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

Author:

Raskob Gary E.1ORCID,Ageno Walter2ORCID,Albers Gregory3ORCID,Elliott C. Gregory4,Halperin Jonathan5ORCID,Maynard Gregory6ORCID,Steg Philippe Gabriel78ORCID,Weitz Jeffrey I.9,Albanese John10,Yuan Zhong11,Levitan Bennett11,Lu Wentao10,Suh Eun Young10,Spiro Theodore12ORCID,Lipardi Concetta10,Barnathan Elliot S.10ORCID,Spyropoulos Alex C.13ORCID

Affiliation:

1. Hudson College of Public Health University of Oklahoma Health Sciences Center Oklahoma City OK

2. Department of Medicine and Surgery University of Insubria Varese Italy

3. Stanford Stroke Center Stanford University Medical Center Stanford CA

4. Department of Medicine Intermountain Medical Center and the University of Utah Salt Lake City UT

5. The Cardiovascular Institute Mount Sinai Medical Center New York NY

6. University of California, Davis Sacramento CA

7. Universite Paris‐Cite Assistance Publique‐Hôpitauxde Paris, and INSERM U‐1148 Paris France

8. Imperial College, Royal Brompton Hospital London United Kingdom

9. McMaster University and the Thrombosis and Atherosclerosis Research Institute Hamilton Ontario Canada

10. Janssen Research & Development, LLC Raritan NJ

11. Janssen Research & Development, LLC Titusville NJ

12. Clinical Development Pharmaceuticals, Bayer U.S. LLC Whippany NJ

13. 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

Abstract

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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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