Benefit-Risk Assessment of Rivaroxaban for Extended Thromboprophylaxis After Hospitalization for Medical Illness.

Autor: Raskob GE; Hudson College of Public Health University of Oklahoma Health Sciences Center Oklahoma City OK., Ageno W; Department of Medicine and Surgery University of Insubria Varese Italy., Albers G; Stanford Stroke Center Stanford University Medical Center Stanford CA., Elliott CG; Department of Medicine Intermountain Medical Center and the University of Utah Salt Lake City UT., Halperin J; The Cardiovascular Institute Mount Sinai Medical Center New York NY., Maynard G; University of California, Davis Sacramento CA., Steg PG; Universite Paris-Cite Assistance Publique-Hôpitauxde Paris, and INSERM U-1148 Paris France.; Imperial College, Royal Brompton Hospital London United Kingdom., Weitz JI; McMaster University and the Thrombosis and Atherosclerosis Research Institute Hamilton Ontario Canada., Albanese J; Janssen Research & Development, LLC Raritan NJ., Yuan Z; Janssen Research & Development, LLC Titusville NJ., Levitan B; Janssen Research & Development, LLC Titusville NJ., Lu W; Janssen Research & Development, LLC Raritan NJ., Suh EY; Janssen Research & Development, LLC Raritan NJ., Spiro T; Clinical Development Pharmaceuticals, Bayer U.S. LLC Whippany NJ., Lipardi C; Janssen Research & Development, LLC Raritan NJ., Barnathan ES; Janssen Research & Development, LLC Raritan NJ., Spyropoulos AC; The Donald and Barbara Zucker School of Medicine at Hofstra/Northwell The Feinstein Institute for Medical Research, and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lennox Hill Hospital New York NY.
Jazyk: angličtina
Zdroj: Journal of the American Heart Association [J Am Heart Assoc] 2022 Oct 18; Vol. 11 (20), pp. e026229. Date of Electronic Publication: 2022 Oct 07.
DOI: 10.1161/JAHA.122.026229
Abstrakt: Background Venous thromboembolism (VTE) often occurs after hospitalization in medically ill patients, but the population benefit-risk of extended thromboprophylaxis remains uncertain. Methods and Results The MARINER (Medically Ill Patient Assessment of Rivaroxaban Versus Placebo in Reducing Post-Discharge Venous Thrombo-Embolism Risk) study (NCT02111564) was a randomized double-blind trial that compared thromboprophylaxis with rivaroxaban 10 mg daily versus placebo for 45 days after hospital discharge in medically ill patients with a creatinine clearance ≥50 mL/min. The benefit-risk balance in this population was quantified by calculating the between-treatment rate differences in efficacy and safety end points per 10 000 patients treated. Clinical characteristics of the study population were consistent with a hospitalized medical population at risk for VTE. Treating 10 000 patients with rivaroxaban resulted in 32.5 fewer symptomatic VTE and VTE-related deaths but was associated with 8 additional major bleeding events. The treatment benefit was driven by the prevention of nonfatal symptomatic VTE (26 fewer events). There was no between-treatment difference in the composite of critical site or fatal bleeding. Conclusions Extending thromboprophylaxis with rivaroxaban for 45 days after hospitalization provides a positive benefit-risk balance in medically ill patients at risk for VTE who are not at high risk for bleeding. Registration URL: https://clinicaltrials.gov/; Unique identifier: NCT02111564.
Databáze: MEDLINE
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