BACKGROUND:Drug-eluting stents (DES) are associated with a 2% annual failure rate and have worse outcomes at coronary bifurcations. Recent randomized control data have shown the noninferiority of drug-coated balloons (DCB) vs stents at 1 year. Possible benefits of DCBs include the lack of a metal prosthesis, absence of stent malapposition, lack of obligate antiplatelet treatment, and maintenance of vessel geometry and function. HYPOTHESIS:The use of DCBs in the treatment of nonleft main bifurcation disease is noninferior to a DES strategy for Target Bifurcation Failure at 1 year. STRATEGY DESIGN:The EBC DCB trial is a nonblinded, investigator-initiated, randomized control trial that will recruit 750 patients with nonleft main bifurcations requiring revascularization. Both main vessel and side branch must have significant atheroma. Subacute (NSTEMI and unstable angina) and elective presentations will be eligible for inclusion. Patients will be randomized to either a step-wise provisional DES or a DCB strategy. Major exclusion criteria include STEMI in the previous 48 hours, chronic total occlusions, and in-stent restenosis. The primary endpoint of Target Bifurcation Failure is a composite of cardiovascular death, target bifurcation myocardial infarction, or target bifurcation revascularization. Patients will be followed up at 6 months, 1, 3, 5, and 8 years. If noninferiority is met, superiority will be tested. SUMMARY:EBC DCB is an open-label, multicenter, international randomized control trial comparing the use of DCB and DES in the treatment of coronary artery bifurcation disease. The trial is registered at clinicaltrials.gov (NCT06822322).

Background. Despite technological innovations and improvements in stents and devices, sex-related discrepancies are still reported in the outcomes after ST-segment elevation myocardial infarction (STEMI), depending on biological and sex-specific pathophysiological differences, which have not been completely understood. The aim of the present study was to provide real-world data on the prognostic role of sex among patients with STEMI, enclosed into a recent up-to-date international registry. Methods. The ISACS-STEMI COVID-19 is a large-scale retrospective registry, including STEMI patients treated with mechanical reperfusion between 1 March and 30 June, 2019 and 2020. Patients, treated in 109 centers across Europe, Latin America, Southeast Asia, and North Africa, were grouped according to sex. Primary endpoint: In-hospital mortality; secondary endpoints: Time delay, 30-day mortality, and postprocedural Thrombolysis In Myocardial Infarction (TIMI) 3 flow. Results. We included 16,083 patients, 24.3% females (54.3% hospitalized in 2019, 45.7% in 2020). Women with STEMI were older, more often diabetic and hypertensive (p < 0.001), with a higher prevalence of hypercholesterolemia (p = 0.02), longer ischemia time (p = 0.01), ambulance referral (p = 0.03) and cardiogenic shock at presentation (p = 0.05), but less frequently smokers, with a previous cardiovascular event (p < 0.001) or anterior STEMI (p = 0.03) as compared to males. Preprocedural TIMI 0 flow, multivessel disease, need for thrombectomy (p < 0.001 and p = 0.001, respectively), use of Glycoprotein IIbIIIa inhibitors or cangrelor, radial access and implantation of drug-eluting stents (p < 0.001, p < 0.001 and p = 0.001, respectively) were also more common in men. Impaired postprocedural epicardial reperfusion (TIMI flow 0-2) was observed more frequently in females as compared to males (10% vs. 7.2%; adjusted OR [95% CI] = 1.30 [1.13-1.49], p = 0.01). In-hospital mortality was 5.8%, significantly higher among women (8.3% vs. 5%, p < 0.001, adjusted HR [95% CI] = 1.26 [1.06-1.5], p = 0.01). Similar data were observed for 30-day mortality (10.3% vs. 6.2%, p < 0.001, adjusted HR [95% CI] = 1.22 [1.06-1.38], p = 0.007). Conclusions. Among STEMI patients being treated with the most updated standard of care for primary percutaneous coronary intervention, female sex is still associated with higher complexity and impaired prognosis, displaying suboptimal epicardial reperfusion and increased in-hospital and 30-day mortality.

Background:There is a lack of robust comparative data between limus drug-coated balloons (DCBs) versus paclitaxel-coated balloons (PCBs) on their efficacy and safety in treating in-stent restenosis (ISR). Aims:The objective of this systematic review and meta-analysis was to compare the efficacy and safety of limus DCBs versus PCBs in terms of clinical and angiographic outcomes during a 12-month follow-up. Methods:Following PRISMA guidelines, we systematically explored PubMed, Scopus, and Cochrane databases up to 20 February 2025 for studies comparing limus DCBs versus PCBs in terms of safety, efficacy, and angiographic outcomes in treating ISR. The primary outcomes were the incidence of clinically driven target lesion revascularisation (TLR) and failure (TLF). Secondary endpoints were major adverse cardiovascular events (MACE) and angiographic findings during follow-up. Results:Data from six randomised controlled trials (RCTs), including a total of 639 patients treated with limus DCBs and 569 with PCBs for ISR, were analysed with a mean follow-up of 12 months. In this analysis, all six RCTs reported on TLR (limus DCB 14% vs PCB 11.4%) and TLF (limus DCB 15% vs PCB 14%) incidence, showing no significant difference between the limus DCB and PCB groups. No significant differences were observed in MACE (16.4% vs 13.5%), all-cause mortality (1.8% vs 1.4%), cardiac death (1.4% vs 1.0%) or target vessel myocardial infarction (0.9% vs 1.0%), for limus DCBs versus PCBs, respectively. Angiographic outcomes showed no significant differences in post-intervention minimal lumen diameter (standardised mean difference [SMD] +0.06, 95% confidence interval [CI]: -0.07 to 0.18; I2=0%) or binary restenosis (limus DCB 19.5% vs PCB 12.9%) at follow-up between the groups. The risk of late lumen loss was also comparable between limus DCBs and PCBs for both in-segment (SMD +0.02, 95% CI: -0.18 to 0.23; I2=32%) and in-lesion (SMD -0.03, 95% CI: -0.31 to 0.24; I2=27%) analyses. Low heterogeneity was observed across the studies. Conclusions:Our findings suggest that limus DCBs are equally as effective and safe as PCBs for treating ISR, demonstrating non-inferiority in both clinical and angiographic outcomes at 12 months post-intervention.

BACKGROUND:Several scores have been developed to facilitate risk stratification and early discharge following primary angioplasty, particularly the Zwolle Risk Score (ZRS). However, validation in large-sized studies is still lacking. Therefore, the aim of the current study was to validate the use of the ZRS in a contemporary global population, including patients who were treated during the SARS-CoV-2 pandemic and enrolled in a large intercontinental observational study. METHODS:The ISACS-STEMI COVID-19 is a large-scale retrospective multicenter registry involving primary PCI centers from Europe, Latin America, South-East Asia, and NorthAfrica, including patients treated from March 1st until June 30th, in 2019 and 2020]. ZRS was calculated for each patient. The patients were additionally categorized according to the following values of the ZRS [≤3; 4-6; 7-9; ≥10]. Our study outcomes were in-hospital and 30-day mortality. The discriminatory capacity of the ZRS was assessed by the area under the ROC curve [c statistic] as an index of model performance. RESULTS:Our population is represented by 16084 STEMI patients undergoing mechanical reperfusion enrolled in 109 centers. The score showed a very good performance in the predicting mortality both in-hospital [AUC=0.83 [0.82-0.85], p<0.0001] and at 30- day follow-up [AUC=0.82 [0.81-0.84, p<0.0001]. The results were confirmed when the ZRS was separately applied to patients treated in 2019 and 2020, with good stability across time. ZRS was able to identify a large cohort [n=10672, 66.3%] of low-risk patients [score ≤3] with a very low mortality rate at 2 days [1%] and between 3 and 10 days [0.7%], with a very good negative predictive value for in-hospital [98.3%] and 30-day mortality [97.7%], with similar results in 2019 and 2020. CONCLUSION:This study is the first to demonstrate the good prognostic performance of the ZRS in a large-scale contemporary global multicenter validation set. Similar results were obtained both in the pre-pandemic and the COVID-19 era. ZRS ≤3 identified a very low-risk population that could be discharged early, even during the COVID-19 pandemic, with expected advantages in the availability of hospital beds and nursing staff, costs of medical care, and in-hospital risk of contagion.

Abstract Drug-coated balloon (DCB) therapy promotes beneficial vascular remodeling after percutaneous coronary intervention. However, its mechanisms remain elusive. Given paclitaxel’s neurotoxicity, the effects of paclitaxel (PTX)-DCB treatment on periarterial innervation are unknown. This study assessed the impact of PTX-DCB on periarterial innervation in porcine coronary arteries. Coronary arteries from twelve pigs were treated with balloon catheters across four groups: (1) uncoated balloon (POBA), (2) balloon with 3 µg PTX/mm2 (1 × 3), (3) balloon with 6 µg PTX/mm2 (1 × 6) and (4) two balloons each with 6 µg PTX/mm2 (2 × 6). Quantitative coronary angiography was performed before, during, and after balloon angioplasty, and at day 28 prior to sacrifice. Following sacrifice, tissue samples were taken for histological examination of periarterial nerve fibres. High-dose PTX treatment resulted in late lumen enlargement (+ 0.29 ± 0.60 mm) in the control angiography after 28d compared to POBA treatment (POBA vs. 2 × 6-PTX group (p = 0.0236). Sympathetic nerve fiber density did not differ between the untreated and balloon-treated segments in the POBA group (untreated: 386.5 ± 169.1 nerves/cm2, balloon: 328.5 ± 289.9 nerves/cm2, p = 0.6439) but was significantly reduced in the PTX-treated animals (1 × 3-PTX: untreated: 540.9 ± 216.2 nerves/cm2, balloon: 177.0 ± 130.5 nerves/cm2, p = 0.0020; 1 × 6-PTX: untreated: 546.5 ± 226.8 nerves/cm2, balloon: 142.4 ± 61.7 nerves/cm2, p = 0.0003; 2 × 6-PTX: untreated: 498.6 ± 404.0 nerves/cm2, balloon: 176.5 ± 103.4 nerves/cm2, p = 0.0478). PTX-DCB treatment significantly reduced the proportion of periarterial nerve fibers < 500 µm2 in the balloon-treated segment (p vs. untreated segment: POBA = 0.0267; 1 × 3-PTX = 0.0680; 1 × 6-PTX = 0.0028; 2 × 6-PTX = 0.0391). PTX-DCB therapy exerts previously unrecognized pleiotropic effects by reducing perivascular nerve fiber density, resulting in coronary denervation that may contribute to the luminal gain beyond antiproliferative effects.

INTRODUCTION:Despite the large use of renin-angiotensin system inhibitors (RASI) in STSegment Elevation Myocardial Infarction (STEMI) patients, few data have been reported on the prognostic impact of chronic RASI at admission in patients suffering from STEMI, especially during the COVID-19 pandemic. Therefore, the current study investigated the prognostic impact of chronic RASI at admission in patients suffering from STEMI, including both SARS-CoV-2 positive and negative individuals, enrolled before and during the COVID-19 pandemic. METHODS:We included STEMI patients who received primary percutaneous coronary intervention (PPCI) and were enrolled in the ISACS-STEMI COVID-19 registry. In the present sub-analysis, patients were allocated according to chronic RASI therapy at admission. The primary study endpoint was the occurrence of in-hospital mortality. Secondary endpoints were postprocedural TIMI 3 flow and mortality at 1 month. RESULTS:The overall population was 15,693 patients, including 6,213 patients pretreated with RASI. Several differences in baseline characteristics were observed between the two groups. No difference was observed in the prevalence of SARS-CoV-2 infection. After correction for all baseline confounders, including procedural features, chronic pretreatment with RASI was independently associated with improved postprocedural TIMI 3 flow (OR [95% CI] = 1.14 [1.03-1.35], p = 0.042), lower in-hospital mortality (adjusted OR [95% CI] = 0.64 [0.54-0.75], p < 0.001), and lower 30-day mortality (adjusted OR [95% CI] = 0.62 [0.53-0.73], p < 0.001). CONCLUSION:This is the largest study investigating the prognostic impact and benefits of chronic RASI pre-treatment in STEMI patients undergoing PPCI, including those treated during the COVID19 pandemic. We found that chronic RASI treatment at hospital admission was associated with significant improvement in reperfusion and reduction in mortality, without any negative effect in SARS-CoV-2 positive patients. Results should be interpreted considering the retrospective, nonrandomized nature of the study.

Drug-coated balloon (DCB) therapy has emerged as an alternative to stent-based treatment in coronary artery disease (CAD), particularly in patients where a “leave-nothing-behind” approach may be advantageous. This systematic review aimed to evaluate the current evidence on DCB-only therapy in complex CAD and at assessing its potential role in clinical practice. We performed a systematic review searching PubMed, CENTRAL, SCOPUS, and ICTRP from inception to 24th March 2025 to identify studies investigating a DCB-only strategy in complex CAD, defined as bifurcation and calcified lesions, chronic total occlusions (CTO), three-vessel disease, or left main disease. The main inclusion criteria were (i) studies including patients with complex CAD and (ii) the use of DCB-only therapy as the main treatment strategy. Risk of bias was systematically assessed. A total of 3120 records were identified. After duplicate removal, screening, and full-text review, 34 studies met our inclusion criteria (32 non-randomized, 2 randomized). Seven studies investigated bifurcation lesions (n = 660), nine evaluated CTOs (n = 870), six assessed calcified lesions (n = 455), and 12 included all-comer cohorts with complex lesions (n = 7079). Most studies were conducted in Asia. Overall, DCB-only therapy showed acceptable outcomes in patients with complex CAD. However, 47

Large-bore mechanical thrombectomy (LBMT) is a catheter-directed therapy for acute pulmonary embolism (PE). The relationship between aspirated thrombus weight and volume with outcomes remains unclear. The aim was to evaluate the impact of aspirated thrombus weight and volume on outcomes after LBMT. This prospective, open-label, single-arm, single-center registry study included 48 patients undergoing LBMT using the FlowTriever system (Inari Medical/Stryker, Irvine, CA, USA). Thrombus weight and volume were quantified, and clot composition assessed. Associations between thrombus characteristics and clinical, invasive hemodynamics, echocardiographic parameters, and biomarkers were evaluated immediately after the procedure, at hospital discharge, and at 3-month follow-up. Thrombus material was available in 48 patients (31

The Drug-Coated Balloon (DCB) Academic Research Consortium project originated from the need to overcome the lack of standardization and comparability among studies focusing on drug-coated balloon treatment. The DCB Academic Research Consortium represents a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focusing on percutaneous coronary intervention in Europe, the United States, and Asia. The present consensus document provides a classification of DCB technologies, antiproliferative drugs, and types of elution and coatings. Moreover, by reviewing the available evidence on the use of DCBs for several lesion (restenosis, de novo small and large vessels, bifurcations) and clinical (acute coronary syndromes, diabetes mellitus, multivessel disease, high bleeding risk) settings, it seeks to provide reasonable suggestions for their clinical use. Last, this paper outlines the processes involved in optimal "lesion preparation" before the use of DCBs and the criteria used for assessing results following their use.

There is increasing use of drug-coated balloons (DCBs) in de novo coronary disease, supported by an ever-expanding evidence base. However, DCB-only angioplasty requires a slightly modified lesion preparation strategy to ensure an optimal angioplasty result and minimise the risk of vessel-threatening dissection. In this article, we discuss the importance of optimal lesion preparation and vessel safety based on clinical and angiographic findings, as well as the selection and deployment of appropriate DCB. We outline a new and simplified classification of dissections: those that are safe to leave untreated (type 1) and those that require modification or stenting (type 2). We also present this classification in a simple graphical format. Finally, we provide a checklist for the complete process. This review article aims to accelerate the learning curve for DCB-only percutaneous coronary intervention (PCI), highlighting the importance of lesion preparation and dissection assessment while ensuring patient safety throughout the procedure. We hope this will facilitate the adoption of safe DCB-only PCI.

Coronary bifurcation lesions (CBLs) represent a common and challenging subset of coronary artery disease requiring percutaneous coronary intervention (PCI). While drug-eluting stents (DES) remain the cornerstone of treatment, their use is associated with risks such as restenosis, thrombosis, side branch (SB) jailing and the need for prolonged dual antiplatelet therapy. Drug-coated balloons (DCBs) have emerged as a promising alternative, delivering antiproliferative drugs without permanent implants, thereby reducing the risk of late complications and preserving native vessel geometry. This review explores the role of DCBs in CBL management, particularly for SB treatment within the provisional stenting strategy. Evidence from clinical studies indicates that DCBs significantly reduce late lumen loss and restenosis in the SB compared to plain balloon angioplasty, while simplifying PCI procedures and avoiding extensive stenting. Furthermore, hybrid/blended strategies combining DCBs with DES have shown superior clinical and angiographic outcomes in true CBLs compared to DES-only approaches. Despite their potential, the adoption of DCBs faces challenges, including the need for optimal lesion preparation and a lack of standardised procedural techniques. Existing randomised controlled trials are limited by small sample sizes, design heterogeneity, inclusion of bare metal stents either as comparators or as part of the treatment strategy, and inconsistent use of key procedural steps such as proximal optimisation technique and kissing balloon inflation. This manuscript aims to provide interventional cardiologists with practical guidance for managing CBLs, focusing on the effective integration of DCBs into standalone and hybrid strategies. By emphasising procedural optimisation and complication reduction, this review seeks to promote more standardised and reproducible approaches in clinical practice.

This clinical case highlights the safety and feasibility of drug coated balloon (DCB) angioplasty in a very young patients presenting with STEMI (ST-Elevation Myocardial Infarction) to avoid long-term complications associated with stent implantation, which still amount to 1%-2%. We successfully treated a 25 years old patient with occluded right coronary artery (RCA) with DCB after careful lesion preparation. Moreover, in a control angiogram 7 weeks later the RCA was patent with substantial lumen enlargement of 0.4 mm (RAO projection) to almost 2 mm (LAO projection) in a very short period of time. DCB angioplasty offers a viable alternative to stent implantation in young patients, avoiding the complications associated with permanent metallic implants while promoting vascular remodeling. While we acknowledge that more evidence is needed to optimize patient selection and confirm the long-term benefits of DCB in ACS, this case highlights its efficacy and safety in terms of an individualized treatment strategy.

BACKGROUND AND RATIONALE:In-stent restenosis (ISR) remains the leading cause of treatment failure following percutaneous coronary intervention (PCI) with contemporary drug-eluting stents. Especially in small caliber coronary arteries, restenosis is common following PCI and represents a treatment challenge. Drug-coated balloons (DCB) are an attractive alternative to stents for treatment of both ISR and small vessel disease. The safety and efficacy of the Prevail DCB will be assessed for (1) the treatment of ISR and (2) de novo lesions in small vessels. TRIAL DESIGN:Prevail Global is a prospective, international, dual cohort clinical study enrolling (1) patients undergoing PCI for ISR in a randomized controlled trial (1:1) design comparing the Prevail DCB versus an FDA-approved DCB (AgentTM, Boston Scientific Corporation, Natick MA), and (2) patients with de novo small vessel disease undergoing PCI with the Prevail DCB as part of a single-arm study compared with a historical control. The primary endpoint is target lesion failure, defined as a composite of cardiac death, target vessel myocardial infarction, or clinically-driven target lesion revascularization at 12 months post procedure. Patient follow-up is planned for 1 month, 6 months, and yearly through 5 years. Enrollment is expected to start in early 2025. CONCLUSIONS:The Prevail Global study will directly assess the safety and efficacy of the Prevail DCB for the treatment of ISR and de novo small vessel lesions. TRIAL REGISTRATION:Prevail Global, NCT06535854, is registered at https://clinicaltrials.gov/study/NCT06535854.

Background and Aims In randomized clinical trials of patients undergoing percutaneous coronary intervention (PCI) for de novo small-vessel coronary artery disease (SV-CAD), paclitaxel-coated balloon (PCB) angioplasty showed mid-term angiographic or clinical non-inferiority to drug-eluting stent (DES) implantation. Nevertheless, these trials have sample size limitations, and the relative safety and efficacy beyond the first year remain uncertain.Methods The ANDROMEDA study was a collaborative, investigator-initiated, individual patient data meta-analysis comparing 3 year clinical outcomes between PCB angioplasty and DES implantation for the treatment of de novo SV-CAD. Multiple electronic databases (PubMed, Scopus, ScienceDirect, and Web of Science) were searched from May 2010 to June 2024 to identify eligible trials. All the following eligibility criteria were required: (i) random allocations of treatments; (ii) patients with SV-CAD; (iii) treatment with PCB or DES; and (iv) clinical follow-up of at least 36 months. The primary and co-primary endpoints were major adverse cardiac events (MACE) and target lesion failure (TLF), respectively. The protocol was registered with PROSPERO (CRD42023479035).Results Individual patient data from three randomized trials, including a total of 1154 patients and 1360 lesions, were combined. At 3 years, PCB was associated with a lower risk of MACE compared with DES [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.47-0.96], due to a lower risk of myocardial infarction and target vessel revascularization. This benefit persisted after multivariable adjustment (HR 0.75, 95% CI 0.58-0.96), but did not reach statistical significance in the two-stage analysis (HR 0.67, 95% CI 0.43-1.04). At the landmark analysis, the risk of MACE between groups was consistent over time. At 3 years, TLF was not significantly different between PCB and DES groups. Reconstructed time-to-event information from a fourth trial was included in a sensitivity analysis (1384 patients and 1590 lesions), showing consistent results in terms of TLF (HR 0.87, 95% CI 0.63-1.20). The comparison between PCB and second-generation DES did not reveal significant differences in 3 year TLF (HR 1.03, 95% CI 0.70-1.50).Conclusions In patients undergoing PCI for de novo SV-CAD, PCB angioplasty is associated with a reduction in MACE and a non-significant difference in TLF at 3 year follow-up compared with DES implantation. The restriction of the comparator group to second-generation DES does not alter the main conclusions. Larger trials comparing contemporary devices at a more prolonged follow-up are warranted to confirm these findings.