Critical Care: Heme and infection ICU |

Major Bleeding in Patients Taking Rivaroxaban for VTE Treatment FREE TO VIEW

W. Peacock, MD; Sally Tamayo, MD; Manesh Patel, MD; Nicholas Sicignano, MPH; Kathleen Hopf, MPH; Zhong Yuan, MD
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Naval Medical Center Portsmouth, Portsmouth, VA

Copyright 2016, American College of Chest Physicians. All Rights Reserved.

Chest. 2016;150(4_S):286A. doi:10.1016/j.chest.2016.08.299
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SESSION TITLE: Heme and infection ICU

SESSION TYPE: Original Investigation Slide

PRESENTED ON: Sunday, October 23, 2016 at 07:30 AM - 08:30 AM

PURPOSE: Standard treatment of patients with venous thromboembolism (VTE) is anticoagulation, which increases the risk of bleeding. To evaluate major bleeding (MB) in a post-marketing setting of VTE patients treated with rivaroxaban and to examine potential risk factors.

METHODS: In this retrospective observational study, we queried over 10 million electronic medical records from the U.S. Department of Defense healthcare system to identity patients with VTE [pulmonary embolism (PE) and deep vein thrombosis (DVT)] on rivaroxaban during the period of November 2, 2012 to September 30, 2015. A validated algorithm was used for detection of MB-related hospitalizations. Incidence of MB was calculated using person-time, and patient characteristics were compared between those with and without MB. Risk factors for MB were explored using Cox proportional hazards model.

RESULTS: We identified 9,638 VTE patients on rivaroxaban, 43.7% with PE with or without DVT, and 56.3% with DVT without PE. MB was identified within 130 VTE patients; 74 (56.9%) with DVT and 56 (43.1%) with PE. The overall VTE cohort had a MB incidence rate of 2.47 (95% CI 2.08-2.93) per 100 person-years, primarily in gastrointestinal sites. MB incidence was higher in the DVT cohort versus PE, 2.74 and 2.18 per 100 person-years respectively. Females accounted for 63% of MB patients and 47% of non-MB patients. Mean (SD) age of MB cases was 66.6 (16.8), versus 60.8 (17.5) years among the non-MB group. In general, patients with MB had higher prevalence of comorbidities than those without. Multivariate analyses found the following covariates significantly associated with MB: sex, dementia, anemia, and history of MB. Age was retained in the model due to its confounding relationship with dementia. Adjusted hazard ratios for the significant covariates were: females 1.60 (95% CI 1.11-2.29), dementia 2.01 (95% CI 1.30-3.12), anemia 2.57 (95% CI 1.77-3.73), and history of bleeding 2.73 (95% CI 1.41-5.26). Fatal bleed rate in the overall cohort was 0.06 (95% CI 0.02-0.18) per 100 person-years.

CONCLUSIONS: In a heterogeneous population of 9,638 rivaroxaban users treated for VTE, those with MB tended to be older, female, and have more comorbidities.

CLINICAL IMPLICATIONS: The risk and pattern of bleeding among VTE patients on rivaroxaban is generally consistent with the clinical trial data. The MB risk factors identified in this study may be informative to clinicians who manage these patients. Disclaimer: The views expressed in this abstract are those of the authors and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense or the United States Government. Research data derived from an approved Naval Medical Center, Portsmouth, VA IRB protocol. CAPT Sally Tamayo is a military service member. This work was prepared as part of her official duties. Title 17 U.S.C. 105 provides that ‘Copyright protection under this title is not available for any work of the United States Government.’ Title 17 U.S.C. 101 defines a United States Government work as a work prepared by a military service member or employee of the United States Government as part of that person’s official duties.

DISCLOSURE: W. Peacock: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Peacock reports personal fees from Janssen, during the conduct of the study; and Consultant and Research Grant from Janssen, Consultant for Bayer. Manesh Patel: Consultant fee, speaker bureau, advisory committee, etc.: Dr. Patel reports personal fees from Janssen, during the conduct of the study. Nicholas Sicignano: Other: Mr. Sicignano is an employee of Health ResearchTx, which has a business relationship with Janssen Research and Development. Kathleen Hopf: Other: Ms. Hopf is a contractor for Health ResearchTx, which has a business relationship with Janssen Research and Development. Ms. Hopf was paid to be the medical writer for this manuscript, and to work with both HRTx and Janssen in developing the paper. Zhong Yuan: Employee: I am a salaried employee of Janssen Research & Development, LLC. I own stocks of Johnson & Johnson. The following authors have nothing to disclose: Sally Tamayo

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