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

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:75

Article

Spyropoulos, Alex C.^1,2  Ageno, Walter³  Albers, Gregory W.⁴  Elliott, C. Gregory^5,6  Halperin, Jonathan L.⁷  Hiatt, William R.^8,9  Maynard, Gregory A.¹⁰  Steg, P. Gabriel^11,12  Weitz, Jeffrey, I^13,14  Lu, Wentao¹⁵  Spiro, Theodore E.¹⁶  Barnathan, Elliot S.¹⁵  Raskob, Gary E.¹⁷ 

[1] Donald & Barbara Zucker Sch Med & Hofstra Northwe, Feinstein Inst Med Res, 130 East 77th St, New York, NY 10075 USA

[2] Lenox Hill Hosp, Dept Med, Anticoagulat & Clin Thrombosis Serv, Northwell Hlth, 130 East 77th St, New York, NY 10075 USA

[3] Univ Insubria, Dept Med & Surg, Varese, Italy

[4] Stanford Univ, Med Ctr, Stanford Stroke Ctr, Stanford, CA 94305 USA

[5] Intermt Med Ctr, Dept Med, Salt Lake City, UT USA

[6] Univ Utah, Salt Lake City, UT USA

[7] Mt Sinai Med Ctr, Cardiovasc Inst, New York, NY 10029 USA

[8] Univ Colorado, Div Cardiol, Sch Med, Aurora, CO USA

[9] CPC Clin Res, Aurora, CO USA

[10] Univ Calif Davis, Sacramento, CA USA

[11] Univ Paris, AP HP, INSERM U 1148, Paris, France

[12] Imperial Coll, Royal Brompton Hosp, London, England

[13] McMaster Univ, Hamilton, ON, Canada

[14] Thrombosis & Atherosclerosis Res Inst, Hamilton, ON, Canada

[15] Janssen Res & Dev LLC, Raritan, NJ USA

[16] Bayer US LLC, Pharmaceut, Clin Dev, Thrombosis & Hematol Therapeut Area, Whippany, NJ USA

[17] Univ Oklahoma, Hlth Sci Ctr, Hudson Coll Publ Hlth, Oklahoma City, OK USA

关键词: hospitalized;    major bleeding;    medically ill;    rivaroxaban;    thromboembolic events;   

DOI  :  10.1016/j.jacc.2020.04.071

来源: Elsevier

【 摘 要 】

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) (C) 2020 The Authors. Published by Elsevier on behalf of the American College of Cardiology Foundation.

【 授权许可】

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