Use Of Everolimus-eluting Stents Research Articles

Incidence of Stent Thrombosis in Diabetic and Non-Diabetic Patients Who Underwent Coronary Intervention with Everolimus-Eluting Stent(s) in a Tertiary Care Center in Saudi Arabia

Background: The advent of drug eluting stents (DES) has led to a significant reduction in the risk of repeated revascularization, but studies have shown increased risk of late and very late stent thrombosis. The use of Everolimus eluting stents(EES) has decreased that risk along with decreasing the risk of restenosis. In addition, Diabetes has been found to be an independent predictor of poor survival and increased rate of revascularization. Data on diabetic patients from Arab countries and Saudi Arabia are very limited despite the widespread prevalence of diabetes in those countries. Objective: to evaluate the outcomes of patients treated with EES and whether or not diabetic patients are more susceptible to adverse cardiac events. Methods: An observational single-center study in which 1358 patients underwent PCI with Everolimus eluting stents between 2010 and 2013 with 3-year follow-up. Patients included in the study either presented with acute coronary syndrome or had stable coronary artery disease. Results: A total of 1358 patients had PCI with stent deployment. Stent thrombosis (ST) developed in 14 patients (1.03%). 13 patients (0.93%) were diabetics and 1 patient (0.13%) was non-diabetic and P value = 0.029. Also, diabetics who developed ST had significantly higher HgA1C measurements than diabetics who did not. The frequency of target lesion revascularization in diabetics was 34 (3.6%), while in non-diabetics it was 6 (1.1 %) and P value = 0.005. Overall cardiac death rate was 3.43%, and MI rate was 2%. Conclusion: The incidence of ST in our study in patient who received EES was almost similar to the international results; diabetic patients had more ST and TLR than non-diabetics.

0510: Predictors of angiographic restenosis after drug eluting stents

Drug eluting stents represent a major advance in coronary revascularization reducing neointimal hyperplasia. However, in-stent restenosis (ISR) was not completely eradicated. The aim of our study was to determine the frequency of the ISR, its angiographic and clinical patterns, the time to onset and different predictors of occurrence. We collected retrospectively clinical and angiographic data of 749 patients hospitalized in the cardiology department of the Military Hospital of Tunis between January 2002 and June 2010 and who underwent percutaneous coronary intervention with drug-eluting stents in 1159 lesions. The exclusion of patients without follow-up reduced the size of the population to 577 patients and 936 lesions. The average age of our patients was 59.65±10 years. The prevalence of clinical ISR was 18.9% per patient and 15.9% per lesion. Its average time to onset was 27.6±20 months. Acute coronary syndrome was the most frequent clinical presentation (83.4%). The focal angiographic form was predominant (64%). Predictors of ISR in univariate analysis were: dyslipidemia (p=0.001), overweight (p=0.001), stenting of proximal left anterior descending artery (p=0.002), severe calcifications (p=0.001), B2 and C lesions (p=0.001), restenosis lesion (p=0.19), reference vessel diameter (p=0.003), minimal lumen diameter (p=0.006), lesion length (p=0.02), sirolimus eluting stent (p=0.001). Protective factors were: use of everolimus eluting stent (p=0.001) and inflation pressure >16 atmospheres (p=0.022). Predictors in multivariate analysis were: restenosis lesion (OR=32, p=0.012) and severe calcifications (OR=38, p=0.016). Inflation pressure >16 atmospheres was a protective factor (OR=27, p=0.017). The ISR remains a potential risk even with drug-eluting stents. A better understanding of its characteristics could provide solutions and reduce its prevalence and complications.

Everolimus-Eluting Stents or Bypass Surgery for Multivessel Coronary Disease

BackgroundResults of trials and registry studies have shown lower long-term mortality after coronary-artery bypass grafting (CABG) than after percutaneous coronary intervention (PCI) among patients with multivessel disease. These previous analyses did not evaluate PCI with second-generation drug-eluting stents.MethodsIn an observational registry study, we compared the outcomes in patients with multivessel disease who underwent CABG with the outcomes in those who underwent PCI with the use of everolimus-eluting stents. The primary outcome was all-cause mortality. Secondary outcomes were the rates of myocardial infarction, stroke, and repeat revascularization. Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.ResultsAmong 34,819 eligible patients, 9223 patients who underwent PCI with everolimus-eluting stents and 9223 who underwent CABG had similar propensity scores and were included in the analyses. At a mean follow-up of 2.9 years, PCI with everolimus-eluting stents, as compared with CABG, was associated with a similar risk of death (3.1% per year and 2.9% per year, respectively; hazard ratio, 1.04; 95% confidence interval [CI], 0.93 to 1.17; P=0.50), higher risks of myocardial infarction (1.9% per year vs. 1.1% per year; hazard ratio, 1.51; 95% CI, 1.29 to 1.77; P<0.001) and repeat revascularization (7.2% per year vs. 3.1% per year; hazard ratio, 2.35; 95% CI, 2.14 to 2.58; P<0.001), and a lower risk of stroke (0.7% per year vs. 1.0% per year; hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). The higher risk of myocardial infarction with PCI than with CABG was not significant among patients with complete revascularization but was significant among those with incomplete revascularization (P=0.02 for interaction).ConclusionsIn a contemporary clinical-practice registry study, the risk of death associated with PCI with everolimus-eluting stents was similar to that associated with CABG. PCI was associated with a higher risk of myocardial infarction (among patients with incomplete revascularization) and repeat revascularization but a lower risk of stroke. (Funded by Abbott Vascular.)

Trial of Everolimus-Eluting Stents or Bypass Surgery for Coronary Disease

BackgroundMost trials comparing percutaneous coronary intervention (PCI) with coronary-artery bypass grafting (CABG) have not made use of second-generation drug-eluting stents.MethodsWe conducted a randomized noninferiority trial at 27 centers in East Asia. We planned to randomly assign 1776 patients with multivessel coronary artery disease to PCI with everolimus-eluting stents or to CABG. The primary end point was a composite of death, myocardial infarction, or target-vessel revascularization at 2 years after randomization. Event rates during longer-term follow-up were also compared between groups.ResultsAfter the enrollment of 880 patients (438 patients randomly assigned to the PCI group and 442 randomly assigned to the CABG group), the study was terminated early owing to slow enrollment. At 2 years, the primary end point had occurred in 11.0% of the patients in the PCI group and in 7.9% of those in the CABG group (absolute risk difference, 3.1 percentage points; 95% confidence interval [CI], −0.8 to 6.9; P=0.32 for noninferiority). At longer-term follow-up (median, 4.6 years), the primary end point had occurred in 15.3% of the patients in the PCI group and in 10.6% of those in the CABG group (hazard ratio, 1.47; 95% CI, 1.01 to 2.13; P=0.04). No significant differences were seen between the two groups in the occurrence of a composite safety end point of death, myocardial infarction, or stroke. However, the rates of any repeat revascularization and spontaneous myocardial infarction were significantly higher after PCI than after CABG.ConclusionsAmong patients with multivessel coronary artery disease, the rate of major adverse cardiovascular events was higher among those who had undergone PCI with the use of everolimus-eluting stents than among those who had undergone CABG. (Funded by CardioVascular Research Foundation and others; BEST ClinicalTrials.gov number, NCT00997828.)

Acute ischemic events are frequent after primary coronary stenting.

The purpose of this study was to assess the incidence, predictors, and presentation of target vessel failure (TVF) after primary stenting for ST-segment elevation myocardial infarction (MI) as opposed to elective stenting. A total of 8237 consecutive patients undergoing urgent or elective percutaneous coronary intervention (PCI) were enrolled in our database and followed for a median of 1234 days (interquartile range 782-1688 days). Any acute ischemic event attributed to the obstruction of the stented vessel was considered as TVF. Stent thrombosis was classified according to the Academic Research Consortium, whereas restenosis and new culprit lesion were defined as obstructions within or outside stent boundaries, respectively. Unstable clinical presentation required urgent hospital admission or caused unexplained sudden death. Multivariable analyses were performed with Cox proportional hazards regression models. TVF occurred in 4.2% of our population. A measurable proportion of patients had to be re-admitted to hospital: 1.6% because of stent thrombosis, 1.5% because of restenosis, and 0.3% because of new culprit lesion. Ten (0.1%) patients were found victims of sudden death. De-novo lesions showed less TVF [hazard ratio (HR) 0.22, 95% confidence interval (CI) 0.16-0.30, P < 0.0001]. Primary PCI was associated with increased risk of TVF (HR 1.83, 95% CI 1.43-2.36, P < 0.0001), stent thrombosis (HR 2.59, 95% CI 1.80-3.72, P < 0.0001), and MI (HR 2.16, 95% CI 1.61-2.91, P < 0.0001). The events appeared earlier after primary PCI with more than 50% within the first month; after the first year, further occurrences were similar in both groups. Finally, the use of everolimus-eluting stents suggested the best safety profile. The present study shows that acute ischemic events are frequent after primary PCI and occur earlier compared with elective PCI. Particular attention should be directed towards optimal stent selection and implantation technique.

Sex-related Impact on Clinical Outcome of Everolimus-eluting Versus Bare-metal Stents in ST-segment Myocardial Infarction. Insights From the EXAMINATION Trial

Introduction and objectivesThe use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. MethodsThis is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. ResultsOf 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. ConclusionsDespite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men.

Influencia del sexo en los resultados clínicos de los stents liberadores de everolimus en comparación con los stents metálicos sin recubrimiento en el infarto agudo de miocardio con elevación del segmento ST. Perspectivas del ensayo EXAMINATION

Introduction and objectivesThe use of second-generation drug-eluting stents compared with bare-metal stents in patients with ST-segment elevation myocardial infarction reduces the rate of major adverse cardiac events. We aimed to evaluate the impact of sex on the performance of everolimus-eluting stents vs bare-metal stents in ST-segment elevation myocardial infarction at 2-year follow-up. MethodsThis is a sub-study of the EXAMINATION trial that randomized 1498 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention to everolimus-eluting or bare-metal stents. Primary end point was combined all-cause death, any recurrent myocardial infarction, and any revascularization. All end points were analyzed according to sex at 2-year follow-up. ResultsOf 1498 patients included in the trial, 254 (17.0%) were women. Women were older and had higher prevalence of hypertension and lower prevalence of smoking compared with men. In contrast with men, stent diameter was smaller in women. After multivariate analysis, the primary end point was similar between women and men (hazard ratio=0.95; 95% confidence interval, 0.66-1.37), and among women, between those treated with bare-metal vs everolimus-eluting stents (hazard ratio=2.48; 95% confidence interval, 0.95-6.46). Women showed a lower rate of repeat revascularization than men (hazard ratio=0.55; 95% confidence interval, 0.32-0.95) despite worse baseline characteristics. This difference was driven by better performance of the everolimus-eluting stent in women. ConclusionsDespite poorer baseline clinical characteristics, women with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention showed outcomes similar to men. The use of everolimus-eluting stents may represent an added value in women as it showed a reduced rate of repeated revascularization compared to men.Full English text available from: www.revespcardiol.org/en

Dedicated two-stent technique in complex bifurcation percutaneous coronary intervention with use of everolimus-eluting stents: The EES-bifurcation study

ObjectivesTo compare the outcomes of initial one-stent (1S) versus dedicated two-stent (2S) strategies in complex bifurcation percutaneous coronary intervention (PCI) using everolimus-eluting stents (EES). BackgroundPCI of true bifurcation lesions is technically challenging and historically associated with reduced procedural success and increased restenosis. Prior studies comparing initial one-stent (1S) versus dedicated two-stent (2S) strategies using first-generation drug-eluting stents have shown no reduction in ischemic events and more complications with a 2S strategy. MethodsWe performed a retrospective study of 319 consecutive patients undergoing PCI at a single referral center with EES for true bifurcation lesions, defined by involvement of both the main vessel (MV) and side branch (SB). Baseline, procedural characteristics, quantitative coronary angiography and clinical outcomes in-hospital and at one year were compared for patients undergoing 1S (n=175) and 2S (n=144) strategies. ResultsBaseline characteristics were well-matched. 2S strategy was associated with greater SB acute gain (0.65±0.41mm vs. 1.11±0.47mm, p<0.0001). In-hospital serious adverse events were similar (9% with 2S vs. 8% with 1S, p=0.58). At one year, patients treated by 2S strategy had non-significantly lower rates of target vessel revascularization (5.8% vs. 7.4%, p=0.31), myocardial infarction (7.8% vs. 12.2%, p=0.31) and major adverse cardiovascular events (16.6% vs. 21.8%, p=0.21). ConclusionIn this study of patients undergoing PCI for true coronary bifurcation lesions using EES, 2S strategy was associated with superior SB angiographic outcomes without excess complications or ischemic events at one year.

Long-term outcomes of drug-eluting versus bare-metal stent for ST-elevation myocardial infarction.

BackgroundLong-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI) remain uncertain.ObjectiveTo investigate long-term outcomes of drug-eluting stents (DES) versus bare-metal stents (BMS) in patients with ST-segment elevation myocardial infarction (STEMI).MethodsWe performed search of MEDLINE, EMBASE, the Cochrane library, and ISI Web of Science (until February 2013) for randomized trials comparing more than 12-month efficacy or safety of DES with BMS in patients with STEMI. Pooled estimate was presented with risk ratio (RR) and its 95% confidence interval (CI) using random-effects model.ResultsTen trials with 7,592 participants with STEMI were included. The overall results showed that there was no significant difference in the incidence of all-cause death and definite/probable stent thrombosis between DES and BMS at long-term follow-up. Patients receiving DES implantation appeared to have a lower 1-year incidence of recurrent myocardial infarction than those receiving BMS (RR = 0.75, 95% CI 0.56 to 1.00, p= 0.05). Moreover, the risk of target vessel revascularization (TVR) after receiving DES was consistently lowered during long-term observation (all p< 0.01). In subgroup analysis, the use of everolimus-eluting stents (EES) was associated with reduced risk of stent thrombosis in STEMI patients (RR = 0.37, p=0.02).ConclusionsDES did not increase the risk of stent thrombosis in patients with STEMI compared with BMS. Moreover, the use of DES did lower long-term risk of repeat revascularization and might decrease the occurrence of reinfarction.

Effectiveness of everolimus-eluting stents in the treatment of drug-eluting stent versus bare-metal stent restenosis

The efficacy of drug-eluting stents (DES) for the treatment of in-stent restenosis (ISR) after DES implantation is not well defined. This study compared the clinical outcome after the use of everolimus-eluting stents (EES) for the treatment of bare-metal stent (BMS) versus DES restenosis. Ninety-four patients with 94 ISR were included in this study. Sixty-four patients had BMS-ISR and 30 patients had DES-ISR. Patients were treated by repeat PCI using an EES. The primary endpoint of the study was survival free of target lesion revascularization (TLR) at 12 months or DES-ISR versus BMS-ISR patients. The secondary endpoints were survival free of major adverse cardiac events (MACE) and definite stent thrombosis. The baseline clinical and angiographic parameters were comparable between the two groups. Treatment of DES-ISR was associated with higher rates of recurrent TLR, myocardial infarction (MI), and MACE at the 12-month follow-up compared with the treatment of BMS-ISR (23.3 versus 1.6%, P=0.002 for TLR; 13.3 versus 0%, P=0.017 for MI; and 30 versus 4.6%, P=0.003 for MACE). There were no differences in mortality and definite stent thrombosis between both groups (P=0.5686 and 0.6927, respectively). Initial stent number (odds ratio=1.13, 95% confidence interval 1.02-1.25; P=0.024) and initial stent type being a DES (odds ratio=8.11, 95% confidence interval 5.99-10.45; P<0.001) were independent predictors of recurrent TLR after the treatment of ISR using an EES. EES used for the treatment of DES-ISR is associated with higher rates of recurrent revascularization, MI, and MACE compared with EES for the treatment of BMS-ISR.

Safety and efficacy of everolimus‐eluting stents versus paclitaxel‐eluting stents in a diabetic population

This study aimed to analyze the use of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in an unrestricted diabetic population and to compare the performance of these two drug-eluting stents. EES have demonstrated superiority in efficacy when compared to PES in a general population. However, it is controversial whether this superiority holds true in a diabetic population. From March 2004 to May 2010, 968 patients with consecutive diabetes who underwent percutaneous coronary intervention and implantation of an EES (n = 388) or PES (n = 580) at our institution. In-hospital, 1-month, 6-month, and 1-year clinical outcomes were analyzed and compared. Correlates of major adverse cardiac events (MACE) were identified. Baseline clinical characteristics were similar between stent types except for more family history of coronary artery disease in the PES group and more insulin-dependent diabetes and unstable angina at initial diagnosis in the EES group. The PES group had higher number of lesions treated, longer stents used, and a higher proportion of intravascular ultrasound and glycoprotein IIb/IIIa inhibitor use. The EES group had more type C and distal lesions. There was higher target lesion revascularization (TLR)-MACE in the PES group (3.3% vs. 1.0%, P = 0.03) as well as a higher rate of stent thrombosis (ST) (8 patients vs. 0 in the EES group, P = 0.03). ST continued to be higher in the PES group at 6 and 12 months and mortality was higher at 12 months in the PES group (9.4% vs. 5.2%, P = 0.02). After adjustment, no significant differences were found between stent types on Cox regression analysis for hazard ratios at 1-year follow-up of TLR-MACE. In a diabetic population undergoing PCI, the use of an EES compared to PES was associated with lower rates of stent thrombosis; but after adjustment the composite TLR-MACE at 1 year was similar between both stents.

Everolimus-eluting stents for treatment of chronic total coronary occlusions

After successful recanalization of a coronary chronic total occlusion (CTO) the risk for restenosis and subsequent need for repeat intervention is high. Everolimus-eluting stents (EESs) were associated with low rates of restenosis, reintervention and stent thrombosis in non-occluded lesions. We sought to determine the antiproliferative impact of the everolimus-eluting Xience V stent in CTOs. Fifty-three patients with a CTO in a native coronary artery were included. CTO was defined as a duration of occlusion ≥3 months and thrombolysis in myocardial infarction 0 flow. EESs were exclusively implanted to completely cover the occluded and adjacent stenotic segments. Dual antiplatelet therapy was prescribed for 6 months. Follow-up angiography was scheduled at 6 months. Clinical follow-up was done at 12 months. The primary endpoint was late loss at the initial occlusion site. Secondary clinical endpoint was a composite of cardiac death, myocardial infarction not clearly attributable to a non-target vessel and target lesion revascularization. Mean occlusion length was 24 ± 17 mm, ranging from 4 to 74 mm. Mean stent length was 79 ± 36 mm, ranging from 18 to 158 mm. Reference diameter was 3.27 ± 0.58 mm. Late loss at the initial occlusion site was 0.22 ± 0.69 mm. There were six (11%) binary restenosis with a target lesion reintervention in three (6%) patients. There was no death, myocardial infarction or stent thrombosis within 12 months. In patients with successful recanalization of complex CTOs the use of EESs results in a low angiographic late loss and restenosis rate without stent thrombosis throughout 12 months follow-up.

Long-Term Comparison of Everolimus-Eluting and Sirolimus-Eluting Stents for Coronary Revascularization

This study sought to compare the unrestricted use of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention. It is unclear whether there are differences in safety and efficacy between EES and SES during long-term follow-up. Using propensity score matching, clinical outcome was compared among 1,342 propensity score-matched pairs of patients treated with EES and SES. The primary outcome was a composite of death, MI, and target vessel revascularization. The median follow-up was 1.5 years with a maximum of 3 years. The primary outcome occurred in 14.9% of EES- and 18.0% of SES-treated patients up to 3 years (hazard ratio [HR]: 0.83, 95% confidence interval [CI]: 0.68 to 1.00, p = 0.056). All-cause mortality (6.0% vs. 6.5%, HR: 0.92, 95% CI: 0.68 to 1.25, p = 0.59) was similar, risks of myocardial infarction (MI) (3.3% vs. 5.0%, HR: 0.62, 95% CI: 0.42 to 0.92, p = 0.017), and target vessel revascularization (7.0% vs. 9.6%, HR: 0.75, 95% CI: 0.57 to 0.99, p = 0.039) were lower with EES than SES. Definite stent thrombosis (ST) (HR: 0.30, 95% CI: 0.12 to 0.75, p = 0.01) was less frequent among patients treated with EES. The reduced rate of MI with EES was explained in part by the lower risk of definite ST and the corresponding decrease in events associated with ST (HR: 0.25, 95% CI: 0.08 to 0.75, p = 0.013). The unrestricted use of EES appears to be associated with improved clinical long-term outcome compared with SES. Differences in favor of EES are driven in part by a lower risk of MI associated with ST.