Publications by authors named "Pierre-Marie Roy"

98 Publications

Do Not Throw Out the Baby With the Bathwater.

Ann Emerg Med 2022 Jan;79(1):85-86

Département de Médecine d'Urgence, Centre hospitalier universitaire d'Angers, Angers, France; Institut MITOVASC, Centre National de Recherche Scientifique 6015 Institut National de la Santé Et de la Recherche Médicale 1083, Université d'Angers, Angers, France.

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http://dx.doi.org/10.1016/j.annemergmed.2021.09.429DOI Listing
January 2022

Safety and Efficiency of Diagnostic Strategies for Ruling Out Pulmonary Embolism in Clinically Relevant Patient Subgroups : A Systematic Review and Individual-Patient Data Meta-analysis.

Ann Intern Med 2021 Dec 14. Epub 2021 Dec 14.

Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, the Netherlands (M.A.M.S., M.V.H., F.A.K.).

Background: How diagnostic strategies for suspected pulmonary embolism (PE) perform in relevant patient subgroups defined by sex, age, cancer, and previous venous thromboembolism (VTE) is unknown.

Purpose: To evaluate the safety and efficiency of the Wells and revised Geneva scores combined with fixed and adapted D-dimer thresholds, as well as the YEARS algorithm, for ruling out acute PE in these subgroups.

Data Sources: MEDLINE from 1 January 1995 until 1 January 2021.

Study Selection: 16 studies assessing at least 1 diagnostic strategy.

Data Extraction: Individual-patient data from 20 553 patients.

Data Synthesis: Safety was defined as the diagnostic failure rate (the predicted 3-month VTE incidence after exclusion of PE without imaging at baseline). Efficiency was defined as the proportion of individuals classified by the strategy as "PE considered excluded" without imaging tests. Across all strategies, efficiency was highest in patients younger than 40 years (47% to 68%) and lowest in patients aged 80 years or older (6.0% to 23%) or patients with cancer (9.6% to 26%). However, efficiency improved considerably in these subgroups when pretest probability-dependent D-dimer thresholds were applied. Predicted failure rates were highest for strategies with adapted D-dimer thresholds, with failure rates varying between 2% and 4% in the predefined patient subgroups.

Limitations: Between-study differences in scoring predictor items and D-dimer assays, as well as the presence of differential verification bias, in particular for classifying fatal events and subsegmental PE cases, all of which may have led to an overestimation of the predicted failure rates of adapted D-dimer thresholds.

Conclusion: Overall, all strategies showed acceptable safety, with pretest probability-dependent D-dimer thresholds having not only the highest efficiency but also the highest predicted failure rate. From an efficiency perspective, this individual-patient data meta-analysis supports application of adapted D-dimer thresholds.

Primary Funding Source: Dutch Research Council. (PROSPERO: CRD42018089366).
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http://dx.doi.org/10.7326/M21-2625DOI Listing
December 2021

Risk for Recurrent Venous Thromboembolism in Patients With Subsegmental Pulmonary Embolism Managed Without Anticoagulation : A Multicenter Prospective Cohort Study.

Ann Intern Med 2021 Nov 23. Epub 2021 Nov 23.

Department of Medicine, University of Ottawa, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada (A.P., P.P., P.W., M.C.).

Background: The incidence of pulmonary embolism has been increasing, but its case-fatality rate is decreasing, suggesting a lesser severity of illness. The clinical importance of patients with pulmonary embolism isolated to the subsegmental vessels is unknown.

Objective: To determine the rate of recurrent venous thromboembolism in patients with subsegmental pulmonary embolism managed without anticoagulation.

Design: Multicenter prospective cohort study. (ClinicalTrials.gov: NCT01455818).

Setting: Eighteen sites between February 2011 and February 2021.

Patients: Patients with isolated subsegmental pulmonary embolism.

Intervention: At diagnosis, patients underwent bilateral lower-extremity venous ultrasonography, which was repeated 1 week later if results were negative. Patients without deep venous thrombosis did not receive anticoagulant therapy.

Measurements: The primary outcome was recurrent venous thromboembolism during the 90-day follow-up period.

Results: Recruitment was stopped prematurely because the predefined stopping rule was met after 292 of a projected 300 patients were enrolled. Of the 266 patients included in the primary analysis, the primary outcome occurred in 8 patients, for a cumulative incidence of 3.1% (95% CI, 1.6% to 6.1%) over the 90-day follow-up. The incidence of recurrent venous thromboembolism was 2.1% (CI, 0.8% to 5.5%) and 5.7% (CI, 2.2% to 14.4%) over the 90-day follow-up in patients with single and multiple isolated subsegmental pulmonary embolism, respectively. No patients had a fatal recurrent pulmonary embolism.

Limitation: The study was restricted to patients with low-risk subsegmental pulmonary embolism.

Conclusion: Overall, patients with subsegmental pulmonary embolism who did not have proximal deep venous thrombosis had a higher-than-expected rate of recurrent venous thromboembolism.

Primary Funding Source: Heart and Stroke Foundation of Canada and French Ministry of Health Programme Hospitalier de Recherche Clinique.
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http://dx.doi.org/10.7326/M21-2981DOI Listing
November 2021

Risk of symptomatic venous thromboembolism in mild and moderate COVID-19: A comparison of two prospective European cohorts.

Thromb Res 2021 12 8;208:4-10. Epub 2021 Oct 8.

Emergency Department, Angers University Hospital, Angers, France; UNIV Angers, UMR MitoVasc CNRS 6015 - INSERM 1083, Angers, France; FCRIN, INNOVTE, Saint Etienne, France.

Background: Severely ill patients with SARS-CoV-2 have an increased risk of venous thromboembolism (VTE) i.e., deep vein thrombosis and pulmonary embolism. However, the VTE risk in patients with mild and moderate COVID-19, hospitalized or managed at home, remain uncertain. The aims of this study were to assess the rate and the risk factors symptomatic VTE, in patients with mild and moderate COVID-19 and to compare them to a cohort of similar patients without COVID-19.

Methods: Patients presenting to the emergency department (ED) of participating centers for confirmed or probable mild or moderate COVID-19 and not having acute VTE were included. This COVID-19 cohort was retrospectively compared to a prospective cohort of similar ED patients using propensity score matching. The main outcome was the rate of symptomatic VTE within the 28 days after ED presentation.

Results: A total of 2292 patients were included in the COVID-19 cohort. The 28-day incidence of symptomatic VTE was 1.3% (n = 29/2292, 95%CI: 0.9 to 1.8), 2.3% (n = 20/866, 95%CI: 1.5 to 3.5) in moderate COVID-19 patients and 0.6% (n = 9/1426; 95%CI: 0.3 to 1.2) in mild COVID-19 patients managed as outpatients. An age over 65 years and hospitalization were independent risk factors of VTE. After adjustment, patients in the COVID-19 cohort had an absolute increase in over symptomatic VTE risk of +1.69% (95%CI, 0.88 to 2.51) versus patients in the comparison cohort (n = 1539).

Conclusions: Patients with moderate COVID-19 presenting to the ED had a high risk of subsequent VTE.

Trial Registration: Ethics committee of the CHU of Angers (N°2020/87).
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http://dx.doi.org/10.1016/j.thromres.2021.10.001DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498792PMC
December 2021

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

Chest 2021 Oct 8. Epub 2021 Oct 8.

F-CRIN INNOVTE Network, Saint-Etienne, France; Service de Médecine Vasculaire et Thérapeutique, CHU Saint-Etienne, Hôpital Nord, Saint-Etienne, France.

Background: Direct oral anticoagulants (DOACs) are an alternative to low-molecular-weight heparin for treating cancer-associated 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 noninferiority trial, patients with active cancer who had proximal DVT, pulmonary embolism (PE), or both were assigned randomly 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, and 115 patients (76.2%) had metastatic disease. The primary outcome occurred in 4 and 6 patients in the rivaroxaban and dalteparin groups, respectively (both the intention-to-treat and per-protocol populations: cumulative incidence, 6.4% vs 10.1%; subdistribution hazard ratio [SHR], 0.75; 95% CI, 0.21-2.66). 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 nonmajor 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 patients (25.7%) and 20 patients (23.8%) died in the rivaroxaban and dalteparin groups, respectively (hazard ratio, 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 noninferiority, 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 Registry: ClinicalTrials.gov; No.: NCT02746185; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2021.09.037DOI Listing
October 2021

Assessing the clinical probability of pulmonary embolism during pregnancy: The Pregnancy-Adapted Geneva (PAG) score.

J Thromb Haemost 2021 12 21;19(12):3044-3050. Epub 2021 Sep 21.

Division of Angiology and Hemostasis, Faculty of Medicine, Geneva University Hospitals Geneva, Switzerland.

Background: The diagnosis of pulmonary embolism (PE) in pregnant women represents an ongoing challenge. As in the general population, the first step in pregnant women with suspected PE consists of assessing clinical pre-test probability (PTP). However, no dedicated clinical decision rule has been developed in this population.

Objective: To propose a new version of the Geneva score adapted to pregnant women with suspected PE.

Methods: Data from a multicenter, prospective management outcome study including 395 women with suspected PE, in whom PTP was assessed using the Geneva score, were used. We first removed items which were present in none of the patients (cancer, age >65 years). Receiver operating characteristic (ROC) curve analysis was then performed for quantitative variables and the optimal threshold defined. The obtained Pregnancy-Adapted Geneva Score (PAG Score) comprised seven items, including an age 40 years or older and a heart rate >110 beats per minute.

Results: The PAG Score showed a high discriminative power to identify patients with a low, intermediate, or high PTP, associated with increasing prevalence of PE, 2.3%, 11.6%, and 61.5%, respectively. The ROC curves showed an area under the curve of 0.795 for the PAG Score compared to 0.684 for the Geneva score.

Conclusion: In pregnant women with suspected PE, the PAG Score shows a high discriminative power to identify patients at low, intermediate, or high PTP. It has the strength of being a fully objective decision rule, is clinically relevant, easy to compute, and should now be tested in a prospective outcome study.
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http://dx.doi.org/10.1111/jth.15521DOI Listing
December 2021

Adaptation of ED design layout during the COVID-19 pandemic: a national cross-sectional survey.

Emerg Med J 2021 Oct 24;38(10):789-793. Epub 2021 Aug 24.

Emergency Department, University Hospital of Angers, 49100, Angers, France.

Background: The aim was to describe the organisational changes in French EDs in response to the COVID-19 pandemic with regard to architectural constraints and compare with the recommendations of the various bodies concerning the structural adjustments to be made in this context.

Methods: As part of this cross-sectional study, all heads of emergency services or their deputies were contacted to complete an electronic survey. This was a standardised online questionnaire consisting of four parts: characteristics of the responding centre, creation of the COVID-19 zone and activation of the hospital's emergency operations plan, flow and circulation of patients and, finally, staff management. Each centre was classified according to its workload related to COVID-19 and its size (university hospital centre, high-capacity hospital centre and low-capacity hospital centre). The main endpoint was the frequency of implementation of international guidelines for ED organisation.

Results: Between 11 May and 20 June 2020, 57 French EDs completed the online questionnaire and were included in the analysis. Twenty-eight EDs were able to separate patient flows into two zones: high and low viral density (n=28/57, 49.1%). Of the centres included, 52.6% set up a specific triage area for patients with suspected COVID-19 (n=30/57). Whereas, in 15 of the EDs (26.3%), the architecture made it impossible to increase the surface area of the ED.

Conclusion: All EDs have adapted, but many of the changes recommended for the organisation of ED could not be implemented. ED architecture constrains adaptive capacities in the context of COVID-19.
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http://dx.doi.org/10.1136/emermed-2020-211012DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8390146PMC
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

Quality of life in patients with pulmonary embolism treated with edoxaban versus warfarin.

Res Pract Thromb Haemost 2021 Jul 14;5(5):e12566. Epub 2021 Jul 14.

Daiichi Sankyo Pharma Development Basking Ridge NJ USA.

Background: Long-term sequelae of acute pulmonary embolism (PE) include decreased quality of life (QoL). Evidence suggests that adequacy of initial anticoagulant treatment in the acute phase of venous thrombosis has a key impact on late postthrombotic complications. We hypothesize that patients with acute PE treated with edoxaban for acute PE experience have improved QoL compared to those treated with warfarin.

Methods: Patients with PE who participated in the Hokusai-VTE trial were contacted between June 2017 and September 2020 for a single long-term follow-up visit. Main outcomes were the generic and disease-specific QoL measured by the 36-Item Short Form Health Survey (SF-36) and Pulmonary Embolism Quality of Life questionnaire.

Results: We included 251 patients from 26 centers in eight countries, of which 129 (51%) had been assigned to edoxaban and 122 (49%) to warfarin. Patient- and thrombus-specific characteristics were similar in both groups. Mean time since randomization in the Hokusai-VTE trial was 7.0 years (standard deviation, 1.0). No relevant or statistical differences were observed in the QoL for patients treated with edoxaban compared to patients treated with warfarin. The mean difference between patients treated with edoxaban and patients with PE treated with warfarin was 0.8 (95% confidence interval [CI]. -1.6 to 3.2) for the SF-36 summary mental score and 1.6 (95% CI, -0.9 to 4.1) for summary physical score.

Conclusion: Our findings indicate that patients with an index PE treated with edoxaban or warfarin have a similar long-term QoL. Since our study was a follow-up study from a well-controlled clinical trial setting, future studies should be designed in a daily clinical practice setting. We suggest a longitudinal design for investigation of changes in QoL over time.
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http://dx.doi.org/10.1002/rth2.12566DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8279124PMC
July 2021

Contemporary management of acute pulmonary embolism.

Trends Cardiovasc Med 2021 Jun 29. Epub 2021 Jun 29.

Cliniques Universitaires Saint Luc, Emrgency Department; UCLouvain; F-CRIN INNOVTE; Brussels, Belgium. Electronic address:

This review examines the recent progress in the initial management of pulmonary embolism (PE). Diagnostic strategies allowing the safe decrease of imaging testing have been proposed. New modalities of catheter-based interventions have emerged for hemodynamically unstable PE patients. For normotensive PE patients, direct oral anticoagulant treatment has become the new norm and a large proportion of patients are eligible for home treatment.
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http://dx.doi.org/10.1016/j.tcm.2021.06.002DOI Listing
June 2021

Evaluation of HEAR score to rule-out major adverse cardiac events without troponin test in patients presenting to the emergency department with chest pain.

Eur J Emerg Med 2021 Aug;28(4):292-298

Département de Médecine d'Urgence, CHU d'Angers, Institut MITOVASC, UMR CNRS 6015 UMR INSERM 1083, Université d'Angers, Angers, France.

Background And Importance: Current guidelines for patients presenting to the emergency department with chest pain without ST-segment elevation myocardial infarction (non-STEMI) on electrocardiogram are based on troponin measurement. The HEART score is reportedly a reliable work-up strategy that combines clinical evaluation with troponin value. A clinical rule that could select very low-risk patients without the need for a blood test (HEAR score, being the HEART score without the troponin item) would be of great interest.

Objectives: To prospectively assess the safety of a HEAR score <2 to rule-out non-STEMI without troponin measurement. Secondary objective was to assess the safety of a sequential strategy that combines HEAR score and HEART (defined as two-step HEART strategy).

Design, Settings And Participants: Prospective observational study in six emergency departments. Patients with nontraumatic chest pain and no alternative diagnosis were included and followed up for 45 day. Patients were considered at low-risk if the HEAR score was <2 or, for the two-step HEART strategy, if the HEART score was <4.

Outcomes Measure And Analysis: The primary endpoint was the 45-day rate of major adverse cardiac events (MACE) in patients with a HEAR score <2. A HEAR score based strategy was consider safe if the rate of the primary endpoint was below 1%, with an upper margin of the 95% confidence interval (CI) below 3%.

Results: Among 1452 patients included, 1402 were analyzed and 97 (7%) had a MACE during the follow-up period. The HEAR score was <2 in 279 (20%) patients and one presented a MACE [0.4% (95% CI: 0.01-1.98)]. The two-step HEART strategy classified low-risk an additional 476 patients (34%) and one of these 476 patients had a MACE [0.3% (95% CI: 0.03-0.95)]. The two-step HEART strategy would have theoretically avoided 360 troponin measurements (19%).

Conclusions: In our prospective multicenter study, a HEAR based work-up strategy was safe, with a very low risk of MACE at 45 day. We also report that a two-step HEART-based strategy may safely allow significant reduction of troponin measurements in patients presenting to the emergency department with chest pain.
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http://dx.doi.org/10.1097/MEJ.0000000000000791DOI Listing
August 2021

Thromboembolic risk stratification by TRiP(cast) score to rationalise thromboprophylaxis in patients with lower leg trauma requiring immobilisation: a study protocol of the casting stepped-wedge cluster randomised trial.

BMJ Open 2021 06 28;11(6):e045905. Epub 2021 Jun 28.

Emergency Department, University Hospital Centre Angers, Angers, France.

Introduction: Patients with lower limb trauma requiring orthopaedic immobilisation may be at risk of venous thromboembolism but opinions differ about who may benefit from thromboprophylactic anticoagulant treatment.The aim of this CASTING study is to demonstrate the safety of thromboprophylaxis based on the Thrombosis Risk Prediction for patients with cast immobilisation (TRiP(cast) score with regards to the 3-month incidence of symptomatic venous thromboembolism events in low-risk patients not receiving thromboprophylaxis, as well as the usefulness of this strategy on the rate of patients receiving anticoagulant treatment in comparison to current practice.

Methods And Analysis: CASTING will be a stepped-wedge cluster randomised controlled clinical trial, performed in 15 emergency departments in France and Belgium. With their informed consent, outpatients admitted to one of the participating emergency departments for a lower limb trauma requiring orthopaedic immobilisation without surgery will be included. All centres will begin the trial with the 'observational period' and, every 2 weeks, 1 centre will be randomly assigned to switch to the 'interventional period' and to apply the TRiP(cast) score, in which only patients with a score ≥7 will receive thromboprophylactic anticoagulant treatment. The primary endpoint is the rate of clinical thromboembolic events within 90 days following the inclusion of low-risk patients not receiving thromboprophylaxis.

Ethics And Dissemination: The protocol has been approved by the Comité de Protection des Personnes Sud I (Ethics Review ID-RCB: 2019-A01829-48) for France and the Comité d'éthique hôpital-facultaire Saint Luc (N° B403201941338) for Belgium. It is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The findings of this study will be disseminated in peer-reviewed journals and at scientific conferences.

Trial Registration Number: NCT04064489.
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http://dx.doi.org/10.1136/bmjopen-2020-045905DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8240567PMC
June 2021

Outpatient Management of Patients With COVID-19: Multicenter Prospective Validation of the Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection Rule to Discharge Patients Safely.

Chest 2021 10 15;160(4):1222-1231. Epub 2021 May 15.

Département de Médecine d'Urgence, Angers University Hospital, Angers, France; UMR MitoVasc CNRS 6015-INSERM 1083, Health Faculty, Université Angers, Angers, France; FCRIN, INNOVTE, Angers, France.

Background: The Hospitalization or Outpatient Management of Patients With SARS-CoV-2 Infection (HOME-CoV) rule is a checklist of eligibility criteria for home treatment of patients with COVID-19, defined using a Delphi method.

Research Question: Is the HOME-CoV rule reliable for identifying a subgroup of COVID-19 patients with a low risk of adverse outcomes who can be treated at home safely?

Study Design And Methods: We aimed to validate the HOME-CoV rule in a prospective, multicenter study before and after trial of patients with probable or confirmed COVID-19 who sought treatment at the ED of 34 hospitals. The main outcome was an adverse evolution, that is, invasive ventilation or death, occurring within the 7 days after patient admission. The performance of the rule was assessed by the false-negative rate. The impact of the rule implementation was assessed by the absolute differences in the rate of patients who required invasive ventilation or who died and in the rate of patients treated at home, between an observational and an interventional period after implementation of the HOME-CoV rule, with propensity score adjustment.

Results: Among 3,000 prospectively enrolled patients, 1,239 (41.3%) demonstrated a negative HOME-CoV rule finding. The false-negative rate of the HOME-CoV rule was 4 in 1,239 (0.32%; 95% CI, 0.13%-0.84%), and its area under the receiver operating characteristic curve was 80.9 (95% CI, 76.5-85.2). On the adjusted populations, 25 of 1,274 patients (1.95%) experienced an adverse evolution during the observational period vs 12 of 1,274 patients (0.95%) during the interventional period: -1.00 (95% CI, -1.86 to -0.15). During the observational period, 858 patients (67.35%) were treated at home vs 871 patients (68.37%) during the interventional period: -1.02 (95% CI, -4.46 to 2.26).

Interpretation: A large proportion of patients treated in the ED with probable or confirmed COVID-19 have a negative HOME-CoV rule finding and can be treated safely at home with a very low risk of complications.

Trial Registry: ClinicalTrials.gov; No.: NCT04338841; URL: www.clinicaltrials.gov.
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http://dx.doi.org/10.1016/j.chest.2021.05.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123410PMC
October 2021

Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial.

Clin Microbiol Infect 2021 Aug 1;27(8):1124-1130. Epub 2021 Apr 1.

Département de Médecine Intensive-Réanimation, CHU d'Angers, Université d'Angers, Angers, France.

Objectives: To determine whether hydroxychloroquine decreases the risk of adverse outcome in patients with mild to moderate coronavirus disease 2019 (COVID-19) at high risk of worsening.

Methods: We conducted a multicentre randomized double-blind placebo-controlled trial evaluating hydroxychloroquine in COVID-19 patients with at least one of the following risk factors for worsening: need for supplemental oxygen, age ≥75 years, age between 60 and 74 years and presence of at least one co-morbidity. Severely ill patients requiring oxygen therapy >3 L/min or intensive care were excluded. Eligible patients were randomized in a 1:1 ratio to receive either 800 mg hydroxychloroquine on day 0 followed by 400 mg per day for 8 days or a placebo. The primary end point was a composite of death or start of invasive mechanical ventilation within 14 days following randomization. Secondary end points included mortality and clinical evolution at days 14 and 28, and viral shedding at days 5 and 10.

Results: The trial was stopped after 250 patients were included because of a slowing down of the pandemic in France. The intention-to-treat population comprised 123 and 124 patients in the placebo and hydroxychloroquine groups, respectively. The median age was 77 years (interquartile range 58-86 years) and 151/250 (60.4%) patients required oxygen therapy. The primary end point occurred in 9/124 (7.3%) patients in the hydroxychloroquine group and 8/123 (6.5%) patients in the placebo group (relative risk 1.12; 95% CI 0.45-2.80). The rates of positive SARS-CoV-2 RT-PCR tests at days 5 and 10 were 72.8% (75/103) and 57.1% (52/91) in the hydroxychloroquine group, versus 73.0% (73/100) and 56.6% (47/83) in the placebo group, respectively. No difference was observed between the two groups in any of the other secondary end points.

Conclusion: In this underpowered trial involving mainly older patients with mild to moderate COVID-19, patients treated with hydroxychloroquine did not experience better clinical or virological outcomes than those receiving the placebo.

Trial Registration: ClinicalTrials.gov Identifier: NCT04325893 (https://clinicaltrials.gov/ct2/show/NCT04325893).
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http://dx.doi.org/10.1016/j.cmi.2021.03.005DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8015393PMC
August 2021

Derivation and Validation of a 4-Level Clinical Pretest Probability Score for Suspected Pulmonary Embolism to Safely Decrease Imaging Testing.

JAMA Cardiol 2021 06;6(6):669-677

Emergency Department, Cliniques Universitaires Saint Luc, Université Catholique de Louvain, F-CRIN INNOVTE, Brussels, Belgium.

Importance: In patients with suspected pulmonary embolism (PE), overuse of diagnostic imaging is an important point of concern.

Objective: To derive and validate a 4-level pretest probability rule (4-Level Pulmonary Embolism Clinical Probability Score [4PEPS]) that makes it possible to rule out PE solely on clinical criteria and optimized D-dimer measurement to safely decrease imaging testing for suspected PE.

Design, Setting, And Participants: This study included consecutive outpatients suspected of having PE from US and European emergency departments. Individual data from 3 merged management studies (n = 11 114; overall prevalence of PE, 11%) were used for the derivation cohort and internal validation cohort. The external validation cohorts were taken from 2 independent studies, the first with a high PE prevalence (n = 1548; prevalence, 21.5%) and the second with a moderate PE prevalence (n = 1669; prevalence, 11.7%). A prior definition of pretest probability target values to achieve a posttest probability less than 2% was used on the basis of the negative likelihood ratios of D-dimer. Data were collected from January 2003 to April 2016, and data were analyzed from June 2018 to August 2019.

Main Outcomes And Measures: The rate of PE diagnosed during the initial workup or during follow-up and the rate of imaging testing.

Results: Of the 5588 patients in the derivation cohort, 3441 (61.8%) were female, and the mean (SD) age was 52 (18.5) years. The 4PEPS comprises 13 clinical variables scored from -2 to 5. It results in the following strategy: (1) very low probability of PE if 4PEPS is less than 0: PE ruled out without testing; (2) low probability of PE if 4PEPS is 0 to 5: PE ruled out if D-dimer level is less than 1.0 μg/mL; (3) moderate probability of PE if 4PEPS is 6 to 12: PE ruled out if D-dimer level is less than the age-adjusted cutoff value; (4) high probability of PE if 4PEPS is greater than 12: PE ruled out by imaging without preceding D-dimer test. In the first and the second external validation cohorts, the area under the receiver operator characteristic curves were 0.79 (95% CI, 0.76 to 0.82) and 0.78 (95% CI, 0.74 to 0.81), respectively. The false-negative testing rates if the 4PEPS strategy had been applied were 0.71% (95% CI, 0.37 to 1.23) and 0.89% (95% CI, 0.53 to 1.49), respectively. The absolute reductions in imaging testing were -22% (95% CI, -26 to -19) and -19% (95% CI, -22 to -16) in the first and second external validation cohorts, respectively. The 4PEPS strategy compared favorably with all recent strategies in terms of imaging testing.

Conclusions And Relevance: The 4PEPS strategy may lead to a substantial and safe reduction in imaging testing for patients with suspected PE. It should now be tested in a formal outcome study.
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http://dx.doi.org/10.1001/jamacardio.2021.0064DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7931139PMC
June 2021

Suspected Acute Pulmonary Embolism: Gestalt, Scoring Systems, and Artificial Intelligence.

Semin Respir Crit Care Med 2021 04 16;42(2):176-182. Epub 2021 Feb 16.

Emergency Department, Cliniques Universitaires Saint Luc, UCLouvain, F-CRIN INNOVTE, Brussels, Belgium.

Pulmonary embolism (PE) remains a diagnostic challenge in 2021. As the pathology is potentially fatal and signs and symptoms are nonspecific, further investigations are classically required. Based on the Bayesian approach, clinical probability became the keystone of the diagnostic strategy to rule out PE in the case of a negative testing. Several clinical probability assessment methods are validated: gestalt, the Wells score, or the revised Geneva score. While the debate persists as to the best way to assess clinical probability, its assessment allows for the good interpretation of the investigation results and therefore directs the correct diagnostic strategy. The wide availability of computed tomography pulmonary angiography (CTPA) resulted in a major increase in investigations with a moderate increase in diagnosis, without any notable improvement in patient outcomes. This leads to a new challenge for PE diagnosis which is the limitation of the number of testing for suspected PE. We review different strategies recently developed to achieve this goal. The last challenge concerns the implementation in clinical practice. Two approaches are developed: simplification of the strategies versus the use of digital support tools allowing more sophisticated strategies. Artificial intelligence with machine-learning algorithms will probably be a future tool to guide the physician in this complex approach concerning acute PE suspicion.
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http://dx.doi.org/10.1055/s-0041-1723936DOI Listing
April 2021

Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission (POCUSCO): a study protocol of an international study.

BMJ Open 2021 02 10;11(2):e041118. Epub 2021 Feb 10.

Department of Emergency Medicine, University Hospital of Angers, Univ Angers, Angers, France.

Introduction: In the context of the COVID-19 pandemic, early identification of patients who are likely to get worse is a major concern. Severity mainly depends on the development of acute respiratory distress syndrome (ARDS) with a predominance of subpleural lesions. Lung point-of-care ultrasonography (L-POCUS) is highly effective in detecting pulmonary peripheral patterns and may be appropriate for examining patients with COVID-19. We suggest that L-POCUS performed during the initial examination may identify patients with COVID-19 who are at a high risk of complicated treatment or unfavourable evolution.

Methods And Analysis: Point-of-care ultrasonography for risk stratification of non-critical COVID-19 patients on admission is a prospective, multicentre study. Adult patients visiting the emergency department (ED) of participating centres for suspected or confirmed COVID-19 are assessed for inclusion. Included patients have L-POCUS performed within 48 hours following ED admission. The severity of lung damage is assessed using the L-POCUS score based on 36 points for ARDS. Apart from the L-POCUS score assessment, patients are treated as recommended by the WHO. For hospitalised patients, a second L-POCUS is performed at day 5±3. A follow-up is carried out on day 14, and the patient's status according to the Ordinal Scale for Clinical Improvement for COVID-19 from the WHO is recorded.The primary outcome is the rate of patients requiring intubation or who are dead from any cause during the 14 days following inclusion. We will determine the area under the ROC curve of L-POCUS.

Ethics And Dissemination: The protocol has been approved by the French and Belgian Ethics Committees and is carried out in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. The study is funding by a grant from the French Health Ministry, and its findings will be disseminated in peer-reviewed journals and at scientific conferences.

Trial Registration Number: NCT04338100.
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http://dx.doi.org/10.1136/bmjopen-2020-041118DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7878051PMC
February 2021

Acute, major muscular hematoma associated with antithrombotic agents: A multicenter real-world cohort.

Thromb Res 2021 03 26;199:54-58. Epub 2020 Dec 26.

Univ Rennes, CHU Rennes, EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, F 35043 Rennes, France. Electronic address:

Background: There is little data on major muscular hematomas and the little there is has mainly focused on patients exposed to oral anticoagulants.

Objective: To describe the clinical characteristics, management and outcomes of patients admitted to emergency department (ED) for major muscular hematoma associated with an antithrombotic agent, and to identify predictors of in-hospital mortality.

Patients And Methods: Over a three-year period, all consecutive cases of adult patients admitted to the ED of 5 tertiary care hospitals for major muscular hematoma while exposed to an antithrombotic agent were prospectively collected and medically validated. Clinical and biological data, therapeutic management of the bleeding event, and in-hospital mortality were collected from the medical records and compared across five groups of hematoma locations. Potential confounders were taken in account using a multivariate binomial regression model.

Results: Three hundred and seventy-five patients were included (mean age = 81.4 years): 271 were exposed to vitamin K antagonists, 58 to parenteral anticoagulants (heparin, LMWH, fondaparinux), 33 to antiplatelets, and 13 to direct oral anticoagulants. The muscular hematomas were located in the lower limbs (n = 198), the rectus sheath (n = 71), the iliopsoas (n = 45), the upper limbs (n = 33), or elsewhere (n = 28). Reversal therapy was prescribed for 48.5% of patients, red cell transfusions for 63.6%, surgery for 12.3% and embolization for 3.5%. For 84% of patients, hospitalization was required, with a median length of stay of 10 days. Overall, in-hospital mortality was 8.5%. Reversal therapy, the need for intensive care and mortality were significantly more frequent among patients with iliopsoas hematomas. The independent predictors of in-hospital mortality were: decrease in mean arterial pressure (RR = 1.84), decrease in hemoglobin level (RR = 1.37) and the iliopsoas location (RR = 3.06).

Conclusion: Frail elderly patients with major muscular hematomas linked to antithrombotic agents risk substantial morbidity and in-hospital mortality. The iliopsoas location was the most life-threatening bleeding site. Close observation of this population is warranted to ensure better outcomes.
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http://dx.doi.org/10.1016/j.thromres.2020.12.022DOI Listing
March 2021

Prevalence of Pulmonary Embolism Among Patients With COPD Hospitalized With Acutely Worsening Respiratory Symptoms.

JAMA 2021 Jan;325(1):59-68

Département de Médecine Interne et Pneumologie, Centre Hospitalo-Universitaire de Brest, Brest, France.

Importance: The prevalence of pulmonary embolism in patients with chronic obstructive pulmonary disease (COPD) and acutely worsening respiratory symptoms remains uncertain.

Objective: To determine the prevalence of pulmonary embolism in patients with COPD admitted to the hospital for acutely worsening respiratory symptoms.

Design, Setting, And Participants: Multicenter cross-sectional study with prospective follow-up conducted in 7 French hospitals. A predefined pulmonary embolism diagnostic algorithm based on Geneva score, D-dimer levels, and spiral computed tomographic pulmonary angiography plus leg compression ultrasound was applied within 48 hours of admission; all patients had 3-month follow-up. Patients were recruited from January 2014 to May 2017 and the final date of follow-up was August 22, 2017.

Exposures: Acutely worsening respiratory symptoms in patients with COPD.

Main Outcomes And Measures: The primary outcome was pulmonary embolism diagnosed within 48 hours of admission. Key secondary outcome was pulmonary embolism during a 3-month follow-up among patients deemed not to have venous thromboembolism at admission and who did not receive anticoagulant treatment. Other outcomes were venous thromboembolism (pulmonary embolism and/or deep vein thrombosis) at admission and during follow-up, and 3-month mortality, whether venous thromboembolism was clinically suspected or not.

Results: Among 740 included patients (mean age, 68.2 years [SD, 10.9 years]; 274 women [37.0%]), pulmonary embolism was confirmed within 48 hours of admission in 44 patients (5.9%; 95% CI, 4.5%-7.9%). Among the 670 patients deemed not to have venous thromboembolism at admission and who did not receive anticoagulation, pulmonary embolism occurred in 5 patients (0.7%; 95% CI, 0.3%-1.7%) during follow-up, including 3 deaths related to pulmonary embolism. The overall 3-month mortality rate was 6.8% (50 of 740; 95% CI, 5.2%-8.8%). The proportion of patients who died during follow-up was higher among those with venous thromboembolism at admission than the proportion of those without it at admission (14 [25.9%] of 54 patients vs 36 [5.2%] of 686; risk difference, 20.7%, 95% CI, 10.7%-33.8%; P < .001). The prevalence of venous thromboembolism was 11.7% (95% CI, 8.6%-15.9%) among patients in whom pulmonary embolism was suspected (n = 299) and was 4.3% (95% CI, 2.8%-6.6%) among those in whom pulmonary embolism was not suspected (n = 441).

Conclusions And Relevance: Among patients with chronic obstructive pulmonary disease admitted to the hospital with an acute worsening of respiratory symptoms, pulmonary embolism was detected in 5.9% of patients using a predefined diagnostic algorithm. Further research is needed to understand the possible role of systematic screening for pulmonary embolism in this patient population.
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http://dx.doi.org/10.1001/jama.2020.23567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7786241PMC
January 2021

Dabigatran Level Before Reversal Can Predict Hemostatic Effectiveness of Idarucizumab in a Real-World Setting.

Front Med (Lausanne) 2020 16;7:599626. Epub 2020 Dec 16.

Université de Paris, Innovative Therapies in Haemostasis, INSERM, Paris, France.

Idarucizumab has been included in guidelines for the management of bleeding or surgical procedure in dabigatran-treated patients without need for biological monitoring. The aim of the study was to assess the prognostic value of dabigatran plasma level before reversal to test the hemostatic efficacy of idarucizumab. The secondary objectives were (i) to analyze plasma dabigatran level according to the risk of rebound and (ii) to evaluate the incidence of post-reversal non-favorable clinical outcomes (including thromboembolism, bleeding, antithrombotic, and death) and antithrombotic resumption. This was an observational multicentric cohort study, which included all French patients who required idarucizumab for dabigatran reversal. Between May 2016 and April 2019, 87 patients from 21 French centers were enrolled. Patients received idarucizumab for overt bleeding ( = 61), urgent procedures ( = 24), or overdose without bleeding ( = 2). Among patients with major bleeding ( = 57), treatment with idarucizumab was considered effective in 44 (77.2%) of them. Patients who did not achieve effective hemostasis after reversal had a significantly higher mean level of plasma dabigatran at baseline (524.5 ± 386 vs. 252.8 ng/mL ± 235, = 0.033). Furthermore, patients who did not achieve effective hemostasis after reversal had less favorable outcomes during follow-up (46.2 vs. 81.8%, = 0.027). ROC curve identified a cutoff of 264 ng/mL for dabigatran level at admission to be predictive of ineffective hemostasis. No plasma dabigatran rebound was observed after reversal in patients with dabigatran plasma level < 264 ng/mL at baseline. This retrospective study shows that dabigatran level before reversal could predict hemostatic effectiveness and dabigatran plasma rebound after idarucizumab injection.
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http://dx.doi.org/10.3389/fmed.2020.599626DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772865PMC
December 2020

Opinion and practice survey about the use of prognostic models in acute pulmonary embolism.

Thromb Res 2021 02 1;198:40-48. Epub 2020 Nov 1.

Department for Continuing Education Professional Development, University of Oxford, Oxford, United Kingdom; Northern Ireland Network for Trials Methodology Research, Queen's University Belfast, Belfast, United Kingdom.

Introduction: Methods for prognosis assessment and patient management in acute pulmonary embolism (PE) are much debated among physicians. We conducted an online survey to determine physician's attitudes and barriers towards the use of prognostic models when treating patients with acute PE.

Method: Physicians members of the French and the European scientific societies for emergency medicine or of a French thrombosis research network were reached by their respective scientific societies and invited to participate via email. The questionnaire was a mixture of close-ended with yes-no or multiple-choice options and a small number of open-ended questions.

Results: The survey included 461 respondents. The most commonly used prognostic tools were clinical judgment (36%) and prognostic models (29.5%). Prognostic models were used by 57% of respondents in more than half of all cases and prognostic indicators by 62% in addition to prognostic models. Affiliation group and type of hospital emerged as independent predictors for choosing prognostic models. Many (52%) reported lack of familiarity with the models and reported clinical judgment (60%) or hospital checklists (73%) as being as good as or better than prognostic models. The highest acceptable 30-day mortality rate limit for early discharge or outpatient management was deemed to be 1%, but few patients are discharged early or completely managed on an outpatient basis.

Conclusions: This survey provides new information for implementing knowledge translation strategies to improve prognostic risk assessment for acute PE patients, and highlights the need for considering the use of clinical judgment and hospital checklists in future clinical research.
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http://dx.doi.org/10.1016/j.thromres.2020.10.027DOI Listing
February 2021

Identifying Patients with Low Risk of Acute Coronary Syndrome Without Troponin Testing: Validation of the HEAR Score.

Am J Med 2021 04 27;134(4):499-506.e2. Epub 2020 Oct 27.

Kaiser Permanente Southern California, Department of Research & Evaluation, Pasadena; Department of Health Systems Science, Kaiser Permanente School of Medicine, Pasadena.

Background: Current guidelines for patients with suspected acute myocardial infarction are mainly based on troponin testing, commonly requiring an emergency department visit. HEAR score (History, Electrocardiogram, Age, and Risk factors) is a risk stratification tool validated in Europe, deduced from the HEART score (History, Electrocardiogram, Age, Risk factors, and Troponin), already implemented in clinical practice. We aimed to validate the HEAR score to rule out an acute myocardial infarction without needing biomarker testing.

Methods: Retrospective cohort study at 15 emergency departments between May 2016 and December 2017. All adult encounters evaluated for possible acute myocardial infarction with a physician-documented HEART score for health plan members of Kaiser Permanente Southern California were included. Patients with an ST-segment elevation myocardial infarction, those under hospice care, or with a "do not resuscitate" status were excluded. HEAR scores from 0-8 were calculated for each encounter and used to report 30-day acute myocardial infarction or all-cause mortality for each score.

Results: There were 22,109 patient encounters included in the study. Overall, 30-day acute myocardial infarction or death occurred in 1.1% of patients. Among the 4106 patients (19%) with a HEAR score <2, 3 died and 2 experienced an acute myocardial infarction within 30 days (0.1%; 95% confidence interval, 0.1-0.3). Sensitivity and specificity were 97.9% and 18.8%, respectively.

Conclusions: A low HEAR score may accurately identify patients with a very low risk of 30-day acute myocardial infarction or death, representing a cohort of patients who might appropriately forego biomarker testing. Future research is warranted to assess the impact of implementing the HEAR score into routine clinical practice.
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http://dx.doi.org/10.1016/j.amjmed.2020.09.021DOI Listing
April 2021

Outpatient management or hospitalization of patients with proven or suspected SARS-CoV-2 infection: the HOME-CoV rule.

Intern Emerg Med 2020 Nov 4;15(8):1525-1531. Epub 2020 Sep 4.

Emergency Department, CHU Angers, 4 rue Larrey, 49100, Angers, France.

In the context of the COVID-19 pandemic and overloaded hospitals, a central issue is the need to define reliable and consensual criteria for hospitalization or outpatient management in mild cases of COVID-19. Our aim was to define an easy-to-use clinical rule aiming to help emergency physicians in hospitalization or outpatient management decision-making for patients with suspected or confirmed SARS-CoV-2 infection (the HOME-CoV rule). The Delphi method was used to reach a consensus of a large panel of 51 experts: emergency physicians, geriatricians, infectious disease specialists, and ethical consultants. A preliminary list of eligible criteria was compiled based on a literature review. Four rounds of anonymized expert consultations were performed. The experts were asked to score each item as relevant, possibly relevant and non-relevant, as major or minor, and to choose the cut-off. They were also able make suggestions and remarks. Eight criteria constituting the HOME-CoV were selected: six correspond to the severity of clinical signs, one to the clinical course (clinically significant worsening within the last 24 h), and the last corresponds to the association of a severe comorbidity and an inadequate living context. Hospitalization is deemed necessary if a patient meets one or more of the criteria. In the end, 94.4% of the experts agreed with the defined rule. Thanks to the Delphi method, an absolute consensus was obtained of a large panel of experts on the HOME-CoV rule, a decision-making support mechanism for clinicians to target patients with suspected or confirmed COVID-19 requiring hospitalization.Trial registration: NCT04338841.
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http://dx.doi.org/10.1007/s11739-020-02483-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7550768PMC
November 2020

Comparison of the Wells score and the revised Geneva score as a tool to predict pulmonary embolism in outpatients over age 65.

Thromb Res 2020 12 14;196:120-126. Epub 2020 Aug 14.

Centre Hospitalier d'Agen-Nérac, Site St Esprit, 21 route de Villeneuve, 47923 Agen, France.

Title: Comparison of the Wells score and the revised Geneva score as a tool to predict pulmonary embolism in outpatients over 65 years of age.

Introduction: The incidence and mortality of pulmonary embolism (PE) is high in the elderly. The Wells score (SW) and the revised Geneva score (RGS) have been validated in patient populations with a large age range. The aim of this study was to compare the predictive accuracy of these two scores in diagnosis of PE in patients over 65 years of age.

Method: A prospective multicentre study (nine French and three Belgian centres) was conducted at the same time as the PERCEPIC study. A total of 1757 patients admitted with suspected PE were included and divided into two groups according to age (≥65 years or <65 years). The pre-test probability of PE was assessed prospectively for the RGS. The SW was calculated retrospectively. The predictive accuracy of the two scores was compared by the area under the curve (AUC) of the ROC curves.

Results: The overall prevalence of PE was 11.3%. The prevalence among patients aged ≥65 in the low, moderate and high pre-test probability groups, evaluated using the WS and was respectively 13.5% (CI 95%: CI 9.9-17.3), 28.2% (CI 22.1-34.3), 50% (CI 26-74) and 8.1% (CI 3.2-12.9), 22.3% (CI 18.2-26.3), 43.7% (CI 25.6-61.9) using the RGS. The AUC for the WS and RGS for patients aged ≥65 was 0.632 (CI 0.574-0.691) and 0.610 (CI 0.555-0.666). The difference between the AUCs was not statistically significant (p = .441).

Conclusion: In the population for this study, the WS and RGS have the same PE diagnostic accuracy in patients over age 65. This result should be validated in a prospective study that directly compares these scores.
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http://dx.doi.org/10.1016/j.thromres.2020.07.026DOI Listing
December 2020

Major bleeding risk and mortality associated with antiplatelet drugs in real-world clinical practice. A prospective cohort study.

PLoS One 2020 7;15(8):e0237022. Epub 2020 Aug 7.

EA 7449 [Pharmacoepidemiology and Health Services Research] REPERES, Univ Rennes, CHU Rennes, Rennes, France.

Background: Major bleedings other than gastrointestinal (GI) and intracranial (ICH) and mortality rates associated with antiplatelet drugs in real-world clinical practice are unknown. The objective was to estimate major bleeding risk and mortality among new users of antiplatelet drugs in real-world clinical practice.

Methods And Findings: A population-based prospective cohort using the French national health data system (SNIIRAM), identified 69,911 adults living within five well-defined geographical areas, who were new users of antiplatelet drugs in 2013-2015 and who had not received any antithrombotics in 2012. Among them, 63,600 started a monotherapy and 6,311 a dual regimen. Clinical data for all adults referred for bleeding was collected from all emergency departments within these areas, and medically validated. Databases were linked using common key variables. The main outcome measure was time to major bleeding (GI, ICH and other bleedings). Secondary outcomes were death, and event-free survival (EFS). Hazard ratios (HR) were derived from adjusted Cox proportional hazard models. We used Inverse Propensity of Treatment Weighting as a stratified sensitivity analysis according to the antiplatelet monotherapy indication: primary prevention without cardiovascular (CV) risk factors, with CV risk factors, and secondary prevention. We observed 250 (0.36%) major haemorrhages, 81 ICH, 106 GI and 63 other types of bleeding. Incidences were twice as high in dual therapy as in monotherapy. Compared to low-dose aspirin (≤ 100 mg daily), high-dose (> 100 up to 325 mg daily) was associated with an increased risk of ICH (HR = 1.80, 95%CI 1.10 to 2.95). EFS was improved by high-dose compared to low-dose aspirin (1.41, 1.04 to 1.90 and 1.32, 1.03 to 1.68) and clopidogrel (1.30, 0.73 to 2.3 and 1.7, 1.24 to 2.34) respectively in primary prevention with and without CV risk factors.

Conclusion: The incidence of major bleeding and mortality was low. In monotherapy, low-dose aspirin was the safest therapeutic option whatever the indication.

Trial Registration: NCT02886533.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0237022PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7413418PMC
October 2020

Evidence-based guidelines for thromboprophylaxis in patients with lower limb trauma requiring immobilization: an urgent, unmet need.

Eur J Emerg Med 2020 08;27(4):245-246

Emergency Department, Angers university hospital, UMR 1083, UFR santé, Institut Mitovasc, university of Angers, Angers, France.

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http://dx.doi.org/10.1097/MEJ.0000000000000677DOI Listing
August 2020
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