus-eluting stent groups.

AS-215 Incidence and Clinical Impact of Stent Fracture after Everolimus-Eluting Stent

Stent fracture (SF) has currently become an important concern after drug-eluting stent (DES) implantation. Recent clinical trials have demonstrated improved safety and efficacy of everolimus-eluting stent (EES) as compared with first-generation DES. However, the incidence of SF with EES has never been elucidated. We sought to assess the incidence and clinical impact of SF after EES implantation.

Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents: Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials

The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES). Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention. Patient-level data were pooled from the randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) trials. Quantitative angiographic core laboratory data were available for 6,183 patients randomized to EES (n = 3,944) or PES (n = 2,239). Long lesions and small vessels were defined as LL >median (13.4 mm) and RVD ≤median (2.65 mm), respectively. Major adverse cardiac events (MACE) (consisting of cardiac death, myocardial infarction, or ischemia-driven target lesion revascularization) were assessed at 2 years, according to stent type in 3 groups: short lesions in large vessels (group A, n = 1,297); long lesions or small vessels but not both (group B, n = 2,981); and long lesions in small vessels (group C, n = 1,905). The pooled 2-year MACE rates were 5.6%, 8.2%, and 10.4% in Groups A, B, and C, respectively (p < 0.0001). There was no significant interaction between lesion group and stent type (p = 0.64), indicating lower MACE with EES compared with PES regardless of LL and RVD. However, the absolute difference was largest in Groups B and C. In Group A, 2-year MACE rates were not significantly different between EES and PES (4.8% vs. 7.0%, respectively, p = 0.11). In contrast, EES was associated with lower 2-year rates of MACE in Group B (6.6% vs. 11.2%, p < 0.01) and in Group C (9.1% vs. 12.7%, p = 0.008) as well as lower rates of myocardial infarction, target lesion revascularization, and stent thrombosis. Multivariable analysis confirmed EES versus PES as an independent predictor of freedom from MACE in Groups B and C. Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041).

Comparison of Everolimus- and Paclitaxel-Eluting Stents in Patients With Acute and Stable Coronary Syndromes: Pooled Results From the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001). Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041).