Kandzari DE, Böhm M, Schmieder RE
… +6 more, Townsend RR, Schlaich MP, Kario K, Whitbourn R, Gilbertson M, Mahfoud F
EuroIntervention
· 2026 May · PMID 42137915
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BACKGROUND: Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. Late-term follow-up among RDN trials is essential to characterise the durability of its efficacy, and f...BACKGROUND: Catheter-based renal denervation (RDN) is a guideline-recommended therapy for uncontrolled hypertension. Late-term follow-up among RDN trials is essential to characterise the durability of its efficacy, and further study is needed to ascertain the proportion of patients experiencing a clinical benefit. AIMS: We aimed to evaluate 36-month blood pressure (BP) changes after radiofrequency (RF)-RDN across four clinical studies from the SPYRAL programme and to determine the proportion of patients who experienced a clinical benefit. METHODS: Data were pooled from the Global SYMPLICITY Registry DEFINE, SPYRAL First-In-Human, and SPYRAL HTN-OFF MED and -ON MED trials. All patients were treated with RF-RDN (Symplicity Spyral). Medications, BP changes, and adverse events were evaluated through 36 months. RESULTS: A total of 2,137 patients treated with RF-RDN using the Spyral device were included in the analysis. Baseline office systolic (OS)BP was 163±23 mmHg, baseline 24-hour ambulatory systolic (AS)BP was 152±17 mmHg, and the baseline number of antihypertensive medications was 3.8±2.1. At 36 months, the number of medications was 3.5±1.9, and reductions in OSBP and ASBP were significant (-18.1±23.4 mmHg and -13.3±17.6 mmHg, respectively; p<0.0001). Overall, adverse event rates were low. The proportion of patients who experienced a reduction in OSBP ≥10 mmHg, ASBP ≥5 mmHg, and/or ≥1 medication was 88% at 36 months. CONCLUSIONS: In this large, pooled cohort of Spyral RF-RDN patients, there were significant BP reductions through 36 months with few adverse events. Additionally, nearly 9 out of 10 patients experienced a clinical benefit. These findings suggest the long-term efficacy and safety of RF-RDN across a broad spectrum of patients with uncontrolled hypertension.
EuroIntervention
· 2026 May · PMID 42137914
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Aortic stenosis is the most prevalent valvular heart disease in the Western world, affecting over 12% of individuals aged 75 years and older. The optimal timing of transcatheter aortic valve implantation or surgical aort...Aortic stenosis is the most prevalent valvular heart disease in the Western world, affecting over 12% of individuals aged 75 years and older. The optimal timing of transcatheter aortic valve implantation or surgical aortic valve replacement remains one of the most debated topics in contemporary cardiology, particularly for asymptomatic patients with severe disease or symptomatic patients with moderate aortic stenosis. Whilst symptomatic severe aortic stenosis has established indications for intervention, the management of these other groups of patients requires careful consideration of disease progression, myocardial damage, procedural risks, and long-term outcomes. Recent randomised controlled trials have provided preliminary evidence regarding early intervention strategies. This review examines the current evidence base for the timing of aortic valve replacement, with a particular focus on transcatheter aortic valve implantation, and discusses the implications of recent trial data for clinical practice and guideline recommendations.
García-García HM, Bulant CA, Boroni GA
… +17 more, Clausse A, Engstrøm T, Lemos PA, Lecaros Yap NA, Cap M, Iglesias JF, Geuns RV, Lang IM, Spirk D, Häner JD, Koskinas KC, Kakizaki R, Ueki Y, Siontis GCM, Bourantas CV, Blanco PJ, Räber L
EuroIntervention
· 2026 May · PMID 42077033
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BACKGROUND: Predicting the progression/regression of coronary plaque burden is challenging. AIMS: We aimed to develop a deep learning model to forecast changes in percent atheroma volume (ΔPAV) using intravascular ultras...BACKGROUND: Predicting the progression/regression of coronary plaque burden is challenging. AIMS: We aimed to develop a deep learning model to forecast changes in percent atheroma volume (ΔPAV) using intravascular ultrasound (IVUS). METHODS: We analysed data from IBIS-4 and PACMAN-AMI. Core lab measurements of plaque burden were available from IVUS pullbacks. Each model consists of a bidirectional Long Short-Term Memory (biLSTM) layer followed by two fully connected layers with one neuron each, resulting in both a classification for input progression/regression and an estimation of the ΔPAV. RESULTS: For the derivation and validation, a total of 1,960 regions of interest (ROIs) from the IBIS-4 dataset were used. The mean±standard deviation of the model accuracy was 0.85±0.02, the Matthews correlation coefficient was 0.70±0.04, and the F1 score was 0.85±0.02 for both progression and regression classes. In the testing (external validation) process with the PACMAN-AMI dataset, 5,283 ROIs were utilised. The mean ΔPAV was -0.31±5.63, for which 2,665 featured regression with a mean ΔPAV of -4.57±3.73, and 2,618 presented progression with a mean ΔPAV of 4.02±3.55, representing 49.6% of plaque progression prevalence. The predictive performance across the 100 trained models in the testing dataset showed an accuracy of 0.84, a Matthews correlation coefficient of 0.68, and an F1 score for the progression and regression classes of 0.84. CONCLUSIONS: This is the first deep learning model capable of detecting changes in plaque progression by analysing the rate of plaque burden change between adjacent frames.
Brugaletta S, Ortega-Paz L, Gómez-Lara J
… +3 more, Laudani C, Strosio M, Sabaté M
EuroIntervention
· 2026 May · PMID 42077032
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Primary percutaneous coronary intervention is currently the standard of care for the treatment of acute ST-segment elevation myocardial infarction (STEMI). While it can restore flow in the infarcted artery in the majorit...Primary percutaneous coronary intervention is currently the standard of care for the treatment of acute ST-segment elevation myocardial infarction (STEMI). While it can restore flow in the infarcted artery in the majority of cases, some patients experience the so-called "no-reflow" phenomenon, which consists of abnormal myocardial reperfusion occurring after the occluded coronary artery has been opened. It is caused by microvascular obstruction (MVO), and its pathogenesis is multifactorial, including myocardial ischaemia, distal embolisation, and ischaemia-reperfusion injury, combined with individual susceptibility. Currently, there is no consensus on pharmacological or interventional strategies which can prevent or treat it. We herein discuss in detail the pathophysiology of the "no-reflow" phenomenon in STEMI patients, which is closely related to MVO, as well as potential pharmacological and interventional treatments tested in clinical studies.
Andersen BK, Holm NR, Sejr-Hansen M
… +9 more, Erriquez A, Råmunddal T, Stähli BE, Guiducci V, Mogensen LJH, Westra J, Escaned J, Christiansen EH, Of The Favor Iii Europe Investigators OB
EuroIntervention
· 2026 May · PMID 42077029
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BACKGROUND: Quantitative flow ratio (QFR) is an angiography-based method for estimating fractional flow reserve (FFR). The FAVOR III Europe trial showed that QFR guidance did not meet non-inferiority to FFR guidance, as...BACKGROUND: Quantitative flow ratio (QFR) is an angiography-based method for estimating fractional flow reserve (FFR). The FAVOR III Europe trial showed that QFR guidance did not meet non-inferiority to FFR guidance, as measured by a composite endpoint of all-cause death, myocardial infarction, and unplanned revascularisation at 12 months. AIMS: We sought to report the 2-year outcomes of the QFR-guided diagnostic strategy and the FFR-guided strategy as applied in the FAVOR III Europe trial. METHODS: FAVOR III Europe was a multicentre, randomised, open-label, non-inferiority trial. A total of 2,000 patients from 34 European medical centres were randomised to undergo QFR- or FFR-guided revascularisation of intermediate coronary artery stenoses. Endpoints assessed at the 2-year follow-up included the rates of major adverse cardiac events (MACE) and its individual components of all-cause death, myocardial infarction, and unplanned revascularisation. The rates of MACE were compared for superiority by unadjusted Cox regression analysis. The outcomes from 1 to 2 years were explored in a landmark analysis. RESULTS: At 2 years, the rates of MACE were 9.7% in the QFR group and 7.4% in the FFR group (hazard ratio [HR] 1.34, 95% confidence interval [CI]: 0.98-1.81; p=0.064). In the landmark analysis, the rates of MACE between 1 and 2 years were 3.2% in the QFR group and 3.2% in the FFR group (HR 0.97, 95% CI: 0.58-1.62; p=0.92). CONCLUSIONS: The excess risks associated with QFR-guided revascularisation compared with FFR were confined to the first year. From 1 to 2 years, the rates of MACE developed similarly in the QFR and the FFR groups.
Cepas-Guillén P, Albors C, Mill J
… +24 more, Aminian A, Garot P, De Backer O, Nielsen-Kudsk JE, Iriart X, Barreiro-Perez M, Flores-Umanzor E, Cruz-González I, Arzamendi D, Avvedimento M, Nombela-Franco L, Leduc N, Horvilleur J, Kofoed KF, Korsholm K, Cochet H, Estevez-Loureiro R, Barrouhou M, Lafond A, Millán X, Sanchis L, Rodés-Cabau J, Camara O, Freixa X
EuroIntervention
· 2026 Apr · PMID 42003302
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BACKGROUND: Device-related thrombus (DRT) remains a concern after left atrial appendage closure (LAAC), particularly when the device is deeply implanted. However, the mechanistic links between implantation depth, flow dy...BACKGROUND: Device-related thrombus (DRT) remains a concern after left atrial appendage closure (LAAC), particularly when the device is deeply implanted. However, the mechanistic links between implantation depth, flow dynamics, and DRT risk are not well understood. AIMS: We therefore aimed to evaluate the impact of LAAC device implantation depth on local flow characteristics and its association with DRT using patient-specific computational fluid dynamics (CFD). METHODS: The study included 285 patients undergoing LAAC with either Amplatzer Amulet or WATCHMAN devices at 10 centres. Patient-specific CFD simulations were performed using postprocedural computed tomography and echocardiography-derived boundary conditions to assess blood flow dynamics. The primary endpoint was the comparison of CFD-derived flow indices - device surface velocity index (DSVI), endothelial cell activation potential (ECAP), and the presence of eddies/stagnated flow - between proximal and distal device implantation groups. Secondary analyses explored the relationship between these flow features and DRT. RESULTS: Proximal implants (57.2%) showed more favourable flow patterns: higher DSVI (0.11 m/s vs 0.09 m/s; p=0.002), lower ECAP (0.75 vs 0.90; p=0.003), and fewer recirculating zones (40.5% vs 74.6%; p<0.001). DRT incidence increased with greater implantation depth, paralleled by worsening flow indices. A composite CFD-based DRT risk score, incorporating ECAP, implantation depth, and flow complexity, demonstrated good discrimination (area under the receiver operating characteristic curve [AUC] 0.81), outperforming anatomical depth alone (AUC 0.71). CONCLUSIONS: Deeper LAAC device implantation is associated with adverse flow profiles and a higher risk of DRT. CFD-based flow characterisation may enhance risk stratification beyond anatomical criteria alone. Further studies incorporating clinical variables are warranted to validate these methods.
Otsuka T, Yamamoto M, Asami M
… +19 more, Naganuma T, Ohno Y, Tani T, Nakazawa G, Izumo M, Saji M, Hachinohe D, Ueno H, Sugiura A, Shimura T, Okazaki S, Morikawa T, Izumi Y, Nakashima M, Kubo S, Shirai S, Watanabe Y, Hayashida K, Of The Ocean-Laac Investigators OB
EuroIntervention
· 2026 Apr · PMID 42003301
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The current standard regimen for antithrombotic therapy after percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) recommends long-term use of antiplatelet agents. Ho...The current standard regimen for antithrombotic therapy after percutaneous left atrial appendage closure (LAAC) in patients with non-valvular atrial fibrillation (NVAF) recommends long-term use of antiplatelet agents. However, this recommendation is not supported by sufficient clinical evidence. Since LAAC is a treatment option for managing patients at high risk of bleeding, it is necessary to clarify whether long-term antiplatelet therapy is truly required after LAAC. The Non-Antithrombotic Versus. Single antiPlatelet Therapy Following Left Atrial Appendage Closure (NAPT-LAAC) trial, a prospective, randomised, controlled, open-label, blinded-endpoint multicentre study, will be conducted in Japan. It was designed to evaluate whether non-antithrombotic therapy is non-inferior to antiplatelet monotherapy after 45 days of oral anticoagulant (OAC) monotherapy following LAAC, with respect to the incidence of thrombotic and bleeding composite events in patients with NVAF and high bleeding risk. Patients with NVAF with a CHADS-VA score ≥2 and who successfully undergo LAAC are eligible for inclusion. A total of 500 patients undergoing LAAC will be randomised (1:1) to aspirin monotherapy versus non-antithrombotic therapy for the 45 days following OAC monotherapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, systemic embolism, major bleeding, and clinically relevant non-fatal bleeding during a maximum of 4 years of follow-up. Major bleeding or clinically relevant non-fatal bleeding is defined as Type 2, 3, or 5 bleeding, according to the Bleeding Academic Research Consortium definition. The NAPT-LAAC trial will determine the probable non-inferiority of long-term non-antithrombotic therapy to aspirin monotherapy in patients with NVAF who undergo LAAC. (ClinicalTrials.gov: NCT07125417; jRCTs031250110).
Lee JM, Cho MS, Kang DY
… +21 more, Ahn JM, Oh YS, Lee CH, Choi EK, Lee JH, Kwon CH, Park GM, Choi HO, Park KH, Park KM, Hwang J, Yoo KD, Cho YR, Kim JH, Hwang KW, Jin ES, Kwon O, Kim KH, Park SJ, Nam GB, Park DW
EuroIntervention
· 2026 Apr · PMID 42003300
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BACKGROUND: Renal function is a critical factor of ischaemic and bleeding risks in patients with atrial fibrillation (AF) receiving antithrombotic therapy. AIMS: This study aimed to evaluate the impact of renal dysfuncti...BACKGROUND: Renal function is a critical factor of ischaemic and bleeding risks in patients with atrial fibrillation (AF) receiving antithrombotic therapy. AIMS: This study aimed to evaluate the impact of renal dysfunction in patients with AF and stable coronary artery disease (CAD) undergoing antithrombotic therapy. METHODS: The Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic Stable Coronary Artery Disease (EPIC-CAD) trial randomised patients to edoxaban monotherapy or dual antithrombotic therapy (edoxaban plus a single antiplatelet agent). In this prespecified analysis, patients were stratified by creatinine clearance into low (<50 mL/min) or high (≥50 mL/min) groups according to edoxaban dose-reduction criteria. The primary endpoint was net adverse clinical events (NACE: death from any cause, myocardial infarction, stroke, systemic embolism, urgent revascularisation, or major/clinically relevant non-major bleeding) at 12 months. RESULTS: Of 1,040 randomised patients, 252 (24.2%) had low creatinine clearance; these patients were older and had more comorbidities compared with the 788 patients (75.8%) with high creatinine clearance. Patients with low creatinine clearance experienced higher risks of NACE (hazard ratio [HR] 1.72, 95% confidence interval [CI]: 1.19-2.49; p=0.004), ischaemic events (HR 2.70, 95% CI: 1.09-6.70; p=0.032), and bleeding (HR 1.54, 95% CI: 1.01-2.34; p=0.046). At 12 months, edoxaban monotherapy reduced NACE compared with dual therapy in both the low (12.1% vs 21.7%, HR 0.52, 95% CI: 0.28-0.98; p=0.042) and high creatinine clearance groups (5.2% vs 14.5%, HR 0.40, 95% CI: 0.25-0.65; p<0.001), with no interaction (p for interaction=0.53). CONCLUSIONS: In patients with AF and stable CAD, edoxaban monotherapy led to a lower risk of primary NACE than dual antithrombotic therapy, regardless of renal function. (ClinicalTrials.gov: NCT03718559).
Alvarez-Covarrubias HA, Simonetti F, Mayr NP
… +6 more, Rheude T, Starnecker F, Xhepa E, Thilo C, Adam M, Joner M
EuroIntervention
· 2026 Apr · PMID 42003299
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Recurrent tricuspid valve regurgitation (TVR) after tricuspid transcatheter edge-to-edge repair (T-TEER) poses a significant challenge, particularly when centrally positioned clips impede subsequent transcatheter tricusp...Recurrent tricuspid valve regurgitation (TVR) after tricuspid transcatheter edge-to-edge repair (T-TEER) poses a significant challenge, particularly when centrally positioned clips impede subsequent transcatheter tricuspid valve replacement (TTVR). Electrosurgical laceration and stabilisation of T-TEER (ELASTA-T) has been developed to facilitate TTVR by enabling controlled single leaflet device attachment (SLDA). The aim of this manuscript is to provide a step-by-step standardised description of the ELASTA-T strategy, outlining essential procedural principles, the required equipment, and technical steps. ELASTA-T involves intentional detachment of the most centrally placed tricuspid clip using electrosurgical leaflet laceration. A modified coronary guidewire shaped into a "flying V" - based on Bioprosthetic Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction (BASILICA) and Laceration of the Anterior Mitral leaflet to Prevent Outflow ObstructioN (LAMPOON) principles - is positioned across the target leaflet using bilateral femoral vein access, deflectable guiding sheaths, microcatheters, and a snare-assisted venovenous rail. Laceration is performed under fluoroscopic and transoesophageal echocardiographic guidance, with preventive haemodynamic support on standby because of the risk of transient severe TVR. After laceration, the clip is mobilised towards the septal leaflet to avoid interference with valve deployment, followed by immediate implantation of a dedicated transcatheter tricuspid valve (TTV). ELASTA-T allows safe and reproducible SLDA, creating adequate central space for accurate positioning and full expansion of a TTV. Detachment can be reliably confirmed by fluoroscopy and transoesophageal echocardiography. By removing any mechanical obstruction from centrally placed clips, the technique facilitates secure TTVR anchoring and may reduce paravalvular regurgitation. This step-by-step framework may support procedural standardisation and broader adoption, ultimately improving outcomes in this high-risk population.
Raona V, Gitto M, Oliva A
… +12 more, Sartori S, Feng Y, Vogel B, Di Muro FM, Chiarito M, Krishnan P, Sweeny J, Moreno P, Kini A, Dangas G, Sharma S, Mehran R
EuroIntervention
· 2026 Apr · PMID 41943632
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BACKGROUND: A substantial proportion of patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) experience recurrent ischaemic events. Guidelines recommend risk stratification at...BACKGROUND: A substantial proportion of patients with chronic coronary syndrome (CCS) undergoing percutaneous coronary intervention (PCI) experience recurrent ischaemic events. Guidelines recommend risk stratification at the time of PCI and consideration for prolonged dual antiplatelet therapy in high ischaemic risk (HIR) patients. AIMS: This study aimed to evaluate the prevalence and prognostic impact of guideline-defined HIR criteria in a large, real-world cohort of CCS patients undergoing PCI. METHODS: We retrospectively analysed CCS patients treated with drug-eluting stents at Mount Sinai Hospital between 2012 and 2022. Per the 2024 European Society of Cardiology guidelines on the management of CCS, HIR criteria included left main stenting, stent length >60 mm, diabetes mellitus, chronic kidney disease, bifurcation, and chronic total occlusion (CTO). Prognostic associations were assessed using multivariate Cox regression. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), including death, myocardial infarction (MI), or stroke. RESULTS: Of 15,336 CCS patients, 10,952 (71.4%) met at least one HIR criterion. Overall, HIR status and most of its individual components, with the exception of bifurcation and CTO, predicted MACCE. Increasing numbers of HIR criteria were significantly associated with higher MACCE (p for trend<0.001), as well as the individual components of death (p for trend<0.001) and MI (p for trend<0.001). CONCLUSIONS: In a real-world CCS cohort, guideline-defined HIR status was associated with increased MACCE. However, as almost three-quarters of patients met at least one HIR criterion, risk stratification accuracy at the time of PCI may have been limited.