(rivaroxaban)
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Last Updated: 11/12/2024
On May 4, 2023, the American Geriatric Society (AGS) published the Updated AGS Beers Criteria®
The inclusion of rivaroxaban in the same category as warfarin (ie, as a medication to be avoided in the older adults) is not supported by the available evidence from randomized controlled trials (RCTs).2
In contrast to the AGS Beers Criteria, guidelines issued by several professional societies endorse the use of rivaroxaban for NVAF and VTE and do not differentiate among DOACs. These guidelines recommend that selection of an anticoagulant should be based on the absolute and relative risks of stroke and bleeding for each individual patient, in addition to the cost, tolerability, patient preference, potential for drug interactions, and other clinical characteristics.
Rivaroxaban (and all DOACs) should be “used with caution” in older adults given the positive benefit-risk profile of rivaroxaban vs warfarin in RCTs; the lack of head-to-head RCTs for rivaroxaban vs other DOACs; and the need to use caution with all anticoagulants, given their potential for causing an expected increase in the bleeding risk.
Additional information listing statement excerpts from the Beers Criteria Guidelines is presented in Table: Statement Excerpts From the Beers Criteria Guidelines.6
Rivaroxaban may be a reasonable option in select circumstances. |
The criteria are a blunt instrument, and it is not possible to delineate all specialized use cases and possible exceptions to the criteria. |
Prescribing for older adults is often a complex endeavor involving consideration of many factors, particularly the preferences and goals of the older person and their family. |
Medications listed in the Beer’s Criteria are potentially inappropriate, not definitely inappropriate. |
Use of a medication with a recommendation to “avoid” is not an absolute contraindication, but rather a situation that calls for shared decision-making between the patient and their provider, with considerations for patient preferences, financial situation, and goals of care. |
Organization | Guideline Title | Summary of DOAC Recommendation | Excludes Rivaroxaban in Comparison to Other DOACs | Highest LOE for the Recommendation |
---|---|---|---|---|
AGS | American Geriatrics Society 2023 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults1 |
| Yes | Observational studies/network meta-analysis |
AHA/ACC/HRS | 2023 ACC/AHA/ACCP/HRS Guideline for the Diagnosis and Management of Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines10 |
| No | RCT |
AHA/ASA | 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association11 |
| No | RCT |
AAFP | 2017 Pharmacologic Management of Newly Detected Atrial Fibrillation: Updated Clinical Practice Guideline From the American Academy of Family Physicians12 |
| No | RCT |
AAN | 2014 Summary of Evidence-Based Guideline Update: Prevention of Stroke in Nonvalvular Atrial Fibrillation: Report of the Guideline Development Subcommittee of the American Academy of Neurology13 |
| No | RCT |
CCS | The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation14 |
| No | RCT |
CHEST | 2018 Antithrombotic Therapy for Atrial Fibrillation CHEST Guideline and Expert Panel Report15 | In patients with AF who are eligible for OAC therapy, we recommend NOACs over VKAs (strength of recommendation, strong; quality of evidence, moderate). | No | RCT |
ESC | 2020 ESC Guidelines for the Diagnosis and Management of Atrial Fibrillation Developed in Collaboration With the European Association for Cardio-Thoracic Surgery (EACTS)16 |
| No | RCT |
ESO | 2019 Antithrombotic Treatment for Secondary Prevention of Stroke and Other Thromboembolic Events in Patients With Stroke or Transient Ischemic Attack and Nonvalvular Atrial Fibrillation: A European Stroke Organisation Guideline17 |
| No | RCT |
NICE | 2021 National Institute for Health and Care Excellence (NICE). Atrial Fibrillation: Diagnosis and Management18 |
| No | RCT |
Abbreviations: AAFP, American Academy of Family Physicians; AAN, American Academy of Neurology; ACC, American College of Cardiology; ACCP, American College of Clinical Pharmacy; AF, atrial fibrillation; AGS, American Geriatrics Society; AHA, American Heart Association; ASA, American Stroke Association; CCS, Canadian Cardiovascular Society; CHA2DS2-VASc, congestive heart failure, hypertension, age ≥75 (doubled), diabetes, stroke (doubled), vascular disease, age 65 to 74 and sex category (female); CHEST, The American College of Chest Physicians; COR, Class of Recommendation; CrCl, creatinine clearance; DOAC, non-vitamin K direct acting oral anticoagulant; ESC, European Society of Cardiology; ESO, European Stroke Organisation; EVID, evidence-based conclusions for the systematic review; HRS, Heart Rhythm Society; INR, international normalized ratio; LOE, level of evidence; NICE, National Institute for Health and Care Excellence; NOAC, non-vitamin K antagonist oral anticoagulant; NVAF, nonvalvular atrial fibrillation; OAC, oral anticoagulation; RCT, randomized controlled trial; RELA, (strong evidence from) related conditions not systematically reviewed; TIA, transient ischemic attack; VKA, vitamin K antagonist; VTE, venous thromboembolism. |
Organization | Guideline Title | Summary of DOAC Recommendation | Excludes Rivaroxaban in Comparison to Other DOACs | Highest LOE for the Recommendation |
---|---|---|---|---|
AGS | American Geriatrics Society 2023 Updated AGS Beers Criteria® for Potentially Inappropriate Medication Use in Older Adults1 |
| Yes | Observational studies/network meta-analysis |
ASH | American Society of Hematology 2020 Guidelines for Management of Venous Thromboembolism: Treatment of Deep Vein Thrombosis and Pulmonary Embolism19 |
| No | RCT |
BTS | 2018 British Thoracic Society Guideline for the Initial Outpatient Management of Pulmonary Embolism (PE)20 |
| No | RCT |
CHEST | 2021 Antithrombotic Therapy for VTE Disease: Second Update of the CHEST Guideline and Expert Panel Report21 |
| No | RCT |
CMAJ | 2015 Diagnosis and Management of Iliofemoral Deep Vein Thrombosis: Clinical Practice Guideline22 | For patients with acute iliofemoral DVT and no cancer, treatment with the following alternative regimens may be initiated: LMWH, switched to dabigatran after 1 week; rivaroxaban; or apixaban (I, B, strong, moderate). | No | RCT |
ESC | 2022 Second Consensus Document on Diagnosis and Management of Acute Deep Vein Thrombosis: Updated Document Elaborated by the ESC Working Group on Aorta and Peripheral Vascular Diseases and the ESC Working Group on Pulmonary Circulation and Right Ventricular Function23 |
| No | RCT |
ESC | 2019 ESC Guidelines for the Diagnosis and Management of Acute Pulmonary Embolism Developed in Collaboration With the European Respiratory Society (ERS): The Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC)24 |
| No | RCT |
NICE | 2020 National Institute for Health and Care Excellence (NICE). Venous Thromboembolic Diseases: Diagnosis, Management and Thrombophilia Testing25 | Anticoagulation treatment for confirmed DVT or PE: Offer either apixaban or rivaroxaban to people with confirmed proximal DVT or PE (but see recommendations 1.3.11 to 1.3.20 for people with any of the clinical features listed in recommendation 1.3.7).
Long-term anticoagulation for secondary prevention: Take into account the person's preferences and their clinical situation when selecting an anticoagulant for long-term treatment. | No | RCT |
Abbreviations: AGS, American Geriatric Society; ASH, American Society of Hematology; bid, twice a day; BTS, British Thoracic Society; CHEST, The American College of Chest Physicians; CMAJ, Canadian Medical Association Journal; COR, class of recommendation; DOAC, non-vitamin K direct-acting oral anticoagulant; DVT, deep vein thrombosis; ESC, European Society of Cardiology; LMWH, low-molecular-weight heparin; LOE, level of evidence; NICE, National Institute for Health and Care Excellence; NOAC, non-vitamin K antagonist oral anticoagulant; od, once daily; PE, pulmonary embolism; RCT, randomized controlled trial; VKA, vitamin K antagonist; VTE, venous thromboembolism. |
A literature search of MEDLINE®, EMBASE®, BIOSIS Previews®, and DERWENT® (and/or other resources, including internal/external databases) was conducted on 30 October 2024.
1 | By the 2023 American Geriatrics Society Beers Criteria® Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria® for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052-2081. |
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