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- SourceAvailable from: Radosław Litwinowicz[Show abstract] [Hide abstract]
ABSTRACT: Determine if readmission to the intensive care unit (ICU) after cardiac surgery procedures is associated with increased mortality. This was a retrospective non-randomized study to evaluate the cause of readmission and mortality rate in patients readmitted to the ICU after cardiac surgery and to compare the clinical variables of patients readmitted to the ICU who died and those who survived. The study was performed in a single university hospital. This was an analysis of 10,992 consecutive adult patients. Readmission rate to the ICU, mortality rate, the reason for readmission to the ICU, type of surgery, length of stay, cause of mortality, and day of the week of ICU readmission were analyzed. All patients underwent cardiac surgery at a single center and were discharged after primary stay from the ICU. A total of 197 (1,8%) of 10,992 patients were readmitted to the ICU. In-hospital mortality rate for patients readmitted and not readmitted to the ICU was 23.9% and 4.7%, respectively. The main causes of ICU readmission were cardiac (40%) and respiratory (37%) complications. The mortality rate in readmitted patients who underwent coronary artery bypass graft (CABG) or valve surgery was 26% and 19%, respectively. Patient readmission to the ICU following cardiac surgery was associated with a 5-fold increase in hospital mortality rate compared to non-readmitted patients. The highest mortality rate was observed among readmitted patients who underwent CABG. Older age, previous myocardial infarction, and initial long length of stay in the post-operative ward were independent risk factors for death after readmission to the ICU. Copyright © 2015 Elsevier Inc. All rights reserved.
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ABSTRACT: Abstract LBA8006^ Background: RAM is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2. The REVEL study evaluated the efficacy and safety of RAM+DOC vs. PL+DOC (DOC) in patients (pts) with stage IV nonsquamous (NSQ) and squamous (SQ) NSCLC after platinum-based therapy. Methods: Pts with NSQ and SQ stage IV NSCLC were randomized 1:1 (stratified by sex, region, ECOG PS, and prior maintenance therapy) to receive DOC 75 mg/m2 in combination with either RAM 10 mg/kg or PL on day 1 of a 21-day cycle until disease progression, unacceptable toxicity, or death. The primary endpoint was overall survival (OS). Secondary efficacy endpoints included progression-free survival (PFS), and objective response rate (ORR). Results: Between Dec 2010 and Feb 2013, 1,253 pts (26.2% SQ) were randomized (RAM+DOC: 628; DOC: 625). Pt characteristics were balanced between arms. ORR was 22.9% for RAM+DOC and 13.6% for DOC (P<0.001). The hazard ratio (HR) for PFS was 0.762 (P<0.0001); median PFS was 4.5 months (m) for RAM+DOC vs. 3.0m for DOC. REVEL met its primary endpoint; the OS HR was 0.857 (95% CI 0.751, 0.98; P=0.0235); median OS was 10.5m for RAM+DOC vs. 9.1m for DOC. OS was longer for RAM+DOC in most pt subgroups, including SQ and NSQ histology. Grade ≥3 adverse events (AEs) occurring in >5% of pts on RAM+DOC were neutropenia (34.9% vs. 28.0%), febrile neutropenia (15.9% vs. 10.0%), fatigue (11.3% vs. 8.1%), leukopenia (8.5% vs. 7.6%), hypertension (5.4% vs. 1.9%), and pneumonia (5.1% vs. 5.8%). Grade 5 AEs were comparable between arms (5.4% vs. 5.8%), as was pulmonary hemorrhage (any grade; all pts: 2.1% vs. 1.6%; SQ pts: 3.8% vs. 2.4%). Conclusions: REVEL demonstrated a statistically significant improvement in ORR, PFS, and OS for RAM+DOC vs DOC in NSCLC pts with stage IV NSCLC as second-line treatment after platinum-based therapy. Benefits were similar in NSQ and SQ pts, and no unexpected AEs were identified. Clinical trial information: NCT01168973.
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