Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol.

INTRODUCTION: Mechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT. METHODS AND ANALYSIS: DIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0-2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0-2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0-1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment. ETHICS AND DISSEMINATION: The DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal. TRIAL REGISTRATION NUMBER: NCT03969511.

The mortality rates in registries of patients with STEMI are highly affected by inclusion criteria and population characteristics.

BACKGROUND: Different mortality rates are reported in registries of patients with ST-segment elevation myocardial infarction (STEMI), but comparisons between registries are challenging. AIMS: To determine whether the higher mortality rate in our regional French registry (SCALIM) is related to different inclusion criteria and demographic characteristics. METHODS: The SCALIM registry included all patients with STEMI within the first 24 h in the region of Limousin, France (06/2011-01/2015). To compare mortality rates with other contemporary registries in France and European neighbouring countries, the others' inclusion criteria were applied to the SCALIM registry. RESULTS: Among 1501 patients included, in-hospital and 1-month mortality were 8.2% and 8.8% respectively, significantly higher than many other registries. The use of inclusion criteria from EMUST (France), MINAP (UK) or LOMBARDIMA (Italy) markedly decreased the number of enrolled patients by 64%, 36%, and 21%, respectively. When those inclusion criteria were applied to the SCALIM registry, difference in in-hospital and 1-month mortality rates between other registries and ours remained significant. In the multivariate analysis, age, initial acute pulmonary oedema (Killip class ≥2), complication occurring before percutaneous coronary intervention, absence of transfer to an interventional cardiology centre for primary angioplasty and lack of reperfusion therapy within 12 h were associated with higher risk of 1-month mortality (all p < 0.05). Age (65 versus 63.3 years, p < 0.001) was higher and reperfusion rate (84.2 versus 74.7%, p < 0.001) was significantly lower in SCALIM than FAST-MI, the national French registry on STEMI patients. Interestingly, the 3% of patients included in SCALIM who would be excluded from FAST-MI registry had 91% mortality at one month. CONCLUSION: Higher mortality rate in our regional SCALIM registry is in part due to differences in inclusion criteria and demographic data. Consensus should be made to harmonise inclusion criteria in STEMI registries for the sake of comparability.

Is prehospital endobronchial intubation a risk factor for subsequent ventilator associated pneumonia? A retrospective analysis.

More than half of patients under mechanical ventilation in the intensive care unit (ICU) are field-intubated, which is a known risk factor for ventilator associated pneumonia (VAP). We assessed whether field endobronchial intubation (EBI) is associated with the development of subsequent VAP during the ICU stay. This retrospective, nested case-control study was conducted in a cohort of field-intubated patients admitted to an ICU of a teaching hospital during a three-year period. Cases were defined as field-intubated patients with EBI and controls corresponded to field-intubated patients with proper position of the tracheal tube on admission chest X-ray. Primary endpoint was the development of early VAP. Secondary endpoints included the development of early ventilator associated tracheo-bronchitis, late VAP, duration of mechanical ventilation, length of stay and mortality in the ICU. A total of 145 patients were studied (mean age: 54 ± 19 years; men: 74%). Reasons for field intubation were predominantly multiple trauma (49%) and cardiorespiratory arrest (38%). EBI was identified in 33 patients (23%). Fifty-three patients (37%) developed early or late VAP. EBI after field intubation was associated with a nearly two-fold increase of early VAP, though not statistically significant (30% vs. 17%: p = 0.09). No statistically significant difference was found regarding secondary outcomes. The present study suggests that inadvertent prehospital EBI could be associated with a higher incidence of early-onset VAP. Larger studies are required to confirm this hypothesis. Whether strategies aimed at decreasing the incidence and duration of EBI could reduce the incidence of subsequent VAP remains to be determined.