Safety Of Drug-eluting Stents Research Articles

COMPARISON OF DRUG-ELUTING STENTS VERSUS BARE-METAL STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE

Coronary artery disease is a condition that affects millions of people worldwide and can lead to serious complications such as heart attack or stroke. Objectives: The study compares drug-eluting stents to bare-metal stents for treating coronary artery disease. Methods: The present study aimed to compare the efficacy and safety of drug-eluting stents (1) versus bare metal stents (BMS) for the treatment of coronary artery disease (CAD). The study was conducted at Cardiology Department Hayat Abad Medical Complex Peshawar Pakistan, from 01 January 2022 till 30 June 2022. The study included a total of 384 patients with CAD who underwent percutaneous coronary intervention (PCI) with either DES or BMS. Results: The study included a total of 384 patients with CAD who underwent PCI with either DES or BMS. The mean age of the study participants was 58.2 ± 9.4 years, and 75.8% were male. The baseline characteristics, including demographic data, clinical presentation, cardiovascular risk factors, and angiographic findings, were comparable between the two groups. Conclusion: In conclusion, our study contrasting medication-eluting stents versus exposed metal stents for the treatment of coronary supply route sickness found that drug-eluting stents were related to a lower chance of unfriendly heart occasions, including objective vessel revascularization, myocardial dead tissue, and cardiovascular demise, contrasted with uncovered metal stents.

Recent Advancements in Drug-Eluting Stents: A Comprehensive Review

Drug-eluting stents (DES) have revolutionized the field of interventional cardiology by significantly reducing restenosis rates compared to bare-metal stents (BMS). Over the past two decades, there have been remarkable advancements in DES technology aimed at improving efficacy, safety, and long-term outcomes. This comprehensive review provides an overview of recent developments in DES design, drug formulations, coatings, and delivery systems. It discusses the clinical evidence supporting the efficacy and safety of next-generation DES and explores emerging strategies to address remaining challenges, such as late stent thrombosis and neo atherosclerosis. Additionally, the paper examines future directions in DES research, including bioresorbable stents, drug-free coatings, and personalized approaches to stent selection.

Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.

Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting. All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up. A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment. In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.

Valuation of the Use of Bioabsorbable Stents versus Metallic Stents in Percutaneous Coronary Intervention: An Integrative Review

The integrative review addresses the evolution and efficacy of stents in the treatment of coronary artery disease (CAD). Recent research highlights the importance of percutaneous coronary interventions (PCI) in improving CAD treatment, emphasizing the innovation of bioabsorbable stents (BVS) compared to metallic stents, particularly drug-eluting stents (DES). The objective was to compare the efficacy, safety, long-term outcomes, and cost-effectiveness of BVS and DES. Methodologically, the review involved a bibliographic search in databases such as PubMed, SciELO, and Google Scholar, selecting studies from 2013 to 2023 that analyzed aspects such as restenosis rates and incidence of adverse events. Results indicate that BVS exhibit initial efficacy like DES in restoring blood flow but with higher rates of restenosis and thrombosis in some studies. Economic analysis suggests that although BVS are initially more expensive, they may be cost-effective in the long term due to the reduction in late complications. The conclusion underscores the need for continuous improvements in BVS materials and designs, as well as adequate training of professionals to optimize implantation and clinical outcomes. Future clinical trials and long-term follow-up studies are essential to validate the benefits of BVS and justify their adoption in clinical practice. Continuous research and collaboration between developers and clinicians are crucial to overcoming barriers and realizing the potential of BVS in percutaneous coronary intervention.

Drug-coated balloon versus drug-eluting stent for treating de novo large vessel coronary artery disease: a systematic review and meta-analysis of 13 studies involving 2888 patients.

Drug-coated balloon (DCB) is an established treatment option for in-stent restenosis and small vessel, de novo, coronary artery disease (CAD). Although the use of this tool is increasing in everyday practice, data regarding performance in the treatment of de novo, large vessel CAD (LV-CAD) is still lacking. A systematic review and meta-analysis were conducted to evaluate the efficacy and safety of DCB versus drug-eluting stent (DES) in this setting. A comprehensive literature search was performed including Medline, Embase, and Cochrane electronic databases up to January 24, 2024, for studies which compared the efficacy and safety of DCB versus DES in the treatment of de novo lesions in large vessels (≥ 2.5mm), reporting at least one clinical outcome of interest (PROSPERO ID: CRD42023470417). The analyzed outcomes were cardiovascular death (CVD), myocardial infarction (MI), target lesion revascularization (TLR), all-cause death (ACD), and late lumen loss (LLL) at follow-up. The effect size was estimated using a random effects model as risk ratio (RR) and mean difference (MD) and relative 95% confidence interval (CI). A total of 13 studies (6 randomized controlled trials and 7 observational studies) involving 2888 patients (DCB n = 1334; DES n = 1533) with de novo LV-CAD were included in this meta-analysis following our inclusion criteria. No differences were observed between DCB and DES in terms of CVD (RR 0.49; 95% CI [0.23-1.03]; p = 0.06), MI (RR 0.48; 95% CI [0.16-1.45]; p = 0.89), TLR (RR 0.73; 95% CI [0.40-1.34]; p = 0.32), ACD (RR 0.78; 95% CI [0.57-1.07]; p = 0.12), and LLL (MD - 0.14; 95% CI [- 0.30 to 0.02]; p = 0.10) at follow-up. DES proved a higher mean acute gain versus DCB [1.94 (1.73, 2.14) vs 1.31 (1.02, 1.60); p = 0.0006]. Our meta-analysis showed that DCB PCI might provide a promising option for the management of selected, de novo LV-CAD compared to DES. However, more focused RCTs are needed to further prove the benefits of a "metal-free" strategy in this subset of CAD.

Shortened Duration of Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention: A Contemporary Clinical Review

Percutaneous coronary intervention with stent implantation is an integral aspect of minimally interventional cardiac procedures. The technology and techniques behind stent design and implantation have evolved rapidly over several decades. However, continued discourse remains around optimal peri- and post-interventional management with dual antiplatelet therapy to minimise both major cardiovascular or cerebrovascular events and iatrogenic bleeding risk. Standard guidelines around dual antiplatelet therapy historically recommended long-term dual antiplatelet therapy for 12 months (with consideration for >12 months in certain patients); however, emerging data and generational improvements in the safety of drug-eluting stents have ushered in a new era of short-term therapy to reduce the incidence of major bleeding events. This case review will provide an overview of the current state of guidelines around duration of dual antiplatelet therapy and examine recent updates and continued gaps in existing research.

Plaque burden is associated with minimal intimal coverage following drug-eluting stent implantation in an adult familial hypercholesterolemia swine model

Safety and efficacy of coronary drug-eluting stents (DES) are often preclinically tested using healthy or minimally diseased swine. These generally show significant fibrotic neointima at follow-up, while in patients, incomplete healing is often observed. The aim of this study was to investigate neointima responses to DES in swine with significant coronary atherosclerosis. Adult familial hypercholesterolemic swine (n = 6) received a high fat diet to develop atherosclerosis. Serial OCT was performed before, directly after, and 28 days after DES implantation (n = 14 stents). Lumen, stent and plaque area, uncovered struts, neointima thickness and neointima type were analyzed for each frame and averaged per stent. Histology was performed to show differences in coronary atherosclerosis. A range of plaque size and severity was found, from healthy segments to lipid-rich plaques. Accordingly, neointima responses ranged from uncovered struts, to minimal neointima, to fibrotic neointima. Lower plaque burden resulted in a fibrotic neointima at follow-up, reminiscent of minimally diseased swine coronary models. In contrast, higher plaque burden resulted in minimal neointima and more uncovered struts at follow-up, similarly to patients’ responses. The presence of lipid-rich plaques resulted in more uncovered struts, which underscores the importance of advanced disease when performing safety and efficacy testing of DES.

COMPARISON OF DRUG-ELUTING STENTS VERSUS BARE METAL STENTS FOR THE TREATMENT OF CORONARY ARTERY DISEASE

Coronary artery disease is a condition that affects millions of people worldwide and can lead to serious complications such as heart attack or stroke. The study's main objective is to compare drug-eluting stents versus bare-metal stents for treating coronary artery disease. The present study aimed to compare the efficacy and safety of drug-eluting stents (DES) versus bare metal stents (BMS) for the treatment of coronary artery disease (CAD). The study was conducted at two tertiary care hospitals, Hayatabad Medical Complex and Lady Reading Hospital in Peshawar, Pakistan, from July 2019 to July 2020. The study included a total of 384 patients with CAD who underwent percutaneous coronary intervention (PCI) with either DES or BMS. The study included a total of 384 patients with CAD who underwent PCI with either DES or BMS. The mean age of the study participants was 58.2 ± 9.4 years, and 75.8% were male. The baseline characteristics, including demographic data, clinical presentation, cardiovascular risk factors, and angiographic findings, were comparable between the two groups. In conclusion, our study contrasting medication-eluting stents versus exposed metal stents for treating coronary supply route sickness found that drug-eluting stents were related to a lower chance of unfriendly heart occasions, including objective vessel revascularization, dead myocardial tissue, and cardiovascular demise, contrasted with uncovered metal stents.

Drug-Coated Balloon and Drug-Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease.

Background Patients with severe-stage chronic kidney disease (CKD) were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCBs) and drug-eluting stents (DESs) versus plain balloon angioplasty (POBA) and bare metal stents (BMSs). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods and Results We studied patients undergoing femoropopliteal interventions (September 2016-December 2018) from Medicare-linked VQI (Vascular Quality Initiative) registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4 and 5) CKD receiving DCB/DES, and (4) severe-stage CKD receiving POBA/BMS. We studied 8799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% versus 51% in patients with early-stage versus severe-stage CKD. Twenty-four-month mortality risk for patients with early-stage CKD receiving DCB/DES (reference) was 21% versus 28% (hazard ratio [HR], 1.47 [95% CI, 1.31-1.65]) for those receiving POBA/BMS; patients with severe-stage CKD: those receiving DCB/DES had a 49% (HR, 2.61 [95% CI, 2.06-3.31]) mortality risk versus 52% (HR, 3.64 [95% CI, 2.91-4.55]) for those receiving POBA/BMS (interaction P<0.001). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES versus POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P=0.06) but was higher for the POBA/BMS group at 18 months (post hoc P<0.05). Patients with early-stage CKD receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, and 16% for severe-stage CKD-POBA/BMS (interaction P<0.001). DCB/DES versus POBA/BMS amputation rates in patients with severe-stage CKD did not differ (post hoc P=0.820). Conclusions DCB/DES versus POBA/BMS use in patients with severe-stage CKD was associated with lower mortality and no difference in amputation outcomes.

Cre8 Drug Eluting Stent Performance in Daily Cardiology Practice.

In patients undergoing percutaneous coronary intervention (PCI), drug eluting stents (DES) are currently the standard of care. Stent design and alloy composition, biocompatibility of the drug-eluting polymer coating, the antiproliferative agent properties and release are the three main characteristics that affects DES performance. Cre8 (Alvimedica, Istanbul, Turkey) is a polymer-free amphilimus-eluting stents (PF-AES). In this study, we aimed to investigate the clinical efficacy and safety of Cre8 DES in daily cardiology practice. Patients presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) including unstable angina pectoris (USAP), myocardial infarction with and without ST-segment elevation and treated with PCI using Cre8 DES between December 2015 and 2016 were retrospectively analyzed in this study. Between December 2015 and 2016, 808 lesions of 664 patients treated with Cre8 DES in a single center were included in this retrospective analysis. The mean age of study group was 60 years (between 33 and 93 years) and were predominantly consisting of male patients (79.4%). The median follow-up duration was 487 days (min: 30 days, max: 919 days) and two-thirds of all patients presented with ACS. The culprit lesion was on left anterior descending artery (LAD) (40.5%) and right coronary artery (RCA) (25.9%) in most of the patients. The procedural success rate was 97.3%. Most of the lesions were type B1 (40.6%) according to American College of Cardiology/American Heart Association (ACC/AHA) coronary lesion classification. The device oriented primary end-point defined as target lesion failure (TLF) occurred in 52 (6.4%) of 808 lesions. The primary safety end-point was cardiac death in 20 patients (3.0%) and target vessel myocardial infarction in 2 patients (0.3%). Target vessel revascularization (TVR) occurred in 29 patients (4.4%) as primary safety endpoint. Multivariable logistic regression analysis revealed diabetes mellitus and ejection fraction as the predictors of mortality and device oriented primary end-point. This trial revealed clinical efficacy and safety of Cre8 stents in real world practice. Device oriented primary end points were similar with previous studies which are randomized, open label in nature and showed the efficacy and safety of Cre8 stent towards latest generation DES.

Abstract 10491: Drug-Coated Balloon and Drug-Eluting Stent Safety in Patients With Femoropopliteal and Severe Chronic Kidney Disease

Background: Severe-stage chronic kidney disease (CKD) patients were excluded from femoropopliteal disease trials evaluating drug-coated balloons (DCB) and drug-eluting stents (DES) vs. plain balloon angioplasty (POBA) and bare metal stents (BMS). We examined the interaction between CKD status and device type for the association with 24-month all-cause mortality and major amputation risk. Methods: We studied patients undergoing femoropopliteal interventions (9/2016-12/2018) from Medicare-linked VQI registry data. We compared outcomes for: (1) early-stage CKD (stages 1-3) receiving DCB/DES, (2) early-stage CKD receiving POBA/BMS, (3) severe-stage (4-5) CKD receiving DCB/DES, (4) severe-stage CKD receiving POBA/BMS. Results: We studied 8,799 patients (early-stage CKD: 94%; severe-stage: 6%). DCB/DES use was 57% vs. 51% in early-stage vs. severe-stage CKD patients. Twenty-four-month mortality risk for early-stage CKD patients receiving DCB/DES (reference group) was 21% vs. 28% (HR=1.47, 95% CI, 1.31-1.65) for those receiving POBA/BMS; severe-stage CKD patients: those receiving DCB/DES had a 49% (HR=2.61,95% CI, 2.06-3.31) mortality risk vs. 52% (HR=3.64, 95% CI, 2.91-4.55) for those receiving POBA/BMS (interaction P&lt;0.001) ( Figure ). Adjusted analyses attenuated these results. For severe-stage CKD, DCB/DES vs. POBA/BMS mortality risk was not significant at 24 months (post hoc comparison P=0.06) but was higher for POBA/BMS group at 18 months (post hoc P&lt;0.05). Early-stage CKD patients receiving DCB/DES had the lowest 24-month amputation risk (6%), followed by 11% for early-stage CKD-POBA/BMS, 15% for severe-stage CKD-DCB/DES, 16% for severe-stage CKD-POBA/BMS (interaction P&lt;0.001). DCB/DES vs. POBA/BMS amputation rates in severe-stage CKD patients did not differ (post hoc P=0.820). Conclusion: DCB/DES vs. POBA/BMS use severe-stage CKD patients was associated with lower mortality and no difference in amputation outcomes.

Bioresorbable vascular scaffolds versus conventional drug-eluting stents across time: a meta-analysis of randomised controlled trials

BackgroundBioresorbable vascular scaffolds (BVS) were designed to reduce the rate of late adverse events observed in conventional drug-eluting stents (DES) by dissolving once they have restored lasting patency.ObjectivesCompare the safety...

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The development of bare metal coronary stents revolutionized the treatment of coronary artery disease by reducing rates of acute vessel closure and restenosis associated with balloon angioplasty. However, bare metal stents (BMS) resulted in high rates of restenosis and led to the development of drug-eluting stents (DES). Those first-generation DES were followed by successive generations of DES that included improvements, such as biodegradable and more biocompatible polymers. Despite the superiority of the current DES compared to BMS, a subset of patients still receives BMS. The following paper reviews the literature comparing the safety and efficacy of newer generation DES to BMS in such patients and ultimately challenges the use of BMS in contemporary current DES era.

Safety and Efficacy of Modern Stents in Patients with Metabolic Syndrome

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE.

Drug-coated balloons for small coronary artery disease in patients with chronic kidney disease: a pre-specified analysis of the BASKET-SMALL 2 trial

BackgroundData on the safety and efficacy of drug-coated balloon (DCB) compared to drug-eluting stent (DES) in patients with chronic kidney disease (CKD) are scarce, particularly at long term. This pre-specified analysis aimed to investigate the 3-year efficacy and safety of DCB versus DES for small coronary artery disease (< 3 mm) according to renal function at baseline.MethodsBASKET-SMALL-2 was a large multi-center, randomized, controlled trial that tested the efficacy and safety of DCBs (n = 382) against DESs (n = 376) in small vessel disease. CKD was defined as eGFR < 60 ml/min/1.73m2. The primary endpoint was the composite of cardiac death, non-fatal myocardial infarction, and target vessel revascularization (MACE) during 3 years.ResultsA total of 174/758 (23%) patients had CKD, out of which 91 were randomized to DCB and 83 to DES implantation. The primary efficacy outcome during 3 years was similar in both, DCB and DES patients (HR 0.98; 95%-CI 0.67–1.44; p = 0.937) and patients with and without CKD (HR 1.18; 95%-CI 0.76–1.83; p = 0.462), respectively. Rates of cardiac death and all-cause death were significantly higher among patients with CKD but not affected by treatment with DCB or DES. Major bleeding events were lower in the DCB when compared to the DES group (12 vs. 3, HR 0.26; 95%-CI 0.07–0.92; p = 0.037) and not influenced by presence of CKD.ConclusionsThe long-term efficacy and safety of DCB was similar in patients with and without CKD. The use of DCB was associated with significantly fewer major bleeding events (NCT 01574534).Graphical Central Illustration. Drug-coated balloon versus drug-eluting stents in small coronary artery disease with and without chronic kidney disease, a prespecified subgroup analysis of the BASKET-SMALL 2 trial

Improved Outcomes of Combined Main Branch Stenting and Side Branch Drug-Coated Balloon versus Two-Stent Strategy in Patients with Left Main Bifurcation Lesions.

Background Drug-eluting stent (DES) plus drug-coated balloon (DCB) is a safe and effective treatment strategy for coronary artery bifurcation lesions, but there is no report about this strategy being used for left main (LM) bifurcation lesions. We aim to explore the efficacy and safety of DES plus DCB in the treatment of LM bifurcation lesions. Methods A total of 100 patients diagnosed with LM bifurcation lesions by coronary angiography were retrospectively enrolled at our center from January 2018 to December 2019. They received either a two-stent strategy or a main branch (MB) stenting plus side branch (SB) DCB strategy and were accordingly divided into the 2-DES group and the DES + DCB group. Patients treated with DES + DCB were compared with a cohort of matched patients treated with a 2-DES strategy. Clinical data was collected and quantitative coronary analysis was performed. Results For immediate postoperative angiography, though the two groups had no differences in the minimal luminal diameter (MLD) and luminal stenosis of MB, the DES + DCB group had significantly lower SB ostial MLD and a higher degree of residual lumen stenosis than the 2-DES group (P < 0.05). At the time of follow-up, the SB ostial MLD of the DES + DCB group was higher than that of the 2-DES group, but lumen stenosis, late lumen loss (LLL), and LLL at the distal end of the left MB were all smaller than those of the 2-DES group (Ps < 0.05). Furthermore, the incidence of lumen restenosis and MACE between the two groups had no significance. Conclusion The combination of DES and DCB is relatively safe and effective for the treatment of LM bifurcation lesions, and this strategy seems to have advantages in reducing LLL at the SB ostium.

Drug-coated balloon versus drug-eluting stent in acute myocardial infarction: A protocol for systematic review and meta-analysis.

Background:Previous studies comparing the published literature on drug-eluting stents (DES) and drug-coated balloon (DCB) have drawn divergent conclusions, as these studies are limited by small sample sizes. To overcome these limitations, we thus conducted a high-quality systematic review and meta-analysis to assess the efficacy and safety of DCB versus DES for patients with acute myocardial infarction (AMI). It was hypothesized that DCB use at the AMI is associated with decreased risk of cardiovascular disease and death.Methods:The electronic databases Embase, Medline, PubMed, and Cinahl were searched from the earliest available date until August 2021. Study included in our study had to meet all of the following inclusion criteria: all randomized controlled trials to assess the efficacy and safety of DES versus DCB in the treatment of AMI were considered eligible for analysis; participants received DCB or DES; reporting the available data on cardiac death, all-cause death, myocardial infarction, target lesion revascularization, target vessel revascularization, major adverse cardiac events, and stent thrombosis. Review Manager Software (v 5.3; Cochrane Collaboration) was used for the meta-analysis. Two of us independently assessed the risk of bias in the included studies using parameters defined in the Cochrane Handbook for Systematic Reviews of Interventions criteria.Results:It was hypothesized that DCB use at the AMI is associated with decreased risk of cardiovascular disease and death.Registration number:10.17605/OSF.IO/AVTYW.

24-Month Efficacy and Safety Results from Japanese Patients in the IMPERIAL Randomized Study of the Eluvia Drug-Eluting Stent and the Zilver PTX Drug-Coated Stent

PurposeThe purpose of the study is to report 24-month efficacy and safety results for the Japanese patient cohort in a prospective randomized controlled trial (RCT) of drug-eluting stent (DES) use for peripheral artery disease.Materials and methodsPatients in the global IMPERIAL RCT had femoropopliteal lesions treated with either the Eluvia DES (Boston Scientific, Marlborough, MA, USA) or the Zilver PTX drug-coated stent (Cook Medical, Bloomington, IN, USA). At 24 months, assessments included duplex ultrasound imaging for core laboratory vessel patency measurement, target lesion revascularization (TLR) rates, and clinical outcome measures.ResultsThe Japanese cohort included 84 patients (56 treated with Eluvia and 28 with Zilver PTX). The clinically driven TLR rates were 5.6% (3/54) and 18.5% (5/27) for patients treated with Eluvia and Zilver PTX, respectively (difference -13.0%, 95%CI -28.8, 2.9%; p = 0.11). The Kaplan–Meier estimates for freedom from clinically driven TLR at 24 months were 94.3% for patients who received Eluvia and 80.4% for those who received Zilver PTX (log rank p = 0.05), and for primary patency they were 88.5% and 80.4%, respectively (log rank p = 0.28). Mortality rates were 5.6% (3/54) and 11.1% (3/27); p = 0.39. Rutherford classification improved by at least one category without TLR for 91.8% (45/49) and 68.2% (15/22) of patients (p = 0.03). Walking impairment score improvements were sustained over time.ConclusionThe results at 24 months support the efficacy and safety of DES in Japanese patients, with sustained clinical improvements and numerically fewer reinterventions for those treated with Eluvia.Clinical trial RegistrationClinicaltrials.gov identifier NCT02574481.https://clinicaltrials.gov/ct2/show/NCT02574481Level of EvidenceEBM Level III; cohort analysis of randomized trial.

Surface Modification with NGF-Loaded Chitosan/Heparin Nanoparticles for Improving Biocompatibility of Cardiovascular Stent.

Late thrombosis and restenosis remain major challenges to the safety of drug-eluting stents. Biofunctional modification to endow the surface with selective anticoagulation and promote endothelium regeneration has become a hotpot recently. In this study, chitosan and heparin were found to form three-dimensional nanoparticles by spontaneous electrostatic interaction. Based on the specific binding properties between heparin and nerve growth factor (NGF), a new type of NGF-loaded heparin/chitosan nanoparticles was constructed for surface modification. The results of material characterization show that the nanoparticles are successfully immobilized on the surface of the material. In vitro blood compatibility and endothelial cell compatibility assay showed that the modified surface could selectively inhibit platelet adhesion and smooth muscle cell overproliferation, while accelerating endothelialization via promoting endothelial cell proliferation and enhancing endothelial progenitor cell mobilization.

Efficacy and safety of drug-eluting stents in elderly patients: A meta-analysis of randomized trials.

Current guidelines recommend newer generation drug-eluting stents (DES) over bare-metal stents (BMS) in patients with ischemic heart disease. However, there is no age-specific recommendation in elderly patients. Meta-analysis was performed of 6 randomized studies enrolling 5,042 elderly patients who underwent percutaneous coronary intervention (PCI) with stent implantation (DES, n = 2,579; BMS, n = 2,463). Combined data indicated a significant reduction in major adverse cardiovascular events (MACEs) with use of DES (odds ratio [OR] 0.56, 95% confidence interval [CI] 0.44-0.71, p < 0.001). Moreover, use of DES was associated with a significantly lower incidence of myocardial infarction (OR 0.54, 95% CI 0.36-0.81, p = 0.003) and repeat revascularization (OR 0.44, 95% CI 0.31-0.62, p < 0.001), was compared to that with the use of BMS. Stent thrombosis and bleeding complication rates were not significantly different between groups. In a subgroup meta-analysis, short duration (1 or 6 months) dual antiplatelet therapy (DAPT) was associated with a significantly lower MACE rate (OR 0.49, 95% CI 0.34-0.80; p = 0.003) in elderly patients who underwent PCI with everolimuseluting stent implantation, compared with that using long duration DAPT. This meta-analysis provides clinically relevant evidence that DES rather than BMS should be selected for elderly patients.