Search Results (314)

Background: Whether the comparative effectiveness of a drug-coated balloon (DCB)-based versus drug-eluting stent (DES)-only percutaneous coronary intervention (PCI) strategy differs between stable angina (SA) and acute coronary syndrome (ACS) remains uncertain. Methods: In this observational, registry-based study, we analyzed 11,522 patients (4490 with SA and 7032 with ACS) from two multicenter registry sources who had undergone PCI in routine clinical practice; the treatment strategy was not assigned by a study protocol. Within each presentation, the DCB-based and DES-only strategies were compared using propensity-score overlap weighting. Complementary within-strategy analyses compared SA with ACS. The primary outcome was the 3-year rate of major adverse cardiac and cerebrovascular events (MACCE). Results: In both presentations, a DCB-based strategy was associated with a lower 3-year risk of MACCE than a DES-only strategy, with a stronger association in SA (overlap-weighted hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.22–0.49) than in ACS (HR, 0.73; 95% CI, 0.59–0.91; p-for-interaction < 0.001). Within-strategy analyses localized this effect modification to the DCB-based group: SA was associated with a lower risk of MACCE than ACS (HR, 0.47; 95% CI, 0.31–0.69) in the DCB-based group, whereas this gradient was absent in the DES-only group. The incidence of major bleeding was lower with the DCB-based strategy in both presentations. Conclusions: A DCB-based PCI strategy was associated with lower 3-year event rates than a DES-only strategy in both SA and ACS, with the strongest relative association in SA. These observational findings are hypothesis-generating and warrant confirmation in randomized trials. Full article

Background: The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) of the left main coronary artery remains uncertain because this lesion involves a large myocardial territory and requires a careful balance between ischemic protection and bleeding risk. This review aimed to provide an updated, left-main-focused synthesis of the evidence on DAPT duration after PCI and to clarify how treatment should be individualized according to clinical presentation, lesion complexity, procedural strategy, intravascular imaging, and validated ischemic and bleeding risk scores. Methods: This narrative review with a structured literature search examined studies published from January 2010 through May 2026 in PubMed/MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and Google Scholar. From 248 identified records, 62 studies met the eligibility criteria and were included in the qualitative synthesis, comprising 38 randomized controlled trials and 24 observational studies or pooled analyses. The review prioritized direct left-main-specific evidence while also incorporating broader PCI studies with left-main subgroups and indirect contextual evidence relevant to antiplatelet decision-making. Independent screening, duplicate data extraction, and qualitative risk-of-bias assessment were performed, but the review was not prospectively registered, and no meta-analysis was conducted. Results: The available evidence supports an individualized rather than fixed DAPT strategy after left main PCI. In stable patients with anatomically simple left main lesions and acceptable bleeding risk, 6–12 months of DAPT appears generally sufficient, whereas patients with acute coronary syndromes, two-stent distal bifurcation strategies, high thrombotic burden, or other high-ischemic-risk features may derive greater benefit from extending therapy beyond 12 months when bleeding risk is low. Contemporary guideline recommendations are broadly aligned with this risk-adapted approach, and recent trials further refine decision-making: PARTHENOPE provided randomized support for risk-score-guided personalization of DAPT duration, whereas NEO-MINDSET cautioned against immediate aspirin withdrawal after PCI in acute coronary syndromes. Intravascular imaging, especially IVUS and OCT, improves procedural optimization and may help contextualize post-PCI thrombotic risk, although current data do not validate imaging findings alone as a stand-alone criterion for abbreviated DAPT. Conclusions: DAPT duration after left main PCI should be individualized by integrating clinical presentation, lesion and procedural complexity, intravascular imaging, and validated ischemic and bleeding risk tools. A personalized, risk-adapted strategy currently offers the most appropriate framework for balancing ischemic benefit against bleeding harm in this high-risk population. Full article

Background: Coronary stenting remains the cornerstone of interventional cardiology. Drug-eluting stents (DES) have reduced restenosis compared to bare-metal stents (BMS), but their high cost and need for prolonged dual antiplatelet therapy (DAPT) limit accessibility in many regions. Recent evidence has revisited the potential role of systemic pharmacologic adjuncts—oral sirolimus (rapamycin), prednisone and colchicine—as cost-effective therapies to mitigate restenosis and adverse events following BMS implantation. Objective: This review critically evaluates the clinical and mechanistic evidence supporting the use of oral immunosuppressive or anti-inflammatory drugs following BMS implantation, with emphasis on their applicability in both resource-limited and general cardiology settings. Three randomized clinical trials comparing this strategy against DES are analyzed and discussed in this review. Conclusions: Oral sirolimus, prednisone, and colchicine demonstrate promising anti-inflammatory and antiproliferative effects that translate into clinical outcomes comparable to DES in a highly select population. Their systemic administration following BMS implantation may provide a feasible, cost-effective alternative where DES use is restricted by cost or clinical contraindications. Larger-scale, long-term trials are warranted to confirm safety, optimize dosing, and identify ideal patient populations for this “pharmacologic stent hybrid” strategy. Full article

The latest drug-eluting stents (DESs) are the gold standard for patient treatment during percutaneous coronary intervention (PCI). The latest advancements in DES innovation have resulted in the development of new stent technologies with reduced thickness in the struts. The new DES design, ultrathin-strut DESs, features struts measuring less than 70 μm in thickness. The evidence for these devices is derived from observational studies, extensive meta-analyses, and randomized trials with long-term outcomes. The investigation is focused on determining the comparative performance of ultrathin-strut DESs and conventional new-generation DESs across various clinical settings and patient lesion profiles. The objective of the seminar is to examine recent advancements in the use of very thin DESs and the potential of computational modeling in coronary arteries during PCI. An analysis of the mechanical performance of ultrathin DESs has been conducted in terms of radial expansion and stresses within the stent-vessel system. Residual stresses generated by the crimping process will also be considered. Full article

Bleeding is one of the most common and feared complications after coronary angiography and percutaneous coronary intervention (PCI). It is associated with longer hospital stays, higher mortality, and worse clinical outcomes. As the number of patients at high bleeding risk (HBR) continues to grow, preventing bleeding has become an important part of PCI management. This practical review summarizes current evidence on how to assess bleeding risk and reduce bleeding before, during, and after PCI. Several tools, including the BARC classification, ARC-HBR criteria, PRECISE-DAPT, and DAPT scores, help identify patients who may benefit from tailored treatment. Current strategies include the use of radial access, optimized anticoagulation, appropriate selection of antiplatelet therapy, newer-generation drug-eluting stents, and shorter durations of dual antiplatelet therapy in selected HBR patients. We also discuss the management of patients with atrial fibrillation requiring oral anticoagulation, as well as those with anemia or thrombocytopenia. Although significant progress has been made, several questions remain unanswered, particularly regarding transfusion thresholds, antithrombotic therapy in complex patients, and the best balance between bleeding and ischemic risks. Ongoing clinical trials are expected to provide further evidence and help improve the management of patients undergoing PCI. Full article

Background and Clinical Significance: Iatrogenic aorto-ostial dissection is a rare but potentially life-threatening complication of percutaneous coronary intervention (PCI), most commonly involving the right coronary artery. Although ostial stenting is generally considered the standard bailout strategy, failure of initial sealing may occur in selected anatomical settings and remains poorly understood. A focused narrative review of the literature was conducted through PubMed/MEDLINE, Scopus and Web of Science to identify reports of PCI-related aorto-coronary dissection with particular attention to dissection morphology, propagation mechanisms, bailout strategies, and outcomes after ostial stenting; Case Presentation: A 76-year-old man presented with non-ST-elevation myocardial infarction. Coronary angiography showed severe ostial right coronary artery (RCA) disease and significant left anterior descending artery stenosis. Following drug-eluting stent implantation in the RCA, extensive aorto-ostial dissection with retrograde extension into the sinus of Valsalva occurred. Initial ostial stenting failed to seal the dissection and was complicated by hyperacute stent thrombosis. After successful rewiring of the true lumen, a second overlapping drug-eluting stent was implanted using a stent-in-stent technique, followed by prolonged balloon inflation, achieving complete sealing and stabilization. Serial computed tomography angiography confirmed stability, and staged PCI of the LAD was successfully performed five days later; Conclusions: Failure of primary sealing may depend not only on procedural factors but also on dissection morphology. Transverse dissections with wide entry tears may be less effectively sealed by a single ostial stent, whereas overlapping stenting with prolonged balloon inflation may represent a more effective bailout strategy. Full article

Background: Coronary in-stent restenosis (ISR) remains a major limitation of percutaneous coronary intervention (PCI) with drug-eluting stents (DES), adversely affecting long-term outcomes. Most available prediction models rely on invasive procedural variables and have been developed predominantly in high-income populations, limiting their generalizability. This study aimed to identify independent predictors of coronary ISR and to develop and internally validate a clinically applicable risk stratification model based on routinely available clinical, laboratory, and procedural factors in a cohort of patients from Kazakhstan. Methods: In this retrospective case–control study, 910 patients with coronary artery disease (CAD) who underwent follow-up coronary angiography after PCI between January 2018 and July 2025 were included. The study comprised 455 patients with angiographically confirmed coronary in-stent restenosis and 455 patients without restenosis selected using a consecutive sampling approach. Clinical characteristics, laboratory parameters, echocardiographic findings, and angiographic data were analyzed. Independent predictors were identified using multivariable binary logistic regression. Model discrimination was assessed using receiver operating characteristic (ROC) curve analysis, and internal validation was performed using bootstrap resampling. Results: The mean age was 62.9 ± 8.9 years, and 75.2% of patients were male. Restenosis was independently associated with prior myocardial infarction (MI) (OR 2.20; 95% CI 1.65–2.80), type 2 diabetes mellitus (T2DM) (OR 2.60; 95% CI 1.93–3.47), and smoking (OR 1.40; 95% CI 1.01–1.89). Patients with restenosis demonstrated a less favorable inflammatory and metabolic profile, including higher NLR, MHR, atherogenic index, and TyG index (all p < 0.05). LVEF was significantly lower, while multivessel disease and the number of implanted stents was higher (p < 0.001). A risk stratification model incorporating T2DM, the number of implanted stents, MPV, neutrophil count, HDL-C, LVEF demonstrated good discrimination (AUC 0.828) and 74.4% accuracy. Conclusions: The proposed model demonstrated good discrimination and satisfactory internal validity with limited optimism after internal bootstrap validation. It may serve as a useful tool for patient risk stratification after PCI. External validation in independent cohorts is required before widespread clinical implementation. Full article

Background and Objectives: Red cell distribution width–standard deviation (RDW-SD) has been associated with systemic inflammation and adverse cardiovascular outcomes, but its relationship with the angiographic severity and morphological complexity of drug-eluting stent-in-stent restenosis (ISR) has not been systematically characterized. The present study investigated whether RDW-SD is associated with angiographic restenosis severity and restenotic lesion complexity, and compared its performance with the platelet distribution width (PDW), Metabolic Stress Index (MSI), and Platelet-to-HDL Ratio (PHR). Materials and Methods: In this retrospective single-center observational study, 290 patients undergoing clinically indicated repeat coronary angiography following prior drug-eluting stent (DES) implantation were enrolled. Angiographic luminal narrowing was quantified by QCA and categorized as reference (<50% in-stent luminal narrowing; n = 111), intermediate ISR (50–69%; n = 76), and severe ISR (≥70%; n = 103). The Mehran classification was applied to patients with ISR ≥50% and dichotomized as Mehran class I–II (n = 91) vs. Mehran class III–IV (n = 70). Multivariable logistic regression, hierarchical modeling, and incremental discrimination analyses (IDI and NRI) were performed for both binary outcomes. Results: RDW-SD differed significantly across angiographic severity groups (Kruskal–Wallis H = 51.14, p < 0.001), being highest in the ISR ≥70% group [44.6 fL (IQR 43.8–45.3)] and lowest in the ISR 50–69% group [43.2 fL (42.7–43.7)]. A parallel pattern was observed across Mehran class (H = 50.57, p < 0.001; Mehran class III–IV: 44.9 fL [44.2–45.8]). In multivariable analysis, RDW-SD independently associated with ISR ≥70% (OR = 1.228 per 0.5 fL, 95% CI 1.122–1.344, p < 0.001) and Mehran class III–IV (OR = 1.274, 95% CI 1.155–1.406, p < 0.001). Hierarchical modeling showed that adding RDW-SD improved the AUC from 0.603 to 0.719 for ISR ≥ 70% and from 0.592 to 0.757 for Mehran class III–IV (LRT p < 0.001 for both), with incrementally larger IDI and NRI gains for the Mehran class III–IV outcome. PDW did not retain significance after adjustment; MSI and PHR were not significantly associated with either outcome. Conclusions: RDW-SD was independently associated with both angiographic ISR severity and Mehran morphological complexity in patients with established drug-eluting stent restenosis, with numerically greater model discrimination for the Mehran class III–IV endpoint. These findings suggest that RDW-SD may provide complementary information regarding restenosis burden and complexity in patients with established ISR. Prospective studies are required to validate these observations and determine their clinical relevance. Full article

Percutaneous coronary intervention (PCI) using drug-coated balloons (DCBs) may provide outcomes comparable to drug-eluting stents (DESs) due to the absence of a permanent implant and improved coronary artery remodelling. This study compared clinical outcomes of DCB-only angioplasty with DESs in a real-world setting. All patients undergoing PCI with DCBs or DESs for de novo disease were included in a propensity score-matched analysis using prospective and retrospective collected data from a single centre. The primary outcome was target lesion revascularisation (TLR) at 12 months. The secondary outcomes were major adverse cardiac events (MACEs) defined as a composite of all-cause death, myocardial infarction, or TLR at 12 months. Propensity matching produced 904 DCB lesions (719 patients) matched to 1424 DES lesions (1271 patients). The DCB group had smaller coronary arteries, shorter treated segments, and more bifurcation lesions. The mean age was 65 years, 22% of patients had prior MI, 16% had diabetes, and 58% had acute coronary syndromes. The rate of TLR at 12 months was as follows: 2.3% with DCBs; 2.5% with DESs (OR 0.86, p = 0.726, 95% CI 0.37–2.02). MACE was 8.2% with DCBs and 7.3% for DESs (OR 1.04, 95% CI 0.73–1.47). Results suggest comparable outcomes in patients who received paclitaxel DCBs compared to DESs without excess MACE, highlighting the need for randomised controlled trials. Full article

Percutaneous coronary intervention (PCI) treats focal coronary obstruction by compressing plaque, injuring the vessel wall, and placing a metallic or bioresorbable scaffold. Most treated segments heal, but a small minority enter a prolonged, excessive, or unstable repair state that contributes to in-stent restenosis (ISR), in-stent neoatherosclerosis, and stent thrombosis (ST). Human evidence is strongest for delayed healing, uncovered struts, macrophage-rich neoatherosclerosis, and hypersensitivity-associated late thrombosis, whereas routine immune biomarker-guided care remains unsupported. The practical question addressed here is therefore not whether inflammation participates, which is established, but which immune signals, read together with intravascular imaging, could realistically change post-PCI management. The narrowed lumen is only the visible endpoint; beneath it sits vascular repair shaped by device-material exposure, local haemodynamics, and host immunity. Endothelial denudation and platelet activation initiate fibrin deposition, complement signalling, and release of damage-associated molecular patterns (DAMPs). Neutrophils, monocytes, and macrophages dominate early, followed by lymphocytes and vascular smooth muscle cells that remodel the repair compartment. Drug-eluting stents (DES) have markedly reduced early neointimal hyperplasia, yet selected late failures still involve delayed endothelial recovery, chronic peristrut inflammation, hypersensitivity, and neoatherosclerotic transformation. Immune biology is useful at the bedside only when interpreted with procedural context, device design, and patient phenotype. Imaging-defined endpoints and paired immune phenotyping are therefore needed to guide treatment by mechanism instead of angiography or isolated biomarkers. Full article

Coronary in-stent restenosis (ISR) remains a major contributor to repeat revascularisation despite advances in drug-eluting stent (DES) technology. Its persistence reflects a complex and heterogeneous interplay among mechanical, biological, and procedural factors, and understanding the dominant mechanism in each case is fundamental to effective treatment selection. This narrative review provides a contemporary, mechanism-guided approach to the practical management of coronary ISR. We summarise the definition, incidence, and classification of ISR—including the Mehran, Waksman, and SCAI 2023 time-based frameworks—and outline patient-related, procedural, anatomical, and stent-related risk factors. The pathophysiology of neointimal hyperplasia and neoatherosclerosis is discussed with reference to its clinical implications. Intracoronary imaging with intravascular ultrasound (IVUS) or optical coherence tomography (OCT) is central to ISR characterisation and treatment planning. Current international guidelines support imaging use in ISR management, though it is important to recognise that this recommendation is based largely on observational and surrogate-endpoint data rather than ISR-specific randomised trials demonstrating reductions in hard clinical outcomes, and practical barriers including cost, availability, and operator expertise must be acknowledged. Evidence-based treatment strategies—including drug-coated balloons (DCB), repeat DES implantation, lesion-modifying therapies, vascular brachytherapy, and coronary artery bypass grafting—are reviewed critically with reference to contemporary trial data and their specific clinical applicability. The choice between DCB and repeat DES is addressed with greater nuance, accounting for ISR type (BMS-ISR versus DES-ISR), lesion pattern, stent layering, and bleeding risk. Management considerations in complex subsets—chronic total occlusion ISR, left main ISR, saphenous vein graft ISR, and recurrent ISR—are also addressed. We propose a practical, substrate-driven management framework aligned with the 2024 ESC, 2021 ACC/AHA/SCAI, and 2018 JCS/JSCVS guidelines. Future research priorities include ISR-specific randomised trials with hard clinical endpoints, prospective validation of imaging-guided treatment algorithms, head-to-head comparisons of DCB platforms, and investigation of pharmacological strategies targeting neoatherosclerosis progression. Full article

Coronary drug-eluting stents (DESs) are the current clinical standard, yet delayed endothelialization remains a critical challenge. Graphene-based coatings have emerged as promising cardiovascular biomaterials due to their favorable hemocompatibility and ability to support endothelial cell growth. In this study, we evaluated the in vivo performance of graphene-coated stents (GCSs) compared with commercial sirolimus-eluting stents in a Polish White swine model (n = 10). Stents were implanted into major coronary branches, with follow-up at 30 and 90 days using quantitative coronary angiography (QCA), optical coherence tomography (OCT), and cryogenic scanning electron microscopy (cryo-SEM). No systemic toxicity, mortality, thrombotic events, or ischemic complications were observed during the study period. QCA demonstrated no significant differences in percent diameter stenosis between GCSs and DESs at either 30 days (12.3 ± 6.1% vs. 8.6 ± 5.8%, p = 0.2782) or 90 days (18.3 ± 10.5% vs. 9.6 ± 6.6%, p = 0.1074). OCT analysis confirmed comparable lumen and neointimal parameters between groups, while demonstrating a favorable, although non-significant, trend toward a lower percentage of uncovered struts in GCSs. Cryo-SEM imaging demonstrated stable tissue integration and a preserved healing response surrounding GCSs. Collectively, these findings indicate that GCSs are safe and biocompatible and demonstrate mid-term vascular performance comparable to clinically used DES platforms. The presented results support further investigation of graphene-based coatings as potential surface-modification strategies for coronary stents. Full article

Background: The permanence of contemporary coronary stents is associated with chronic complications, particularly in-stent restenosis and stent thrombosis. Poly-L-lactic-acid-based bioresorbable stents were withdrawn given late stent thrombosis risk. Magnesium-based bioresorbable stents (MgBRS) have emerged as promising alternatives. This study documents the safety and efficacy profile of MgBRS generations. Methods: A systematic review was performed using EMBASE, MEDLINE and Web of Science (2007 to August 2025). Studies include individuals requiring percutaneous coronary intervention for coronary artery disease with MgBRS. Primary outcomes were cardiac death, definite/probable scaffold thrombosis and target vessel failure (TVF), organised into ≤12, ≤24, ≤36 and ≤60 months. The secondary outcome was late lumen loss (LLL). Results: Four MgBRS generations were identified: AMS-1, DREAMS 1G, Magmaris and Freesolve; and 25 studies were included. Cardiac death and stent thrombosis rates were under 1.0% up to 24 months for all, and 0% with Freesolve at 36 months. AMS-1 had the highest TVF rate at 44.4% at 12 months, improving to 3.6% at 36 months in Freesolve. Only Magmaris had 60-month data, showing 3.4% cardiac death, 2.7% stent thrombosis and 16.4% TVF rates. The data suggest improvement in 12-month LLL: DREAMS 1G (0.4 ± 0.3 mm), Magmaris (0.5 ± 1.1 mm) and Freesolve (0.2 ± 0.4 mm). Conclusions: Each successive generation demonstrated improvement in all studied outcomes since the underperformance of AMS-1. The favourable performance of Freesolve is comparable to contemporary drug-eluting stents. Results of randomised head-to-head trials are anticipated. Full article

Additive manufacturing has emerged as a transformative technology for fabricating complex drug-eluting medical devices, offering unprecedented design freedom and functional integration capabilities. This comprehensive review systematically analyzes 3D printing technologies applied to pharmaceutical device manufacturing, focusing on drug-eluting vascular stents as a representative application. This review covers six primary additive manufacturing techniques, ranging from high-resolution vat photopolymerization (25 μm resolution) to direct energy deposition, with a focus on their capabilities for produce pharmaceutical devices with controlled drug release properties. Novel 4D/5D/6D printing technologies introduce stimuli-responsive behaviors enabling programmable drug release profiles and adaptive device functionality. Manufacturing process optimization reveals superior design flexibility compared to conventional methods, with 85–95% reduction in design iteration time and elimination of tooling costs for complex geometries. The material landscape encompasses traditional metals (316L stainless steel, cobalt–chromium), biodegradable polymers (polylactic acid, PLA; polycaprolactone, PCL; poly(lactic-co-glycolic acid), PLGA), shape-memory materials (i.e., polymers and alloys capable of recovering a pre-programmed shape upon exposure to a specific stimulus such as body temperature, moisture, or light), and advanced nanocomposites, each offering distinct drug-loading capacities (100–500 μg/cm²) and release kinetics. Critical challenges include standardization requirements (International Organization for Standardization (ISO) 5840 and American Society for Testing and Materials (ASTM) F2606), pharmaceutical-grade manufacturing protocols, and regulatory pathways for novel drug-device combinations. This review identifies key research priorities including development of biocompatible printing materials, accelerated drug release testing protocols, and scalable manufacturing processes suitable for medical device production. This analysis demonstrates that 3D printing enables integration of multiple pharmaceutical functions within single devices, controlled spatiotemporal drug delivery, and elimination of secondary manufacturing steps for drug coating processes, advancing the development of next-generation therapeutic medical devices. Full article

Polymer coatings are integral to nearly every modern cardiovascular and endovascular device, including drug-eluting stents (DESs) and drug-coated balloons (DCBs), bioabsorbable vascular scaffolds (BVSs), occluders, grafts, and catheter and guidewire hydrophilic surfaces. Persistent complications, including late stent thrombosis, delayed endothelialization, hypersensitivity, and restenosis, show that coatings actively shape biological responses rather than acting as inert drug carriers. Their surface chemistry, drug release kinetics, and degradation behavior are upstream determinants of blood– and tissue–material responses that govern healing and failure. This review frames coating selection as a structure–property–biological response problem. It surveys the major classes of synthetic polymer coatings and the defining surface and bulk properties. This review also examines how composition and architecture control drug release, and traces the interfacial cascade of protein adsorption, coagulation and complement activation, platelet and leukocyte responses, and neutrophil extracellular trap (NET) formation. These mechanisms are linked to contemporary design strategies that improve hemocompatibility, limit thrombosis, promote endothelial recovery, and tune degradation, and to the standardization and translation gaps that remain. The central message is that polymer coatings are not biologically equivalent. Their surface chemistries and degradation profiles determine the thrombo-inflammatory outcomes. Therefore, coating design should be guided by intended biological response, not drug release alone. Full article