Safety Of Everolimus-eluting Stents Research Articles

One-year efficacy and safety of everolimus eluting stents (Xience Prime BTK®) to treat infrapopliteal lesions in patients with critical ischemia

One-year efficacy and safety of everolimus eluting stents (Xience Prime BTK®) to treat infrapopliteal lesions in patients with critical ischemia

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.

Abstract 16128: Vascular Healing Response After Everolimus Eluting Stent Implantation in Patients With or Without Diabetes Mellitus -Evaluation With Optical Coherence Tomography

Introduction: Clinical introduction of percutaneous coronary intervention (PCI) with drug eluting stent has substantially decreased the rate of in-stent restenosis (ISR). However, it is reported that patients with diabetes mellitus (DM) still have higher incidence of restenosis and secondary cardiovascular events than patients without DM. Using intravascular optical coherence tomography (OCT), we evaluated the effect of DM on healing process of coronary artery after everolimus eluting stents (EES) implantation in the comparison with non-DM patients. Methods and Results: We studied 26 DM patients (65.1±11.9y/o) and 59 non-DM patients (68.1±9.4y/o) who received OCT-guided EES implantation. The second OCT examination was performed on 296±71.1 days after implantation (291±74.2days vs. 298±70.3days, p=0.51). OCT cross-sectional images of the second study were examined to determine the condition of neointimal coverage over every strut in 1mm interval (DM; 725 cross-sections and 5742 struts, non-DM; 1482 cross-sections and 12098 struts). In addition, neointimal thickness (NIT) over each strut measured and tissue characteristics were examined. One in-stent restenosis with clinical manifestation was observed in each group. Average NIT was significantly thicker in DM group than in non-DM group (107±99.2μm vs. 92±74.6μm, p<0.01). The incidence of malapposed struts without neointimal coverage were very low and similar in both groups (0.22±0.54 vs. 0.13±0.72%, p=0.43). The frequency of OCT-defined unstable neointimal characteristics was significantly higher rate in DM than non-DM group (14.5±18.9% vs. 6.67±14.5%, p=0.03). Conclusions: EES implanted in DM patients showed acceptable neointimal proliferation and uncovered stent struts similar to non-DM patients, suggesting the mid-term efficacy and safety of EES in DM patients. However, long-term follow-up should be necessary because of the high incidence of unstable neointimal characteristics which might be a substrate for the future development of neoatherosclerosis.

TCT-574 Comparison of everolimus-eluting stents with first (paclitaxel, sirolimus) and second-generation (zotarolimus, biolimus) drug-eluting stents in patients with acute coronary syndromes [Katowice-Zabrze Registry on first and second generation DES

The aim of this study was to compare the efficacy and safety of everolimus-eluting stents (EES) in treatment of patient with coronary artery disease (CAD) as compared to other drug eluting stents (DES): paclitaxel eluting stents (PES), sirolimus eluting stents (SES), zotarolimus eluting stents (ZES

Safety and efficacy of everolimus- versus sirolimus-eluting stents: A systematic review and meta-analysis of 11 randomized trials

While EES have proven superior to paclitaxel-eluting stents, it remains uncertain whether EES improve clinical outcomes compared to SES, which are the most efficacious among the first-generation drug-eluting stents. We performed a meta-analysis of randomized trials comparing the efficacy and safety of everolimus-eluting stents (EES) versus sirolimus-eluting stents (SES) in patients undergoing percutaneous coronary intervention. From online and offline search until December 2011, we identified 11 randomized trials (total 12,869 patients). The primary endpoint was major adverse cardiac events. The risk of major adverse cardiac events did not differ significantly between the patients treated with EES versus SES [OR, 0.90 (95% CI, 0.77-1.04); P = .162]. However, we found a significant reduction in the risk of repeat revascularization in the EES arm [OR, 0.85 (95% CI, 0.71-1.00); P = .047]. There were no significant differences regarding the risk of cardiac death [OR, 0.97 (95% CI, 0.74-1.27); P = .834], or myocardial infarction [OR, 0.95 (95% CI, 0.75-1.20), P = .656]. The risk of definite or probable stent thrombosis tended to be lower [OR, 0.68 (95% CI, 0.45-1.02); P = .065], while definite ST was significantly lower [OR, 0.44 (95% CI, 0.25-0.80); P = .007] with EES. In a large systematic overview of comparative trials involving percutaneous revascularization with drug-eluting stents, treatment with EES significantly reduced the risk of repeat revascularization and definite ST compared to SES. We found no significant differences in the risk of cardiac death or myocardial infarction.

Comparison of Everolimus-Eluting Stent With Paclitaxel-Eluting Stent in Long Chronic Total Occlusions

The aim of the present study was the comparison of the everolimus-eluting stent (EES) with the paclitaxel-eluting stent (PES) in patients treated for long chronic total occlusions (CTOs). Previous randomized trials have shown the superiority of EESs over PESs. No data exist about the efficacy and safety of EESs in patients treated for complex CTOs requiring multiple stent implantation. We identified 258 patients treated for CTOs who received multiple EESs (n = 112) or PESs (n = 146), with a total stent length of ≥40 mm. The primary end point was in-segment restenosis, defined as >50% luminal narrowing at the segment site, including the stent and 5 mm proximal and distal to the stent edges of the target vessel, on the follow-up angiogram. The secondary end point was the 9-month composite of major adverse cardiovascular events. The 2 patient groups were similar in all baseline characteristics. The median lesion length was 48 mm in the EES group and 46 mm in the PES group (p = 0.793). The incidence of the primary end point of the study was 11.8% in the EES group and 31.4% in the PES group (p = 0.001). The major adverse cardiovascular event rate was lower in the EES group than in the PES group (8.9% and 22.6%, respectively, p = 0.003). Definite or probable stent thrombosis occurred in 5 patients in the PES group (3.4%), with no stent thrombosis occurring in the EES group (p = 0.048). On multivariate analysis, EES was the only variable independently related to the risk of binary angiographic restenosis with an odds ratio of 0.29 (95% confidence interval 0.14 to 0.62; p = 0.002). In conclusion, in patients treated for long CTOs and requiring multiple stent implantation, EESs performed better than PESs, with a >50% reduction in the risk of restenosis and major adverse cardiovascular events.