In this section, we highlight the key high-impact studies, updates, and analyses published in medicine during the past week.
Age of Transfused Blood in Critically Ill Adults
Whether the administration of fresh red blood cells instead of red blood cells that have been stored for a period of time improves outcomes in critically ill patients is unclear. In this international multicenter, randomized, blinded trial conducted between 2009 and 2014, 2430 critically ill patients were assigned to receive red blood cells that have been stored for less than 8 days or red blood cells that were the oldest compatible units available in the blood bank. The primary outcome studied was mortality at 90 days. Red blood cells delivered to the group that received the fresh samples were stored for 6.1±4.9 days (mean±SD) and the aged samples were stored for 22.0±8.4 days (difference significant, p<0.001). 90 day mortality was 37.0% in the fresh blood group and 35.3% in the standard blood group (absolute risk difference: 1.7; 95% CI: -2.1-5.5). The hazard ratio for death in the fresh blood group as compared to the standard blood group was 1.1 (95% CI: 0.9-1.2; p value=0.38). No significant differences in groups were found for major illness, duration of respiratory, hemodynamic, or renal support, length of stay in the hospital, or transfusion reactions. The study thus concluded that transfusion of fresh blood cells did not decrease mortality in critically ill patients compared to the transfusion of standard red blood cells.
The data is limited for the use of folic acid for the primary prevention of stroke. In this randomized, doubled blinded clinical trial conducted between 2008-2013 in 32 communities in China, 20702 adults with hypertension and no prior strokes or myocardial infarctions were randomized to receive either 10 mg of enalapril and folic acid or 10 mg of enalapril alone. First stroke was the primary outcome. Secondary outcomes were first ischemic stroke, first hemorrhagic stroke, a composite of cardiovascular events, and mortality from all causes. 2.7% of patients in the enalapril and folic acid cohort experienced first stroke as compared to 3.4% in the enalapril alone group over a median of 4.5 years (hazard ration, 0.79; 95% CI 0.68-0.93). First ischemic stroke and composite cardiovascular events were similarly lower in the folic acid and enalapril group as compared to enalapril alone. No significant difference was observed in the risk of hemorrhagic stroke or all cause deaths between two groups. Thus, addition of folic acid appears to have beneficial effects in patients with hypertension.
Randomized Trial of Primary PCI with or without Routine Manual Thrombectomy
Whether manual thrombectomy improves outcomes of primary percutaneous coronary intervention (PCI) is unclear. 10,732 patients with STEMIs were randomized to manual thrombectomy with PCI versus PCI alone. Primary outcomes included composite deaths from cardiovascular causes, recurrent myocardial infarction, cardiogenic shock, or heart failure within 180 days. Safety was evaluated by the risk of stroke within 30 days. 6.9% of patients in the thrombectomy group versus 7% of patients in the PCI alone group experienced the primary outcome (hazard ratio in thrombectomy group, 0.99; 95% CI: 0.85-1.15; p value 0.86). Stroke within 30 days was observed in 0.7% of patients in the thrombectomy group as compared to 0.3% of patients in the PCI alone group (hazard ratio, 2.06; 95% CI: 1.13-3.75; p value 0.02). Thus, manual thrombectomy did not reduce deaths within 180 days but increased the risk of stroke within 30 days in patients with STEMIs.
The safety and efficacy of bivalirudin as compared to heparin in the treatment of patients with myocardial infarctions with the need for percutaneous coronary interventions is unknown. In this 82 center, open label, randomized trial in China between 2012 and 2013, 2194 patients were assigned to bivalirudin alone group, heparin alone group or heparin plus tirofiban (glycoprotein IIb/IIa inhibitor) group. The primary outcome was 30 day net adverse clinical events. Safety was measured by rates of acquired thrombocytopenia at 30 days and stent thrombosis at 30 days and 1 year. 8.8% of patients in the bivalirudin group as compared to 13.2% of patients in the heparin group experienced net adverse clinical events at 30 days (relative risk, RR, 0.67; 95% CI, 0.50-0.90; difference -4.3%; 95% CI: -7.5% to -1.1%; p=0.008). 17.0% of patients in the heparin plus tirofiban group experienced net adverse clinical events at 30 days (RR for bivalirudin vs heparin plus tirofiban, 0.52; 95% CI, 0.39-0.69; difference -8.1%; 95% CI, -11.6% to -4.7%; p <0.001). No difference was observed in the rates of acquired thrombocytopenia or stent thrombosis at 30 days or 1 year. Thus, bivalirudin appears to be superior to either heparin or heparin plus tirofiban in patients with myocardial infarctions undergoing primary percutaneous coronary interventions.
This case report described the treatment of Ebola virus and its complications, including vascular leakage and multiorgan failure, at a tertiary care center under biosafety level 4 conditions. The case report describes a 38 year old man, who was working as a physician in Sierra Leone and acquired an Ebola virus infection. He subsequently received treatment starting at day 5 after the disease onset at a high level isolation unit at the University Hospital in Frankfurt, Germany. Within 72 hours of admission, he developed lung, kidney and gastrointestinal tract failures. He received a full diagnostic work up, required mechanical ventilation due to pulmonary edema and the vascular leak syndrome, received a 3 day treatment course of FX06, which is a fibrin derived peptide that is under current investigation for the treatment of the vascular leak syndrome, received broad spectrum empiric antimicrobial therapy and the renal replacement therapy. Following, the patient recovered fully, showing that the treatment of Ebola virus appears to be effective in a setting of a specialized hospital with the necessary resources.
Image: PD
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