Drug-eluting Stent Technology Research Articles

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.

Outcomes, risk factors, and procedural management of acute myocardial infarction caused by stent thrombosis

Coronary stent thrombosis (ST) is a rare but severe complication of percutaneous coronary interventions (PCIs) with significant implications for patient outcomes. Despite advancements in antiplatelet medications and drug-eluting stent (DES) technology, ST remains associated with considerable morbidity and mortality. Notably, ST is an adverse event arising from various factors, including patient characteristics, stent-related issues, and procedural complications. In such a context, intravascular imaging (IVI) plays a pivotal role in assessing the underlying mechanisms and guiding treatment decisions. The use of thrombus aspiration and intracoronary antithrombotic therapies have been debated in the context of de novo acute myocardial infarction, but they could have a remarkable role for ST. However, the optimal management of ST requires individualized approaches tailored to patient-specific factors. This review provides a comprehensive analysis of the current understanding of ST, encompassing its incidence, outcomes, and risk factors, focusing on procedural acute management.

Outcome of Primary Percutaneous Coronary Intervention for STEMI due to Stent Thrombosis

Background: Stent thrombosis (ST) is a critical complication following percutaneous coronary intervention (PCI), contributing significantly to morbidity and mortality in patients with ST-elevation myocardial infarction (STEMI). Advances in drug-eluting stent technology and antiplatelet therapy have mitigated, but not eliminated, the risk of ST. The management of STEMI due to ST in resource-limited settings remains a challenging endeavor, necessitating a comprehensive evaluation of treatment outcomes. Objective: To assess the mortality rates and clinical outcomes following primary PCI in patients with STEMI attributed to stent thrombosis in a resource-constrained setting, and to analyze the association of mortality with patient age and TIMI flow grade post-PCI. Methods: This quasi-experimental study was conducted at Lady Reading Hospital, Peshawar, from July to December 2023. A total of 150 patients presenting with STEMI due to ST and undergoing PCI were included. Diagnostic measures included electrocardiography, troponin levels, echocardiography, and angiography to assess left ventricular function and stent thrombosis. The procedures were performed by experienced interventional cardiologists, followed by standard post-procedure management. Data analysis was performed using SPSS version 25, focusing on mortality rates, the association of mortality with patient age, and TIMI flow grades. Results: Among the 150 patients studied, mortality was observed in 36 cases (24%). The mean age of patients who died was 48.33 years (SD = 14.267), compared to 42.47 years (SD = 12.618) for survivors, with a significant association between age and mortality (P = 0.02). Analysis of TIMI flow grade post-PCI revealed a strong correlation with mortality; patients with TIMI flow grades I and II exhibited higher mortality rates, with a highly significant P value of 0.0001. Conclusion: The study highlights a significant mortality rate among patients with STEMI due to stent thrombosis undergoing primary PCI in a resource-limited setting. Advanced age and lower TIMI flow grades post-PCI were significantly associated with increased mortality. These findings underscore the necessity for vigilant post-PCI monitoring and tailored management strategies to improve clinical outcomes in this high-risk population.

The bioresorbable magnesium scaffold (Magmaris)-State of the art: From basic concept to clinical application.

Since its introduction to clinical practice, coronary artery stent implantation has become a crucial part of the therapy of coronary artery disease (CAD). Despite the undeniable evolution of percutaneous coronary revascularization procedures, drug-eluting stent (DES) technology shows some limitations. To overcome these limitations bioresorbable vascular scaffolds (BRS) were designed as a vessel-supporting technology allowing for anatomical and functional restoration of the vessel after the scaffold intended resorption. Various materials have been proposed as the basis of the scaffold backbone. In this narrative review, we present second-generation magnesium-alloy bioresorbable scaffold devices (Magmaris; Biotronik). Additionally, we discuss available preclinical and clinical data regarding this new magnesium BRS.

Ultrathin Struts Drug-Eluting Stents: A State-of-the-Art Review.

New-generation drug-eluting stents (DESs) represent the standard of care for patients undergoing percutaneous coronary intervention (PCI). Recent iterations in DES technology have led to the development of newer stent platforms with a further reduction in strut thickness. This new DES class, known as ultrathin struts DESs, has struts thinner than 70 µm. The evidence base for these devices consists of observational data, large-scale meta-analyses, and randomized trials with long-term follow-up, which have been conducted to investigate the difference between ultrathin struts DESs and conventional new-generation DESs in a variety of clinical settings and lesion subsets. Ultrathin struts DESs may further improve the efficacy and safety profile of PCI by reducing the risk of target-lesion and target-vessel failures in comparison to new-generation DESs. In this article, we reviewed device characteristics and clinical data of the Orsiro (Biotronik, Bülach, Switzerland), Coroflex ISAR (B. Braun Melsungen, Germany), BioMime (Meril Life Sciences Pvt. Ltd., Gujarat, India), MiStent (MiCell Technologies, USA), and Supraflex (Sahajanand Medical Technologies, Surat, India) sirolimus-eluting stents.

An appraisal of polymers of DES technology and their impact on drug release kinetics

Drug-eluting stents (DES) are the best choice of the current era to open the occluded arteries. Its success depends upon the concentration of the drug and overall release kinetics, which in turn is subjected to the polymeric drug carrier and mechanism of drug release at the target area. Each generation of DES possess different characteristics based on different aspects i.e., polymer type, coating layer thickness, and drug concentration have been discussed. This review paper discusses all the polymers utilized in DES systems and their release profiles when combined with multiple drugs for the treatment of coronary heart disease.

Late Catch-up In-Stent Restenosis and Stent Thrombosis for 2nd Generation Biodegradable Polymer Drug Eluting Stents

Second generation drug-eluting stents (DES) have reduced the rate of in-stent restenosis (ISR) to < 10% [1, 2] in patients undergoing PCI. However, late catch-up in-stent restenosis remains an issue despite the advent in drug-eluting stent technology from 1st to 2nd generation drug eluting stents. The late catch-up phenomenon has been associated with serious consequences and adverse events and remains an important issue in modern practice, despite medical advances with more biocompatible and biodegradable polymers, as well as new therapeutic agents and thinner scaffolds in the development of 2nd generation DES polymer systems. The idea behind biodegradable polymers has been to provide a more controlled elution profile for DES drugs, allowing for long-term therapeutic, but sub-toxic, drug levels in the arterial tissue to prevent ISR and stent thrombosis. However, the late catch-up phenomenon remains an issue resulting in 2ndary revascularization beyond the first year of primary PCI, as it is defined as ISR >1 year. Late stent thrombosis (<1 year) and very late stent thrombosis (>1 year) also remain an issue for biodegradable polymer systems. A long-term presence of the polymer can cause inflammation and thrombogenesis, which is dependent upon polymer degradation kinetics in case of biodegradable polymer DES systems. However, the cause of late catch-up restenosis and stent thrombosis is multi-factorial from a drug-in-polymer formulation perspective of drug release kinetics, e.g., drug elution profile, drug physiochemical properties, and polymer degradation kinetics. It appears that the focus should be on controlling burst release for both late catch-up restenosis and stent thrombosis phenomena.

Progress in Drug-Delivery Systems in Cardiovascular Applications: Stents, Balloons and Nanoencapsulation

Drug-delivery systems in cardiovascular applications regularly include the use of drug-eluting stents and drug-coated balloons to ensure sufficient drug transfer and efficacy in the treatment of cardiovascular diseases. In addition to the delivery of antiproliferative drugs, the use of growth factors, genetic materials, hormones and signaling molecules has led to the development of different nanoencapsulation techniques for targeted drug delivery. The review will cover drug delivery and coating mechanisms in current drug-eluting stents and drug-coated balloons, novel innovations in drug-eluting stent technologies and drug encapsulation in nanocarriers for delivery in vascular diseases. Newer technologies and advances in nanoencapsulation techniques, such as the use of liposomes, nanogels and layer-by-layer coating to deliver therapeutics in the cardiovascular space, will be highlighted.

PCI or CABG for Left Main Disease: Does Disease Location Matter?

This review attempts to specifically assess impact of disease location in left main artery on mortality and cardiovascular outcomes in patients treated with percutaneous coronary intervention versus coronary artery bypass surgery. The management of left main disease, once thought to be the sole province of cardiothoracic surgeon, has recently undergone a reappraisal by thecardiovascular medicine community. For many years, societal guideline recommendations advised bypass surgery as the "de rigeur" method of revascularization for unprotected left main disease. However, recent studies suggest that coronary intervention, especially with advances in drug-eluting stent technology, has mounted a serious challenge to surgical bypass in treatment of this disease. Although overall mortality rates are comparable for percutaneous coronary intervention and bypass surgery, left main disease location does influence long-term outcomes for percutaneous coronary intervention more than bypass surgery. A patient- and lesion-centered approach to treatment of this disease may provide optimal outcomes.

The Contemporary Management of Left Main Coronary Artery Disease.

The 'gold standard' in the management of left main coronary artery disease has historically been coronary artery bypass surgery. Recent innovations in drug-eluting stent technology coupled with the increasing utility of physiology and imaging guidance for procedures have led to an evolving role of percutaneous coronary intervention in left main disease of low and intermediate anatomical complexity. This revascularization modality carries the clear advantage of being less invasive and significantly reduced recovery times. This practice is currently supported by international guidelines, however, it remains a controversial topic in the field of interventional cardiology, and the long-term outcomes of a percutaneous strategy have been questioned. This review describes the current evidence base for the assessment and choice of intervention in left main coronary artery disease. The percutaneous revascularization techniques and use of imaging to optimize procedures and improve clinical outcomes have been discussed.

Percutaneous Coronary Intervention with Stenting versus Coronary Artery Bypass Grafting in Stable Coronary Artery Disease.

The debate over coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) with stent placement for the treatment of stable multivessel coronary artery disease (CAD) continues in spite of numerous studies investigating the issue. This paper reviews the most recent randomized control trials (RCT) and meta-analyses of pooled RCT data to help address this issue. General trends demonstrated that CABG was superior in all-cause mortality and fulfilling the need for repeat revascularization. These advantages tended to be more pronounced in multivessel CAD and diabetes, and less so in left main CAD. PCI showed a consistently lower rate of cerebrovascular events. CABG continues to offer significant advantages over PCI, even as drug-eluting stent technology continues to evolve. The ideal endpoint for comparing PCI and CABG remains to be determined. Furthermore, additional research is required to further refine patient selection criteria for each intervention.

Antegrade and retrograde in‐stent tibial artery chronic total occlusion recanalization with double kiss crush (DK crush) stenting of previous stent

Below the knee (BTK) peripheral arterial disease often presents with critical limb ischemia (CLI) clinically with involvement of more than one tibial vessels. Drug eluting stent (DES) technology for treatment of BTK disease has shown promising long-term durable results; however, currently only coronary DESs are available for application in the United States. Although coronary bifurcation stenting techniques are backed by extensive data in literature, there is a scarcity of data for the treatment of tibial bifurcation disease. Bifurcation angles in the tibials are similar to those in the coronaries and therefore the same two stent bifurcation technique can be applied in BTK disease. Double Kiss crush (DK crush) stenting has superior outcomes when compared to provisional or culotte stenting in randomized coronary trials (based on Medina classification). We present a case of BTK CLI with tibial bifurcation chronic total occlusion treated with two stent DK crush technique using coronary DES.

Ultrathin biodegradable polymer sirolimus-eluting stent versus contemporary durable polymer everolimus-eluting stent for percutaneous coronary intervention: a meta-analysis of randomized trials.

Improvements in coronary drug-eluting stent technology has focused on reducing the long-term complications associated with the effects of the residual footprint on the vessel wall. Although many of the newer stents have exhibited noninferiority to the durable polymer everolimus-eluting stent (DP-EES), they have yet to exhibit clear superiority. We compared the performance of the latest ultrathin strut biodegradable polymer sirolimus-eluting stents (BP-SES) to DP-EES. We searched the electronic databases for randomized controlled trials comparing BP-SES to DP-EES. A random effect meta-analysis was performed using the Poisson regression model. The primary end point was target lesion failure (TLF), a composite of target vessel myocardial infarction (TVMI), cardiac death and target lesion revascularization (TLR). There was no difference between the stents in stent thrombosis [incidence rate ratio (IRR) = 0.79, 95% confidence interval (CI) 0.58-1.06), TLR (IRR = 0.88, 95% CI 0.57-1.38), TVMI (IRR = 0.79, 95% CI 0.61-1.01), cardiac death (IRR = 0.99, 95% CI 0.76-1.29) and target vessel failure (IRR = 0.82, 95% CI 0.64-1.06). In addition, there was no difference in TLF (IRR = 0.82, 95% CI 0.64-1.06). There was evidence of reduced TLF in small vessels with BP-SES based on definition used (defined as ≤2.75 mm; IRR 0.64, 95% CI 0.46-0.91 versus ≤3 mm; IRR 1.11, 95% CI 0.90-1.36). In our study, the performance of the latest generation BP-SES was comparable to DP-EES but failed to show superiority. The possible benefit in patients with small vessels should be explored future trials.

Device profile of the Resolute Onyx Zotarolimus eluting coronary stent system for the treatment of coronary artery disease: overview of its safety and efficacy

ABSTRACT Introduction: The increasing complexity of patients undergoing percutaneous coronary intervention (PCI) regarding both coronary anatomy and comorbidities requires dedicated devices. The Resolute Onyx (R-Onyx, Medtronic, CA, USA) stent is a novel durable polymer zotarolimus-eluting stent (ZES) promising better deliverability, increased radiopacity and lower thrombogenicity. Areas covered: In this review, we discuss device features, preclinical evidence, and clinical studies including patients treated with R-Onyx. The BIONYX and Onyx ONE studies were two major landmark trials demonstrating non-inferiority of R-Onyx as compared to other latest generation devices. We also elaborate on alternative innovations in drug-eluting stent (DES) technology and how R-Onyx fits into this field. Expert opinion: R-Onyx is designed to address the challenges of contemporary PCI, but evidence on its clinical performance is largely derived from studies on older generation devices from the ZES family. Nonetheless, all clinical studies on R-Onyx consistently show excellent outcomes, with particularly low rates of stent thrombosis, making it a promising candidate for short dual antiplatelet regimens. In addition, R-Onyx is available with a wide range of stent diameters allowing accurate sizing for both very small and very large coronary vessels.

The Firehawk Stent: A Review of a Novel Abluminal Groove-Filled Biodegradable Polymer Sirolimus-Eluting Stent.

Despite recent advances in drug-eluting stent (DES) technology, late adverse events remain concerns after percutaneous coronary intervention. The persistence of polymer material on DES has been suggested as a trigger for chronic inflammation. The Firehawk, a novel DES, has a unique design with recessed abluminal grooves, to which sirolimus and biodegradable polymer are applied. The Firehawk stent is designed to minimize polymer volume and antiproliferative drug concentration to reduce inflammation and hypersensitivity reactions. Several recent trials have reported the clinical outcomes of this device. This article provides a review of the current clinical evidence concerning the Firehawk stent.

CRT-300.01 Impact of Near-Infrared Spectroscopy Intravascular Ultrasound Imaging Evaluation on Major Adverse Cardiovascular Events in Patients With Chronic Renal Insufficiency

Chronic renal insufficiency (CRI) was reported as a residual independent risk and prognostic factor of coronary artery disease in the latest drug-eluting stent (DES) era with mature DES technology and developed medical treatment. Near infrared spectroscopy intravascular ultrasound imaging (NIRS-IVUS

Design of equipment for preparing drug-eluting stents with single-sided coating.

Drug-eluting stent technology has rapidly developed in recent years. In particular, stents are used in percutaneous coronary intervention (PCI), which has become a vital method in clinic treatment. Although various methods are currently used to prepare drug-eluting stents, these methods are associated with respective limitations. To design equipment for preparing drug-eluting stents with single-sided coating and to precisely accomplish the drug-coating process for a single side. This coating equipment prepared stents in three stages: the precise displacement and translational motion and rotational motion of the operating platform; the recognition and positioning of the stent strut; and the utilisation of a pL-scale inkjet system. In order to control and synchronise the work of each subsystem, a central processing unit was installed. Through the analysis and solutions of various problems occurring in the experiment, the spraying equipment was improved, and its functions were perfected. Thus, the successful operation of the spraying equipment was realised. The design of the equipment introduced in this article meets the requirements for preparing drug-eluting stents.

Overview of the latest developments in the field of drug-eluting stent technology.

Angioplasty with stent implantation is considered to be the basic treatment method of stenosis of blood vessels. The process of stent implantation changed through the years, from stents made only from metals, produced from polymers, to biodegradable ones and those which elute drugs. The purpose of this review is to outline the development of this medical procedure and present the advantages and disadvantages of each type of stent.

TCT-629 Impact of Diabetes Mellitus on 1-Year Clinical Outcomes of Ultra-Thin Strut (60 μm) Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stents

Diabetes mellitus is highly associated with the occurrence of coronary artery disease. Despite several improvements in drug-eluting stent technology, patients with diabetes mellitus are affected by a higher rate of adverse events after percutaneous coronary intervention (PCI), mainly in terms of

Nationwide trends in drug-coated balloon and drug-eluting stent utilization in the femoropopliteal arteries

ObjectiveDrug-coated balloons (DCB) and drug-eluting stents (DES) have significantly altered treatment paradigms for femoropopliteal lesions. We aimed to describe changes in practice patterns as a result of the infusion of these technologies into the treatment of peripheral arterial disease. MethodsWe queried the Vascular Quality Initiative registry from 2010 to 2017 for all peripheral vascular interventions involving the superficial femoral artery and/or the popliteal artery. Cases were divided into a PRE and a POST era with a cutoff of September 2016, when specific device identity was first recorded in Vascular Quality Initiative. For each artery, a primary treatment was identified as either plain balloon angioplasty, atherectomy, DCB, bare-metal stent, or DES. The relative distribution of primary treatments between the PRE and POST eras was evaluated, as were lesion characteristics associated with DCB and DES use and regional variability in the adoption of these new technologies. ResultsOf 210,666 arteries in the dataset, 91,864 femoropopliteal arteries (across 74,842 procedures in 55,437 patients) were included. Each artery received 1.5 ± 0.6 treatments. Primary treatment use changed from 40% balloon angioplasty, 45% stenting, and 15% atherectomy in the PRE era to 22% plain balloon angioplasty, 26% bare-metal stent, 8% atherectomy, 37% DCB, and 8% DES in the POST era (P < .001). Forty-three percent of arteries received a drug-containing device as a primary or adjunctive therapy and 1.3% received both a DCB and DES in the POST era. DCB use as the primary treatment was highest in lesions with length 10.0 to 19.9 cm (42%), TransAtlantic InterSociety A, B, or C lesions (38%), and lesions with mild to no calcification (38%). DES use was highest in lesions with a length of 20 cm or more (12%), TransAtlantic InterSociety D lesions (13%), and lesions with moderate to severe calcification (9%). The range of use across 18 regions was 125 to 40% for DCB and 1% to 14% for DES. Regional variability was greater for DES (SD 4% vs mean 8%) than for DCB (SD 7% vs mean 29%). ConclusionsThere has been a rapid dissemination of DCB and DES technology in the femoropopliteal vessels, with nearly one-half of arteries receiving a drug-containing therapy in modern practice. DCBs are most used in medium length, minimally calcified lesions and DESs are most used in longer, more heavily calcified lesions. There is significant regional variability in adoption, especially with DES.