Everolimus-eluting Stent Implantation In Patients Research Articles

Ultra-thin everolimus-eluting stents in atherosclerotic lesions: Three years follow-up with subgroup analysis of ultra-long stents

ObjectivesTo assess the long-term (3 years) safety and efficacy of Tetrilimus everolimus-eluting stent (EES) and subgroup analysis of outcomes of ultra-long (44/48 mm) Tetrilimus EES implantation in patients with long coronary lesions. Material and methodsIn this observational, single-centre, single-arm, investigator-initiated registry, 558 patients who underwent implantation of Tetrilimus EES for the treatment of coronary artery disease were retrospectively included. The primary endpoint was occurrence of any major adverse cardiac event (MACE) at 12 months follow-up (composite of cardiac death, myocardial infarction [MI], and target lesion revascularization [TLR]) and we hereby report 3 years follow-up data. Stent thrombosis was assessed as a safety endpoint. A subgroup analysis of patients with long coronary lesions is also reported. ResultsA total of 558 patients (57.0 ± 10.2 years) received 766 Tetrilimus EES (1.3 ± 0.5 stents/patient) to treat 695 coronary lesions. In subgroup analysis of 143 patients implanted with ultra-long EES, 155 lesions were intervened successfully with only one Tetrilimus EES (44/48 mm) implanted per lesion. At 3 years, event rates of 9.1% MACE with predominance of MI (4.4%), followed by 2.9% TLR and 1.7% cardiac death, and only 1.0% stent thrombosis were reported in overall population, while in a subgroup of patients implanted with ultra-long EES, 10.4% MACE and 1.5% stent thrombosis were reported. ConclusionsThree years clinical outcomes showed favourable long-term safety and excellent performance of Tetrilimus EES in high-risk patients and complex coronary lesions in routine clinical practice, including a subgroup of patients with long coronary lesions, with acceptable primary and safety endpoints.

Predictors of Irregular Protrusion After Everolimus-Eluting Stent Implantation in Patients with Stable Coronary Artery Disease.

This study aimed to investigate clinical and preintervention optical coherence tomography (OCT) findings to predict irregular protrusion (IRP) immediately after stent implantation.We evaluated 84 lesions treated with cobalt-chromium everolimus-eluting stent (CoCr-EES) from the MECHANISM Elective study. Patients were divided into two groups according to the presence of IRP [IRP: n = 16, non-IRP: n = 68]. Optical coherence tomography images before intervention and immediately after stenting were evaluated with standard qualitative and quantitative OCT analyses.Total cholesterol and the prevalence of ruptured plaque before intervention were significantly higher in the IRP group than in the non-IRP group [199 ± 37 mg/dL versus 176 ± 41 mg/dL; P = 0.022, 31% versus 7%; P = 0.008]. Total lipid length tended to be longer in the IRP group than in the non-IRP group [19.6 ± 9.2 mm versus 15.5 ± 9.3 mm; P = 0.090]. The prevalence of ruptured plaque, and total cholesterol levels were independent predictors of IRP immediately after stenting by multivariate logistic regression analysis [OR: 4.6, 95% confidence interval: 1.01-21.23, P = 0.048, OR: 1.02, 95% confidence interval: 1.00-1.03, P = 0.046]. IRP post-CoCr-EES implantation was completely resolved at follow-up OCT.The prevalence of ruptured plaque before intervention and total cholesterol levels were independent predictors of IRP after CoCr-EES implantation in patients with stable coronary artery disease.

Vascular remodeling after everolimus-eluting stent implantation in non-ST segment elevation acute coronary syndrome: optical coherence tomography

Highlights. Vascular healing response after stenting depends on both, procedure- and patient-related factors. The patient's age, lipid metabolism, the presence of heart failure, myocardial infarction, and the thickness of epicardial adipose tissue affect vascular remodeling after everolimus-eluting stent implantation.Aim. To identify factors affecting vascular healing response after everolimus-eluting stent implantation in patients with non-ST segment elevation acute coronary syndrome.Methods. 45 patients with non-ST segment elevation acute coronary syndrome who underwent everolimus-eluting stent implantation were included in a study. Stenting was performed without intravascular imaging guidance. All patients underwent repeated coronary angiography and optical coherence tomography of the stented segment 6 (±2) months after the indexed procedure. 39,860 struts in 4,576 sections were analyzed. The number of uncovered and malapposed struts was estimated, and the healing score was calculated. Cardiovascular death, repeated myocardial infarction, and repeated revascularization of the stented segment 12 months after the stenting were evaluated as a combined endpoint.Results. 5 patients out of 45 reached the endpoint (11.1%), the main component of which was repeated revascularization. Patients who reached the endpoint had a lower healing score (4.5±2.6 and 19.9±17.9, respectively; p = 0.038). The healing score was lower in men (13.7±14.7 and 26.0±20.0, respectively; p = 0.041), those who had myocardial infarction at the time of stenting (5.5±6.7 for myocardial infarction and 19.8±17.9 for unstable angina, p = 0.045), and those who did not have heart failure (12.2±12.4 and 36.7±19.0, respectively; p = 0.0006). The healing score depended on the severity of the coronary lesion (24.8±19.4 for multivessel lesions, 10.0±8.7 for single-vessel lesions, and 7.3±6.3 for two-vessel lesions, respectively; p = 0.019). The linear regression reported the correlation of the healing score with age, atherogenicity coefficient, and the presence of chronic heart failure. The modified healing score depended on the epicardial fat thickness, atherogenicity coefficient, and blood urea level.Conclusion. The nature and degree of vascular remodeling after everolimus-eluting stent implantation depends on the patient's age, diagnosis, heart failure, lipid metabolism, and the severity of the coronary lesion. The evaluation of vascular healing response may influence the decision on the duration of dual antiplatelet therapy

TCT-506 Cut-off value of malapposition volume on resolution of acute incomplete stent apposition at one month using serial optical coherence tomography after cobalt- chromium everolimus-eluting stent implantation in patients with stable coronary artery disease.

A previous optical coherence tomography (OCT) study showed that incomplete stent apposition (ISA) of drug eluting stents is a major risk factor for stent thrombosis. The cobalt-chromium everolimus-eluting stent (CoCr- EES) incorporating a highly biocompatible stent is used in combination with short

TCT-503 Cut-off value of strut vessel distance on resolution of acute incomplete stent apposition at one month using serial optical coherence tomography after cobalt- chromium everolimus-eluting stent implantation in patients with stable coronary artery disease

TCT-503 Cut-off value of strut vessel distance on resolution of acute incomplete stent apposition at one month using serial optical coherence tomography after cobalt- chromium everolimus-eluting stent implantation in patients with stable coronary artery disease

TCT-651 Coronary Risk Factors Associated with OCT Macrophage Images and their Response After CoCr Everolimus-Eluting Stent Implantation in Patients with Stable Coronary Artery Disease: Subanalysis of the MECHANISM-Elective study

The purpose of this study was to evaluate the accumulation of optical coherence tomography (OCT)-macrophages and OCT findings after CoCr everolimus-eluting stent placement, in addition to coronary risk factors. A total of 89 lesions in 89 patients were registered in the 1 and 3-month cohort of the

Coronary risk factors associated with OCT macrophage images and their response after CoCr everolimus-eluting stent implantation in patients with stable coronary artery disease

Background and aimsThe aim of this study was to evaluate the accumulation of optical coherence tomography (OCT)-macrophages and OCT findings after CoCr everolimus-eluting stent placement, in addition to coronary risk factors. MethodsA total of 89 lesions in 89 patients were registered in the 1- and 3-month cohort of the multi-centre study. Lesion characteristics and post-procedure OCT images were evaluated immediately and 1 and 3 months after stenting. Patients were divided into low and high macrophage grade groups based on the median macrophage grade. ResultsLow-density lipoprotein cholesterol (LDL-C) levels, the prevalence of diabetes mellitus, HbA1c and blood glucose levels in the high macrophage grade group were significantly higher than in the low macrophage grade group (p = 0.025, p = 0.040, p = 0.032, and p = 0.010). Moreover, total lipid arc and length and number of thin-cap fibroatheromas (TCFAs) in the high macrophage grade group were significantly higher than in the low macrophage group (p = 0.008, p = 0.002, and p = 0.012). After CoCr everolimus-eluting stenting, there was a trend towards a greater number, height, and area of irregular protrusions in the high macrophage grade group compared to the low macrophage grade group (p = 0.091, p = 0.059, and p = 0.085). Multivariate logistic regression analysis showed that diabetes mellitus was a significant predictor of high macrophage grades (odds ratio: 2.8, 95% CI: 1.1–7.3, p = 0.030). ConclusionsThe accumulation of OCT-macrophages was associated with diabetes mellitus in patients with coronary artery disease. Moreover, macrophage accumulation and diabetes mellitus may be associated with irregular protrusions just after stenting.

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.

Optical coherence tomography follow-up 18 months after titanium-nitride-oxide-coated versus everolimus-eluting stent implantation in patients with acute coronary syndrome

Background Inadequate neointimal coverage of stent struts is associated with late stent thrombosis. Purpose To demonstrate the extent of neointimal coverage and strut malapposition in titanium-nitride-oxide-coated bioactive stents (BAS) versus everolimus-eluting stents (EES) by optical coherence tomography (OCT) performed at 18-month follow-up. Material and Methods In the BASE-ACS trial, 827 patients presenting with acute coronary syndrome were randomized to receive either BAS or EES. Forty patients (20 BAS, 20 EES) underwent OCT at 18-month follow-up for evaluation of stent strut coverage, malapposition, and neointimal hyperplasia (NIH). Primary endpoint was binary stent strut coverage (ratio of covered struts to all analyzed struts multiplied by 100). Co-primary endpoint was the percentage of malapposed struts. Results We analyzed 3465 struts in 330 cross-sections of BAS and 3327 struts in 316 cross-sections of EES. Binary stent strut coverage, based on strut-level analysis, was higher with BAS versus EES (99.5% versus 94.2%, respectively; P < 0.001), the strut-level percentage of malapposed struts was lower with BAS (0.6% versus 2.5%, respectively; P < 0.001). Yet, the mean NIH thickness was greater with BAS (237 ± 125 versus 108 ± 62 µm, respectively; P < 0.001). Conclusion In the current post-hoc analysis with OCT performed at 18 months, binary strut coverage, based on strut-level analysis, was higher with BAS versus EES; strut-level malapposed struts were fewer with BAS; yet, BAS induced thicker NIH.

Effects of daily glucose fluctuations on the healing response to everolimus-eluting stent implantation as assessed using continuous glucose monitoring and optical coherence tomography.

BackgroundSeveral studies have revealed that glucose fluctuations provoke oxidative stress that leads to endothelial cell dysfunction, progression of coronary atherosclerosis, and plaque vulnerability. However, little is known regarding their effect on neointimal growth after stenting in patients with coronary artery disease (CAD). We aimed to investigate the effects of glucose fluctuations on neointimal growth after everolimus-eluting stent (EES) implantation.MethodsThis study examined 50 patients who underwent a 9-month follow-up using optical coherence tomography (OCT) after EES implantation. Glucose fluctuation was expressed as the mean amplitude of glycemic excursion (MAGE), and was determined via continuous glucose monitoring before stenting. At the OCT follow-up, we evaluated the percentage of uncovered struts and three-dimensional uniformity of neointimal distribution by calculating the mean neointimal thickness (NIT) within 360 equally-spaced radial sectors for every 1-mm cross-sectional OCT analysis, and assessed the incidence of major adverse cardiovascular events (MACE).ResultsWe evaluated 60 lesions in 50 patients. Linear mixed effect models were used to explore the influence of different variables on variability in NIT and the percentage of uncovered struts and to adjust for covariates. Univariate analysis showed that MAGE was most strongly correlated with the previously mentioned OCT measurements (coefficient β ± standard error = 0.267 ± 0.073 and 0.016 ± 0.003, t = 3.668 and 6.092, both P < 0.001, respectively). In multivariate analysis, MAGE had the strongest effect on variability in NIT (coefficient β ± standard error = 0.239 ± 0.093, P = 0.014) and the percentage of uncovered struts (coefficient β ± standard error = 0.019 ± 0.004, P < 0.001). Five lesions in four patients required target lesion revascularization (10.0 %) at a mean duration of 9 months after EES implantation. Compared to non-MACE cases, cases of MACE exhibited a significantly higher MAGE (99 vs. 68; P = 0.004), maximum NIT (580 vs. 330 µm; P = 0.002), and variability in NIT (100 vs. 65; P = 0.007), although there was no significant difference in these groups’ HbA1c levels.ConclusionsGlucose fluctuation may affect vessel healing after EES implantation in patients with CAD who are receiving lipid-lowering therapy. Therefore, glucose fluctuations may be an important target for secondary prevention after coronary stenting, which is independent of dyslipidemia control.

Three-Year Clinical and Angiographic Outcomes After Everolimus-Eluting Stent Implantation in Patients With a History of Coronary Artery Bypass Grafting.

The clinical and angiographic outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stent (EES) implantation in patients with a history of coronary artery bypass grafting (CABG) have yet to be fully investigated. The aim of the present study was to investigate 3-year clinical outcomes after EES implantation in patients with a history of CABG.We retrospectively enrolled 176 consecutive patients who had undergone EES implantation. Three-year clinical follow-up data were obtained from all patients. Follow-up angiograms and serial quantitative coronary angiography analysis (QCA) were performed for 139 (79.0%) patients. Patients from the prior CABG (+) group (n = 17; 9.7%) had higher incidences of target lesion revascularization (TLR; 41.2% versus 3.8%, P < 0.001) and major adverse cardiac events (47.1% versus 15.1%, P = 0.004). A landmark analysis conducted 1 year into our study showed a higher incidence of TLR in the prior CABG (+) group (20.0% versus 3.0%, P = 0.017).The reason for EES implantation in the prior CABG (+) group was saphenous vein graft (SVG) failure in 19 (79.2%) lesions, although the target vessel was the SVG in 8 (33.3%) lesions. There were no significant differences in clinical and follow-up QCA data between the native vessel and SVG PCI groups.This study revealed that a history of CABG was a risk factor for TLR after EES implantation. The major reason for PCI after CABG was SVG failure; both native vessel and SVG PCI showed poor outcomes. Further investigations may be warranted to determine which interventions are most effective in this high-risk subset.

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.

Rationale and design: Impact of intravascular ultrasound guidance on long-term clinical outcomes of everolimus-eluting stents in long coronary lesions

BackgroundAlthough the use of drug-eluting stents (DESs) in patients with coronary artery disease has contributed to a significant reduction in in-stent restenosis and repeat revascularization, treating diffuse long lesions using DESs remains challenging due to the high rates of in-stent restenosis and stent thrombosis. Intravascular ultrasound (IVUS) provides tomographic images of coronary vascular structure and is useful for evaluating lesion morphology and stent optimization during percutaneous coronary intervention. However, it remains controversial whether IVUS guidance in DES implantation for long coronary lesions could reduce adverse clinical outcomes. HypothesisWe hypothesize that the long-term clinical outcomes of IVUS-guided DES implantation would be superior to those of angiography-guided DES implantation in a subset of patients with long coronary lesions. Study designThis study is a randomized, prospective, multi-center trial comparing the long-term clinical outcomes of IVUS-guided and angiography-guided everolimus-eluting stent implantation in patients with long coronary lesions (implanted stent ≥28mm in length). The primary end point is a composite of major adverse cardiac events, including cardiac death, target lesion-related myocardial infarction, or target lesion revascularization at 1year following intervention. A total of 1,400 patients will be required to be enrolled according to sample size calculations. ConclusionThis study will test the hypothesis that IVUS guidance improves long-term clinical outcomes in patients treated with everolimus-eluting stents for long coronary lesions compared with angiographic guidance.

TCTAP A-170 Efficacy of Everolimus-eluting Stent Implantation in Patients with Small Coronary(≦2.5mm) Arteries: Outcomes of 2-year Clinical Follow-up

TCTAP A-170 Efficacy of Everolimus-eluting Stent Implantation in Patients with Small Coronary(≦2.5mm) Arteries: Outcomes of 2-year Clinical Follow-up

Efficacy of everolimus-eluting stent implantation in patients with small coronary arteries: outcomes of 2-year clinical follow-up

Efficacy of everolimus-eluting stent implantation in patients with small coronary arteries: outcomes of 2-year clinical follow-up

Incidence, time course and predictors of early vs. late target lesion revascularisation after everolimus-eluting stent implantation: a SPIRIT V substudy

To evaluate the incidence, time course and predictors of late target lesion revascularisation (TLR) (between one and two years) as compared to early TLR (<1 year) following everolimus-eluting stent implantation in patients enrolled in the SPIRIT V study. The SPIRIT V single-arm study enrolled a total of 2,700 patients (n=2,663 intent-to-treat) with de novo coronary artery lesions undergoing EES implantation. Patients were evaluated at 30 days, one year and two years following the index procedure. All patients who had a clinically driven TLR (not associated with stent thrombosis) were allocated to either the early or the late group. Clinical, angiographic and procedural data were recorded and predictors of early vs. late TLR were assessed by logistic regression analysis. There were no significant differences in baseline demographics and risk factors between the two groups with the exception that patients in the late TLR group were significantly older (68.5 ± 8.5 years vs. 63.5 ± 8.9 years, p=0.022). At two years, only 2.7% (70/2,562) experienced a TLR unrelated to a stent thrombosis event with 1.6% (43/2,627) occurring within one year of the index procedure and 1.1% (27/2,562) occurring between one and two years. There were no differences between the groups in terms of clinical outcomes. Age ≥70 years was the only variable which independently predicted late TLR (OR=4.80 [1.69-13.63], p=0.0032). In this large registry without angiographic follow-up, early (<1 year) and late (>1 year) TLR rates were exceedingly low and thereby confirm the previous findings of randomised controlled studies. Age (>70 years) emerged as the only predictor of late TLR.

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

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. 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. 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). 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.