Johan Bennett

Background/Objectives: Although still considered off-label, there are accumulating data demonstrating that intravascular lithotripsy (IVL) is safe and effective in treating patients with stent failure (SF). Diabetes (DM) is an independent predictor of recurrent SF. Whether IVL has a differential treatment effect depending on the diabetic status of SF patients undergoing IVL has never been studied. Therefore, we aimed to compare IVL outcomes in patients with SF and concomitant DM versus non-DM counterparts. Methods: This is a pre-specified subgroup analysis of the COIL registry (coronary intravascular lithotripsy in patients with stent failure), which included patients who underwent IVL for SF, divided according to the patients’ diabetic status. Procedural and clinical outcomes were compared between DM and non-DM patients. The primary clinical endpoint was major adverse clinical event (MACE) defined as the composite of cardiovascular death, spontaneous myocardial infarction, or target vessel revascularization (TVR) at one-year follow-up. Results: There were 102 patients enrolled in the coronary intravascular lithotripsy in patients with stent failure (COIL) registry, of whom 47 (46.1%) had DM. Most baseline clinical characteristics were similar between the groups, although patients with DM had higher rates of hypertension and hypercholesterolemia. The use of intracoronary imaging (53% and 56%, respectively, p = 0.75) and the procedural success rate (77% vs. 80%, p = 0.68) were similar in DM and non-DM patients. No difference was observed in the incidence of in-hospital (2.1% vs. 1.8%, p = 0.91) and one-year MACE (12.8% vs. 18.2%, p = 0.45). Conclusions: In patients undergoing IVL for the treatment of SF, procedural and one-year clinical outcomes did not differ significantly between DM and non-DM patients, although the limited sample size should be acknowledged.

Background: Early identification and targeted treatment of coronary lesions at higher risk of future events remains a major unmet need in coronary artery disease research. Invasive treatment of such plaques is controversial. The third‐generation bioresorbable magnesium scaffold (DREAMS 3G) may provide a valuable alternative, but it has not been evaluated in this setting. The BIOMAG‐I study, with comprehensive OCT and IVUS imaging, offers a unique opportunity to investigate high‐risk plaque morphology and its vascular response. Aims: We aimed to assess the association between lesions with high‐risk plaque features treated with the DREAMS 3G scaffold and late lumen loss (LLL) at follow‐up. Methods: This post‐hoc analysis included patients with stable coronary artery disease and high‐quality intravascular imaging. High‐risk plaque was defined as μFR > 0.80 with PB ≥ 70%. Subgroups were further stratified by the presence of MLA < 4 mm², TCFA < 80 μm, lipid arc >90°, or all combined PB was assessed by IVUS or estimated by OCT when IVUS was unavailable. LLL was measured at 6 and 12 months. Results: Of 83 patients, 42 (50.6%) met the definition of μFR > 0.80 with PB ≥ 70%. Within this cohort, 41 also had MLA < 4 mm², 23 had TCFA < 80 μm, 16 had lipid arc ≥ 180°, and 16 presented all four features. LLL remained low in the overall PB ≥ 70% group (0.21 ± 0.29 mm at 6 months; 0.27 ± 0.44 mm at 12 months) and was similarly low or even lower across the additional subgroups, including those with all features combined (0.19 ± 0.21 mm and 0.16 ± 0.19 mm). Conclusions: In this sub‐analysis of the BIOMAG‐I trial, the DREAMS 3G bioresorbable magnesium scaffold demonstrated favorable performance, with low LLL and a low rate of clinical outcomes during the resorption period. These findings support DREAMS 3G as a promising “leave‐nothing‐behind” strategy for selected high‐risk plaques, warranting confirmation in larger prospective studies.

Intravascular optical coherence tomography (OCT) has represented a revolutionary invasive imaging method, offering in vivo high-resolution cross-sectional views of human coronary arteries, thereby promoting a significant evolution in the understanding of vascular biology in both acute and chronic coronary pathologies. Since the development of OCT in the early 1990s, this technique has provided detailed insights into vascular biology, enabling a more thorough assessment of coronary artery disease (CAD) and the impact of percutaneous coronary intervention (PCI). Moreover, a series of recent clinical trials has consistently demonstrated the clinical benefits of intravascular imaging (IVI) and OCT-guided PCI, showing improved outcomes compared to angiography-guided procedures, particularly in cases of complex coronary pathology. Nonetheless, despite the advantages of OCT, several limitations remain, including limited penetration depth and the necessity for additional contrast agent administration, which may potentially constrain the widespread adoption of OCT. Moreover, economic and logistical challenges remain, including heterogeneous levels of training among interventional cardiologists, which leads to the underutilization of OCT in the Western world. Meanwhile, emerging technologies and the integration of machine learning and artificial intelligence-based algorithms are set to enhance diagnostic accuracy in daily practice. Future research is necessary to address existing limitations and investigate next-generation devices, further advancing the field of interventional cardiology toward optimal imaging-guided PCI and improved outcomes.

Background: DESyne BDS Plus represents a novel triple drug therapy (TRx) applied on a coronary stent platform eluting the antiproliferative drug Sirolimus along with two anticoagulants (Rivaroxaban and Argatroban) to reduce the site‐specific thrombotic risk. Aims: To assess the feasibility and safety of this novel device against a contemporary drug‐eluting stent. Methods: This prospective, multicenter randomized (1:1) trial included 202 patients assigned between the device group (DESyne BDS Plus) and the control group (DESyne X2). A subgroup of 58 patients underwent imaging follow‐up at 6 months. The blood pharmacokinetics of Sirolimus and both anticoagulants were assessed in 11 nonrandomized patients. Results: The primary endpoint, target lesion failure (TLF) at discharge or 3‐day postprocedure, whichever occurred first, was 0.0% (0/98) in the device and 5.0% (5/100) in the control group ( p _{noninferiority} < 0.001). The secondary endpoint, late lumen loss at 6 months, was 0.14 mm [90% CI: 0.06; 0.23] and 0.09 mm [90% CI: 0.01; 0.18] in the device ( n = 28) and control group ( n = 27), respectively ( p _{noninferiority} < 0.001). Through 24 months, stent thrombosis (definite/probable) was 0.0% (0/97) versus 1.0% (1/96) in the control, p = 0.497, and TLF was 2.1% (2/97) versus 11.3% (11/97), p = 0.010, respectively. Optical coherence tomography findings including strut coverage and neointimal hyperplasia thickness/volume were similar between the groups. The pharmacokinetic study indicated median maximum blood concentrations (C _max ) of Rivaroxaban and Argatroban of 1.38 ng/mL and 1.99 ng/mL, respectively. Conclusions: This is the first clinical evidence of the feasibility of site‐specific antithrombotic therapeutic with two anticoagulants and an antiproliferative mTOR inhibitor.

Background: Antegrade approach remains one of the predominant techniques for CTO PCI. Success rates have increased significantly recently due to advancements in devices and strategies, along with the hybrid algorithm. ReCross is a uniquely modified microcatheter with two over‐the‐wire lumens and three exit ports, offering significant potential for application across all facets of antegrade CTO‐PCI applications. However, there is limited published data investigating its efficacy. Objective: The objective of our study was to analyze the efficiency and outcome of the ReCross device, following an agreed step‐by‐step protocol in contemporary CTO PCI, based on our firsthand experience. Methods: During the period between June 2023 and April 2024, we evaluated patients undergoing CTO PCI at eight participating centers for scheduled clinically necessary CTO PCI with a planned primary antegrade approach using an upfront agreed ReCross strategy. Results: A total of 118 patients who underwent CTO PCI were included in the study. The mean JCTO score was 2.16 ± 0.95. The majority of cases (94%) were successfully resolved using an upfront ReCross strategy with a technical success of 96%, demonstrating a high level of effectiveness. The average procedure time (90 min) observed in our study was notably lower in comparison to other similar studies. There were no procedure‐related mortalities until hospital discharge, although one distal wire perforation complication was reported. Conclusion: Our initial experience with the ReCross microcatheter suggests in select cases with the application of a dedicated algorithm, the antegrade approach can be highly successful.

Despite continuous advances in three-dimensional (3D) fusion imaging, two-dimensional (2D) X-ray-based fluoroscopy is still the gold standard intra-operative image guidance tool in endovascular interventions. The adoption of robotic technology offers the potential to bring intra-operative radiation exposure down to a minimum, or even eliminate it. Non-ionizing approaches, such as Intravascular Ultrasound (IVUS), are progressively explored as standalone or fluoroscopy-adjunct techniques for 3D vasculature reconstruction. We have previously demonstrated the feasibility of real-time 3D Main Vessel (MV) modeling from the fusion of IVUS and EM pose data obtained from sensors embedded at the tip of a robotic catheter. This paper proposes to advance MV modeling towards a comprehensive radiation-free 3D guidance framework by means of intra-operative Side Branch (SB) detection and modeling. Two models are proposed to approximate the geometry of SB vessel ostia: a sphere and a cylinder. An Unscented Kalman Filter (UKF) recursively estimates the state of these models considering the MV model, while the catheters navigates through the vessel. In silico and in vitro validation results show the potential clinical value of the proposed strategy for facilitating safer robotic catheter steering.

A 43-year-old woman with pulmonary arterial hypertension associated with atrial septal defect, surgically repaired 5 years ago, and treated with the endothelin receptor antagonist macitentan monotherapy due to phosphodiesterase-5-inhibitor intolerance, presented for routine outpatient clinical follow-up. She complained of new exertional chest pain and progressive dyspnea (New York Heart Association class III). Clinical Images from Journal of Invasive Cardiology. Cardiac Imaging Pulmonary hypertension