No significant coronary artery lesion is seen on an emergent coronary angiogram in 5 to 10% of patients with myocardial infarction. These patients are most often female, younger and with less risk factors for atherosclerotic disease. Causes of myocardial infarction with no significant coronary artery stenosis (MINOCA) include plaque rupture, coronary artery spasm and coronary microvascular lesions. MINOCA is diagnosed using clinical (prolonged chest pain) ECG and biological (rise in troponin) data. A coronary angiogram is mandatory to confirm the absence of significant coronary artery lesion. Endovascular imaging is often performed. Cardiac MRI confirms the diagnosis of myocardial infarction and rules out other causes of prolonged chest pain and rise of troponin such as myocarditis and Takotsubo syndrome. Long term follow-up by a cardiologist is necessary.
BACKGROUND:Implantation of drug eluting stents (DESs) is currently the default approach for percutaneous coronary interventions, but long-term adverse events still exist. An approach with minimal stenting deserves to be assessed in a randomized trial. We studied a novel sirolimus-eluting balloon (SEB) that elutes sirolimus over a 90-day period using a biodegradable polymer microreservoir technology. METHODS:In a multicenter, open-label, randomized trial, we compared an SEB-based strategy with provisional DES with one of systematic DES for de novo lesions in coronary arteries between 2 and 5 mm in diameter. Subjects were randomized 1:1 before percutaneous coronary intervention. The primary end point was target vessel failure, a composite of cardiac death, target vessel-related myocardial infarction, and clinically driven target vessel revascularization. It was tested for noninferiority at 1 year with the use of an absolute margin equal to 50% of the combined event rate at a significance level of 0.025. The primary analysis population included all randomized subjects with completed or attempted percutaneous revascularization, analyzed according to the intention-to-treat principle. A sensitivity analysis was performed on the per-protocol population. RESULTS:Between August 27, 2021, and July 29, 2024, 3323 participants were randomized and treated in 62 sites. Among 1661 participants in the SEB strategy group, bailout stenting was performed in 343 (20.7%). Target vessel failure occurred over 365 days in 88 (5.3%) and 73 (4.4%) participants in the SEB and the systematic DES strategy groups, respectively (risk difference, 0.91% [95% CI -0.55% to 2.38%]; 1-sided P=0.02 for noninferiority with a 2.44% noninferiority margin). Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group (3.3% versus 2.1%; risk difference, 1.22% [95% CI, 0.11%-2.33%). Safety events, including lesion thrombosis, were low and similar in both groups. Although the results of the per-protocol population (3194 participants, 96%) did not confirm noninferiority (upper boundary of the 95% CI, 2.63; P=0.04), they were similar to the intention-to-treat results in both magnitude and direction. CONCLUSIONS:At 1 year, in the primary intention-to-treat analysis population, a strategy of percutaneous coronary intervention with SEB and provisional DES was noninferior to the systematic use of DES for the primary end point of target vessel failure. The per-protocol population sensitivity analysis did not confirm noninferiority. Clinically driven target vessel revascularization occurred more frequently in the SEB strategy group. At 5 years, target vessel failure will be tested again for noninferiority and for superiority if noninferiority is achieved. REGISTRATION:URL: https://www.clinicaltrials.gov; Unique identifier: NCT04859985.
BACKGROUND:Medium- and long-term outcomes after transcatheter paravalvular leak (PVL) closure remain poorly documented, with limited prospective data on predictors of morbidity and mortality. AIMS:This study aimed to assess medium-term outcomes and identify key predictive factors of mortality or surgical reintervention at 2 years after transcatheter PVL closure. METHODS:The prospective Fermeture de Fuite ParaProthétique (FFPP) Registry included consecutive symptomatic patients undergoing transcatheter PVL closure across 24 European centres between 2017 and 2019. Predictive factors for mortality and surgical reintervention were analysed over a 2-year follow-up. RESULTS:A total of 213 symptomatic patients underwent 237 procedures. The mean age was 68±11 years, with a median European System for Cardiac Operative Risk Evaluation (EuroSCORE) II of 6 (interquartile range [IQR] 4-10). PVL involved the mitral valve in 64.6% of cases and mechanical prostheses in 53.3%. Heart failure and haemolytic anaemia were present in 89.5% and 49.8% of patients, respectively. The transapical approach was used in 6.8% of cases. Technical success was achieved in 87.3% of procedures, and clinical success at 1 month was achieved in 70.5% of patients. The median follow-up was 24.4 months (IQR 23.2-26.4). The survival rate at 2 years without the need for surgical reintervention was 66.1% (95% confidence interval [CI]: 60.1-72.7). Multivariate analysis identified mitral PVL, mechanical valves, and haemolytic anaemia as independent risk factors for adverse outcomes during follow-up. The absence of clinical success at 1 month was the strongest predictor of adverse outcomes (hazard ratio 5.00, 95% CI: 2.70-9.09; p=0.001). CONCLUSIONS:Transcatheter PVL closure offers a durable therapeutic option for high-risk patients when early clinical success is achieved. Mitral valve involvement, mechanical prostheses, and haemolytic anaemia remain key predictors of poor outcomes over a 2-year follow-up.
The Drug-Coated Balloon (DCB) Academic Research Consortium project originated from the need to overcome the lack of standardization and comparability among studies focusing on drug-coated balloon treatment. The DCB Academic Research Consortium represents a collaborative effort between academic research organizations and the most renowned interventional cardiology societies focusing on percutaneous coronary intervention in Europe, the United States, and Asia. The present consensus document provides a classification of DCB technologies, antiproliferative drugs, and types of elution and coatings. Moreover, by reviewing the available evidence on the use of DCBs for several lesion (restenosis, de novo small and large vessels, bifurcations) and clinical (acute coronary syndromes, diabetes mellitus, multivessel disease, high bleeding risk) settings, it seeks to provide reasonable suggestions for their clinical use. Last, this paper outlines the processes involved in optimal "lesion preparation" before the use of DCBs and the criteria used for assessing results following their use.
Le pronostic de l’athérosclérose coronaire a été amélioré essentiellement par la prévention primaire et secondaire, et par les progrès des techniques de l’angioplastie coronaire transluminale percutanée (ATL). Depuis 20 ans, en raison du vieillissement de la population, l’ATC est réalisée chez des sujets de plus en plus âgés. Ces patients sont plus fragiles, avec des comorbidités fréquentes. Ils sont le plus souvent exclus des études randomisées et il n’existe pas de consensus sur l’évaluation du bénéfice risque de la revascularisation coronaire dans cette population. L’évaluation de la fragilité peut se faire par des scores simples complétés éventuellement par une évaluation plus spécialisée. Dans les syndromes coronaires chroniques, l’ATL a pour but d’améliorer la qualité de vie. L’évaluation de la fragilité doit faire partie du bilan et de la décision thérapeutique. Dans les syndromes coronaires aigus, il est difficile voire impossible d’évaluer la fragilité en raison de l’urgence, d’où l’intérêt d’une évaluation préalable, systématique à partir de 70 ans, accessible par le dossier médical commun. Un renforcement de la collaboration entre cardiologues et gériatres, une meilleure prise de conscience chez les cardiologues interventionnels des problèmes liés à la fragilité, un enseignement pour médecins et paramédicaux sur l’évaluation de la fragilité par des scores simples, et une évaluation systématique annuelle à partir de 70 ans peuvent conduire à une meilleure prise en charge de cette population à risque.
The Drug Coated Balloon Academic Research Consortium project originated from the lack of standardization and comparability between studies using drug-coated balloons in the treatment of obstructive coronary artery disease. This document is a collaborative effort between academic research organizations and percutaneous coronary intervention societies in Europe, the USA, and Asia. This consensus sought to standardize study designs and endpoints for clinical trials involving drug-coated balloons, including defining angiographic, intravascular, and non-invasive imaging methods for lesion assessment, alongside considerations for post-revascularization pharmaco-therapy. The concept of 'blended therapy', which advocates for combining device strategies, is also discussed. This paper delineates study types, endpoint definitions, follow-up protocols, and analytical approaches, aiming to provide consistency and guidance for interventional cardiologists and trialists.
Percutaneous coronary intervention (PCI) is the most used method of revascularization. PCI improves mortality and morbidity in acute coronary syndromes, which are best, managed by networks. In contrast, the role of PCI in the treatment of chronic coronary syndromes has undergone major changes with a reduction of indications of coronary angiography and percutaneous coronary intervention. Computed tomography allows a rapid and noninvasive evaluation of coronary artery lesions, and its use is increasing rapidly. Several large-scale, randomized trials have assessed the efficacy of percutaneous coronary intervention in chronic coronary syndromes. Compared to medical therapy, PCI improves quality of life by reducing the rate of chest pain, but no difference in mortality and major cardiovascular events is noted. Indications of percutaneous coronary intervention in chronic coronary syndromes require therefore a careful evaluation of co-morbidities, symptoms, location and complexity of coronary lesions. In the future, the reduction of percutaneous coronary intervention indications in chronic coronary syndromes will reduce the volume of coronary angioplasties in most centers, and probably require changes in the number and location of PCI centers. (c) 2024 l'Academie nationale de medecine. Published by Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
The prognosis for coronary artery disease has substantially improved mostly due to primary and secondary prevention and innovation in percutaneous coronary intervention (PCI). In the last 20 years, the rate of PCI performed in elderly patients has increased. These patients are frailer, and present with more comorbidities. They are poorly represented in most randomized trials are there is no clear consensus on how to evaluate the risk-benefit ratio in this population. Evaluation of frailty can be performed using simple scores and if necessary, a specialized evaluation. In chronic coronary syndromes, the goal of PCI is to improve quality of life. Evaluation of frailty should be performed and be part of the PCI decision process. In acute coronary syndromes, PCI must be performed in a short delay or immediately and assessment of frailty is most often impossible. Performing an annual evaluation of frailty in the general population after 70 years of age which would be available on a dedicated internet platform would improve the decision process in these emergent situations. Improved collaboration between cardiologists and geriatric specialists, increased awareness of frailty by interventional cardiologists, teaching physicians and nurses to evaluate frailty by simple scores, and a yearly evaluation of frailty after the age of 70 could improve the management of this population at risk for PCI. (c) 2025 l'Academie nationale de medecine. Published by Elsevier Masson SAS. All rights are reserved, including those for text and data mining, AI training, and similar technologies.
L’angioplastie percutanée est la méthode de revascularisation coronaire la plus utilisée. Son bénéfice reste indiscutable dans les syndromes coronaires aigus avec une diminution de la morbi-mortalité et justifie la mise en place de réseaux de prise en charge des urgences coronaires. À l’inverse, la prise en charge du syndrome coronaire chronique par l’angioplastie coronaire a connu des modifications importantes avec une diminution des indications de coronarographie et d’angioplastie. L’angioscanner coronaire permet un diagnostic rapide et non invasif des lésions coronaires et son utilisation est en croissance rapide. Plusieurs études randomisées à grande échelle ont remis en cause le bénéfice de l’angioplastie coronaire dans le syndrome coronaire chronique en démontrant une réduction de la fréquence des douleurs angineuses mais une absence de bénéfice en termes de morbi-mortalité. L’indication d’une angioplastie coronaire chez un patient porteur d’un syndrome coronaire chronique doit donc être précédée d’une évaluation soigneuse du terrain, des symptômes, de la morphologie et localisation des lésions coronaires. La diminution des indications d’angioplastie coronaire dans le syndrome coronaire chronique aura des implications sur le volume d’actes réalisés dans les centres d’angioplastie et sur leur répartition géographique.