Publications by authors named "Gilles Chatellier"

201 Publications

Cardiometabolic Disorders and the Risk of Critical COVID-19 as Compared to Influenza Pneumonia.

J Clin Med 2021 Oct 8;10(19). Epub 2021 Oct 8.

Université de Paris, F-75006 Paris, France.

We aimed to compare the influence of cardiometabolic disorders on the incidence of severe COVID-19 vs. non-COVID pneumonia. We included all consecutive patients admitted with SARS-CoV-2-positive pneumonia between 12 March 2020 and 1 April 2020 and compared them to patients with influenza pneumonia hospitalized between December 2017 and December 2019 at the same tertiary hospital in Paris. Patients with COVID-19 were significantly younger and more frequently male. In the analysis adjusted for age and sex, patients with COVID-19 were more likely to be obese (adjOR: 2.25; 95% CI 1.24-4.09; = 0.0076) and receive diuretics (adjOR: 2.13; 95% CI 1.12-4.03; = 0.021) but were less likely to be smokers (adjOR: 0.40; 95% CI 0.24-0.64; = 0.0002), have COPD (adjOR: 0.25; 95% CI 0.11-0.56; = 0.0008), or have a previous or active cancer diagnosis (adjOR: 0.54, 95% CI 0.32-0.91; = 0.020). The rate of ICU admission was significantly higher in patients with COVID-19 (32.4% vs. 5.2% < 0.0001). Obesity was significantly associated with the risk of direct ICU admission in patients with COVID-19 but not in patients with influenza pneumonia. Likewise, pre-existing hypertension was significantly associated with mortality in patients with COVID-19 but not in patients with influenza pneumonia. Cardiometabolic disorders differentially influenced the risk of presenting with severe COVID-19 or influenza pneumonia.
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http://dx.doi.org/10.3390/jcm10194618DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8509116PMC
October 2021

Rivaroxaban versus Dalteparin in Cancer-Associated Thromboembolism: A Randomized Trial.

Chest 2021 Oct 7. Epub 2021 Oct 7.

F-CRIN INNOVTE network, Saint Etienne, France; Service de Médecine Vasculaire et Thérapeutique, CHU de St-Etienne, Saint-Etienne, France.

Background: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated venous thromboembolism (VTE).

Research Question: Is rivaroxaban as efficient and safe as dalteparin to treat patients with cancer-associated VTE?

Study Design And Methods: In a randomized open-label non-inferiority trial, patients with active cancer who had proximal deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) were randomly assigned to therapeutic doses of rivaroxaban or dalteparin for 3 months. The primary outcome was the cumulative incidence of recurrent VTE, a composite of symptomatic or incidental DVT or PE, and worsening of pulmonary vascular or venous obstruction at 3 months.

Results: Of 158 randomized patients, 74 and 84 patients were assigned to receive rivaroxaban and dalteparin, respectively. Mean age was 69.4 years, 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 6.4% vs 10.1%, subdistribution hazard ratio [SHR] 0.75, 95% confidence interval [CI] 0.21-2.66, in both the intention-to-treat and per-protocol populations). Major bleeding occurred in 1 and 3 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 1.4% vs 3.7%, SHR 0.36, 95%CI 0.04-3.43). Major or clinically relevant non-major bleeding occurred in 9 and 8 patients in the rivaroxaban and dalteparin groups, respectively (cumulative incidence 12.2% vs 9.8%, SHR 1.27, 95%CI 0.49-3.26). Overall, 19 (25.7%) and 20 (23.8%) patients died in the rivaroxaban and dalteparin groups, respectively (HR 1.05, 95% CI, 0.56-1.97).

Interpretation: In this trial comparing rivaroxaban and dalteparin in the treatment of cancer-associated VTE, the number of patients was insufficient to reach the predefined criteria for non-inferiority, but efficacy and safety results were consistent with those previously reported with DOACs. An updated meta-analysis of randomized trials comparing DOACs with low-molecular-weight heparin in patients with cancer-associated VTE is provided.

Trial Registration: NCT02746185.
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http://dx.doi.org/10.1016/j.chest.2021.09.037DOI Listing
October 2021

Reduced-dose intravenous thrombolysis for acute intermediate high-risk pulmonary embolism: Rationale and design of the PEITHO-3 trial.

Thromb Haemost 2021 Sep 24. Epub 2021 Sep 24.

Hopital Europeen Georges Pompidou, Paris, France.

Intermediate high-risk pulmonary embolism (PE) is characterised by right ventricular (RV) dysfunction and elevated circulating cardiac troponin levels despite apparent haemodynamic stability at presentation. In these patients, full-dose systemic thrombolysis reduced the risk of haemodynamic decompensation or death but increased the risk of life-threatening bleeding. Reduced-dose thrombolysis may be capable of improving safety while maintaining reperfusion efficacy. The Pulmonary Embolism International Trial (PEITHO)-3 study (EudraCT 2018-000816-96) is a randomised, placebo-controlled, double-blind, multicentre, multinational trial with long-term follow-up. We will compare the efficacy and safety of a reduced-dose alteplase regimen with standard heparin anticoagulation. Patients with intermediate high-risk PE will also fulfil at least one clinical criterion of severity: systolic blood pressure ≤ 110 mmHg, respiratory rate >20 breaths/min, or history of heart failure. The primary efficacy outcome is the composite of all-cause death, haemodynamic decompensation or PE recurrence within 30 days of randomisation. Key secondary outcomes, to be included in hierarchical analysis, are fatal or GUSTO severe or life-threatening bleeding; net clinical benefit (primary efficacy outcome plus severe or life-threatening bleeding); and all-cause death, all within 30 days. All outcomes will be adjudicated by an independent committee. Further outcomes include PE-related death, haemodynamic decompensation, or stroke within 30 days; dyspnoea, functional limitation or RV dysfunction at 6 months and 2 years; and utilisation of healthcare resources within 30 days and 2 years. The study is planned to enrol 650 patients. The results are expected to have a major impact on risk-adjusted treatment of acute PE and inform guideline recommendations.
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http://dx.doi.org/10.1055/a-1653-4699DOI Listing
September 2021

Compared Outcomes of ST-Elevation Myocardial Infarction Patients with Multivessel Disease Treated with Primary Percutaneous Coronary Intervention and Preserved Fractional Flow Reserve of Non-Culprit Lesions Treated Conservatively and of Those with Low Fractional Flow Reserve Managed Invasively: Insights from the FLOWER MI trial.

Circ Cardiovasc Interv 2021 Aug 23. Epub 2021 Aug 23.

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, Université de Paris, Paris, France; AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique (URCEST), Université Pierre et Marie Curie (UPMC-Paris 06), INSERM U-698, Paris, France.

In patients with ST-elevation myocardial infarction (STEMI) and multivessel disease, percutaneous coronary intervention (PCI) for non-culprit lesions guided by FFR is superior to treatment of the culprit lesion alone. Whether deferring non-culprit PCI is safe in this specific context is questionable. We aimed to assess clinical outcomes at one-year in STEMI patients with multivessel coronary artery disease and an FFR-guided strategy for non-culprit lesions, according to whether or not ≥1 PCI was performed. Outcomes were analyzed in patients of the randomized FLOWER MI (Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction) trial in whom, after successful primary PCI, non-culprit lesions were assessed using FFR. The primary outcome was a composite of all-cause death, non-fatal MI, and unplanned hospitalization with urgent revascularization at one year. Among 1,171 patients enrolled in this study, 586 were assigned to the FFR-guided group: 388 (66%) of them had ≥1 PCI and 198 (34%) had no PCI. Mean FFR before decision (i.e., PCI or not) of non-culprit lesions were 0.75±0.10 and 0.88±0.06, respectively. During follow-up, a primary outcome event occurred in 16 of 388 patients (4.1%) in patients with PCI and in 16 of 198 patients (8.1%) in patients without PCI (adjusted hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.88; P = 0.02). In patients with STEMI undergoing complete revascularization guided by FFR measurement, those with ≥1 PCI had lower event rates at 1 year, compared with patients with deferred PCI, suggesting that deferring lesions judged relevant by visual estimation but with FFR >0.80 may not be optimal in this context. Future randomized studies are needed to confirm this data.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.121.011314DOI Listing
August 2021

Effect of anakinra on mortality in patients with COVID-19: a systematic review and patient-level meta-analysis.

Lancet Rheumatol 2021 Oct 9;3(10):e690-e697. Epub 2021 Aug 9.

Rheumatology Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France.

Background: Anakinra might improve the prognosis of patients with moderate to severe COVID-19 (ie, patients requiring oxygen supplementation but not yet receiving organ support). We aimed to assess the effect of anakinra treatment on mortality in patients admitted to hospital with COVID-19.

Methods: For this systematic review and individual patient-level meta-analysis, a systematic literature search was done on Dec 28, 2020, in Medline (PubMed), Cochrane, medRxiv, bioRxiv, and the ClinicalTrials.gov databases for randomised trials, comparative studies, and observational studies of patients admitted to hospital with COVID-19, comparing administration of anakinra with standard of care, or placebo, or both. The search was repeated on Jan 22, 2021. Individual patient-level data were requested from investigators and corresponding authors of eligible studies; if individual patient-level data were not available, published data were extracted from the original reports. The primary endpoint was mortality after 28 days and the secondary endpoint was safety (eg, the risk of secondary infections). This study is registered on PROSPERO (CRD42020221491).

Findings: 209 articles were identified, of which 178 full-text articles fulfilled screening criteria and were assessed. Aggregate data on 1185 patients from nine studies were analysed, and individual patient-level data on 895 patients were provided from six of these studies. Eight studies were observational and one was a randomised controlled trial. Most studies used historical controls. In the individual patient-level meta-analysis, after adjusting for age, comorbidities, baseline ratio of the arterial partial oxygen pressure divided by the fraction of inspired oxygen (PaO/FiO), C-reactive protein (CRP) concentrations, and lymphopenia, mortality was significantly lower in patients treated with anakinra (38 [11%] of 342) than in those receiving standard of care with or without placebo (137 [25%] of 553; adjusted odds ratio [OR] 0·32 [95% CI 0·20-0·51]). The mortality benefit was similar across subgroups regardless of comorbidities (ie, diabetes), ferritin concentrations, or the baseline PaO/FiO. In a subgroup analysis, anakinra was more effective in lowering mortality in patients with CRP concentrations higher than 100 mg/L (OR 0·28 [95% CI 0·17-0·47]). Anakinra showed a significant survival benefit when given without dexamethasone (OR 0·23 [95% CI 0·12-0·43]), but not with dexamethasone co-administration (0·72 [95% CI 0·37-1·41]). Anakinra was not associated with a significantly increased risk of secondary infections when compared with standard of care (OR 1·35 [95% CI 0·59-3·10]).

Interpretation: Anakinra could be a safe, anti-inflammatory treatment option to reduce the mortality risk in patients admitted to hospital with moderate to severe COVID-19 pneumonia, especially in the presence of signs of hyperinflammation such as CRP concentrations higher than 100 mg/L.

Funding: Sobi.
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http://dx.doi.org/10.1016/S2665-9913(21)00216-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8352496PMC
October 2021

Triaging acute pulmonary embolism for home treatment by Hestia or simplified PESI criteria: the HOME-PE randomized trial.

Eur Heart J 2021 08;42(33):3146-3157

F-CRIN, INNOVTE, Saint-Etienne, France.

Aims: The aim of this study is to compare the Hestia rule vs. the simplified Pulmonary Embolism Severity Index (sPESI) for triaging patients with acute pulmonary embolism (PE) for home treatment.

Methods And Results: Normotensive patients with PE of 26 hospitals from France, Belgium, the Netherlands, and Switzerland were randomized to either triaging with Hestia or sPESI. They were designated for home treatment if the triaging tool was negative and if the physician-in-charge, taking into account the patient's opinion, did not consider that hospitalization was required. The main outcomes were the 30-day composite of recurrent venous thrombo-embolism, major bleeding or all-cause death (non-inferiority analysis with 2.5% absolute risk difference as margin), and the rate of patients discharged home within 24 h after randomization (NCT02811237). From January 2017 through July 2019, 1975 patients were included. In the per-protocol population, the primary outcome occurred in 3.82% (34/891) in the Hestia arm and 3.57% (32/896) in the sPESI arm (P = 0.004 for non-inferiority). In the intention-to-treat population, 38.4% of the Hestia patients (378/984) were treated at home vs. 36.6% (361/986) of the sPESI patients (P = 0.41 for superiority), with a 30-day composite outcome rate of 1.33% (5/375) and 1.11% (4/359), respectively. No recurrent or fatal PE occurred in either home treatment arm.

Conclusions: For triaging PE patients, the strategy based on the Hestia rule and the strategy based on sPESI had similar safety and effectiveness. With either tool complemented by the overruling of the physician-in-charge, more than a third of patients were treated at home with a low incidence of complications.
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http://dx.doi.org/10.1093/eurheartj/ehab373DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8408662PMC
August 2021

Differentiating central from peripheral causes of acute vertigo in an emergency setting with the HINTS, STANDING, and ABCD2 tests: A diagnostic cohort study.

Acad Emerg Med 2021 Jul 10. Epub 2021 Jul 10.

Emergency Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France.

Background: Diagnosing stroke in dizzy patients remains a challenge in emergency medicine. The accuracy of the neuroophthalmologic examination HINTS performed by emergency physicians (EPs) is unknown. Our objective was to determine the accuracy of the HINTS examination performed by trained EPs for diagnosing central cause of acute vertigo and unsteadiness and to compare it with another bedside clinical tool, STANDING, and with the history-based score ABCD2.

Methods: This was a prospective diagnostic cohort study among patients with isolated vertigo and unsteadiness seen in a single emergency department (ED). Trained EPs performed HINTS and STANDING tests blinded to attending physicians. ABCD2 ≥ 4 was used as the threshold and was calculated retrospectively. The criterion standard was diffusion-weighted brain magnetic resonance imaging (MRI). Peripheral diagnoses were established by a normal MRI, and etiologies were further refined by an otologic examination.

Results: We included 300 patients of whom 62 had a central lesion on neuroimaging including 49 strokes (79%). Of the 238 peripheral diagnoses, 159 were vestibulopathies, mainly benign paroxysmal positional vertigo (40%). HINTS and STANDING tests reached high sensitivities at 97% and 94% and NPVs at 99% and 98%, respectively. The ABCD2 score failed to predict half of central vertigo cases and had a sensitivity of 55% and a NPV of 87%. The STANDING test was more specific and had a better positive predictive value (PPV; 75% and 49%, respectively; positive likelihood ratio [LR+] = 3.71, negative likelihood ratio [LR-] = 0.09) than the HINTS test (67% and 44%, respectively; LR+ = 2.96, LR- = 0.04). The ABCD2 score was specific (82%, LR+ = 3.04, LR- = 0.56) but had a very low PPV (44%).

Conclusions: In the hands of EPs, HINTS and STANDING tests outperformed ABCD2 in identifying central causes of vertigo. For diagnosing peripheral disorders, the STANDING algorithm is more specific than the HINTS test. HINTS and STANDING could be useful tools saving both time and costs related to unnecessary neuroimaging use.
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http://dx.doi.org/10.1111/acem.14337DOI Listing
July 2021

Health-related quality of life in locally advanced hepatocellular carcinoma treated by either radioembolisation or sorafenib (SARAH trial).

Eur J Cancer 2021 Sep 6;154:46-56. Epub 2021 Jul 6.

Université de Paris, Centre de Recherche de l'Inflammation (CRI), INSERM U1149, F-75018 Paris, France; Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, Clichy, France.

Background: The aim of this ancillary study of the SARAH trial is to compare health-related quality of life (HRQoL) in patients with locally advanced or inoperable hepatocellular carcinoma (HCC) treated with transarterial radioembolisation (TARE) or sorafenib.

Methods: This study included randomised patients who received either TARE or at least one dose of sorafenib with no major deviation in the protocol and who had at least one QoL follow-up assessment in addition to the baseline evaluation. QoL was assessed from the date of randomisation using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire, until disease progression or other reasons for stopping study participation. Data were analysed using linear mixed and time-dependent models.

Results: A total of 285 patients were included (122 and 163, in the TARE and sorafenib groups, respectively). Questionnaire completion rates were similar (77.5% versus 80.4%, in the TARE and sorafenib groups, respectively, p = 0.25). Longitudinal HRQoL analysis showed a significant treatment and time effects for fatigue and global health status, and significant treatment, time and treatment by time interaction effects for appetite loss, diarrhoea and social functioning. The median time to deterioration for the global health status was 3.9 months (95% confidence interval [CI] 3.7-4.3) versus 2.6 months (95% CI 2.0-3.0) in the TARE and sorafenib groups, respectively.

Conclusions: HRQoL was preserved longer with TARE than with sorafenib in locally advanced HCC. These data could be used to optimise management of patients with advanced or inoperable HCC.
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http://dx.doi.org/10.1016/j.ejca.2021.05.032DOI Listing
September 2021

Cost-Utility Analysis of Transarterial Radioembolization With Yttrium-90 Resin Microspheres Compared With Sorafenib in Locally Advanced and Inoperable Hepatocellular Carcinoma.

Clin Ther 2021 May 28. Epub 2021 May 28.

Assistance Publique-Hôpitaux de Paris, DRCI-URC Eco Ile-de-France, Paris, France; Assistance Publique-Hôpitaux de Paris, service de santé publique, Henri Mondor-Albert-Chenevier, Créteil, France; Université de Paris, Research Centre of Research Epidemiology and Statistics (CRESS-UMR1153), Inserm, Paris, France; UPEC, Creteil, France.

Purpose: The SARAH (Sorafenib Versus Radioembolization in Advanced Hepatocellular Carcinoma) trial (ClinicalTrials.gov Identifier NCT01482442) did not show a significant survival benefit for patients treated with transarterial radioembolization (TARE) compared with continuous oral sorafenib. The improved toxicity profile of patients treated with TARE in the trial, however, could result in a quality of life benefit in economic evaluations. Our objective was to perform a cost-utility analysis of TARE versus sorafenib for locally advanced and inoperable hepatocellular carcinoma.

Methods: This study used patient-level data of the SARAH trial regarding resource use, progression-free and overall survival, and quality of life for the within-trial period for the patients who received at least 1 dose of sorafenib or 1 treatment with TARE according to their randomization arm. Data were extrapolated by using a partitioned survival model that incorporated costs and health outcomes, measured in life-years and quality-adjusted life-years (QALYs).

Findings: The use of TARE resulted in an average loss of 0.036 life-year and a gain of 0.006 QALY compared with sorafenib. The aerage cost for the TARE arm was €17,179 (95% CI, 9,926-24,280) higher than the sorafenib arm, for an incremental cost-effectiveness ratio of €3,153,086/QALY. The probabilistic sensitivity analysis revealed a 50% risk that the TARE strategy was dominated. TARE was consistently dominated by sorafenib or had an incremental cost-effectiveness ratio more than €450,000/QALY in all sensitivity analyses.

Implications: This economic evaluation of SARAH found that using radioembolization with yttrium-90 microspheres for the treatment of hepatocellular carcinoma was not a cost-effective option at the usually accepted willingness-to-pay thresholds.
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http://dx.doi.org/10.1016/j.clinthera.2021.04.018DOI Listing
May 2021

Electrochemical skin conductance by Sudoscan®: a new tool to predict intradialytic hypotension.

Nephrol Dial Transplant 2021 07;36(8):1511-1518

Service de Neurologie, Groupe Hospitalier Saint-Joseph, Paris, France.

Background: Intradialytic hypotension (IDH), a common complication in haemodialysis (HD) patients, is associated with multiple risk factors including cardiac dysfunction and alterations of the peripheral autonomic nervous system. To what extent dysautonomia may contribute to the occurrence of IDH remains elusive. We sought to investigate the clinical utility of Sudocan®, a device that quantifies dysautonomia, in the prediction of IDH.

Methods: We conducted a prospective monocentric study in adult HD patients from July 2019 to February 2020. Dysautonomia was assessed by the measurements of hand and foot electrochemical skin conductance (ESC) using Sudocan®, before HD. The primary endpoint was the incidence of IDH (The National Kidney Foundation/Kidney-Dialysis Outcome Quality Initiative definition), according to the presence of a pathological hand and/or foot ESC value, during the 3-month study period.

Results: A total of 176 HD patients (64 ± 14 years old) were enrolled. Mean pre-dialysis HD hand and foot ESC was 45 ± 20 and 54 ± 22 µS, respectively. About 35% and 40% of patients had a pathological ESC at the hand and foot, respectively. IDH occurred in 46 patients. Logistic regression showed that pathologic pre-dialysis HD hand ESC was associated with an increased risk of IDH [odds ratio = 2.56, 95% CI (1.04-6.67), P = 0.04]. The cumulative risk incidence of IHD during the study was 5.65 [95% CI (2.04-15.71), P = 0.001] and 3.71 [95% CI (1.41-9.76), P = 0.008], with a pathological hand and foot ESC, respectively.

Conclusions: A pathological hand ESC, as assessed by a non-invasive Sudoscan® test, is associated with an increased risk of IDH.
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http://dx.doi.org/10.1093/ndt/gfab183DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8311574PMC
July 2021

Multivessel PCI Guided by FFR or Angiography for Myocardial Infarction.

N Engl J Med 2021 07 16;385(4):297-308. Epub 2021 May 16.

From Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou, Université de Paris, INSERM, Paris Centre de Recherche Cardiovasculaire (E.P., D.B., N.D.), AP-HP, Hôpital Saint Antoine, Department of Clinical Pharmacology and Unité de Recherche Clinique, Sorbonne Université, INSERM Unité 698 (T.S.), Université de Paris, INSERM Unité 1148, and Hôpital Bichat, AP-HP (P.G.S.), Sorbonne Université, ACTION Study Group, Institut de Cardiologie (AP-HP), INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (G.M., J.S.), Clinical Research Unit Eco Ile de France, Hôpital Hôtel Dieu, AP-HP (I.D.-Z., A.B.), the Department of Cardiology, Hôpital Lariboisière, AP-HP, INSERM Unité 942, Université de Paris (J.-G.D.), the Department of Cardiology, Hôpital Bichat, AP-HP, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Laboratory for Vascular Translational Science, Université de Paris (G.D.), the Clinical Research Unit and Centre d'Investigation Clinique 1418 INSERM, George Pompidou European Hospital, AP-HP (A.C.N., G. Chatellier), and the French Alliance for Cardiovascular Trials (E.P., T.S., P.G.S., G.L., D.B., G.D., N.D.), Paris, Centre Hospitalier Universitaire (CHU) de Nîmes, Nîmes (G. Cayla), Service de Cardiologie, AP-HP, Université de Paris Est Créteil, Hôpitaux Universitaires Henri Mondor, Créteil, and Unité 955-Mondor Institute for Biomedical Research, Equipe 03, INSERM, Ecole Nationale Vétérinaire d'Alfort, Maisons-Alfort (R.G.), Hôpital du Bon Secours, Metz (K.K.), Clinique St. Martin (J.-F.M.) and the Cardiology Department, Caen University Hospital (V.R.), Caen, the Department of Cardiology, CHU Clermont-Ferrand, CNRS UMR 6602, Université Clermont Auvergne, Clermont-Ferrand, the Cardiac Intensive Care Unit, Heart and Lung Institute, CHU Lille (P.M.), and the Heart and Lung Institute, University Hospital of Lille, Institut Pasteur of Lille, INSERM Unité 1011 (G.L.), Lille, and the Intensive Cardiac Care Unit, Department of Cardiology, Rangueil University Hospital, and the Medical School, Toulouse III Paul Sabatier University, Toulouse (T.L.), Groupement de Coopération Saintaire de Cardiologie de la Côte Basque, Centre Hospitalier de la Côte Basque, Bayonne (J.-N.L.), the Cardiology Department, Hôpitaux de Chartres, Chartres (G.R.), and Physiopathologie et Epidémiologie Cérébro-Cardiovasculaires, Equipe d'Accueil (EA 7460), University of Bourgogne Franche-Comté, and the Cardiology Department, University Hospital Center of Dijon Bourgogne, Dijon (Y.C.) - all in France; Cardiovascular Center Aalst, Aalst, Belgium (B.D.B.); and the Department of Cardiology, Lausanne University Center Hospital, Lausanne, Switzerland (B.D.B.).

Background: In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear.

Methods: In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year.

Results: The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P = 0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively.

Conclusions: In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. (Funded by the French Ministry of Health and Abbott; FLOWER-MI ClinicalTrials.gov number, NCT02943954.).
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http://dx.doi.org/10.1056/NEJMoa2104650DOI Listing
July 2021

Male Sex Is Associated With Cervical Artery Dissection in Patients With Fibromuscular Dysplasia.

J Am Heart Assoc 2021 06 17;10(11):e018311. Epub 2021 May 17.

Department of Neurology Inserm U1237 Normandie UniversitéUniversité Caen NormandieCHU Caen Normandie Caen France.

Background Cervical artery dissection (CeAD) is a frequent manifestation of fibromuscular dysplasia (FMD). However, risk factors for CeAD are unknown. We investigated factors associated with CeAD in the ARCADIA (Assessment of Renal and Cervical Artery Dysplasia) registry. Methods and Results The ARCADIA registry includes women or men aged ≥18 years, with a diagnosis of renal, cervical, or intracranial artery FMD, who were prospectively recruited at 16 university hospitals in France and Belgium. Diagnosis of acute or past CeAD at inclusion was established on imaging according to standard diagnostic criteria. Associations between potential determinants and CeAD were assessed by logistic regression analyses. Among 469 patients (75 men) with FMD, 65 (13.9%) had CeAD. Patients with CeAD were younger, more likely to be men, have a history of migraine, and less likely to have a history of hypertension than patients without CeAD. In the multivariable analysis, male sex (odds ratio [OR], 2.66; 95% CI, 1.34-5.25), history of migraine (OR, 1.90; 95% CI, 1.06-3.39), age ≥50 years (OR, 0.41; 95% CI, 0.23-0.73), history of hypertension (OR, 0.35; 95% CI, 0.20-0.64), and involvement of ≥3 vascular beds (OR, 2.49; 95% CI, 1.15-5.40) were significantly associated with CeAD. To validate the association between CeAD and sex, we performed a systematic review. We collected additional data on sex from 2 published studies and unpublished data from the US Registry for Fibromuscular Dysplasia and the European/International FMD Registry. In the pooled analysis (289 CeAD, 1933 patients), male sex was significantly associated with CeAD (OR, 2.04; 95% CI, 1.41-2.95; =0%). Conclusions In patients with FMD, male sex and multisite involvement are associated with CeAD, in addition to other previously known risk factors. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02884141.
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http://dx.doi.org/10.1161/JAHA.120.018311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8483547PMC
June 2021

New cancer cases at the time of SARS-Cov2 pandemic and related public health policies: A persistent and concerning decrease long after the end of the national lockdown.

Eur J Cancer 2021 06 25;150:260-267. Epub 2021 Feb 25.

Université Paris Est Créteil, INSERM, IMRB, Assistance Publique - Hôpitaux de Paris, Department of Medical Oncology, Henri Mondor and Albert Chenevier Teaching Hospital, Créteil, France.

Introduction: The dissemination of SARS-Cov2 may have delayed the diagnosis of new cancers. This study aimed at assessing the number of new cancers during and after the lockdown.

Methods: We prospectively collected the clinical data of the 11.4 million patients referred to the Assistance Publique Hôpitaux de Paris Teaching Hospital. We identified new cancer cases between 1st January 2018 and 31st September 2020 and compared indicators for 2018 and 2019 to 2020 with a focus on the French lockdown (17th March to 11th May 2020) across cancer types and patient age classes.

Results: Between January and September, 28,348, 27,272 and 23,734 new cancer cases were identified in 2018, 2019 and 2020, respectively. The monthly median number of new cases reached 3168 (interquartile range, IQR, 3027; 3282), 3054 (IQR 2945; 3127) and 2723 (IQR 2085; 2,863) in 2018, 2019 and 2020, respectively. From March 1st to May 31st, new cancer decreased by 30% in 2020 compared to the 2018-19 average; then by 9% from 1st June to 31st September. This evolution was consistent across all tumour types: -30% and -9% for colon, -27% and -6% for lung, -29% and -14% for breast, -33% and -12% for prostate cancers, respectively. For patients aged <70 years, the decrease of colorectal and breast new cancers in April between 2018 and 2019 average and 2020 reached 41% and 39%, respectively.

Conclusion: The SARS-Cov2 pandemic led to a substantial decrease in new cancer cases. Delays in cancer diagnoses may affect clinical outcomes in the coming years.
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http://dx.doi.org/10.1016/j.ejca.2021.02.015DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7904473PMC
June 2021

Patent foramen ovale closure in stroke patients with migraine in the CLOSE trial. The CLOSE-MIG study.

Eur J Neurol 2021 08 16;28(8):2700-2707. Epub 2021 Jun 16.

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Centre d'Investigations Cliniques 1418 (CIC1418), Paris, France.

Background And Purpose: The efficacy of patent foramen ovale (PFO) closure to reduce the frequency of migraine attacks remains controversial.

Methods: This was a planned sub-study in migraine patients enrolled in a randomized, clinical trial designed to assess the superiority of PFO closure plus antiplatelet therapy over antiplatelet therapy alone to prevent stroke recurrence in patients younger than 60 years with a PFO-associated cryptogenic ischaemic stroke. The main outcome was the mean annual number of migraine attacks in migraine patients with aura and in those without aura, as recorded at each follow-up visit by study neurologists.

Results: Of 473 patients randomized to PFO closure or antiplatelet therapy, 145 (mean age 41.9 years; women 58.6%) had migraine (75 with aura and 70 without aura). Sixty-seven patients were randomized to PFO closure and 78 to antiplatelet therapy. During a mean follow-up of about 5 years, there were no differences between antiplatelet-only and PFO closure groups in the mean annual number of migraine attacks, both in migraine patients with aura (9.2 [11.9] vs. 12.0 [19.1], p = 0.81) and in those without aura (12.1 [16.1] vs. 11.8 [18.4], p > 0.999). There were no differences between treatment groups regarding cessation of migraine attacks, migraine-related disability at 2 years and use of migraine-preventive drugs during follow-up.

Conclusions: In young and middle-aged adults with PFO-associated cryptogenic stroke and migraine, PFO closure plus antiplatelet therapy did not reduce the mean annual number of migraine attacks compared to antiplatelet therapy alone, in migraine patients both with and without aura.
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http://dx.doi.org/10.1111/ene.14892DOI Listing
August 2021

Postoperative care fragmentation in bariatric surgery and risk of mortality: a nationwide study.

Surg Obes Relat Dis 2021 Jul 9;17(7):1327-1333. Epub 2021 Mar 9.

Assistance Publique Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Unité d'Épidémiologie et de Recherche Clinique, INSERM, Centre d'Investigation Clinique 1418, Module Épidémiologie Clinique, HEGP, Paris, France; Université de Paris, Paris, France; Centre de Recherche des Cordeliers, INSERM, Sorbonne Université, Université de Paris, 15 Rue de l'école de médecine, Paris, France.

Background: Readmission after bariatric surgery may to lead to fragmentation of care if readmission occurs at a facility other than the index hospital. The effect of readmission to a nonindex hospital on postoperative mortality remains unclear for bariatric surgery.

Objectives: To determine postoperative mortality rates according to readmission destinations.

Setting: Nationwide analysis of all surgical facilities in France.

Methods: Multicenter, nationwide study of adult patients undergoing bariatric surgery from January 1, 2013, through December 31, 2018. Data from all surgical facilities in France were extracted from a national hospital discharge database.

Results: In a cohort of 278,600 patients who received bariatric surgery, 12,760 (4.6%) were readmitted within 30 days. In cases of readmission, 23% of patients were admitted to a nonindex hospital. Patients readmitted to a nonindex facility had different characteristics regarding sex (men, 23.6% versus 18.2%, respectively; P < .001), co-morbidities (Charlson Co-morbidity Index, .74 versus .53, respectively; P < .001), and travel distance (38.3 km versus 26.9 km, respectively; P < .001) than patients readmitted to the index facility. The main reasons for readmission were leak/peritonitis and abdominal pain. The overall mortality rate after readmission was .56%. The adjusted odds ratio (OR) of mortality for the nonindex group was 4.96 (95% confidence interval [CI], 3.1-8.1; P < .001). In the subgroups of patients with a gastric leak, the mortality rate was 1.5% and the OR was 8.26 (95% CI, 3.7-19.6; P < .001).

Conclusion: Readmissions to a nonindex hospital are associated with a 5-fold greater mortality rate. The management of readmission for complications after bariatric surgery should be considered as a major issue to reduce potentially preventable deaths.
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http://dx.doi.org/10.1016/j.soard.2021.03.004DOI Listing
July 2021

Effect of the COVID-19 pandemic on colorectal cancer care in France.

Lancet Gastroenterol Hepatol 2021 05;6(5):342-343

Assistance Publique-Hôpitaux de Paris, Department of Medical Oncology, Henri Mondor and Albert Chenevier Teaching Hospital, Créteil, France.

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http://dx.doi.org/10.1016/S2468-1253(21)00095-9DOI Listing
May 2021

The Epidemiology of Patients' Email Addresses in a French University Hospital: Case-Control Study.

J Med Internet Res 2021 02 24;23(2):e13992. Epub 2021 Feb 24.

Medical Informatics Department, Hôpital Européen Georges-Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France.

Background: Health care professionals are caught between the wish of patients to speed up health-related communication via emails and the need for protecting health information.

Objective: We aimed to analyze the demographic characteristics of patients providing an email, and study the distribution of emails' domain names.

Methods: We used the information system of the European Hospital Georges Pompidou (HEGP) to identify patients who provided an email address. We used a 1:1 matching strategy to study the demographic characteristics of the patients associated with the presence of an email, and described the characteristics of the emails used (in terms of types of emails-free, business, and personal).

Results: Overall, 4.22% (41,004/971,822) of the total population of patients provided an email address. The year of last contact with the patient is the strongest driver of the presence of an email address (odds ratio [OR] 20.8, 95% CI 18.9-22.9). Patients more likely to provide an email address were treated for chronic conditions and were more likely born between 1950 and 1969 (taking patients born before 1950 as reference [OR 1.60, 95% CI 1.54-1.67], and compared to those born after 1990 [OR 0.56, 95% CI 0.53-0.59]). Of the 41,004 email addresses collected, 37,779 were associated with known email providers, 31,005 email addresses were associated with Google, Microsoft, Orange, and Yahoo!, 2878 with business emails addresses, and 347 email addresses with personalized domain names.

Conclusions: Emails have been collected only recently in our institution. The importance of the year of last contact probably reflects this recent change in contact information collection policy. The demographic characteristics and especially the age distribution are likely the result of a population bias in the hospital: patients providing email are more likely to be treated for chronic diseases. A risk analysis of the use of email revealed several situations that could constitute a breach of privacy that is both likely and with major consequences. Patients treated for chronic diseases are more likely to provide an email address, and are also more at risk in case of privacy breach. Several common situations could expose their private information. We recommend a very restrictive use of the emails for health communication.
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http://dx.doi.org/10.2196/13992DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7946586PMC
February 2021

Asymptomatic left ventricular dysfunction in patients with type 2 diabetes free of cardiovascular disease and its relationship with clinical characteristics: The DIACAR cohort study.

Diabetes Obes Metab 2021 02 24;23(2):434-443. Epub 2020 Nov 24.

Department of Cardiology, Fondation Hôpital Saint-Joseph, Paris, France.

Aims: To assess the prevalence, type and clinical factors associated with left ventricular (LV) dysfunction in patients with type 2 diabetes mellitus (T2DM) by performing a comprehensive echocardiographic Doppler assessment including speckle tracking.

Methods: Two hundred T2DM patients without overt cardiovascular disease were prospectively enrolled in a single-centre cohort study between 2018 and 2019.

Results: Left ventricular mass was increased in 24 patients (12%) and relative wall thickness (h/r) was increased in 46 patients (23%). Left atrial (LA) enlargement was observed in 27 patients (13.6%) and global longitudinal strain (GLS) was reduced in 38 patients (20.3%). In univariate analysis, LV hypertrophy (LVH) or increased h/r were associated with age, renal function, hypertension and B-type natriuretic peptide (BNP) plasma level. LA dilation was associated with age, history of hypertension, diabetes duration and complications, insulin treatment, BNP level and renal function. GLS was associated with body mass index (BMI) and, in a borderline manner, with diabetes duration. In multivariate analysis, hypertension was associated with LVH and with h/r and a borderline relationship was observed for female gender (LVH), age and insulin treatment (h/r). Age, hypertension and, in a borderline manner, insulin treatment were associated with LA dilation. BMI and shorter diabetes duration were associated with reduced GLS.

Conclusion: A high prevalence of asymptomatic cardiac dysfunction/structural abnormalities was observed in patients with T2DM without overt cardiac disease and was associated with either age, diabetes duration or treatment and with comorbidities including hypertension and obesity. Whether these preclinical abnormalities are associated with poor outcomes warrants further study.
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http://dx.doi.org/10.1111/dom.14236DOI Listing
February 2021

PROPOSAL FOR A NEW SCORE: HEMORRHOIDAL BLEEDING SCORE (HBS).

Ann Coloproctol 2020 Sep 18. Epub 2020 Sep 18.

GH Paris Saint-Joseph, Service de Proctologie Médico-Chirurgicale, 185, rue Raymond Losserand, 75014 Paris, France.

Purpose: We conducted a prospective study to evaluate a new hemorrhoidal bleeding score (HBS).

Methods: All consecutive patients who had consulted between May 1, 2016, and June 30, 2017 for bleeding hemorrhoidal disease were prospectively assessed at a proctological department. The study was conducted in two stages. A first stage assessed the validity of the score on a prospective patient cohort. A second stage assessed the interobserver reproducibility of the score on another prospective cohort.

Results: One hundred consecutive patients were studied (57 men, mean age 49.70 years). A positive association between HBS and surgery indication was found (p<0.001). A cut-off value of the score of 5 (≤ 5 vs. > 5) separated patients from surgical to medical-instrumental treatment with a sensitivity and specificity of 75.00% and 81.25% respectively. In the multivariate analysis, only HBS was significantly associated with the operative decision (OR: 12.22). Prolapse was no longer significantly associated with the surgical indication. After a mean follow-up after treatment of 7 months, HBS improved statistically significantly (p<0.0001). For the reproducibility of the score, an additional 30 consecutive patients (13 men, mean age 53.14 years) were enrolled with an excellent agreement between two proctologists (kappa= 0.983).

Conclusion: HBS is sensitive, specific and reproducible. It can assess the severity of hemorrhoidal bleeding. It can discriminate between the most severe surgery-indicated patients, and does so in a more efficient way than the Goligher's prolapse score. It also allows to quantify the extent of change in hemorrhoidal bleeding after treatment.
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http://dx.doi.org/10.3393/ac.2020.08.19DOI Listing
September 2020

Anakinra for severe forms of COVID-19 - Authors' reply.

Lancet Rheumatol 2020 Oct 7;2(10):e587-e588. Epub 2020 Aug 7.

Internal Medicine Department, Hôpital Paris Saint-Joseph, Paris 75014, France.

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http://dx.doi.org/10.1016/S2665-9913(20)30274-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413655PMC
October 2020

Anakinra for severe forms of COVID-19: a cohort study.

Lancet Rheumatol 2020 Jul 29;2(7):e393-e400. Epub 2020 May 29.

Rheumatology Department, Hôpital Paris Saint-Joseph, Paris, France.

Background: Coronaviruses can induce the production of interleukin (IL)-1β, IL-6, tumour necrosis factor, and other cytokines implicated in autoinflammatory disorders. It has been postulated that anakinra, a recombinant IL-1 receptor antagonist, might help to neutralise the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)-related hyperinflammatory state, which is considered to be one cause of acute respiratory distress among patients with COVID-19. We aimed to assess the off-label use of anakinra in patients who were admitted to hospital for severe forms of COVID-19 with symptoms indicative of worsening respiratory function.

Methods: The Ana-COVID study included a prospective cohort from Groupe Hospitalier Paris Saint-Joseph (Paris, France) and a historical control cohort retrospectively selected from the Groupe Hospitalier Paris Saint-Joseph COVID cohort, which began on March 18, 2020. Patients were included in the prospective cohort if they were aged 18 years or older and admitted to Groupe Hospitalier Paris Saint-Joseph with severe COVID-19-related bilateral pneumonia on chest x-ray or lung CT scan. The other inclusion criteria were either laboratory-confirmed SARS-CoV-2 or typical lung infiltrates on a lung CT scan, and either an oxygen saturation of 93% or less under oxygen 6 L/min or more, or aggravation (saturation ≤93% under oxygen 3 L/min) with a loss of 3% of oxygen saturation in ambient air over the previous 24 h. The historical control group of patients had the same inclusion criteria. Patients in the anakinra group were treated with subcutaneous anakinra (100 mg twice a day for 72 h, then 100 mg daily for 7 days) as well as the standard treatments at the institution at the time. Patients in the historical group received standard treatments and supportive care. The main outcome was a composite of either admission to the intensive care unit (ICU) for invasive mechanical ventilation or death. The main analysis was done on an intention-to-treat basis (including all patients in the anakinra group who received at least one injection of anakinra).

Findings: From March 24 to April 6, 2020, 52 consecutive patients were included in the anakinra group and 44 historical patients were identified in the Groupe Hospitalier Paris Saint-Joseph COVID cohort study. Admission to the ICU for invasive mechanical ventilation or death occurred in 13 (25%) patients in the anakinra group and 32 (73%) patients in the historical group (hazard ratio [HR] 0·22 [95% CI 0·11-0·41; p<0·0001). The treatment effect of anakinra remained significant in the multivariate analysis (HR 0·22 [95% CI 0·10-0·49]; p=0·0002). An increase in liver aminotransferases occurred in seven (13%) patients in the anakinra group and four (9%) patients in the historical group.

Interpretation: Anakinra reduced both need for invasive mechanical ventilation in the ICU and mortality among patients with severe forms of COVID-19, without serious side-effects. Confirmation of efficacy will require controlled trials.

Funding: Groupe Hospitalier Paris Saint-Joseph.
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http://dx.doi.org/10.1016/S2665-9913(20)30164-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7259909PMC
July 2020

Does a standardized screening for alcohol use disorder at the Emergency Department inform the risk of repeated ED visit?

Gen Hosp Psychiatry 2021 Mar-Apr;69:115-116. Epub 2020 Jul 12.

AP-HP.Centre-Université de Paris, DMU Psychiatrie et Addictologie, Paris, France; Université de Paris, INSERM, Institut de Psychiatrie et Neurosciences de Paris (IPNP), UMR_S1266, Paris, France.

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http://dx.doi.org/10.1016/j.genhosppsych.2020.07.003DOI Listing
July 2020

Relationship of Tumor Radiation-absorbed Dose to Survival and Response in Hepatocellular Carcinoma Treated with Transarterial Radioembolization with Y in the SARAH Study.

Radiology 2020 09 30;296(3):673-684. Epub 2020 Jun 30.

From the Departments of Radiology (A.L.H., M.R., V.V.), Nuclear Medicine (A.D., M.S., R.L.), and Hepatology (L.C.), Assistance Publique-Hôpitaux de Paris, Hôpitaux Universitaires Paris Nord Val de Seine, Hôpital Beaujon, 100 boulevard du Général Leclerc, 92110 Clichy, France; Université Paris-Descartes, Sorbonne Paris Cité, Faculté de Médecine, Paris, France (A.L.H., G.C.); INSERM U1149, Centre de Recherche de l'Inflammation (CRI), Paris, France (A.D., M.R., M.S., L.C., R.L., V.V.); Université Paris Diderot, Sorbonne Paris Cité, Faculté de Médecine, Paris, France (M.R., L.C., R.L., V.V.); Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges-Pompidou, Unité de Recherche Clinique, Paris, France (H.P., G.C.); INSERM, Centre d'Investigation Clinique 1418 (CIC1418), Paris, France (H.P., G.C.); and Centre Eugène Marquis, Rennes, France (E.G.).

Background Little is known about factors that influence the efficacy of transarterial radioembolization (TARE). Purpose To determine the relationship between tumor radiation-absorbed dose and survival and tumor response in locally advanced inoperable hepatocellular carcinoma treated with TARE. Materials and Methods This was a secondary analysis of prospectively acquired data (between December 2011 and March 2015) from participants who received TARE in the Sorafenib versus Radioembolization in Advanced Hepatocellular Carcinoma (SARAH) trial (ClinicalTrials.gov identifier: NCT01482442). Tumor-absorbed dose was computed using technetium 99m (Tc) macroaggregated human albumin (MAA) SPECT/CT. Visual agreement among CT, Tc-MAA SPECT/CT, and yttrium 90 (Y) SPECT/CT or PET/CT was scored as optimal, suboptimal, or not optimal. Overall survival (OS) and tumor response at 6-month follow-up CT (Response Evaluation Criteria in Solid Tumors, version 1.1) were assessed. OS was evaluated using Kaplan-Meier tests. A propensity score comparing participants receiving a tumor dose greater than or equal to 100 Gy (best cut-off according to the receiver operating characteristic curve and median tumor radiation-absorbed dose values in the study groups) with those receiving sorafenib was calculated. Results One hundred twenty-one participants (median age, 67 years; interquartile range [IQR]: 61-73 years; 110 men) were evaluated in the dose-survival group, and 109 (median age, 66 years; IQR: 61-71 years; 100 men) were evaluated in the dose-tumor response group. In the dose-survival group, median OS was 9.3 months (95% confidence interval [CI]: 6.7 months, 10.7 months), and median tumor radiation-absorbed dose was 112 Gy (IQR: 68-220 Gy). Participants who received at least 100 Gy ( = 67) had longer survival than those who received less than 100 Gy (median, 14.1 months [95% CI: 9.6 months, 18.6 months] vs 6.1 months [95% CI: 4.9 months, 6.8 months], respectively; < .001), and those with optimal agreement ( = 24) had the longest median OS (24.9 months; 95% CI: 9.6 months, 33.9 months). In the dose-tumor response group, tumor radiation-absorbed dose was higher in participants with disease control versus those with progressive disease (median, 121 Gy [IQR: 86-190 Gy] vs 85 Gy [IQR: 58-164 Gy]; = .02). The highest disease control rate was observed in 31 of 40 participants (78%) with a tumor radiation-absorbed dose greater than or equal to 100 Gy and optimal agreement. Conclusion Higher tumor radiation-absorbed dose computed at technetium 99m macroaggregated human albumin SPECT/CT was associated with better overall survival and disease control in hepatocellular carcinoma treated with transarterial radioembolization with yttrium 90 in the Sorafenib versus Radioembolization in Advanced Hepatocellular Carcinoma trial. © RSNA, 2020 See also the editorial by Sofocleous and Kamarinos in this issue.
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http://dx.doi.org/10.1148/radiol.2020191606DOI Listing
September 2020

Performances of a Solution to Semi-Automatically Fill eCRF with Data from the Electronic Health Record: Protocol for a Prospective Individual Participant Data Meta-Analysis.

Stud Health Technol Inform 2020 Jun;270:367-371

Sanofi R&D, Paris, France.

Clinical trial data collection still relies on a manual entry from information available in the medical record. This process introduces delay and error risk. Automating data transfer from Electronic Health Record (EHR) to Electronic Data Capture (EDC) system, under investigators' supervision, would gracefully solve these issues. The present paper describes the design of the evaluation of a technology allowing EHR to act as eSource for clinical trials. As part of the EHR2EDC project, for 6 ongoing clinical trials, running at 3 hospitals, a parallel semi-automated data collection using such technology will be conducted focusing on a limited scope of data (demographic data, local laboratory results, concomitant medication and vital signs). The evaluation protocol consists in an individual participant data prospective meta-analysis comparing regular clinical trial data collection to the semi-automated one. The main outcome is the proportion of data correctly entered. Data quality and associated workload for hospital staff will be compared as secondary outcomes. Results should be available in 2020.
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http://dx.doi.org/10.3233/SHTI200184DOI Listing
June 2020

ALGINATE versus NPWT in the Preparation of Surgical Excisions for an STSG: ATEC Trial.

Plast Reconstr Surg Glob Open 2020 Mar 27;8(3):e2691. Epub 2020 Mar 27.

Department of Plastic, Cosmetic and Reconstructive Surgery, Hospital Tenon, Paris, France.

A calcium alginate dressing (ALGINATE) and negative pressure wound therapy (NPWT) are frequently used to treat wounds which heal by secondary intention. This trial compared the healing efficacy and safety of these 2 treatments.

Methods: This randomized, non-inferiority trial enrolled patients who underwent skin excision (>30 cm), which was left open to heal by secondary intention. They received ALGINATE or NPWT by a centralized randomization. Follow-up was performed weekly until optimal granulation tissue was obtained. The primary outcome was time to obtain optimal granulation tissue for a split thickness skin graft take (non-inferiority margin: 4 days). Secondary outcomes were occurrence of adverse events (AEs) and impact of the treatments on the patient's daily life.

Results: ALGINATE and NPWT were applied to 47 and 48 patients, respectively. The mean time to optimal granulation was 19.98 days (95% CI, 17.7-22.3) with ALGINATE and 20.54 (95% CI, 17.6-23.5) with NPWT. Between group difference was -0.56 days (95% CI -4.22 to 3.10). The non-inferiority of ALGINATE versus NPWT was demonstrated. No AE related to the treatment occurred with ALGINATE versus 14 AEs with NPWT. There was no difference in the impact of the treatments on the patient's daily life.

Conclusion: This trial demonstrates that ALGINATE has a similar healing efficacy to that of NPWT and that is markedly better with regard to patient safety.
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http://dx.doi.org/10.1097/GOX.0000000000002691DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7253249PMC
March 2020

NEMESIS: Noninferiority, Individual-Patient Metaanalysis of Selective Internal Radiation Therapy with Y Resin Microspheres Versus Sorafenib in Advanced Hepatocellular Carcinoma.

J Nucl Med 2020 12 1;61(12):1736-1742. Epub 2020 May 1.

National Institute of Gastroenterology "S. de Bellis" Research Hospital, Bari, Italy.

In randomized clinical trials, no survival benefit has been observed for selective internal radiation therapy (SIRT) over sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study aimed to assess, through a metaanalysis, whether overall survival (OS) with SIRT, as monotherapy or followed by sorafenib, is noninferior to sorafenib and to compare safety profiles for patients with advanced HCC. We searched MEDLINE, EMBASE, and the Cochrane Library up to February 2019 to identify randomized clinical trials comparing SIRT, as monotherapy or followed by sorafenib, with sorafenib monotherapy among patients with advanced HCC. The main outcomes were OS and frequency of treatment-related severe adverse events (≥grade 3). The per-protocol population was the primary analysis population. A noninferiority margin of 1.08 in terms of hazard ratio was prespecified for the upper boundary of 95% confidence interval for OS. Prespecified subgroup analyses were performed. Three randomized clinical trials, involving 1,243 patients, comparing sorafenib with SIRT (SIRveNIB and SARAH) or SIRT followed by sorafenib (SORAMIC), were included. After randomization, 411 of 635 (64.7%) patients allocated to SIRT and 522 of 608 (85.8%) allocated to sorafenib completed the studies without major protocol deviations. Median OS with SIRT, whether or not followed by sorafenib, was noninferior to sorafenib (10.2 and 9.2 mo [hazard ratio, 0.91; 95% confidence interval, 0.78-1.05]). Treatment-related severe adverse events were reported in 149 of 515 patients (28.9%) who received SIRT and 249 of 575 (43.3%) who received sorafenib only ( < 0.01). SIRT as initial therapy for advanced HCC is noninferior to sorafenib in terms of OS and offers a better safety profile.
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http://dx.doi.org/10.2967/jnumed.120.242933DOI Listing
December 2020

EMERGEncy versus delayed coronary angiogram in survivors of out-of-hospital cardiac arrest with no obvious non-cardiac cause of arrest: Design of the EMERGE trial.

Am Heart J 2020 04 17;222:131-138. Epub 2020 Jan 17.

Cardiology Department, European Hospital Georges Pompidou, Assistance Publique- Hôpitaux de Paris, Paris Descartes University, Sudden Cardiac Death Expert Center, INSERM U 971, Paris, France. Electronic address:

Background: In adults, the most common cause of out-of-hospital cardiac arrests (OHCA) is acute coronary artery occlusion. If an immediate coronary angiogram (CAG) is recommended for survivors presenting a ST segment elevation on the electrocardiogram (ECG) performed after resuscitation, there is still a debate regarding the best strategy in patients without ST segment elevation.

Hypothesis: Performing an immediate CAG after an OHCA without ST segment elevation on the post-resuscitation ECG and no obvious non-cardiac cause of arrest could lead to a better 180-day survival rate with no or minimal neurological sequel as compared with a delayed CAG performed 48 to 96 hours after the arrest.

Design: The EMERGE trial is a prospective national, randomized, open and parallel group trial, in which 970 survivors of OHCA will be randomized (1:1) to either immediate (as soon as possible after return of spontaneous circulation) or delayed (48 to 96 h) CAG. Participants will be OHCA patients with no ST segment elevation on the post resuscitation ECG and no obvious non-cardiac cause of arrest. The primary endpoint of the study is the 180-day survival rate with no or minimal neurological sequel corresponding to Cerebral Performance Category (CPC) 1 or 2. The secondary endpoints are: occurrence of shock during the first 48 hours, ventricular tachycardia and/or fibrillation during the first 48 hours, change in left ventricular ejection fraction between baseline and 180 days assessed by echocardiogram, neurological status evaluated by the CPC score at intensive care unit (ICU) discharge and day 90 neurological status assessed by the Glasgow Outcome Scale Extended score (GOSE) at 90 and 180 days, overall survival rate, and hospital length of stay.

Summary: The EMERGE trial is a prospective, multicenter, randomized, controlled trial that will assess the 180-day survival rate with no or minimal neurologic sequel in patients resuscitated from an OHCA without ST segment elevation and who will be managed with either immediate or delayed CAG.
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http://dx.doi.org/10.1016/j.ahj.2020.01.006DOI Listing
April 2020
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