Supported by educational grants from Boehringer Ingelheim, Bristol-Myers Squibb Company and Pfizer Alliance, and Portola Pharmaceuticals Inc.

SUMMARY

Anticoagulant therapy plays a vital role in treating patients and preventing serious and potentially fatal complications resulting from venous thromboembolism (VTE) and atrial fibrillation. Direct acting oral anticoagulants (DOACs), such as dabigatran, rivaroxaban, apixaban, and edoxaban offer several advantages over traditional vitamin K antagonist therapy. Most notably, DOACs have a more predictable anticoagulant response, fewer drug interactions, and significantly less risk of hemorrhagic stroke when compared to warfarin. In the past, the absence of a clear, effective reversal strategy was a concern with the new oral anticoagulant agents. In order to address these concerns, therapeutic agents targeting DOAC reversal have been in development for several years. This case-based enduring module discusses the efficacy and safety of these new and emerging anticoagulation reversal agents as well as recommended strategies for DOAC reversal.

GOAL

To provide hospitalists with clinical data regarding new and emerging reversal therapies for direct-acting anticoagulants as well as effective strategies to manage patients who require DOAC reversal.

TARGET AUDIENCE

This initiative has been designed to meet the educational needs of hospitalists, residents, surgeons, anesthesiologists and other hospital-based providers who care for patients requiring DOAC reversal. 

LEARNING OBJECTIVES

After completing the module, the participant should be able to:

• Review the evidence supporting safety and efficacy of DOAC therapy for approved clinical indications.
• Evaluate the mechanism of action, efficacy and clinical indications of DOAC reversal agents.     
• Assess currently recommended strategies for DOAC reversal and risk of adverse effects.
• Develop anticoagulation reversal treatment regimens for DOACs accounting for individual patient-specific factors.

CME INFORMATION

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education through the providership of University of Virginia School of Medicine, ASiM, and the Society of Hospital Medicine. The University of Virginia School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

The University of Virginia School of Medicine designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit.^TM Physicians should claim only the credit commensurate with the extent of their participation in the activity

Release date: February 1, 2017                     Expiration date: February 1, 2020

Estimated time to complete activity: 1 hour

FACULTY & FACULTY DISCLOSURES

Full Disclosure Policy Affecting CME Activities:
The University of Virginia School of Medicine, as an ACCME accredited provider, endorses and strives to comply with the Accreditation Council for Continuing Medical Education (ACCME) Standards of Commercial Support, Commonwealth of Virginia statutes, University of Virginia policies and procedures, and associated federal and private regulations and guidelines on the need for disclosure and monitoring of proprietary and financial interests that may affect the scientific integrity and balance of content delivered in continuing medical education activities under our auspices.

The University of Virginia School of Medicine requires that all CME activities accredited through this institution be developed independently and be scientifically rigorous, balanced and objective in the presentation/discussion of its content, theories and practices.

All faculty presenters participating in an accredited CME activity are expected to disclose relevant financial relationships with commercial entities occurring within the past 12 months (such as grants or research support, employee, consultant, stock holder, member of speakers bureau, etc.). The University of Virginia School of Medicine will employ appropriate mechanisms to resolve potential conflicts of interest to maintain the standards of fair and balanced education to the participant. Questions about specific strategies can be directed to the Office of Continuing Medical Education, University of Virginia School of Medicine, Charlottesville, Virginia.

The faculty and staff of the University of Virginia Office of Continuing Medical Education and ASiM have no financial affiliations to disclose.

The following relationships have been reported for faculty of this activity:

Kurt Pfeifer, MD, FACP (Course Director)
Professor of Medicine – General Internal Medicine
Medical College of Wisconsin
Milwaukee, Wisconsin
Dr Pfeifer reports having no significant financial or advisory relationships with corporate organizations related to this activity.

Scott Kaatz, DO, MSc, FACP, SFHM
Senior Staff Hospitalist
Medical Director for Professional Development and Research
Division of Hospital Medicine
Henry Ford Hospital
Detroit, Michigan
Dr Kaatz reports serving as a consultant, on a speakers’ bureau and/or as a faculty/peer reviewer for, and on an advisory committee/board for Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, CSL Behring, Daiichi Sankyo, Janssen, and Pfizer Inc; and on an advisory board/committee for Portola Pharmaceuticals Inc.

Aditya M. Sharma (Peer Reviewer)
Director, Vascular Medicine Fellowship
Program Director, Heart and Vascular Anticoagulation and Medical Optimization Clinic
Assistance Professor of Medicine (Cardiovascular Medicine) and Emergency Medicine
University of Virginia School of Medicine
Charlottesville, Virginia
Dr Sharma reports having no significant financial or advisory relationships with corporate organizations related to this activity. 

Disclosure of Discussion of Non-FDA–Approved Uses for Pharmaceutical Products and/or Medical Devices
The University of Virginia School of Medicine, as an ACCME provider, requires that all faculty presenters identify and disclose any off-label uses for pharmaceutical and medical device products. The University of Virginia School of Medicine recommends that each physician fully review all the available data on new products or procedures prior to clinical use.

All faculty have indicated that they have not referenced unlabeled or unapproved uses of drugs or devices.

SHM CONFLICT OF INTEREST DISCLOSURE POLICY

In accordance with the ACCME Standards for Commercial Support, SHM requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. SHM resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs. All relevant financial relationships shall be disclosed to participants prior to the start of the activity.

Furthermore, SHM seeks to verify that all scientific research referred to, reported, or used in a continuing medical education (CME) activity conforms to the generally accepted standards of experimental design, data collection, and analysis. SHM is committed to providing its learners with high-quality CME activities that promote improvements in healthcare and not those of a commercial interest.

DISCLAIMER

The opinions and recommendations expressed by faculty and other experts are based on current scientific evidence and standards of care and their professional expertise. This enduring material is produced for educational purposes only.  The University of Virginia School of Medicine implements specific educational planning processes to ensure that content is patient-centric and independent. The University of Virginia School of Medicine recommends that each physician fully review all the available data on new products or procedures prior to clinical use.

INSTRUCTIONS 

The following is an interactive educational module designed to help you gauge your basic knowledge of the topic and then direct you to areas you may need to focus on. It consists of 3 sections: a non-designated preassessment, a study program, and a CME postassessment. All 3 sections must be completed to receive CME credit.

TABLE OF CONTENTS

Preassessment

DOAC Reversal: Patient Management Implications for the Hospitalist
Scott Kaatz, DO, MSc, FACP, SFHM

Postassessment and Evaluation