Search Results (215)

Background: In patients with coronary artery disease, bare-metal stents (BMS) are considered a safer but less effective treatment than drug-eluting stents (DES). Oral colchicine therapy may compensate for this limitation of BMS. This randomized trial compared the cost-effectiveness of two different revascularization strategies during percutaneous coronary intervention (PCI). Methods: Between March 2020 and April 2022, 410 patients were randomly treated with PCI with BMS plus colchicine (BMS-CO: 205 patients) or DES (205 patients) The patients in the BMS-CO group received 0.5 mg oral doses of colchicine for 3 months. The primary endpoint was major adverse cardiac and cerebrovascular events (MACEs), defined as the composite of death, myocardial infarction, stroke, or target vessel revascularization (TVR), and the costs of each treatment strategy. The secondary endpoints included the individual components of MACEs. Results: No significant differences were observed in baseline characteristics, and 76% of the patients presented with acute coronary syndromes. The median follow-up period was 36.8 months. Five percent of the patients in the BMS-CO group discontinued study medication. The cumulative incidence of MACEs was not significantly different, with 12.7% in the BMS-CO group and 15.6% in the DES2G group (p = 0.39) as well individual components of the clinical endpoint. The cumulative costs were lower in the BMS-CO group than in the DES2G group (USD 4826.4 ± 2512 vs. USD 5708 ± 3637, p < 0.001). Conclusions: In the 3 years, the DES strategy failed to be cost-saving compared to BMS-CO. However, due to the small sample size, the equivalence in clinical outcomes with both strategies can occur by chance (NCT04382443). Full article

Drug-eluting stents, which release antiproliferative agents such as sirolimus and everolimus, were developed to reduce the risk of restenosis associated with bare-metal stents. However, despite their proven clinical efficacy, concerns remain regarding in-stent restenosis due to delayed endothelial healing and the risk of late thrombotic events. In this study, we aimed to determine the vascular effects of sirolimus and everolimus on isolated human saphenous vein (SV) samples obtained from patients undergoing coronary artery bypass surgery. SV rings were subjected to sirolimus and everolimus in acute and pretreatment conditions in vitro. Increasing concentrations of sirolimus (10⁻⁸–10⁻⁵ M), everolimus (10⁻⁸–10⁻⁵ M), and their vehicle were administered to SV rings precontracted with phenylephrine (Phe,10⁻⁶–5 × 10⁻⁶ M) to evaluate their direct vascular effects. Additionally, SV rings were incubated (16 h) either with sirolimus (10⁻⁵ M), everolimus (10⁻⁶ M), or the vehicle. Thereafter, the contractile responses to Phe (10⁻⁸–10⁻⁴ M), and the endothelium-dependent and endothelium-independent relaxant responses to acetylcholine (ACh, 10⁻⁸–10⁻⁴ M) and sodium nitroprusside (SNP,10⁻⁸–10⁻⁴ M) were determined, respectively. Our findings demonstrated that sirolimus and everolimus did not exert direct relaxant and modulatory effects on vascular function in isolated human SVs. Hence, the preservation of contractile and relaxant responses with sirolimus and everolimus may have clinical implications in the context of DES implantation. Full article

Background: The increasing prevalence of severe calcified coronary artery disease has expanded the role of rotational atherectomy (RA) in percutaneous coronary intervention (PCI). In the drug-eluting stent (DES) era, RA remains a key tool for complex lesion modification. This review focuses on its clinical outcomes and evolving indications. Methods: This review was conducted as a narrative review, focusing on the most relevant clinical studies regarding RA in the DES era. Articles were identified through a systematic PubMed search. Results: Comparing to early-generation DES, new-generation DES (NG-DES) demonstrate superior outcomes due to thinner struts and biocompatible polymers. RA plays a critical role in challenging scenarios, including chronic total occlusions and de novo small vessel lesions. Despite these advances, further randomized controlled trials are needed to validate the long-term safety and efficacy of RA-based strategies. Conclusions: This review highlights the clinical outcomes of RA in the DES era and its evolving role in contemporary cardiology. RA has shown promising potential for broader clinical applications in complex coronary artery disease. However, critical knowledge gaps remain. Further research is needed to refine RA-based strategies. Full article

A biofilm is a community of microbial cells which are enclosed in an external matrix and separated by a network of water channels attached to natural or artificial surfaces. Biofilms formed inside biliary stents consist of a mixed spectrum of bacterial communities, most of which usually originate from the intestines. The patency of biliary stents is the most important problem. Stent occlusion can threaten the health and even life of patients. The main cause of this phenomenon is bile sludge, which is an excellent environment for the multiplication and existence of microorganisms. Due to the great clinical importance of maintaining the patency of biliary stents, several methods have been developed to prevent the accumulation of sludge and the subsequent formation of biofilm; these include, among others, the use of anti-adhesive materials, coating the inner surface of stents with metal cations (silver, copper) or other antimicrobial substances, the implementation of biodegradable drug-eluting biliary stents and the development of a new stent design with an anti-reflux effect. This article presents the latest information on the formation of biofilms in biliary stents, as well as historical and future methods of prevention. Full article

Renal artery stenosis (RAS) is a vascular condition characterized by narrowing of one or both renal arteries, leading to reduced blood flow to the kidneys, activation of the renin–angiotensin–aldosterone system (RAAS), and subsequent renovascular hypertension. Overactivation of the same cascade potentiates the production of angiotensin II, which induces systemic vasoconstriction, increases sodium and water retention via aldosterone, and activates the sympathetic nervous system. Angiotensin II is also implicated in endothelial dysfunction, oxidative stress, and chronic inflammation, thus impairing vascular remodeling and arterial stiffness, all of which serve to accelerate cardiovascular complications, such as left ventricular hypertrophy, heart failure, and myocardial infarction. RAS is usually due in at least 90% of cases to atherosclerosis, which typically affects older people with diabetes and smoking as risk factors. There are two types of RAS: unilateral and bilateral. Bilateral RAS is commonly associated with flash pulmonary edema, a life-threatening emergency condition in which alveolar space flooding can occur within minutes. RAS typically remains asymptomatic until the late stage with complications of hypertension, ischemic nephropathy, or chronic kidney disease. FMD tends to create structural abnormalities of the artery, whereas atherosclerosis causes plaque formation and endothelial dysfunction of the artery. Epidemiological surveys have revealed that the prevalence of RAS ranges from 4% to 53% and is especially high among patients with hypertension, cardiovascular disease, or CKD. Diagnosis is based on clinical suspicion and supported by imaging studies, including Doppler ultrasound, computed tomography angiography, and magnetic resonance angiography. Early detection also relies on certain laboratory biomarkers, especially in identifying high-risk patients. These markers would include increased plasma renin activity, elevated aldosterone-renin ratio, and inflammatory markers, including C-reactive protein and endothelin-1. Treatment would also involve pharmacological approaches, including RAAS inhibitors, beta-blockers, and statins, and interventional treatments, including angioplasty and stenting in patients with severe forms of the disease. However, the Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL) Trial showed that most patients would likely require medical therapy, and that intervention should be reserved for those with uncontrolled hypertension, progressive renal dysfunction, or recurrent episodes of pulmonary edema. Other emerging therapies include drug-eluting balloons, bioresorbable stents, and gene-editing techniques, all of which have shown great promise in the few studies that have been conducted, although further evaluation is needed. Despite these advances, there are still gaps in knowledge regarding patient stratification, biomarker validation, and the development of personalized treatment strategies. This article reviews the complexities of RAAS and its systemic impact on cardiovascular and renal health. Future research can therefore focus on improving early diagnosis, optimizing patient selection for intervention, and developing new therapies to slow disease progression and mitigate complications. Full article

Background: There are no data regarding the outcomes of patients with stent thrombosis (ST) being treated with drug-coated balloon (DCB) angioplasty. Our aim was to compare the outcomes of patients with ST treated with DCB vs. a drug eluting stent (DES). Methods: In this registry analysis, we identified all patients treated for ST in our institution from June 2011 until November 2019. We excluded patients who died in the cath lab, patients with uncrossable lesions, and patients treated with thrombectomy only. Patient outcomes were obtained from Hospital Episodes Statistics from NHS England. The primary endpoint of this study was the composite of cardiovascular mortality, acute coronary syndrome, or target lesion revascularisation. The data were analysed with Cox regression and Kaplan–Meier estimator plots. Results: A total of 173 patients were identified; 92 treated with DCB-only, 36 with balloon angioplasty (BA), 26 with DES, and 19 with a combination of DES and DCB. We compared the outcomes of 92 patients with DCB versus 20 patients with DES, all of which had presented with late or very late ST. There was no difference between DCB and DES in terms of the primary endpoint (p = 0.06). Multivariate analysis identified diabetes (adverse) and the use of GPIIbIIIa inhibitor (favourable) as the only independent predictors of the primary endpoint. Implantation of a DES was independently associated with worse cardiovascular mortality. Conclusions: This is the first study assessing the outcomes of patients with ST treated with DCB only. It has demonstrated that DCBs are an attractive therapeutic option with a tendency towards favourable outcomes when compared to DESs. Full article

Introduction: Percutaneous coronary intervention (PCI) with drug-eluting stents (DES) is a cornerstone of the management of ischemic heart disease. However, in-stent restenosis (ISR) remains a significant clinical challenge, occurring in approximately 5–10% of patients undergoing PCI. This study is designed to compare the efficacy and safety of the primary therapeutic approaches for DES-ISR, specifically drug-coated balloons (DCBs)—paclitaxel-coated balloons (PCBs) and sirolimus-coated balloons (SCBs)—with a new-generation everolimus-eluting stent (EES), contributing to the evolving field of personalized medicine. Methods and Analysis: This prospective, multicentre, randomised, non-inferiority trial aims to enroll 150 patients with DES-ISR, who will be randomised into one of the following: SCB, PCB, or EES. The primary endpoint comparing DCB and EES is late lumen loss (LLL) at 6 months, as measured by quantitative coronary angiography (QCA). Secondary endpoints comparing the three arms include a device-oriented composite endpoint, intraluminal gain, optical coherence tomography (OCT) measured LLL, and correlations between LLL and quantitative flow ratio (QFR). The primary endpoint will be analysed using a non-inferiority design, with a margin set at 0.25 mm, for which the sample size was calculated. Statistical analysis of the primary endpoint will be conducted on an intention-to-treat basis with a one-tailed Mann–Whitney U test with a significance level of 95. Secondary endpoints will be analysed via superiority testing using ANOVA, the Kruskal–Wallis test, logistic regression, or Fisher’s exact test, as appropriate. Ethics and Dissemination: The study protocol has been approved by the Medical Devices Department of the Hungarian National Institute of Pharmacy and Nutrition, ensuring compliance with ethical standards as outlined in the Declaration of Helsinki. All investigators declare no conflicts of interest related to this study. The trial is registered in ClinicalTrials.gov under the ID: NCT04862052. Full article

Background/Objectives: Drug-eluting stents (DESs) remain the standard of treatment for patients with ST-elevation myocardial infarction (STEMI). However, complications such as stent thrombosis and in-stent restenosis still pose significant risks. Drug-coated balloons (DCBs) have emerged as a promising alternative, but data for this clinical scenario are still scarce. The objective was to evaluate the safety and efficacy of DCB culprit-lesion primary percutaneous coronary intervention (pPCI) in patients presenting with STEMI and to evaluate its impact on the microcirculatory territory. Methods: An observational retrospective study was conducted across six European centers. Results: In total, 118 patients were included. Of these, 82.2% were male, with a median age of 67 years (IQR 36–92); 28% patients presented with stent thrombosis and most of them (94%) underwent paclitaxel-DCB-pPCI. The median follow-up was 23.2 months (IQR 6.7–77.3). Target lesion failure (TLF) rates were low (3.4%), with no differences between patients presenting with native coronary vessel and stent thrombosis (4.7% vs. 0%; p = 0.205). Overall mortality rates at follow-up were 7%, with only 1.8% attributed to cardiac causes. A target lesion revascularization (TLR) rate of 1.8% was observed, with no target vessel myocardial infarction reported. A subgroup of patients (42; 35.6%) underwent an adenosine-free angiographic microvascular resistance (AMR) analysis. The median AMR was 4.7 (3.9–5.5) and was greater in the stent thrombosis group than in the native coronary group (5.1 vs. 4.6; p = 0.038) with no clinical differences between patients based on the AMR. Conclusions: DCB-pPCI has emerged as an alternative potential treatment for patients presenting with STEMI, with few long-term adverse cardiac events. Despite the encouraging outcomes, these findings underscore the need for a large randomized clinical trial powered by a relevant clinical outcome in order to elucidate the role of DCB-PCI in patients presenting with STEMI. Full article

Arterial diseases (ADs) are a significant health problem, with high mortality and morbidity rates. Endovascular interventions, such as balloon angioplasty (BA), bare-metal stents (BMSs), drug-eluting stents (DESs) and drug-coated balloons (DCBs), have made significant progress in their treatments. However, the issue has not been fully resolved, with restenosis remaining a major concern. In this context, bioresorbable vascular stents (BVSs) have emerged as a promising area of investigation. This manuscript includes articles that assess the use of BVSs. Studies have identified ongoing challenges, such as negative vascular remodeling and elastic recoil post-angioplasty, stent-related injury, and in-stent restenosis following BMS placement. While DESs have mitigated these issues to a considerable extent, their durable structures are unable to prevent late stent thrombosis and delay arterial recovery. BVSs, with their lower support strength and tendency towards thicker scaffolds, increase the risk of scaffold thrombosis. Despite inconsistent study results, the superiority of BVSs over DESs has not been demonstrated in randomized trials, and DES devices continue to be the preferred choice for most cases of arterial disease. Esprit BTK (Abbott Vascular) received approval from the US FDA for below-knee lesions in 2024, offering hope for the use of BVSs in other vascular conditions. Enhancing the design and thickness of BVS scaffolds may open up new possibilities. Large-scale and longer-term comparative studies are still required. This article aims to provide an overview of the use of biodegradable stents in the endovascular treatment of vascular stenosis. Full article

Background/Objectives: Acute stent thrombosis (ST) is a rare yet severe complication following percutaneous coronary intervention (PCI). Herein, we investigated the possible association between routinely available coagulation and fibrinolysis markers with early ST. Methods: Within a single-center registry, we investigated the association between the preprocedural platelet count, plasma levels of fibrinogen and D-Dimer, and the incidence of early ST in the first 30 days after PCI. Results: Out of 10,714 consecutive patients who underwent PCI using drug-eluting stents (DESs), the preprocedural platelet count, fibrinogen, and D-Dimer measurements were available in 6337, 6155, and 956 patients, respectively. Fifty-eight patients (0.92%) experienced an early ST within 30 days after PCI. Compared with those without ST, patients with early ST showed significantly elevated preprocedural platelet counts (p < 0.05) and fibrinogen levels (p < 0.05). D-Dimer levels were not associated with early ST. Patients in the fifth quintile of platelet count had a significantly increased risk for early ST (HR 2.43; 95% CI 1.43–4.14; p = 0.001) compared with patients in the lower four quintiles. In addition, patients in the fifth quintile of fibrinogen also had a significantly increased risk for early ST (HR 1.86; 95% CI 1.07–3.26; p < 0.05) compared with patients in the lower four quintiles. These associations were independent of clinical risk factors, the number of stents, the presence of acute coronary syndromes, and white blood cell count. Conclusions: Preprocedural platelet counts and fibrinogen plasma levels can identify patients at elevated risk of early ST after implantation of DESs in addition to procedure-level and device-related risk factors. Full article

Percutaneous Coronary Intervention (PCI) is a treatment method that involves reopening narrowed arteries with a balloon catheter that delivers a cylindrical, mesh-shaped implant device to the site of the stenosis. Currently, by applying a coating to a bare metal stent (BMS) surface to improve biocompatibility, the main risks after PCI, such as restenosis and thrombosis, are reduced while maintaining the basic requirements for the mechanical behavior of the stent itself. In this work, for the first time, the development and optimization process of the spatial structure of the Co-Cr stent (L-605) with a graphene-based coating using cold-wall chemical vapor deposition (CW-CVD) to ensure uniform coverage of the implant was attempted. The CW-CVD process allows the coating of 3D structures, minimizing thermal stress on the surrounding equipment and allowing the deposition of coatings on temperature-sensitive materials. It produces uniform and high-purity films with control over the thickness and composition. The reduced heating of the chamber walls minimizes unwanted reactions, leading to fewer impurities in the final coating. The graphene layers obtained using Raman spectroscopy at different parameters of the CW-CVD process were verified, their properties were investigated, and the functional mechanical behavior of the studied graphene-covered stent was confirmed. In vitro, graphene-coated stents promoted rapid endothelial cell repopulation, an advantage over gold-standard drug-eluting stents delaying re-endothelialization. Also, full-range biocompatibility studies on potential allergic, irritation, toxicological, and pyrogenic reactions of new material in vivo on small animal models demonstrated excellent biocompatibility of the graphene-coated stents. Full article

Background: This study was conducted to address the lack of reports comparing the clinical outcomes of non-ST-segment elevation myocardial infarction (NSTEMI) and STEMI based on left ventricular ejection fraction (LVEF). Methods: A total of 9854 patients from the Korea Acute Myocardial Infarction Registry-National Institute of Health dataset were classified into three LVEF categories: heart failure (HF) with reduced ejection fraction (EF) (HFrEF, n = 1250), HF with mildly reduced EF (HFmrEF, n = 2383), and HF with preserved EF (HFpEF, n = 6221). Each group was further divided into NSTEMI and STEMI groups. The primary clinical outcome was the incidence of patient-oriented composite outcomes, defined as all-cause death, recurrent myocardial infarction, any repeat coronary revascularization, hospitalization for HF, and stroke. Results: Following adjustment, in-hospital mortality rates were comparable between the NSTEMI and STEMI groups in the HFrEF and HFmrEF groups. However, 3-year mortality rates were higher in the NSTEMI group. In contrast, in the HFpEF group, the STEMI group had higher rates of in-hospital all-cause death (p = 0.001) and cardiac death (p < 0.001) compared to the NSTEMI group, which was associated with increased 3-year all-cause death (p = 0.026) and cardiac death (p < 0.001) in the STEMI group. When in-hospital mortality was excluded, no difference in 3-year mortality rates was observed between the NSTEMI and STEMI groups in the HFpEF group. Conclusions: In-hospital mortality and 3-year outcomes varied across LVEF groups. Therefore, comparing NSTEMI and STEMI based on LVEF provides valuable insights into the differences in patient outcomes. Full article

Although the complication rate of percutaneous coronary intervention is low, coronary artery perforation occurs in 0.2–0.5% of cases. Intracoronary glue injection is not an established treatment option, with only a few cases reported in the literature and no reported use of n-hexyl-cyanoacrylate. Case report: A 75-year-old man was diagnosed with a non-ST elevation myocardial infarction. Since there was no acute chest pain and no signs of ongoing ischemia on the ECG, diagnostic coronary angiography was performed the day after arrival. The coronary angiography revealed a proximal subocclusion of the left anterior descending artery. The lesion was successfully predilated, and a drug-eluting 5 × 28 mm stent was implanted, occluding two small diagonal branches. While attempting to create a gap in the stent to revascularize the occluded branch, a side branch perforation was detected. This was successfully treated by occluding the branch with an intracoronary cyanoacrylate glue injection. No signs of cardiac tamponade were observed during follow-up after the procedure, and the patient was soon discharged to rehabilitation. Conclusions: Coronary artery perforation is a serious complication of percutaneous coronary intervention. Intracoronary glue injection and embolization of the perforated side branch appear to be a safe and effective technique for managing this complication. Full article

Inflammation is a major component of the pathogenesis of atherosclerosis and the formation of in-stent restenosis (ISR). A novel flavonoid, DHIF, attenuates reactive oxygen species and nf-κB signaling and has potential to limit ISR via antioxidant action. While current drug eluting stents (DESs) perform well in clinical practice, new therapies to prevent ISR without dependance on cytotoxic drugs are warranted. Our objective was to test whether DHIF reduces ISR in a hyperlipidemic rabbit aorta model of ISR via attenuated inflammatory responses. WHHL rabbit aortas (n = 24) were denuded. Six weeks after injury, stents were implanted into the denuded aortas. DHIF was dissolved in carboxymethyl cellulose (CMC) and administered orally with two doses. CMC served as a control. The animals were sacrificed six weeks after stenting. ISR was evaluated from stent histomorphometry and immunohistology was used to assess the inflammatory and antiproliferative effects of the treatment. ISR was reduced from 20.9 ± 3.0% in controls to 15.2 ± 2.4% (p = 0.0009) and 16.4 ± 2.1% (p = 0.004) in the low- and high-dose groups, respectively. The neointimal area covered by macrophages was 32 ± 9.3% in the controls, 17.2 ± 5.9% (p = 0.005) in the low-dose group and 19.4 ± 7.9% (p = 0.008) in the high-dose group. DHIF significantly reduces ISR and local inflammation in stented arterial regions and could be used to reduce ISR when bare metal stents are used. Targeting local inflammation in the arterial wall may provide a way to reduce ISR in a clinical setting and further studies are warranted. Full article

The interventional treatment of coronary artery disease (CAD) has undergone significant improvements thanks to technological innovations. Nowadays, percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is the standard of care for the treatment of CAD. Nevertheless, the non-negligible incidence of in-stent restenosis (ISR) and suboptimal results in various anatomical settings has led to the development of drug-coated balloons (DCBs). DCBs are catheter-based balloons whose surface is coated with an anti-proliferative drug (mainly Paclitaxel or Sirolimus) loaded onto the balloon surface with different technologies and dose concentrations. In the beginning, these devices were used for the treatment of ISR showing an excellent efficacy profile in the inhibition of intimal hyperplasia. Subsequently, several studies evaluated their use in other angiographical and clinical contexts such as de novo lesions, small vessel disease, diffuse coronary disease, bifurcation lesions, acute coronary syndromes, high-bleeding risk and diabetic patients. This comprehensive review aims to describe the main DCB platforms on the market, their fields of application with the main supporting studies and their future perspectives. Full article