Importance: The use of intravascular imaging for calcified plaque characterization and preparation has been advocated over conventional methods to improve percutaneous coronary intervention (PCI) outcomes, but this approach has never been evaluated.Objective: To determine if optical coherence tomography (OCT) is superior to angiography for calcified lesions PCI guidance.Design, Setting, and Participants: The CALIPSO (Calcified Lesion Intervention Planning Steered by OCT) trial was a prospective, multicenter, open-label, randomized clinical trial that included patients with stable moderate to severe calcified coronary lesions on coronary angiography scheduled for PCI. The trial was conducted at 12 sites in France between December 2021 and June 2023, and data were analyzed from December 2023 to April 2024.Intervention: After diagnostic coronary angiography, eligible patients were randomly assigned in a 1:1 ratio to receive OCT-guided PCI or angiography-guided PCI. In the OCT group, the procedures were guided by OCT analysis and predefined standardized management algorithms. Patients from both arms had control post-PCI OCT analysis after procedure completion for primary end point measurement.Main Outcomes and Measures: The primary end point was the minimal stent area (MSA) measured by OCT in both groups. Secondary key safety end points included periprocedural myocardial infarction, radiation dose, contrast medium volume, and procedure duration.Results: A total of 143 patients were randomized, and 134 were included in the final analysis (65 in the OCT group and 69 in the angiography group). Median (IQR) patient age was 73.0 (66.0-78.0) years, and 25 patients (18.7%) were female. The baseline characteristics of the groups were comparable, but the use of intravascular lithotripsy was more frequent in the OCT arm (30 patients [46%] vs 8 patients [12%]; P < .001). The final median (IQR) MSA was larger in the OCT group than in the angiography group (6.5 [5.5-8.1] mm2 vs 5.0 [4.1-6.1] mm2; P < .001). There was no difference in periprocedural complications incidence, contrast medium volume, or procedure duration between groups.Conclusions and Relevance: The CALIPSO randomized clinical trial showed that OCT guidance associated with predefined algorithmic management achieved better stent implantation results than angiography guidance in patients with calcified lesions PCI, without any additional safety concern.Trial Registration: ClinicalTrials.gov Identifier: NCT05301218
20 August 2024 in Journal of the American Heart Association
Background: Percutaneous left atrial appendage closure (LAAC) has been suggested as an alternative to long‐term oral anticoagulation for nonvalvular atrial fibrillation, but comparative data remain scarce. We aimed to assess ischemic and bleeding outcomes of LAAC compared with vitamin K antagonists (VKAs) or direct oral anticoagulants (DOACs) for the prevention of cardioembolic events in patients with atrial fibrillation. Methods and Results: Embase and MEDLINE were searched for randomized trials comparing LAAC, VKAs, and DOACs. The primary efficacy end point was any stroke or systemic embolism. Treatment effects were calculated from a network meta‐analysis and ranked according to the surface under the cumulative ranking curve. Seven trials and 73 199 patients were included. The risk of the primary end point was not statistically different between LAAC versus VKAs (odds ratio [OR], 0.92 [95% CI, 0.62–1.50]) and LAAC versus DOACs (OR, 1.11 [95% CI, 0.71–1.73]). LAAC and DOACs resulted in similar risk of major or minor (OR, 0.93 [95% CI, 0.61–1.42]) and major bleeding (OR, 0.92 [95% CI, 0.58–1.46]); however, after exclusion of procedural bleeding, bleeding risk was significantly lower in those undergoing LAAC. Both LAAC and DOACs reduced the risk of all‐cause death compared with VKAs (LAAC versus VKAs: OR, 0.70 [95% CI, 0.53–0.91]; DOACs versus VKAs: OR, 0.90 [95% CI, 0.85–0.95], respectively). DOACs ranked as the best treatment for stroke or systemic embolism prevention (66.9%) and LAAC for reducing major bleeding (63.9%) and death (96.4%). Conclusions: As a nonpharmacological alternative to oral anticoagulation for atrial fibrillation, LAAC showed similar efficacy and safety compared with VKAs or DOACs. Prospective confirmation from larger studies is warranted.
26 November 2014 in European Heart Journal - Cardiovascular Imaging
Aims We investigated the feasibility of thrombus quantification by frequency-domain optical coherence tomography (FD-OCT) methods in patients with highly thrombotic acute coronary syndrome (ACS) treated by deferred stenting strategy. Methods and results Patients were suitable for inclusion if they presented (i) an ACS that was successfully revascularized by manual thrombo-aspiration and (ii) a large residual thrombus on coronary angiography and initial FD-OCT analysis. These patients underwent a second procedure including FD-OCT analysis after several days of optimal antithrombotic therapy. Serial area measurements within the athero-thrombotic culprit lesion were performed to evaluate the OCT-thrombus score, volume, and length. Sixteen patients (88% men/age = 59.3 ± 4.1 years/94% STEMI) were included in the study. The mean delay between OCT analyses was 3.9 ± 0.3 day. No adverse event was observed during this interval. We observed a reduction of thrombus burden between the two analyses, as assessed by the significant reductions in OCT-thrombus score (22.3 ± 2.6 vs. 10.3 ± 1.3, P < 0.001), OCT-thrombus volume (9.6 ± 2.3 vs. 3.6 ± 0.9 mm3, P = 0.003), and OCT-thrombus length (11.1 ± 1.4 vs. 7.4 ± 0.8 mm, P = 0.01). The percentages of OCT-thrombus score and volume reduction were highly correlated with the inter-OCT analyses delay (respectively ρ = 0.65 and ρ = 0.84, P < 0.01 for both). Conclusion FD-OCT assessment of thrombus volume in selected ACS patients is feasible, safe, and could allow clot regression monitoring in vivo .
Remarkable progress has been made in the pharmacological management of patients with cardiovascular disease, including the frequent use of antithrombotic agents. Nonetheless, bleeding complications remain frequent and potentially life-threatening. Therapeutic interventions relying on prompt antithrombotic drug reversal or removal have been developed to assist clinicians in treating patients with active bleeding or an imminent threat of major bleeding due to urgent surgery or invasive procedures. Early phase studies on these novel strategies have shown promising results using surrogate pharmacodynamic endpoints. However, the benefit of reversing/removing antiplatelet or anticoagulant drugs should always be weighed against the possible prothrombotic effects associated with withdrawal of antithrombotic protection, bleeding, and surgical trauma. Understanding the ischemic-bleeding risk tradeoff of antithrombotic drug reversal and removal strategies in the context of urgent high-risk settings requires dedicated clinical investigations, but challenges in trial design remain, with relevant practical, financial, and ethical implications.
Background: Hypertension remains the leading global risk factor for cardiovascular morbidity and mortality, with suboptimal control rates despite guideline-directed therapies. Digital health and artificial intelligence (AI) technologies offer novel approaches for improving diagnosis, monitoring, and individualized treatment of hypertension. Objectives: To critically review the current landscape of AI-enabled digital tools for hypertension management, including emerging applications, implementation challenges, and future directions. Methods: A narrative review of recent PubMed-indexed studies (2019–2024) was conducted, focusing on clinical applications of AI and digital health technologies in hypertension. Emphasis was placed on real-world deployment, algorithmic explainability, digital biomarkers, and ethical/regulatory frameworks. Priority was given to high-quality randomized trials, systematic reviews, and expert consensus statements. Results: AI-supported platforms—including remote blood pressure monitoring, machine learning titration algorithms, and digital twins—have demonstrated early promise in improving hypertension control. Explainable AI (XAI) is critical for clinician trust and integration into decision-making. Equity-focused design and regulatory oversight are essential to prevent exacerbation of health disparities. Emerging implementation strategies, such as federated learning and co-design frameworks, may enhance scalability and generalizability across diverse care settings. Conclusions: AI-guided titration and digital twin approaches appear most promising for reducing therapeutic inertia, whereas cuffless blood pressure monitoring remains the least mature. Future work should prioritize pragmatic trials with equity and cost-effectiveness endpoints, supported by safeguards against bias, accountability gaps, and privacy risks.