Targeted prophylactic anticoagulation based on the TRiP(cast) score in patients with lower limb immobilisation: a multicentre, stepped wedge, randomised implementation trial.

BACKGROUND: Prophylactic anticoagulation in emergency department patients with lower limb trauma requiring immobilisation is controversial. The Thrombosis Risk Prediction for Patients with Cast Immobilisation-TRiP(cast)-score could identify a large subgroup of patients at low risk of venous thromboembolism for whom prophylactic anticoagulation can be safely withheld. We aimed to prospectively assess the safety of withholding anticoagulation for patients with lower limb trauma at low risk of venous thromboembolism, defined by a TRiP(cast) score of less than 7. METHODS: CASTING was a stepped-wedge, multicentre, cluster-randomised trial with blinded outcome assessment. 15 emergency departments in France and Belgium were selected and randomly assigned staggered start dates for switching from the control phase (ie, anticoagulation prescription according to the physician's usual practice) to the intervention phase (ie, targeted anticoagulation according to TRiP(cast) score: no prescription if score <7 and anticoagulation if score was ≥7). Patients were included if they presented to a participating emergency department with lower limb trauma requiring immobilisation for at least 7 days and were aged 18 years or older. The primary outcome was the 3-month cumulative rate of symptomatic venous thromboembolism during the intervention phase in patients with a TRiP(cast) score of less than 7. The targeted strategy was considered safe if this rate was less than 1% with an upper 95% CI of less than 2%. The primary analysis was performed in the intention-to-treat population. This study is registered at ClinicalTrials.gov (NCT04064489). FINDINGS: Between June 16, 2020, and Sept 15, 2021, 15 clusters and 2120 patients were included. Of the 1505 patients analysed in the intervention phase, 1159 (77·0%) had a TRiP(cast) score of less than 7 and did not receive anticoagulant treatment. The symptomatic venous thromboembolism rate was 0·7% (95% CI 0·3-1·4, n=8/1159). There was no difference between the control and the intervention phases in the cumulative rate of symptomatic venous thromboembolism or in bleeding rates. INTERPRETATION: Patients with a TRiP(cast) score of less than 7 who are not receiving anticoagulation have a very low risk of venous thromboembolism. A large proportion of patients with lower limb trauma and immobilisation could safely avoid thromboprophylaxis. FUNDING: French Ministry of Health.

Effectiveness of a multimodal intervention to improve blood culture collection in an adult emergency department.

We investigated the impact of a multimodal intervention to improve the compliance of BC collections as a composite outcome, taking into account both blood volume collected and absence of solitary BC. We performed a quasi-experimental study using a before-after design (5 months for pre- and post-intervention evaluation) in an adult emergency department at a tertiary care hospital that showed that a multimodal intervention was associated with a dramatic increase in the proportion of blood cultures that were collected as recommended per national guidelines, from 17.3% (328/1896) to 68.9% (744/1080), P < 0.0001. The implementation of such intervention in other settings could improve the diagnosis of bloodstream infections and reduce irrelevant costs.

Out-of-Hospital Cardiac Arrest Detection by Machine Learning Based on the Phonetic Characteristics of the Caller's Voice.

INTRODUCTION: Out-of-hospital cardiac arrest (OHCA) is a major public health issue. The prognosis is closely related to the time from collapse to return of spontaneous circulation. Resuscitation efforts are frequently initiated at the request of emergency call center professionals who are specifically trained to identify critical conditions over the phone. However, 25% of OHCAs are not recognized during the first call. Therefore, it would be interesting to develop automated computer systems to recognize OHCA on the phone. The aim of this study was to build and evaluate machine learning models for OHCA recognition based on the phonetic characteristics of the caller's voice. METHODS: All patients for whom a call was done to the emergency call center of Rennes, France, between 01/01/2017 and 01/01/2019 were eligible. The predicted variable was OHCA presence. Predicting variables were collected by computer-automatized phonetic analysis of the call. They were based on the following voice parameters: fundamental frequency, formants, intensity, jitter, shimmer, harmonic to noise ratio, number of voice breaks, and number of periods. Three models were generated using binary logistic regression, random forest, and neural network. The area under the curve (AUC) was the primary outcome used to evaluate each model performance. RESULTS: 820 patients were included in the study. The best model to predict OHCA was random forest (AUC=74.9, 95% CI=67.4-82.4). CONCLUSION: Machine learning models based on the acoustic characteristics of the caller's voice can recognize OHCA. The integration of the acoustic parameters identified in this study will help to design decision-making support systems to improve OHCA detection over the phone.

Ground-level falls among nonagenarians: the impact of pre-injury antithrombotic therapy.

Among nonagenarians admitted to our emergency department (ED) for ground-level falls, we assessed the impact of pre-injury antithrombotic (AT) treatment on the post-traumatic consequences, and identified risk factors for 1-month mortality. All eligible patients were consecutively included over an 18-month period. Head trauma was attested by reliable medical history, witnesses or recent external signs. Patient characteristics, post-traumatic consequences and outcomes were compared across patients with and without AT. Risk factors for 1-month mortality were assessed using multivariate logistic regression analyses. 1014 consecutive nonagenarians were analysed, 675 (66.6%) with AT and 339 (33.4%) without. Head trauma (n = 429, 42.3%) was significantly more frequent among patients with AT (49.2 vs 28.6%, p < 0.001). Intracranial hemorrhage (ICH, n = 43, 4.2%), mostly subdural hematomas (58%), were more frequently found among patients with AT (p < 0.015). At least one fracture was diagnosed for 23.9% of the population, mostly hip fractures, without any significant association with AT. At 1 month, 103 patients (10.2%) had died. The independent risk factors for 1-month mortality were: ICH associated with head trauma (OR = 5.9, 95% CI 2.5-14), Glasgow coma score ≤ 12 at admission (OR = 10; 95% CI 2.2-46), atrial fibrillation (OR = 2.2, 95% CI 1.4-3.4) and age ≥ 95 years (OR = 1.6, 95% CI 1.0-2.5). Our results support accurate and regular assessment of the benefit/risk ratio for antithrombotic treatment among elderly people at high risk for falls.

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

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.

Analysis of the Feasibility of a Vaccination Campaign against Influenza Epidemic and COVID-19 Pandemic in French Emergency Departments: A National Survey.

BACKGROUND: Vaccination is one of the most effective ways to fight the influenza epidemic and the coronavirus disease 2019 (COVID-19) pandemic, which represent a major public issue. The objective was to investigate the adherence of heads of French emergency departments (ED) and nursing departments on a potential vaccination campaign of healthcare workers (HCW) and patients in ED. METHOD: In February 2021, ED and nursing department heads were asked to answer a national survey. It included 24 questions designed to cover some dimensions, including characteristics of the hospital and emergency departments (ED) and questions on vaccination. RESULTS: 414 responses out of 800 questionnaires (51.8%) were collected. Scores out of 10 were, respectively, 7 (6-8) and 8 (6-9) for vaccination against influenza and COVID-19 for HCW and 2 (2-3) and 2 (2-4) for ED patients (H = 989.3; p < 0.0001). Multivariate logistic regression found that the existence of a vaccine program in the hospital and the use of point of care influenza PCR in ED were positively associated with the acceptance of influenza vaccination campaign for HCW (p = 0.003) and patients (p = 0.015). Factors limiting adherence to a vaccination program of HCW and patients were lack of medical staff (p = 0.041 for HCW and p < 0.0001 for patients), overcrowded ED (p < 0.001), and the inability to follow up with patients after the ED visit (p < 0.0001). CONCLUSIONS: There have been many missed opportunities for influenza vaccination, and there is pressure to vaccinate against COVID-19 as soon as possible. Vaccination campaigns in ED could help to improve vaccination coverage. ED staff are more likely to vaccinate HCW than patients. There are factors that support the implementation of such programs, which can be grouped into a culture of diagnosis, control, and prevention of viral infectious diseases within the hospital and ED. On the other hand, there are limiting factors, such as overcrowding and lack of personnel.

Machine learning is the key to diagnose COVID-19: a proof-of-concept study.

The reverse transcription-polymerase chain reaction (RT-PCR) assay is the accepted standard for coronavirus disease 2019 (COVID-19) diagnosis. As any test, RT-PCR provides false negative results that can be rectified by clinicians by confronting clinical, biological and imaging data. The combination of RT-PCR and chest-CT could improve diagnosis performance, but this would requires considerable resources for its rapid use in all patients with suspected COVID-19. The potential contribution of machine learning in this situation has not been fully evaluated. The objective of this study was to develop and evaluate machine learning models using routine clinical and laboratory data to improve the performance of RT-PCR and chest-CT for COVID-19 diagnosis among post-emergency hospitalized patients. All adults admitted to the ED for suspected COVID-19, and then hospitalized at Rennes academic hospital, France, between March 20, 2020 and May 5, 2020 were included in the study. Three model types were created: logistic regression, random forest, and neural network. Each model was trained to diagnose COVID-19 using different sets of variables. Area under the receiving operator characteristics curve (AUC) was the primary outcome to evaluate model's performances. 536 patients were included in the study: 106 in the COVID group, 430 in the NOT-COVID group. The AUC values of chest-CT and RT-PCR increased from 0.778 to 0.892 and from 0.852 to 0.930, respectively, with the contribution of machine learning. After generalization, machine learning models will allow increasing chest-CT and RT-PCR performances for COVID-19 diagnosis.

Inter-hospital transport of critically ill patients to manage the intensive care unit surge during the COVID-19 pandemic in France.

BACKGROUND: The COVID-19 pandemic led authorities to evacuate via various travel modalities critically ill ventilated patients into less crowded units. However, it is not known if interhospital transport impacts COVID-19 patient's mortality in intensive care units (ICUs). A cohort from three French University Hospitals was analysed in ICUs between 15th of March and the 15th of April 2020. Patients admitted to ICU with positive COVID-19 test and mechanically ventilated were recruited. RESULTS: Among the 133 patients included in the study, 95 (71%) were male patients and median age was 63 years old (interquartile range: 54-71). Overall ICU mortality was 11%. Mode of transport included train (48 patients), ambulance (6 patients), and plane plus helicopter (14 patients). During their ICU stay, 7 (10%) transferred patients and 8 (12%) non-transferred patients died (p = 0.71). Median SAPS II score at admission was 33 (interquartile range: 25-46) for the transferred group and 35 (27-42) for non-transferred patients (p = 0.53). SOFA score at admission was 4 (3-6) for the transferred group versus 3 (2-5) for the non-transferred group (p = 0.25). In the transferred group, median PaO2/FiO2 ratio (P/F) value in the 24 h before departure was 197 mmHg (160-250) and remained 166 mmHg (125-222) in the first 24 h post arrival (p = 0.13). During the evacuation 46 (68%) and 21 (31%) of the patients, respectively, benefited from neuromuscular blocking agents and from vasopressors. Transferred and non-transferred patients had similar rate of nosocomial infections, 37/68 (54%) versus 34/65 (52%), respectively (p = 0.80). Median length of mechanical ventilation was significantly increased in the transferred group compared to the non-transferred group, 18 days (11-24) and 14 days (8-20), respectively (p = 0.007). Finally, ICU and hospital length of stay did not differ between groups. CONCLUSIONS: In France, inter-hospital evacuation of COVID-19 ventilated ICU patients did not appear to increase mortality and therefore could be proposed to manage ICU surges in the future.

Prevention of hypothermia in trauma victims - the HYPOTRAUM 2 study.

INTRODUCTION: Hypothermia is common in trauma patients. It contributes to increasing mortality rate. Hypothermia is multifactorial, favoured by exposure to cold, severity of the patient's state and interventions such as infusion of fluids at room temperature. AIM: To demonstrate that specific management of hypothermia (or of the risk of hypothermia) increases the number of trauma patients arriving at the hospital with a temperature >35°C. DESIGN: This is a prospective, multicentre, open-label, pragmatic, cluster randomized clinical trial of an expected 1,200 trauma patients included by 12 out-of-hospital mobile intensive care units (MICU). Trauma patients are included in a prehospital setting if they present at least one of the following criteria known to be associated with an increased incidence of hypothermia: ambient temperature <18°C, Glasgow coma scale <15, systolic arterial blood pressure <100 mm Hg or body temperature <35°C. Patients are randomized, by cluster, to receive a conventional management or 'interventional' nursing management associating: continuous epitympanic temperature monitoring, early installation in the heated ambulance (temperature target >30°C controlled by infrared thermometer), protection by a survival blanket, and use of heated solutes (temperature objective >35°C controlled by infrared thermometer). The primary end point is the prevalence of hypothermia on arrival at the hospital. The hypothesis tested is a reduction from 20% to 13% in the prevalence of hypothermia. Secondary end points are to evaluate the interaction between the effectiveness of the measures taken and: (1) the severity of the patients assessed by the Revised Trauma Score; (2) the meteorological conditions when they are managed; (3) the time of care; and (4) therapeutic interventions. DISCUSSION: This trial will assess the effectiveness of an invasive, out-of-hospital, temperature management on the onset of hypothermia in moderate to severe trauma patients. IMPACT: Specific management of hypothermia is expected to decrease hypothermia in trauma patients.

Nitrous oxide/oxygen plus acetaminophen versus morphine in ST elevation myocardial infarction: open-label, cluster-randomized, non-inferiority study.

BACKGROUND: Studies have shown disparate results on the consequences of morphine use in ST-segment elevation myocardial infarction (STEMI). No study has evaluated alternative treatments that could be at least non-inferior to morphine without its potentially damaging consequences for myocardial function and platelet reactivity. The aim of this study was to evaluate whether nitrous oxide/oxygen plus intravenous acetaminophen (NOO-A) is non-inferior to morphine to control chest pain in STEMI patients. METHODS: This multicenter, open-label, cluster-randomized, controlled, non-inferiority study compared NOO-A with morphine in 684 prehospital patients with ongoing suspected STEMI of < 12 h duration and a pain rating score ≥ 4. The primary endpoint was the proportion of patients achieving pain relief (numeric rating score ≤ 3) after 30 min. Secondary safety endpoints included serious adverse events and death at 30 days. RESULTS: The median baseline pain score was 7.0 in both groups. The primary endpoint occurred in 51.7% of the NOO-A group and 73.6% of the morphine group (absolute risk difference - 21.7%; 95% confidence interval - 29.6 to - 13.8). At 30 days, the rate of serious adverse events was 16.0 and 18.8% in the NOO-A and morphine groups respectively (p = NS). The rate of death was 1.8% (NOO-A group) and 3.8% (morphine group) (p = NS). CONCLUSION: Analgesia provided by NOO-A was inferior to morphine at 30 min in patients with acute STEMI in the prehospital setting. Rates of serious adverse events did not differ between groups. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02198378.

Patient care pathways in acute heart failure and their impact on in-hospital mortality, a French national prospective survey.

BACKGROUND: Our purpose was to describe the care pathway of patients hospitalized for acute heart failure (AHF) and investigate whether a management involving a cardiology department had an impact on in-hospital mortality. METHODS: Between June 2014 and October 2018, we included patients hospitalized for AHF in 24 French hospitals. Characteristics of the episode, patient's care pathway and outcomes were recorded on a specific assessment tool. The primary outcome was the association between patient care pathway and in-hospital mortality. The independent association between admission to a cardiology ward and in-hospital mortality was assessed through a multivariate regression model and propensity score matching. RESULTS: A total of 3677 patients, mean age of 78, were included. The in-hospital mortality rate was 8% (n = 287) and was associated on multivariate regression with advanced age, presence of sepsis, of cardiogenic shock, high New York Heart Association (NYHA) score and increased plasma creatinine level on admission. High blood pressure and admission to a cardiology department appeared as protective factors. After propensity score matching, hospitalization in a cardiology department remained a protective factor of in-hospital mortality (OR = 0.61 [0.44-0.84], p = 0.002). CONCLUSION: A hospital course of care involving a cardiology department was associated with an increase in hospital survival in AHF patients. These finding may highlight the importance of collaboration between cardiologists and other in-hospitals specialties, such as emergency physicians, in order to find the best in-hospital pathway for patients with AHF.Clinical Trial NCT03903198.

Assessment of procedural pain in French emergency departments: a multi-site, non-interventional, transverse study in patients with minor trauma injury.

Objective: To determine the mean number of procedural painful episodes per patient, and to retrieve information regarding diagnosis, therapeutic procedures and analgesic management, in patients visiting Emergency Departments (EDs) for minor trauma. Methods: This observational, non-interventional, multicenter study in adult patients was performed in 35 French EDs. All patients entering the EDs for minor trauma on a specified day between noon and 10 pm were registered; consenting patients were included in the study. Pain intensity was assessed using a verbal Numerical Rating Scale from 0 (no pain) to 10 (worst possible pain). An episode was described as painful if the difference in pain intensity between pain just before the procedure and maximal pain during the procedure was ≥2. Two independent nurses recorded data on 1 day in each center. Results: Overall, 909 patients were registered, 422 were included in the study, and complete data for 409 patients (1899 procedures) were available for analysis. The mean number of painful episodes per patient was 1.0 ± 1.3. Fifty-one percent of patients reported at least one painful procedure episode. Twenty-one percent of procedures were considered painful. Clinical examination was the procedure most often reported as painful. No preventive or curative analgesic treatment was reported in 95.1% of procedures. Conclusions: There is a need for improvement in routine pain assessment and, therefore, procedural pain management for ED patients. Specific protocols should be developed for procedural pain management, and teams should be trained especially for procedures usually not considered painful.

Impact of acute infarct-related artery patency before percutaneous coronary intervention on 30-day outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention in the EUROMAX trial.

AIMS: Early infarct-related artery patency has been associated with improved outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. However, it is unknown whether this relationship persists in contemporary practice with pre-hospital initiation of treatment, use of novel P2Y12 inhibitors and frequent use of drug-eluting stents. The purpose of the study was to determine the impact of early infarct-related artery patency on outcomes in the contemporary EUROMAX trial. METHODS AND RESULTS: A total of 2218 patients were enrolled. The current analysis was done on 1863 patients who underwent percutaneous coronary intervention and had infarct-related artery patency data. Thirty-day outcomes were compared according to infarct-related artery flow before percutaneous coronary intervention (Thrombolysis in Myocardial Infarction (TIMI) flow 0/1 vs. TIMI flow 2/3), and interaction with antithrombotic strategy was examined. A patent infarct-related artery (TIMI flow 2/3) was present in 707 patients (37.9%) and was associated with a higher rate of final TIMI 3 flow grade (98.9 vs. 92.6%; p<0.001). At 30 days, a patent infarct-related artery was associated with lower rates of cardiac death (1.3% vs. 2.9%; p=0.026) and the composite of death or myocardial infarction (2.7% vs. 4.6%; p=0.039). There were no interactions between antithrombotic treatment and the impact of infarct-related artery patency on cardiac death, myocardial infarction, or the composite of death or myocardial infarction (Breslow-Day interaction p-values of 0.21, 0.33 and 0.46, respectively). CONCLUSION: Despite evolution in primary percutaneous coronary intervention strategies, early infarct-related artery patency is still associated with higher procedural success and improved clinical outcomes. The choice of antithrombotic strategy did not interact with the benefits of a patent infarct-related artery at presentation.

One-Year Mortality for Bivalirudin vs Heparins Plus Optional Glycoprotein IIb/IIIa Inhibitor Treatment Started in the Ambulance for ST-Segment Elevation Myocardial Infarction: A Secondary Analysis of the EUROMAX Randomized Clinical Trial.

Importance: Uncertainty exists regarding potential survival benefits of bivalirudin compared with heparin with routine or optional use of glycoprotein IIb/IIIa inhibitors (GPIs) in patients with ST-segment elevation myocardial infarction (STEMI). Few data are available regarding long-term mortality in the context of contemporary practice with frequent use of radial access and novel platelet adenosine diphosphate P2Y12 receptor inhibitors. Objective: To assess the effect of bivalirudin monotherapy compared with unfractionated or low-molecular-weight heparin plus optional GPIs on 1-year mortality. Design, Setting, and Participants: This international, randomized, open-label clinical trial (EUROMAX [European Ambulance Acute Coronary Syndrome Angiography]) included 2198 patients with STEMI undergoing transport for primary percutaneous coronary intervention from March 10, 2010, through June 20, 2013, and followed up for 1 year. Patients were randomized (1:1) in ambulance to bivalirudin monotherapy vs unfractionated or low-molecular-weight heparin plus optional GPIs (control group). Analysis was based on intention to treat. Main Outcomes and Measures: The primary outcome of this prespecified analysis was 1-year mortality. All deaths were adjudicated as cardiac or noncardiac by an independent, blinded clinical events committee. One-year mortality was assessed and examined across multiple prespecified subgroups. Results: Of the 2198 patients enrolled (1675 men [76.2%] and 523 women [23.8%]; median [interquartile range] age, 62 [52-72] years), complete 1-year follow-up data were available for 2164 (98.5%). All-cause 1-year mortality occurred in 118 patients (5.4%). The number of all-cause deaths was the same for both treatment groups (59 deaths; relative risk [RR], 1.02; 95% CI, 0.72-1.45; P = .92). No differences were noted in the rates of 1-year cardiac death (44 [4.0%] for the bivalirudin group vs 48 [4.3%] for the control group; RR, 0.93; 95% CI, 0.63-1.39; P = .74) or noncardiac death (15 [1.4%] for the bivalirudin group vs 11 [1.0%] for the control group; RR, 1.39; 95% CI, 0.64-3.01; P = .40). Results were consistent across the prespecified patient subgroups. The rate of deaths occurring from 30 days to 1 year was also similar (27 [2.5%] in the bivalirudin group vs 25 [2.3%] in the control group; RR, 1.10; 95% CI, 0.64-1.88; P = .73). Conclusions and Relevance: In patients with STEMI who were being transported for primary percutaneous coronary intervention, treatment with bivalirudin or with heparin with optional use of GPI resulted in similar 1-year mortality. The reduced composite end point of death and/or major bleeding at 30 days in the bivalirudin arm of the EUROMAX trial did not translate into reduced cardiovascular or all-cause death at 1 year. Trial Registration: clinicaltrials.gov Identifier: NCT01087723.

Diabetes education of patients and their entourage: out-of-hospital national study (EDUCATED 2).

AIMS: To determine the contributing factors in the successful diabetes education of patients and their entourage. METHODS: Prospective observational study conducted in a pre-hospital setting by 17 emergency services across France (September 2009-January 2011) included all insulin-treated patients (≥18 years) provided that at least one family member was present on scene. Data were collected from patients and their entourage: (1) personal details including language proficiency and educational attainment, (2) treatments, (3) diabetes-related data (log sheets, glucose meter, glucagon, glycated hemoglobin, prior hypoglycemic episodes); (4) care by diabetologist, general practitioner and/or visiting nurse. The main end points were ability to measure capillary blood sugar (patient) and awareness of hypoglycemia symptoms and ability to administer glucagon (entourage). RESULTS: Overall, 561 patients and 736 family members were included; 343 patients (61%) were experiencing a hypoglycemic episode (<2.5 mmol/L). A total of 141 (75%) patients and 343 (50%) family members could measure capillary blood sugar. They could name a median of 2 [0-3‰] hypoglycemia symptoms although 217 (39%) patients and 262 (39%) family members could name no symptom. Few patients (33%) had glucagon available. In multivariate analyses, the main factor associated with better patient education was care by a diabetologist. Lack of an educational qualification and visits by a nurse were associated with poor patient education, and French mother tongue and care by a diabetologist with better education of the entourage. CONCLUSIONS: In France, diabetic patients and their entourage are inadequately educated. Their education benefits most from care by a diabetologist.

Frequency and prognostic significance of access site and non-access site bleeding and impact of choice of antithrombin therapy in patients undergoing primary percutaneous coronary intervention. The EUROMAX trial.

BACKGROUND: The overall impact of post percutaneous coronary intervention (PCI) bleeding on long term prognosis after acute coronary syndromes (ACS) has been established, but it may differ between access and non-access related bleeding events. The impact of antithrombin choice on bleeding may also differ according to the origin of the bleed. We sought to determine the origin of bleeding relative to the access site, its prognostic significance and the respective impact of antithrombin therapy in the EUROMAX trial. METHODS: We performed a blinded review of the case records of all TIMI major or minor bleeds in the EUROMAX trial and assigned them in one of 2 categories: access site bleeds (ASB), or rest of bleeds (ROB). Incidence of bleeding for each category was assessed according to randomization to antithrombotic treatment. RESULTS: A total of 231 out of 2198 patients suffered a TIMI major/minor bleed (10.5%) and ASB accounted for 48.5%, while ROB for 51.5% of the bleeds. Thirty day mortality was 2.5% (50/1967) for patients without a bleed, 2.7% (3/112, p=0.76 vs. no bleed) for patients with ASB, and 10.9% (13/119, p<0.0001 vs. no bleed) for ROB patients. The use of bivalirudin reduced both ASB and ROB with relative risk reductions of 34% and 46% respectively. CONCLUSIONS: In contemporary primary PCI, bleeding originates with equal frequency either at or away from the access site. Access site bleeds were not associated with an excess in 30day mortality, but the rest of the bleeds were. Bivalirudin is associated with a lower risk of bleeding irrespective of origin. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT01087723.

Early invasive strategy in high-risk acute coronary syndrome without ST-segment elevation. The Sisca randomized trial.

BACKGROUND: The optimal therapeutic strategy for patients with high-risk acute coronary syndrome without ST-segment elevation (NSTE-ACS) remains unclear. OBJECTIVE: Our aim was to compare the effectiveness of an early invasive strategy and a delayed invasive strategy in the management of high-risk NSTE-ACS patients. METHODS: This randomized clinical trial in a primarily pre-hospital setting enrolled patients with chest pain, electrocardiographic criteria for an NSTE-ACS, and at least one criterion of severity (ESC criterion or TIMI score >5). Patients were randomized to either an early invasive strategy (tirofiban infusion and coronary angiography within 6h) or delayed invasive strategy (as per guidelines and physician discretion; coronary angiography within 6h was not advised). The primary endpoint was the cumulative incidence of deaths, myocardial infarctions, or urgent revascularizations at 30days of follow-up. Secondary endpoints were failure of delayed management, length of hospital stay and long-term mortality. RESULTS: Between January 2007 and February 2010, 170 patients were enrolled. The cumulative incidence of adverse outcomes was significantly lower for early invasive than delayed management (2% [95% CI 0-9] vs. 24% [95% CI 16-35], p<10(-4)). Delayed management failed in 24% of cases. The length of hospital stay was significantly shorter in patients undergoing angioplasty or treated with tirofiban within 6h (p=0.0003). Long-term mortality was 16% in both arms after a median follow-up of 4.1years. CONCLUSION: An early invasive strategy reduced major adverse cardiac events in patients with high-risk NSTE-ACS. Early angiography or tirofiban (GP IIb/IIIa inhibitor) infusion proved necessary in a quarter of patients assigned to delayed management.

ST-segment-elevation myocardial infarction patients randomized to a pharmaco-invasive strategy or primary percutaneous coronary intervention: Strategic Reperfusion Early After Myocardial Infarction (STREAM) 1-year mortality follow-up.

BACKGROUND: In the Strategic Reperfusion Early After Myocardial Infarction (STREAM) trial, a pharmaco-invasive (PI) strategy was compared with primary percutaneous coronary intervention (pPCI) in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset but unable to undergo pPCI within 1 hour. At 30 days, the PI approach was associated with a nominally but nonstatistically significant lower incidence of the composite primary end point of death, shock, congestive heart failure, and reinfarction when compared with pPCI. The aim of the present study was to determine the effect of these strategies on 1-year mortality. METHODS AND RESULTS: Vital status at 1 year was available in 936 of 944 (99.2%) and 941 of 948 (99.3%) patients in the PI and pPCI arm, respectively. At 1 year, all-cause mortality rates (6.7% versus 5.9%) were similar for PI and pPCI-treated patients (P=0.49; risk ratio, 1.13; 95% confidence interval, 0.79-1.62). Cardiac mortality rates were similar as well (4.0% versus 4.1%, P=0.93; risk ratio, 0.98; 95% confidence interval, 0.62-1.54). Overall, only 34 patients died between day 30 and 1 year, 20 in the PI arm and 14 in the pPCI arm, of whom 20 died of noncardiac reasons (13 in the PI and 7 in the pPCI arm). There was no significant difference in 1-year all-cause mortality between the 2 groups among the prespecified key subgroups. CONCLUSIONS: At 1 year, mortality rates in the PI and pPCI arms were similar in ST-segment-elevation myocardial infarction patients presenting within 3 hours after symptom onset and unable to undergo pPCI within 1 hour. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00623623.