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Atrial fibrillation (AF) is a common cardiac arrhythmia associated with increased morbidity and mortality. Patients with AF are at risk of stroke and systemic embolism (SSE), which can cause death, disability, and impaired quality of life. Antithrombotic therapies, such as oral anticoagulant and antiplatelet drugs, can reduce the risk for stroke and systemic thromboembolism and are recommended for most AF patients with risk factors for stroke. The risk of stroke varies considerably across patients; therefore, major guidelines recommend antithrombotic therapy based on risk assessment, quantified using a validated tool such as the CHADS2 score.
There are decades of experience with the use of the vitamin K antagonist (VKA) warfarin, as well as compelling evidence of efficacy with regard to stroke prevention. However, individualized dose adjustments and laboratory monitoring are required, and warfarin remains a frequent cause of drug-related emergency hospitalization in the elderly. New oral anticoagulants (NOACs) may feature more predictable pharmacokinetics and dosing, but there is less clinical experience outside of randomized controlled trials (RCTs) with these drugs at the moment. These NOACs include the direct thrombin inhibitor, dabigatran, and the direct factor Xa inhibitors, rivaroxaban and apixaban, which have been approved for use for the prevention of SSE in patients with AF. However, uncertainty remains regarding whether these agents show increased real-world benefits compared with warfarin. Although considered less effective at stroke prevention than anticoagulant therapy, antiplatelet agents may nevertheless be an option for selected patients.
The Canadian Agency for Drugs and Technologies in Health (CADTH) previously reviewed the clinical effectiveness and cost-effectiveness of the NOACs compared with warfarin. At that time, apixaban was not approved for use in Canada, and was therefore not included in the Canadian Drug Expert Committee (CDEC) recommendation; in addition, antiplatelet drugs were not included. The current review was undertaken to allow the development of recommendations that include all the NOACs as well as the antiplatelet agents, acetylsalicylic acid (ASA) and clopidogrel.
Committee Members: Dr. Robert Peterson (Chair), Dr. Ahmed Bayoumi, Dr. Bruce Carleton, Ms. Cate Dobhran, Mr. Frank Gavin, Dr. John Hawboldt, Dr. Peter Jamieson, Dr. Julia Lowe, Dr. Kerry Mansell, Dr. Irvin Mayers, Dr. Yvonne Shevchuk, Dr. James Silvius, and Dr. Adil Virani.
Regrets: Three CDEC members were not available to participate in deliberations and voting.
Conflicts of Interest: None
Three external Clinical Experts attended the meeting and participated in the discussion, but did not vote on the recommendations.
About this document: The Therapeutic Review Recommendations or Advice are formulated following a comprehensive evidence-based review of the medication’s efficacy or effectiveness and safety and an assessment of its cost-effectiveness. Therapeutic Review clinical and economic reports are based on published information available up to the time that CDEC made its recommendation. Input from stakeholders, such as drug manufacturers, patient groups, and health-related professional associations or organizations is considered in the preparation of this Recommendations document.
CDEC is a Committee of the CADTH. It makes recommendations and provides advice to Canadian jurisdictions to use in making informed decisions. It is made up of experts in drug evaluation and drug therapy and public members.
The Final CDEC Therapeutic Review Recommendations or Advice neither takes the place of a medical professional providing care to a particular patient nor is it intended to replace professional advice.
CADTH is not legally responsible for any damages arising from the use or misuse of any information contained in or implied by the contents of this document.
The statements, conclusions, and views expressed herein do not necessarily represent the view of Health Canada or any provincial, territorial, or federal government or the manufacturer.
Production of this report is made possible through a financial contribution from Health Canada and the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Saskatchewan, and Yukon.
The Therapeutic Review Framework describes the Therapeutic Review process in detail.49
Except where otherwise noted, this work is distributed under the terms of a Creative Commons Attribution-NonCommercial- NoDerivatives 4.0 International licence (CC BY-NC-ND), a copy of which is available at http://creativecommons.org/licenses/by-nc-nd/4.0/
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