Eurointervention最新文献

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.

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.

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.

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.

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 cm² 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.

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, P2Y₁₂ 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.