Atrial fibrillation, intra-ventricular thrombus, and other anticoagulant indications relationship with adverse outcomes in acute anterior myocardial infarction patients

International audienceBackground: The aim of this study was to assess the predictive value of atrial fibrillation (AF), left ventricular thrombus (LVT), and other oral anticoagulant (OAC) indications on 1-year major adverse cardio-cerebrovascular events (MACCE) and bleeding in acute anterior ST-elevated myocardial infarction (STEMI) patients treated by primary percutaneous coronary intervention (PPCI). Methods: Our study population included 969 anterior STEMI patients referred for PPCI from the prospective multicenter CIRCUS trial. Patients with a formal indication of OAC within the first year were compared to those without indication. Results: A total of 161 (16.6%) patients were eligible for OAC after anterior STEMI mainly for AF (51.5%) and LVT (39.7%). This group had a higher morbidity profile despite similar reperfusion settings - 67% of them were treated with OAC. At 1 year, OAC indication was associated with a significant increase in MACCE rate [OR 3.37 95% CI (2.36;4.82) p \textless 0.001] as well as bleeding [OR = 1.96 95% CI (1.09;3.50) p = 0.02]. After adjustment for principal confounders, OAC indication remained strongly associated with MACCE [HR 3.40 (1.26;9.14) p = 0.016]. Conclusions: In a prospective cohort of anterior STEMI, AF, LVT, and other OAC indications were present upon discharge in 1 patient out of 6 and only two thirds were treated with OAC. OAC indication was independently associated with an increased risk of MACCE and bleeding at one year. (C) 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved

Non-culprit artery myocardial infarction and complex coronary lesions in anterior ST-elevated myocardial infarction patients.

International audienceAims: Periprocedural myocardial infarctions have been reported in the setting of planned percutaneous coronary intervention (PCI). We assessed the prevalence of nonculprit artery acute myocardial infarction (NCAMI) and its relationship with coronary artery characteristics, final infarct size, and 1-year adverse clinical outcomes in a population of anterior ST-elevated myocardial infarction (STEMI) patients.Methods and results: Late gadolinium-enhanced cardiac magnetic resonance (LGE-CMR) studies were performed within 7 days of admission in 129 anterior STEMI patients from the CIRCUS trial treated by primary PCI. Infarct in the noninfarct artery territory (circumflex, right coronary) was assessed on LGE-CMR and T2-weighted images. Eleven (8.5%) patients exhibited NCAMI. The only independent characteristic significantly associated with NCAMI was the presence of multiple complex coronary lesions (odds ratio = 12.9, 95% confidence interval [3.1-53.4]; p < 0.001). There was a significantly increased infarct size in NCAMI patients compared to patients without NCAMI (45.8 ± 20.4% of the left ventricle [LV] vs. 31.0 ± 15.1% of LV, respectively; p = 0.02), with lower LV ejection fraction (46 ± 10% vs. 34 ± 8%, respectively; p < 0.001).Conclusion: NCAMIs are present in 8.5% of anterior STEMI patients and are significantly associated with multiple complex coronary lesions without significant relationship to any revascularization procedural technique. NCAMI was associated with a greater infarct size and reduced LVEF but not worse clinical outcomes at 1 year

Incidence and Significance of Spontaneous ST Segment Re-elevation After Reperfused Anterior Acute Myocardial Infarction ― Relationship With Infarct Size, Adverse Remodeling, and Events at 1 Year―

International audiencebeen associated with the extent of myocardial damage, re-infarction, left ventricular (LV) remodeling, and mortality. 1-5 Regression of ST segment elevation has been used in several studies to assess the quality of reperfusion. 6-9 T he electrocardiogram (ECG) is the first-line diagnostic tool in ST elevation myocardial infarction (STEMI). The ECG is a simple and easily reproducible test, with a non-ambiguous diagnostic ability. ST segment resolution is commonly used as a marker of successful reperfusion. It is an independent prognostic parameter of subsequent adverse events in STEMI patients. In many studies, the absence of ST segment resolution has Background: Up to 25% of patients with ST elevation myocardial infarction (STEMI) have ST segment re-elevation after initial regression post-reperfusion and there are few data regarding its prognostic significance

Correction to: Recombinant human interleukin-7 reverses T cell exhaustion ex vivo in critically ill COVID-19 patients

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Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial)

Abstract: Background Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients. Methods CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow <= 1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1: 1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in theminutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular (LV) ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction. Results Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015. Conclusions The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up

Implementation of a centralized pharmacovigilance system in academic pan‐European clinical trials : experience from EU‐Response and conect4children consortia

Setting-up a high quality, compliant and efficient pharmacovigilance (PV) system in multi-country clinical trials can be more challenging for academic sponsors than for companies. To ensure the safety of all participants in academic studies and that the PV system fulfils all regulations, we set up a centralized PV system that allows sponsors to delegate work on PV. This initiative was put in practice by our Inserm-ANRS MIE PV department in two distinct multinational European consortia with 19 participating countries: conect4children (c4c) for paediatrics research and EU-Response for Covid-19 platform trials. The centralized PV system consists of some key procedures to harmonize the complex safety processes, creation of a local safety officer (LSO) network and centralization of all safety activities. The key procedures described the safety management plan for each trial and how tasks were shared and delegated between all stakeholders. Processing of serious adverse events (SAEs) in a unique database guaranteed the full control of the safety data and continuous evaluation of the risk-benefit ratio. The LSO network participated in efficient regulatory compliance across multiple countries. In total, there were 1312 SAEs in EU-Response and 83 SAEs in c4c in the four trials. We present here the lessons learnt from our experience in four clinical trials. We managed heterogeneous European local requirements and implemented efficient communication with all trial teams. Our approach builds capacity for PV that can be used by multiple academic sponsors