BackgroundRisk stratification of patients in the emergency department can be strengthened using prognostic biomarkers, but the impact on patient prognosis is unknown. The aim of the TRIAGE III trial was to investigate whether the introduction of the prognostic and nonspecific biomarker: soluble urokinase plasminogen activator receptor (suPAR) for risk stratification in the emergency department reduces mortality in acutely admitted patients.MethodsThe TRIAGE III trial was a cluster-randomized interventional trial conducted at emergency departments in the Capitol Region of Denmark. Eligible hospitals were required to have an emergency department with an intake of acute medical and surgical patients and no previous access to suPAR measurement. Three emergency departments were randomized; one withdrew shortly after the trial began. The inclusion period was from January through June of 2016 consisting of twelve cluster-periods of 3-weeks alternating between intervention and control and a subsequent follow-up of ten months. Patients were allocated to the intervention if they arrived in interventional periods, where suPAR measurement was routinely analysed at arrival. In the control periods suPAR measurement was not performed. The main outcome was all-cause mortality 10 months after arrival of the last patient in the inclusion period. Secondary outcomes included 30-day mortality.ResultsThe trial enrolled a consecutive cohort of 16,801 acutely admitted patients; all were included in the analyses. The intervention group consisted of 6 cluster periods with 8900 patients and the control group consisted of 6 cluster periods with 7901 patients. After a median follow-up of 362 days, death occurred in 1241 patients (13.9%) in the intervention group and in 1126 patients (14.3%) in the control group.The weighted Cox model found a hazard ratio of 0.97 (95% confidence interval, 0.89 to 1.07; p = 0.57). Analysis of all subgroups and of 30-day all-cause mortality showed similar results.ConclusionsThe TRIAGE III trial found no effect of introducing the nonspecific and prognostic biomarker suPAR in emergency departments on short- or long-term all-cause mortality among acutely admitted patients. Further research is required to evaluate how prognostic biomarkers can be implemented in routine clinical practice.Trial registrationclinicaltrials.gov, NCT02643459. Registered 31 December 2015.Electronic supplementary materialThe online version of this article (10.1186/s13049-018-0539-5) contains supplementary material, which is available to authorized users.
Funding Acknowledgements Type of funding sources: Foundation. Main funding source(s): Novo Nordisk Foundation Background Previous studies have found lower survival rate and neurological outcomes for female patients with out-of-hospital cardiac arrest (OHCA) compared to males. Recently, the effect of liberal or restrictive oxygenation and lower or higher mean arterial blood-pressures (MAP) on outcome in comatose OHCA patients were investigated; showing no differences between the target groups. Evidence concerning sex differences in outcome after appropriate oxygenation and different MAP levels in comatose OHCA patients is limited. Purpose The aim of this study was to investigate whether female sex was associated with higher rates of unfavourable outcome after treatment with oxygenation and MAP in comatose patients after OHCA related to outcome. Methods Adult comatose OHCA patients (age ≥18 years) of presumed cardiac cause were included in a dual-center, double-blind, randomized trial with a 2-by-2 factorial design. Patients were allocated by a 1:1:1:1 ratio into a MAP target of 63 mm Hg or 77 mm Hg and arterial oxygen concentration during mechanical ventilation of 9–10 kPa (restrictive) or 13–14 kPa (liberal). The primary outcome was a composite of all causes of death within a year or hospital discharge with a cerebral performance category (CPC) of 3 or 4. Results Of the 789 included comatose OHCA patients, 152 (19%) were women. Mean age of women and men were similar, 61±14 years and 63±13 years, respectively. Comorbidities and characteristics of the cardiac arrest were comparable between sexes except for ischemic heart disease, which was more frequent in men (12% women, 24% men) and pulseless electrical activity, which was more frequent in women (8% women, 4% men). CPC 3 or 4 occurred equally in women and men (both 3%). Women had a higher, but non-significant one-year all-cause mortality (women: 42%, men: 35%), Figure 1. In a univariate Cox regression model, the difference in all-cause mortality was not significant (HR: 1.25, CI: 0.95-1.63), but showed significance after adjustment for age (HR: 1.31, CI: 1.004-1.72). Conclusion Men and women in comatose after OHCA had similar unfavourable outcome when treated in the same manner with oxygenation and MAP.
Funding Acknowledgements Type of funding sources: None. Background Differences in outcome between men and women among patients with acute myocardial infarction (AMI) have previously been investigated[1–4], while evidence concerning sex differences in patients with AMI complicated by cardiogenic shock (AMICS) is limited. Purpose The aim of this study was to investigate sex differences in patients with AMICS related to demographics, treatment and long-term outcome. Methods All adult patients (age ≥18 years) with AMICS hospitalized at one of two tertiary heart centers with a catchment area corresponding to 4 million citizens were included in this study. In the study period from January 1st, 2010 to December 31st, 2017, a total of 1716 AMICS patients were identified following individual validation. Data regarding patient characteristics, treatment and clinical outcome including short-term follow-up were extracted from medical records and an 8,5-year long-term follow-up were obtained from the national patients registry. A multivariate cox regression model was used to adjust for significant sex differences known to be associated with outcome in AMICS including age and an out-of-hospital cardiac arrest (OHCA) presentation. Results Of the 1716 included AMICS patients, 438 (26%) were women. Women were older than men, 71±12 years and 66±11 years, P=<0.0001, respectively. Patients characteristics were similar between sex except for hypertension which was more common among women. Women were more often initially admitted to a local hospital (41% women and 30% men, P=<0.0001), while more men presented with OHCA (25% women and 48% men, P=<0.0001), which persisted after adjustment for age. At the time of shock development, women and men were comparable regarding blood pressure (mean: both 82 mmHg, P=0.44), heart rate (mean: 88 vs. 85 bpm, P=0.10), p-lactate (median: 5.2 vs. 5.5 mM, P=0.07), and left ventricular ejection fraction (median: both 30%, P=0.11). However, fewer women were treated with mechanical circulatory support (19% women and 26% men, P=0.002), which persisted following multivariate adjustment. Additionally, women were associated with a lower use of acute revascularization (83% women and 88% men, P=0.006) including percutaneous coronary intervention (n=1405) and coronary artery bypass graft (n=101) and mechanical ventilation (67% women and 82% men, P=<0.0001). These significant signals did not remain following cox regression analysis. Women had a significantly higher short-term as well as long-term mortality rate, which persisted in the multivariate model (Figure 1). Conclusion Women were associated with lower use of mechanical circulatory support devices among AMICS patients. Women had a significantly higher short- and long-term mortality rate compared to men.
ObjectiveTo prospectively validate the CT-Valve score, a new risk score designed to identify patients with valvular heart disease at a low risk of coronary artery disease (CAD) who could benefit from multislice CT (MSCT) first instead of coronary angiography (CAG).MethodsThis was a prospective cohort study of patients referred for valve surgery in the Capital Region of Denmark and Odense University Hospital from the 1 February 2015 to the 1 February 2017. MSCT was implemented for patients with a CT-Valve score ≤7 at the referring physician’s discretion. Patients with a history of CAD or chronic kidney disease were excluded. The primary outcome was the proportion of patients needing reevaluation with CAG after MSCT and risk of CAD among the patients determined to be low to intermediate risk.ResultsIn total, 1149 patients were included. The median score was 9 (IQR 3) and 339 (30%) had a score ≤7. MSCT was used for 117 patients. Of these 29 (25%) were reevaluated and 9 (7.7%) had CAD. Of the 222 patients with a score ≤7 that did not receive an MSCT, 14 (6%) had significant CAD. The estimated total cost of evaluation among patients with a score ≤7 before implementation was €132 093 compared with €79 073 after, a 40% reduction. Similarly, estimated total radiation before and after was 608 mSv and 362 mSv, a 41% reduction. Follow-up at a median of 32 months (18–48) showed no ischaemic events for patients receiving only MSCT.ConclusionThe CT-Valve score is a valid method for determining risk of CAD among patients with valvular heart disease. Using a score ≤7 as a cut-off for the use of MSCT is safe and cost-effective.
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