XARELTO®: Clinical trial for venous thromboembolism (VTE) prophylaxis in acutely ill medical patients◇

The MAGELLAN trial studied acutely ill medical patients at risk for a VTE in both inpatient and outpatient settings1

MAGELLAN Overall (N=8101) VIEW OUTCOMES>  MAGELLAN Subgroup (N=6447) VIEW OUTCOMES> 

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A diagram detailing the use of XARELTO® in the MAGELLAN studyA diagram detailing the use of XARELTO® in the MAGELLAN study

Based on other Analyses, 5 additional exclusion criteria were applied to create the MAGELLAN subgroup1

Diagram explaining the size of the XARELTO® MAGELLAN subgroup Diagram explaining the size of the XARELTO® MAGELLAN subgroup

Who were the patients evaluated for inpatient and extended VTE prophylaxis in the MAGELLAN subgroup?1,2

Conditions that put med ill patients at higher risk of bleeding when used for VTE prophylaxis in the MAGELLAN studyConditions that put med ill patients at higher risk of bleeding when used for VTE prophylaxis in the MAGELLAN study

Exclusion Criteria

Five key risk factors for major bleeding were identified and applied as exclusion criteria to MAGELLAN overall:

  1. History of bronchiectasis, pulmonary cavitation, or pulmonary hemorrhage.
  2. Active cancer (ie, undergoing acute, in-hospital cancer treatment).
  3. Active gastroduodenal ulcer in the 3 months prior to treatment.
  4. History of bleeding within the last 3 months prior to treatment.
  5. Receiving DAPT.

◇For VTE prophylaxis in acutely ill medical patients at risk for thromboembolic complications who are not at high risk of bleeding.

*Major bleeding was defined as clinically overt bleeding associated with a drop in hemoglobin of ≥2 g/dL, a transfusion of ≥2 units of packed red blood cells or whole blood, bleeding at a critical site, or with a fatal outcome.

†In addition to the aforementioned, additional VTE risk factors include D-dimer levels that are elevated beyond 2 times the upper limit of normal, chronic venous insufficiency, severe varicosis, recent major surgery, and recent serious trauma (6 to 12 weeks).3

‡The decision regarding initiation setting should be based on the prescriber's clinical judgment.

BMI = body mass index; CrCl = creatinine clearance; DAPT = dual antiplatelet therapy; PE = pulmonary embolism; VTE = venous thromboembolism.

Next:Acutely Ill Medical Efficacy Profile

References: 1. Cohen AT, Spiro TE, Büller HR, et al; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368(6):513-523. 2. Supplement to: Cohen AT, Spiro TE, Büller HR, et al; MAGELLAN Investigators. Rivaroxaban for thromboprophylaxis in acutely ill medical patients. N Engl J Med. 2013;368:1-14. Accessed November 8, 2021. https://www.nejm.org/doi/suppl/10.1056/NEJMoa1111096/suppl_file/nejmoa1111096_appendix.pdf 3. Cohen AT, Spiro TE, Spyropolous AC, et al; MAGELLAN Study Group. D-dimer as a predictor of venous thromboembolism in acutely ill, hospitalized patients: a subanalysis of the randomized controlled MAGELLAN trial. J Thromb Haemost. 2014;12(4):479-487. 4. The EINSTEIN–PE Investigators. Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366(14):1287-1297. 5. The EINSTEIN Investigators. Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363(26):2499-2510. 6. Weitz JI, Lensing AWA, Prins MH, et al; EINSTEIN CHOICE Investigators. Rivaroxaban or aspirin for extended treatment of venous thromboembolism. N Engl J Med. 2017;376(13):1211-1222. 7. Eriksson BI, Borris LC, Friedman RJ, et al; RECORD1 Study Group. Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty. N Engl J Med. 2008;358(26):2765-2775. 8. Kakkar AK, Brenner B, Dahl OE, et al; RECORD2 Investigators. Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial. Lancet. 2008;372(9632):31-39. 9. Lassen MR, Ageno W, Borris LC, et al; RECORD3 Investigators. Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty. N Engl J Med. 2008;358(26):2776-2786.