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Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

ABSTRACT: BACKGROUND:Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown. OBJECTIVES:The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge. METHODS:MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ?50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events. RESULTS:In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). CONCLUSIONS:Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).

SUBMITTER: Spyropoulos AC

PROVIDER: S-EPMC7308003 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Spyropoulos Alex C AC Ageno Walter W Albers Gregory W GW Elliott C Gregory CG Halperin Jonathan L JL Hiatt William R WR Maynard Gregory A GA Steg P Gabriel PG Weitz Jeffrey I JI Lu Wentao W Spiro Theodore E TE Barnathan Elliot S ES Raskob Gary E GE

Journal of the American College of Cardiology 20200601 25

<h4>Background</h4>Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown.<h4>Objectives</h4>The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge.<h4>Methods</h4> ...[more]

PMID: 32586587

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Project description:BackgroundSurgical prophylaxis for venous thrombo-embolic disease (VTE) includes risk assessment, chemical prophylaxis and mechanical prophylaxis (graduated compression stockings [GCS] and/or intermittent pneumatic compression devices [IPCD]). Although there is overwhelming evidence for the need and efficacy of VTE prophylaxis in patients at risk, only about a third of those who are at risk of VTE receive appropriate prophylaxis.ObjectiveThere is debate as to the best combination of VTE prophylaxis following abdominal surgery due to lack of evidence. The aim of this survey was to understand this gap between knowledge and practice.MethodsIn 2019 and 2020, a survey was conducted to investigate the current practice of venous thromboembolism (VTE) prophylaxis for major abdominal surgery, with a focus on colorectal resections. The study received ethics approval and involved distributing an 11-item questionnaire to members of two professional surgical societies: the Colorectal Surgical Society of Australia and New Zealand (CSSANZ) and the General Surgeons Australia (GSA).ResultsFrom 214 surgeons: 100% use chemical prophylaxis, 68% do not use a risk assessment tool, 27% do not vary practice according to patient risk factors while > 90% use all three forms of VTE prophylaxis at some stage of treatment. Most surgeons do not vary practice between laparoscopic and open colectomy/major abdominal surgery and only 33% prescribe post-discharge chemical prophylaxis. 42% of surgeons surveyed had equipoise for a clinical trial on the use of IPCDs and the vast majority (> 95%) feel that IPCDs should provide at least a 2% improvement in VTE event rate in order to justify their routine use.ConclusionMost surgeons in Australia and New Zealand do not use risk assessment tools and use all three forms of prophylaxis regardless. Therfore there is a gap between practice and VTE prophylaxis for the use of mechanical prophylaxis options. Further research is required to determine whether dual modality mechanical prophylaxis is incrementally efficacious. Trial Registration- Not Applicable.

Project description:BackgroundSeveral biomarkers of AKI have been examined for their ability to predict AKI before serum creatinine. Few studies have focused on using kidney biomarkers to better predict major adverse kidney events (MAKE), an increasingly used composite outcome in critical care nephrology research.MethodsSingle-center prospective study collecting blood and urine samples from critically ill patients with AKI Kidney Disease Improving Global Outcomes stage 2 or above, and matched controls from a single, tertiary care intensive care unit (ICU). Samples were collected at 24-48 hours after AKI diagnosis (patients) or ICU admission (controls), 5-7 days later, and 4-6 weeks after discharge for patients with AKI. The primary outcome of interest was MAKE at hospital discharge (MAKE-DC), consisting of the composite end point of death, RRT dependence, or a decrease in estimated glomerular filtration to <75% of baseline.ResultsSerum/urinary neutrophil gelatinase-associated lipocalin (NGAL), serum/urinary cystatin C, and urinary kidney injury molecule-1 early in the AKI or ICU course were all significantly higher in patients with MAKE-DC compared with those not experiencing MAKE-DC. Additionally, serum/urinary NGAL and serum cystatin C measurements at the first time point remained significantly associated with MAKE events at 3, 6, and 12 months. Serum cystatin C, and to a lesser extent serum NGAL, significantly improved upon a logistic regression clinical prediction model of MAKE-DC (AUROC 0.94 and 0.87 versus 0.83; P=0.001 and P=0.02, respectively). Patients without MAKE-DC experienced a greater decline in serum NGAL from first to second measurement than those patients experiencing MAKE-DC.ConclusionsEarly measures of kidney biomarkers in patients who are critically ill are associated with MAKE-DC. This relationship appears to be greatest with serum NGAL and cystatin C, which display additive utility to a clinical prediction model. Trending serum NGAL may also have utility in predicting MAKE-DC.

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Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

Publications

Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.

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