Search Results (227)

Restenosis is the main cause of failure after stent implantation during angioplasty. The localized, sustained delivery of an antirestenotic drug may reduce smooth muscle cell (SMCs) proliferation and thereby limit neointimal hyperplasia. The aim of this study was to develop degradable sirolimus-eluting polymer coatings that can be applied on bioresorbable polymer-based scaffolds via an ultrasonic coating system. This is a novel approach because the detailed analysis of the coating procedure on bioresorbable polymeric scaffolds with the use of an ultrasonic system has not been reported thus far. It has been observed that the ultrasonic technique facilitates formation of a smooth coating, well-integrated with the scaffold. However, the drug dose is affected by the concentration of the coating solution and the number of layers. Therefore, these parameters can be used for tailoring the drug dose and release process. Although all types of the developed coatings provided sirolimus elution for at least 3 months, a more uniform, diffusion-controlled release profile was observed from coatings obtained from the 1.0% polymeric solution. The released drug showed antiproliferative activity against vascular SMCs, without any hemolytic or thrombogenic effects. The results of the study may be advantageous for further progress in the development and medical translation of polymeric vascular scaffolds with antirestenotic activity. Full article

Colchicine is a potent alkaloid with well-established anti-inflammatory properties. It shows significant promise in treating classic immune-mediated inflammatory diseases, as well as associated cardiovascular diseases, including atherosclerosis. However, its clinical use is limited by a narrow therapeutic window, dose-limiting systemic toxicity, variable bioavailability, and clinically significant drug–drug interactions, partly mediated by modulation of P-glycoprotein and cytochrome P450 3A4 metabolism. This review explores advanced delivery strategies designed to overcome these limitations. We critically evaluate lipid-based systems, such as solid lipid nanoparticles, liposomes, transferosomes, ethosomes, and cubosomes; polymer-based nanoparticles; microneedles; and implants, including drug-eluting stents. These systems ensure targeted delivery, improve pharmacokinetics, and reduce toxicity. Additionally, we discuss chemical derivatization approaches, such as prodrugs, codrugs, and strategic ring modifications (A-, B-, and C-rings), aimed at optimizing both the efficacy and safety profile of colchicine. Combinatorial nanoformulations that enable the co-delivery of colchicine with synergistic agents, such as glucocorticoids and statins, as well as theranostic platforms that integrate therapeutic and diagnostic functions, are also considered. These innovative delivery systems and derivatives have the potential to transform colchicine therapy by broadening its clinical applications while minimizing adverse effects. Future challenges include scalable manufacturing, long-term safety validation, and the translation of research into clinical practice. Full article

Background: Although contemporary stent technology has significantly evolved, a substantial number of patients present with stent failure (SF), the clinical expression of which is either in-stent restenosis (ISR) or stent thrombosis (ST). Methods: In this observational, single-center study, we aimed to compare the clinical characteristics, clinical presentation, angiographic findings and subsequent management of patients who underwent percutaneous coronary intervention (PCI) for SF, either ISR or ST, with patients who had PCI for de novo lesions. Results: Over a period of two years (September 2022–October 2024), 1120 patients underwent PCI, of whom 9% had SF. Of the 101 SF cases, the majority (76 cases, 75%) had ISR, while the rest (25 cases, 25%) had ST. Regarding baseline characteristics, patients who underwent PCI for SF had a higher incidence of diabetes mellitus (53% vs. 29%; p < 0.001), dyslipidemia (88% vs. 50%; p < 0.001) as well as prior coronary artery bypass grafting surgery (7.9% vs. 3.7%; p = 0.043), while they were less likely to be current smokers (33% vs. 52%; p < 0.001). SF PCI patients presented more frequently with unstable angina (17% vs. 8.9%; p = 0.010). A new stent was implanted in less than half of SF cases (i.e., stent implantation, 44% vs. 91%; p < 0.001). On the other hand, in the clinical setting of SF, drug-coated balloons (44% vs. 5.3%; p < 0.001) and plain balloon angioplasty (8.9% vs. 0.7%; p < 0.001) was applied more frequently compared with de novo lesions. Furthermore, the usage of cutting/scoring balloons and lithotripsy was significantly higher in the SF group (8.9% vs. 0.4% and 12% vs. 3%, respectively; p < 0.001 for both). Intracoronary imaging guidance was more commonly used in the SF group (33% vs. 13%; p < 0.001). Stent malapposition (44%) and neoatherosclerosis (67%) were the most common mechanisms of ST and ISR, respectively, as identified by intravascular imaging modalities. Finally, the success rates were comparable (96% vs. 98%; p = 0.150) between the two groups. Conclusions: Approximately one of ten patients underwent PCI because of the failure of a previously implanted stent. Use of intracoronary imaging is significantly higher in the clinical context of SF. While DES implantation remains the standard of practice for de novo lesions, DCBs are a popular alternative, especially for ISR cases. Interventional cardiologists who are involved in the treatment of SF cases should be familiar with interpreting intravascular imaging to guide the use of the adjunctive device required to ensure that optimal procedural results in SF cases are obtained. Full article

Coronary artery disease is the most common cause of mortality worldwide. Percutaneous coronary intervention represents an important method of treatment. Over time, the methods have been refined to improve safety and efficacy. With the development of drug-eluting stents, in-stent restenosis has importantly decreased, but it remains a relevant concern in terms of the need for additional revascularization procedures or recurrent coronary events. Different platforms, polymers, and anti-proliferative agents have been tested, mostly demonstrating non-inferiority when compared. Additional devices, such as drug-coated balloons, bioresorbable scaffold systems, gene-eluting stents and bioadaptor implants have been developed. As none of the aforementioned methods demonstrated considerable superiority over the others, the search for the ideal treatment method continues. Based on currently available data, the ideal treatment method could be a personalized approach combining different revascularization methods. Additional research with subpopulation group studies, different associated diseases or vessels affected, and longer follow-up are required to determine better subgroups of patients that would benefit most from specific treatment methods. Full article

Background/Objectives: Polymer-free drug-eluting stents (PF-DESs) aim to mitigate long-term adverse effects associated with polymer-based platforms. However, clinical comparisons with biodegradable polymer DESs (BP-DESs) remain limited. The objective of this review is to assess the efficacy and safety of PF-DESs versus thin-struts (<100 μm) BP-DESs in patients undergoing percutaneous coronary intervention (PCI). Methods: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing PF-DESs and BP-DESs in adults undergoing PCI. PubMed, Embase, and CENTRAL were searched up to 1 February 2025. A random-effects model was used to calculate pooled risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI). Outcomes included myocardial infarction (MI), all-cause and cardiac death, target lesion revascularization (TLR), stent thrombosis, and angiographic/OCT parameters. Subgroup and sensitivity analyses were conducted for outcomes with high heterogeneity (I² > 50%). Results: Nine RCTs (n = 9597) were included. At 12 months, no significant differences were found between PF-DESs and BP-DESs for TLR (RR 1.51; 95% CI: 0.83–2.75), MI, or stent thrombosis. At 24 months, MI and all-cause death were similar between groups. A subgroup analysis showed lower cardiac death with the BioFreedom stent (RR 0.57; 95% CI: 0.35–0.90), not observed in non-BioFreedom devices. No significant differences were detected in angiographic or OCT outcomes, though heterogeneity was high. Conclusions: PF-DESs and BP-DESs demonstrated comparable clinical performance. The observed benefit in cardiac death with BioFreedom may reflect device-specific effects and merits further investigation. Full article

The current management of patients with acute coronary syndrome (ACS) and bleeding disorders, such as hemophilia, is supported by small retrospective studies or expert consensus documents. Moreover, people with hemophilia are less likely to receive invasive treatments like percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) for ACS compared to those without hemophilia, which could affect their cardiovascular outcomes. A multidisciplinary team with an expert hematologist is essential to properly define the therapeutic strategy, which should balance both the thrombotic and bleeding risks. We report a clinical case that illustrates an alternative revascularization strategy for hemophilic patients presenting with ACS and with a pattern of diffuse coronary atherosclerotic disease (CAD), encompassing drug-coated balloons (DCBs) in combination with spot stenting. The proposed approach might avoid a full-length drug-eluting stent (DES) implantation and also allow a short dual antiplatelet therapy (DAPT) regimen that is desirable in patients at a very high bleeding risk (HBR) like hemophiliacs. Furthermore, we have provided a review of the available literature on this topic and a focus on the main recommendations for managing ACS, in response to the presented clinical case. Finally, this article aims to share information and develop more confidence in the current guidelines on the treatment of hemophiliacs who need myocardial revascularization. Full article

With the advancement of interventional coronary procedures, drug-coated balloons have become an increasingly common alternative to drug-eluting stents in the treatment of various lesions. This paradigm shift stems from several advantages that DCBs entail, including a reduction in stent length burden, the possibility of late vessel positive remodeling, and the preservation of bifurcation anatomy. Conversely, several studies compared the efficacy of DCB treatment to stents or POBA in various scenarios. In this review, we will discuss the areas in which a DCB can be of paramount importance. We will begin by examining the role of DCBs in in-stent restenosis, for which the current practice guidelines do not clearly state the role of this technology, as opposed to the previous ones, in which it was mentioned as a first-line armamentarium. We will then discuss the indications and advantages of using DCBs in de novo lesions, concerning both small and large vessels, with growing emphasis on diffuse lesions. Lastly, we will address the current data on the use of DCBs in special scenarios such as the treatment of chronic total occlusion and left main and bifurcation lesions, without forgetting the primordial role of drug-eluting stents in all these lesions. Full article

Globally, cardiovascular disease is a leading cause of disability and early death, affecting 422.7 million people and causing 17.9 million deaths (31% of global deaths) in 2015. Peripheral arterial disease, previously overlooked compared to coronary artery disease, is now recognised as a major contributor to cardiovascular morbidity and mortality, with distinct characteristics. After noninvasive methods, the femoropopliteal segment is frequently treated with revascularisation, which is recommended for claudication and chronic limb-threatening ischemia (CLTI). Challenges such as mechanical stresses, chronic occlusions, extensive plaque, and calcification affect procedural success and vessel patency. Innovations were needed to address these issues, and vascular drug delivery devices have become integral to endovascular treatment. We review the current literature concerning a diverse range of these devices in clinical use and their role in managing symptomatic patients. Full article

Drug-coated balloons (DCBs) have emerged as a compelling alternative to drug-eluting stents in the treatment of coronary artery disease (CAD), offering the advantage of local drug delivery without permanent vascular scaffold implantation. Initially developed for managing in-stent restenosis, DCBs seem appealing for broader indications, particularly in small vessel disease and bifurcation lesions. While paclitaxel-based DCBs remain the most investigated, newer limus formulations are showing promise and appear to be a valid alternative in early trials. Evidence from recent randomized clinical trials (RCTs) and meta-analyses highlights DCBs as a safe and effective option in selected patients, with potential benefits including lower restenosis rates, reduced need for dual antiplatelet therapy, and avoidance of late stent-related complications. As new large-scale trials near completion, DCBs are poised to take on a broader role in the treatment of CAD, particularly in patients where “leaving nothing behind” offers a clinical advantage. This review offers an overview of the DCB platforms commercially available, showing pharmacological differences, providing current indications in practical guidelines, and analyzing the most recent and impactful RCTs and meta-analyses in the field. Full article

High bleeding risk (HBR) is a challenge in patients with complex coronary lesions undergoing percutaneous coronary intervention (PCI). This study investigates HBR in a wide and comprehensive cohort of patients undergoing left main (LM) PCI and reports in-hospital and follow-up outcomes. The analysis was performed on data from the DELTA (Drug Eluting Stent for Left Main Coronary Artery) 2 Registry, which included patients who underwent LM PCI at 19 centres worldwide. The patients were defined to be at HBR if ≥1 major criterion or ≥2 minor criteria from the Academic Research Consortium (ARC) were met. The primary endpoint was a composite of all-cause death, myocardial infarction (MI) or cerebrovascular accident (CVA) at median follow-up. A total of 1531 patients were included, and the rate of HBR was 65.8%. Besides the different clinical characteristics embedded in the ARC definition, HBR patients had higher prevalence of acute coronary syndrome (ACS) at presentation (49.2% vs. 26.8%, p < 0.001) and experienced higher in-hospital mortality (1.8% vs. 0.2%; p = 0.029) and MI (5.0% vs. 2.1%, p = 0.009). The median follow-up was 473 days. The rate of the primary endpoint was more than three times higher in HBR patients (20.8% vs. 6.1%; HR 3.3; 95%CI: 2.2–4.8) and driven by all-cause death at multivariate regression analysis. Conversely, no significant difference in target lesion revascularization and probable or defined stent thrombosis was reported. HBR patients undergoing LM PCI experienced higher rates of all-cause death at follow-up; similar outcomes were also reported in-hospital. Full article

Drug-coated balloons (DCBs) have emerged as a promising alternative therapeutic strategy to traditional drug-eluting stent (DES) implantation in various coronary artery lesion scenarios, aiming to minimize complications associated with permanent metallic scaffolds, such as chronic inflammation, delayed vessel healing, and stent thrombosis. This review systematically evaluates the current clinical evidence supporting the use of DCBs across diverse anatomical and clinical contexts, including small-vessel disease, in-stent restenosis, bifurcation lesions, diffuse coronary lesions, acute coronary syndromes, and chronic total occlusions, as well as in special patient populations such as individuals with diabetes mellitus or at high bleeding risk. The literature analysis incorporated recent randomized controlled trials, observational studies, and real-world registries, highlighting the clinical efficacy, safety profiles, and specific advantages of DCB angioplasty. The findings consistently demonstrated non-inferior clinical outcomes of DCBs compared to DESs across multiple lesion types, with particular benefits observed in special populations, including reduced restenosis rates and comparable major adverse cardiac events (MACEs). Nevertheless, clinical data gaps remain, emphasizing the need for larger, longer-term randomized trials to refine patient selection and procedural techniques. In conclusion, DCB angioplasty represents a viable and effective alternative to conventional stenting, particularly advantageous in complex lesions and specific patient subsets, pending further definitive evidence. Full article

Background/Objectives: We sought to confirm the performance and safety of the Pantera Lux paclitaxel-coated balloon (pDCB) when used as per the instructions for use at a single high-volume center. Methods: In this retrospective analysis, 386 consecutive patients were categorized into three groups: the treatment of drug-eluting stent in-stent restenosis (DES-ISR) lesions (n = 191), bare-metal stent in-stent restenosis (BMS-ISR) lesions (n = 127), and de novo lesions (n = 68). The primary endpoint at 12 months was target-lesion revascularization (TLR). Secondary endpoints were device success, target-vessel myocardial infarction (TV-MI), and cardiac death. Results: The baseline characteristics were balanced between the groups, with a median age of 71.3 years, 25% being female, 32% being diabetic. The majority presented with chronic coronary syndrome (82.9%). Type C lesions were more often observed in the DES-IRS group as compared with the BMS-IRS and de novo groups (15.6% vs. 7.9% vs. 7.4%, p < 0.001). Cutting balloons were more often used in the DES-IRS group (41.0% vs. 19.7% vs. 1.5%, p < 0.001). The residual stenosis rate was 7.6% vs. 3.3% vs. 7.3% (p = 0.002). The TLR at 12 months was 8.9% vs. 2.4% vs. 1.5% (p = 0.013). Device success was achieved in 98.8% vs. 98.5% vs. 100% of cases (p = 0.8). TV-MI occurred in 3.2% vs. 0.8% vs. 1.5% (p = 0.5) and cardiac death in 2.6% vs. 0.0% vs. 2.9% (p = 0.13) in DES-IRS vs. BMS-IRS vs. de novo lesions. Conclusions: In this single-center observation, we confirmed the safety and efficacy of the Pantera Lux paclitaxel-coated balloon for the treatment of DES-IRS, BMS-IRS, and de novo lesions with low TLR rates at 12 months. Full article

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