Shin D, Volleberg RHJA, Parikh R
… +20 more, Yang Koo CC, Malik S, Cannata M, Caron E, Ciftcikal Y, Sakai K, Cao JJ, Chen L, Sosa F, Weber J, Khan JM, Cohen DJ, Moses JW, van Royen N, Collet C, Shlofmitz RA, Shlofmitz E, Jeremias A, Khalique OK, Ali ZA
EuroIntervention
· 2025 Oct · PMID 41051153
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BACKGROUND: Photon-counting detector computed tomography (PCD-CT) offers enhanced spatial resolution and reduced blooming artefacts, potentially improving the evaluation of stented coronary vessels. AIMS: This study aime...BACKGROUND: Photon-counting detector computed tomography (PCD-CT) offers enhanced spatial resolution and reduced blooming artefacts, potentially improving the evaluation of stented coronary vessels. AIMS: This study aimed to assess the diagnostic performance of dual-source PCD-CT in detecting obstructive in-stent restenosis (ISR). METHODS: We identified consecutive patients with prior coronary stent implantation who underwent clinically indicated coronary computed tomography angiography (CCTA) with PCD-CT and subsequent invasive coronary angiography within 90 days between 2023 and 2024. Obstructive ISR (≥50% diameter stenosis) was determined by visual assessment of CCTA and invasive quantitative coronary angiography (QCA) in a blinded fashion. The diagnostic performance of CCTA for ISR was compared with that of QCA. RESULTS: A total of 283 stented lesions from 171 patients were included. Of these, only 3 lesions (1.1%) were deemed indeterminate by PCD-CT. Using invasive QCA as the reference standard, PCD-CT demonstrated a lesion-level sensitivity of 80.0%, specificity of 90.4%, positive predictive value (PPV) of 58.2%, negative predictive value (NPV) of 96.4%, and an overall diagnostic accuracy of 88.9% for detecting obstructive ISR. In a subgroup analysis according to the stent diameter (<3.00 mm [n=83] vs ≥3.00 mm [n=108]), there were no significant differences in sensitivity (87.5% vs 86.7%; p=1.00), specificity (93.3% vs 92.5%; p=1.00), PPV (58.3% vs 65.0%; p=1.00), NPV (98.6% vs 97.7%; p=1.00), or overall diagnostic accuracy (92.8% vs 91.7%; p=1.00), respectively. CONCLUSIONS: PCD-CT demonstrated good diagnostic performance for evaluating obstructive ISR using QCA as the reference standard, regardless of stent diameter.
Volleberg RHJA, Rroku A, Mol JQ
… +12 more, Hermanides RS, van Leeuwen M, Berta B, Meuwissen M, Alfonso F, Wojakowski W, Belkacemi A, De Luca G, Rodwell L, Roleder T, Kedhi E, van Royen N
EuroIntervention
· 2025 Oct · PMID 41051151
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BACKGROUND: High-risk coronary plaques (HRPs) are associated with adverse cardiovascular outcomes. However, the clinical practicality of HRP identification is challenged by their modest prevalence and low positive predic...BACKGROUND: High-risk coronary plaques (HRPs) are associated with adverse cardiovascular outcomes. However, the clinical practicality of HRP identification is challenged by their modest prevalence and low positive predictive value. AIMS: We aimed to evaluate the association between clinical risk factors and HRPs, as well as the clinical impact of HRPs across different clinical risk profiles. METHODS: This is a pooled analysis of individual patient data from the prospective observational COMBINE (OCT-FFR) and PECTUS-obs studies. A modified version of the Thrombolysis in Myocardial Infarction Risk Score for Secondary Prevention (TRS-2P) was used for risk stratification. The composite endpoint of major adverse cardiovascular events (MACE) was evaluated on a patient level, and target lesion failure (TLF), also a composite endpoint, was evaluated on a lesion level. RESULTS: Among 810 patients, 311, 265, and 234 were at low (TRS-2P 0-1), intermediate (TRS-2P 2), and high risk (TRS-2P ≥3), respectively. The modified TRS-2P had no discriminative value for the identification of patients with an HRP (area under the receiver operating characteristic curve 0.51, 95% confidence interval [CI]: 0.47-0.56). A consistent trend towards worse clinical outcome in the presence of an HRP was observed across different clinical risk profiles (p=0.539 for MACE and 0.337 for TLF). For TLF, the highest event rate per 100 lesion-years was observed in high-risk patients with HRPs (6.28, 95% CI: 3.52-10.36; 13.6% absolute risk at 2 years). CONCLUSIONS: HRPs are associated with a negative clinical outcome, without apparent differences between clinical risk profiles. This highlights the independent value of optical coherence tomography for prognostication beyond clinical risk factors. The high event rates in high-risk patients with HRPs necessitate the search for additional therapeutic strategies to mitigate this risk.
Husain A, Jelisejevas J, Millar K
… +15 more, Alnuwakhtha A, Ferkh A, Delarive J, Gill H, Althekrallah J, Offen S, Tzimas G, Ye J, Leipsic JA, Blanke P, Sathananthan J, Wood DA, Sellers SL, Meier D, Webb JG
EuroIntervention
· 2025 Oct · PMID 41051150
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BACKGROUND: Incomplete expansion of balloon-expandable (BE) transcatheter heart valves (THVs) is sometimes treated by ad hoc post-dilatation with an overfilled or larger valvuloplasty balloon. The efficacy of this approa...BACKGROUND: Incomplete expansion of balloon-expandable (BE) transcatheter heart valves (THVs) is sometimes treated by ad hoc post-dilatation with an overfilled or larger valvuloplasty balloon. The efficacy of this approach has not been rigorously evaluated, although increased risk for adverse events has been demonstrated. Observational experience suggests that post-dilatation using the original delivery system balloon at the identical filling volume (i.e., double-tap) may routinely improve the degree of THV expansion with low risk. AIMS: We sought to assess the safety and efficacy of a strategy of routine double-tap after BE transcatheter aortic valve implantation (TAVI). METHODS: Patients undergoing TAVI with the SAPIEN 3 Ultra (S3U) valve were prospectively included. Patients with severe annular or subannular calcification were excluded. A validated method of fluoroscopic analysis was utilised to assess the cross-sectional area at the inflow, midpoint, and outflow of the THV before and after double-tap. Thirty-day clinical outcomes were documented. RESULTS: Routine double-tap was performed in 102 patients. Despite nominal deployment, all patients had some degree of THV underexpansion after the first inflation. Fluoroscopic analysis documented an increase in minimal THV expansion by cross-sectional area of 9.8% for the 20 mm S3U (p=0.151), 9.9% for the 23 mm S3U (p<0.001), 9.2% for the 26 mm S3U (p<0.001), and 8.6% for the 29 mm S3U (p=0.002). There was no stroke or cardiovascular mortality at 30 days. CONCLUSIONS: In favourable anatomy, routine double-tap after BE TAVI improved THV expansion with no safety concerns. The impact of this strategy on THV function, haemodynamic profile, and durability remains to be determined.
Mangner N, Sharma SK, O'Connor C
… +26 more, Kaki A, Dangas GD, Moses JW, Mahmud E, Tarantini G, Achenbach S, Pocock SJ, O'Neill WW, Grines CL, Lansky AJ, Wollmuth JR, Narula J, Karmpaliotis DI, Faraz HA, Basir MB, Bharadwaj AS, Ali ZA, Simonton C, Bilazarian SD, Kapur NK, Chapman RC, Bentley D, Popma JJ, Maehara A, Windecker S, Stone GW
EuroIntervention
· 2025 Sep · PMID 41024656
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Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention...Coronary artery disease (CAD) is the leading cause of heart failure with reduced ejection fraction (HFrEF). Coronary artery bypass grafting (CABG) improves long-term mortality in HFrEF. Percutaneous coronary intervention (PCI) is often performed as an alternative to CABG in patients at high surgical risk. However, in patients with HFrEF and limited myocardial reserve, PCI may result in haemodynamic instability, increasing risk and precluding optimal revascularisation. Mechanical circulatory support (MCS) during high-risk PCI may enhance haemodynamic stability during the procedure and enable complete revascularisation. We thus performed the PROTECT IV trial to determine whether PCI with routine use of the Impella CP microaxial flow pump improves early and late outcomes in patients with HFrEF and complex CAD compared with PCI with or without use of an intra-aortic balloon pump (IABP). PROTECT IV is a prospective, multicentre, randomised, parallel-controlled, open-label, superiority trial with an adaptive design. Patients with complex CAD and left ventricular ejection fraction ≤40% (n=1,252) deemed at excessive surgical risk for bypass grafting by the Heart Team will be randomised in a 1:1 ratio to PCI with Impella CP versus PCI with or without an IABP. The primary endpoint is the composite of all-cause death, stroke, myocardial infarction, unplanned clinically driven revascularisation, durable left ventricular assist device implant or heart transplant, or other hospitalisation for cardiovascular causes at 3-year follow-up, with at least 1-year follow-up in all patients. Prespecified substudies will evaluate the impact of MCS on renal function, the procedural role of right heart catheterisation, and the utility of myocardial viability assessment. The PROTECT IV trial will determine whether routine MCS with Impella CP during high-risk PCI improves the prognosis of patients with complex CAD and HFrEF.
Tarantini G, Kim WK, Kaleschke G
… +5 more, Holzamer A, Mangner N, Parma R, Cardaioli F, Fovino LN
EuroIntervention
· 2025 Sep · PMID 40958625
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Editorial note: On 28 May 2025, the manufacturer announced the global discontinuation of sales of its ACURATE neo2 and ACURATE Prime aortic valve systems. The following correspondence, submitted and accepted prior to the...Editorial note: On 28 May 2025, the manufacturer announced the global discontinuation of sales of its ACURATE neo2 and ACURATE Prime aortic valve systems. The following correspondence, submitted and accepted prior to the market withdrawal, discusses clinical experience with this device. Though no longer relevant for current practice, the Editorial Board believes it is important to document these findings in the interest of transparency and completeness of the scientific record. Accordingly, we are publishing this work as a Research Correspondence, with acknowledgement of the device's discontinued status.
Kim JH, Kang DY, Ahn JM
… +8 more, Kweon J, Chae J, Wee SB, An SY, Park H, Kang SJ, Park DW, Park SJ
EuroIntervention
· 2025 Sep · PMID 40958624
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BACKGROUND: Intracoronary imaging-guided percutaneous coronary intervention (PCI) has demonstrated clinical benefit over angiography-guided PCI for left main coronary artery (LM) disease. However, the optimal minimal ste...BACKGROUND: Intracoronary imaging-guided percutaneous coronary intervention (PCI) has demonstrated clinical benefit over angiography-guided PCI for left main coronary artery (LM) disease. However, the optimal minimal stent area (MSA) thresholds to predict cardiovascular outcomes remain incompletely defined. AIMS: This study aimed to evaluate intravascular ultrasound (IVUS)-measured segmental MSA after LM crossover stenting. METHODS: We identified 829 consecutive patients who underwent IVUS-guided PCI for unprotected LM disease using a single-stent crossover technique. The final MSA was measured at the proximal LM, distal LM, and left anterior descending artery (LAD) ostium. The primary outcome was 5-year major adverse cardiac events (MACE), including all-cause death, myocardial infarction, and target lesion revascularisation. RESULTS: The MSA cutoff values best predicting 5-year MACE were 11.4 mm² for the proximal LM (area under the curve [AUC] 0.62), 8.4 mm² for the distal LM (AUC 0.58), and 8.1 mm² for the LAD ostium (AUC 0.57). Based on these cutoff values, stent underexpansion in the proximal LM was significantly associated with increased risk of 5-year MACE (adjusted hazard ratio [HR] 2.34; p<0.001). Additionally, patients with simultaneous stent underexpansion in both the distal LM and LAD ostium exhibited a significantly higher risk of 5-year MACE compared with those having adequate expansion or only single-site underexpansion (adjusted HR 2.57; p<0.001). CONCLUSIONS: Achieving sufficient stent expansion in the proximal LM and preventing underexpansion in both the distal LM and LAD ostium are critical for improving long-term clinical outcomes. The identified MSA thresholds may serve as practical benchmarks for stent optimisation during LM PCI.
Overduin DC, van Ginkel DJ, Bor WL
… +43 more, Kobari Y, Aarts HM, Dubois C, De Backer O, Rooijakkers MJP, Rosseel L, Veenstra L, van der Kley F, van Bergeijk KH, van Mieghem NM, Agostoni P, Voskuil M, Schotborgh CE, Ijsselmuiden AJJ, Van Heyden JAS, Hermanides RS, Barbato E, Mylotte D, Fabris E, Frambach P, Dujardin K, Ferdinande B, Peper J, Rensing BJWM, Timmers L, Swaans MJ, Brouwer J, Nijenhuis VJ, Adriaenssens T, Vriesendorp PA, Montero-Cabezas JM, Jattari HE, Halim J, Van den Branden BJL, Leonora R, Vanderheyden M, Lauterbach M, Wykrzykowska JJ, van 't Hof AWJ, van Royen N, Tijssen JGP, Delewi R, Ten Berg JM
EuroIntervention
· 2025 Sep · PMID 40958621
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BACKGROUND: Bleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identi...BACKGROUND: Bleeding remains a frequent complication after transcatheter aortic valve implantation (TAVI). Recently, the Valve Academic Research Consortium High Bleeding Risk (VARC-HBR) criteria were introduced to identify patients at (very) high risk of bleeding. AIMS: This study aimed to evaluate the validity of the VARC-HBR criteria for predicting bleeding risk in TAVI patients and to compare its performance with other existing criteria. METHODS: Data were obtained from the POPular PAUSE TAVI trial, a randomised clinical trial that evaluated the safety and efficacy of continuation versus interruption of oral anticoagulation during TAVI. Major and minor bleeding risk criteria were identified at baseline, and bleeding events were recorded up to 30 days after TAVI. Patients were classified into three groups: those with ≤1 minor criterion (moderate risk), those with 1 major or 2 minor criteria (high risk), and those with ≥2 major or ≥3 minor criteria (very high risk). RESULTS: A total of 856 patients were included: 332 (39%) were classified at moderate bleeding risk, 337 (39%) at high bleeding risk, and 187 (22%) at very high bleeding risk. Major bleeding occurred in 4.2% of moderate-risk patients, 9.5% in the high-risk group, and 15.0% in the very high-risk group (p<0.001). Receiver operating characteristic analysis showed moderate discriminative performance (area under the curve=0.64, 95% confidence interval: 0.58-0.70). Despite higher-than-expected event rates, the VARC-HBR criteria demonstrated good calibration with observed outcomes. CONCLUSIONS: The VARC-HBR criteria effectively identified distinct subgroups with a stepwise increase in major bleeding post-TAVI. However, their predictive performance for individual risk was moderate.
Meier D, Delarive J, Lai A
… +11 more, Hahn RT, Cavalcante JL, Asgar AW, Latib A, Garg P, Kodali S, Bapat VN, Settergren M, Sathananthan J, Meduri CU, Sellers SL
EuroIntervention
· 2025 Sep · PMID 40958620
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BACKGROUND: The DurAVR transcatheter heart valve (THV) is a novel biomimetic balloon-expandable valve with promising early clinical results. AIMS: We aimed to assess the hydrodynamic performance of the DurAVR THV in nati...BACKGROUND: The DurAVR transcatheter heart valve (THV) is a novel biomimetic balloon-expandable valve with promising early clinical results. AIMS: We aimed to assess the hydrodynamic performance of the DurAVR THV in native, valve-in-valve (ViV), and redo-transcatheter aortic valve implantation (TAVI) procedures against commercially available THVs on the bench. METHODS: The hydrodynamic function of the DurAVR THV was assessed by simulating native valve deployments at 0 mm, 3 mm, and 6 mm depths, compared to SAPIEN 3 (S3), Evolut PRO, Navitor, and ACURATE neo2 (ACn2) valves. For ViV simulations, THVs were implanted in 21 mm and 23 mm Magna Ease, Mosaic, and Hancock bioprostheses. For redo-TAVI simulations, the DurAVR THV was assessed within S3, Evolut PRO, Navitor, and ACn2 valves. RESULTS: For native TAVI simulations, the DurAVR THV demonstrated superior or comparable hydrodynamic performance, independent of implant depth, with an effective orifice area (EOA) ≥3 cm and a mean gradient (MG) <6 mmHg. The DurAVR THV had nil to mild pinwheeling (0-2%) at all depths, while the S3 and Evolut PRO showed moderate pinwheeling at 6 mm depth. For ViV simulations, the DurAVR THV exhibited larger EOAs and lower MGs than the comparator THVs and showed no more than mild pinwheeling in all ViV configurations. For redo-TAVI simulations, the DurAVR THV exhibited larger EOAs and lower MGs in each simulation compared to all other THVs tested, with no more than mild pinwheeling observed in all configurations except when implanted within the Evolut PRO. CONCLUSIONS: In this bench study, the DurAVR THV demonstrated excellent hydrodynamic performance in native, ViV, and redo-TAVI simulations. Future large-scale studies are needed to confirm these findings in clinical application and further characterise the valve's short- and long-term performance.
Castiello DS, Oliva A, Andò G
… +16 more, Niccoli G, Pelliccia F, Moscarella E, Montone RA, Gragnano F, Porto I, Calabrò P, Rosa S, Spaccarotella CAM, Fabris E, Esposito G, Indolfi C, Sinagra G, Filardi PP, Piccolo R, Cardiology Of The Italian Society Of Cardiology OBOTWGOI
EuroIntervention
· 2025 Sep · PMID 40958619
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Over the past decades, percutaneous coronary intervention (PCI) has become the most common modality for myocardial revascularisation, and it is increasingly used in patients with advanced coronary artery disease. Antithr...Over the past decades, percutaneous coronary intervention (PCI) has become the most common modality for myocardial revascularisation, and it is increasingly used in patients with advanced coronary artery disease. Antithrombotic therapy, including antiplatelet and anticoagulant drugs, plays a key role and should be part of the optimal revascularisation strategy in the early phase as well as in the long-term prevention of ischaemic events. An antithrombotic therapy regimen of increased intensity and/or duration may mitigate part of the ischaemic burden associated with complex PCI. However, patients undergoing complex PCI are often at increased bleeding risk, challenging, therefore, the decision-making process. In this setting, the optimal antithrombotic treatment is still a matter of debate and has become a field of intensive research. In this state-of-the-art review, we analyse the evidence related to the different approaches regarding the periprocedural and long-term antithrombotic management of patients undergoing complex PCI. Since a "one-size-fits-all" approach cannot be justified in this clinical setting, our aim is to tailor the antithrombotic strategy to each patient's profile and PCI complexity. We discuss the type and duration of antithrombotic regimens that can be selected for patients undergoing complex PCI, with a focus on prolonged dual antiplatelet therapy, P2Y receptor inhibitor monotherapy, and dual pathway inhibition. We also address antithrombotic management in specific scenarios (left main disease, coronary bifurcations, chronic total occlusion) and in patients undergoing complex PCI who require oral anticoagulant therapy.
Rossello X, Sánchez PL, Owen R
… +22 more, Raposeiras-Roubín S, Poletti F, Barrabés JA, Anguita M, Dominguez-Rodriguez A, Lombardi M, Pocock S, Díez-Villanueva P, Vives-Borrás M, Rollán MJ, D'Orazio S, Escalera N, Isabel-Santos A, Chiampan A, de Diego O, López-Benito M, Moreno E, Rincón-Díaz LM, París H, Latini R, Fuster V, Ibanez B
EuroIntervention
· 2025 Dec · PMID 40887991
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BACKGROUND: Current guidelines recommend beta blockers after myocardial infarction (MI) regardless of left ventricular ejection fraction (LVEF), aiming to reduce reinfarction and ventricular arrhythmias. However, recent...BACKGROUND: Current guidelines recommend beta blockers after myocardial infarction (MI) regardless of left ventricular ejection fraction (LVEF), aiming to reduce reinfarction and ventricular arrhythmias. However, recent trials have challenged this practice in patients without reduced LVEF. Whether beta blocker withdrawal in these patients increases short-term or recurrent ischaemic events remains uncertain. AIMS: We aimed to evaluate the short-term ischaemic safety of beta blocker withholding or withdrawal at hospital discharge in patients with MI and LVEF >40% and to determine the effect of beta blocker therapy on a broad composite ischaemic endpoint. METHODS: This is a post hoc analysis of the REBOOT trial, in which patients with MI and LVEF >40% were randomised to beta blocker therapy or no beta blocker at discharge. The incidence of short-term (3-month) and recurrent ischaemic events (a composite of cardiac death, reinfarction, sustained ventricular tachycardia/fibrillation, resuscitated cardiac arrest, or unplanned revascularisation) was assessed overall and according to prior beta blocker use. RESULTS: From the 8,438 patients in the intention-to-treat population of the trial, information regarding beta blocker history was available for 8,401. Of these, 12.1% were on chronic beta blocker therapy before MI. Overall, withholding or withdrawing beta blockers was not associated with increased short-term ischaemic risk (hazard ratio [HR] 1.13, 95% confidence interval [CI]: 0.74-1.72). Over a median follow-up of 3.7 years, there were no differences in recurrent ischaemic events between groups (HR 0.98, 95% CI: 0.82-1.16), nor significant interactions with prior beta blocker therapy. In patients who were on a beta blocker before the index MI, randomisation to no beta blocker (withdrawal) was not associated with an increased risk of ischaemic events during trial follow-up (composite ischaemic endpoint HR 0.93, 95% CI: 0.64-1.34). CONCLUSIONS: In patients with MI and LVEF >40%, beta blocker withholding or withdrawal at discharge was not associated with increased short-term or recurrent ischaemic events, supporting the safety of this strategy in contemporary clinical practice.