Bleeding risk with apixaban and dabigatran similar to aspirin

Embargoed for release until 5:00 p.m. ET on Monday 10 February 2025   

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Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.         
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1. Bleeding risk with apixaban and dabigatran similar to aspirin

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-02132

URL goes live when the embargo lifts          

A systematic review and meta-analysis estimating the differences in bleeding risks between therapeutic-dose non-vitamin K oral anticoagulants (NOACs) and single antiplatelet therapy (aspirin) found that rates of major bleeding for therapeutic-dose apixaban and dabigatran were similar to low-dose aspirin, but rates were higher for rivaroxaban. These findings can help patients with atrial fibrillation (AF) and clinicians better understand the bleeding risks associated with anticoagulants versus aspirin. The study is published in Annals of Internal Medicine.

Researchers from McMaster University and colleagues studied data from nine randomized controlled trials with 26,224 patients comparing bleeding risks of therapeutic-dose NOACs to single antiplatelet therapy. Included RCTs had a minimum treatment duration of three months and studies assessing low-dose NOACs and using two or more antithrombotic therapies were excluded. Patients in the included trials were characterized as having a recent history of stroke, history of clinical AF and intracranial hemorrhage, history of AF considered unsuitable for vitamin K antagonist therapy, subclinical AF detected on pacemakers and defibrillators, and venous thromboembolism after six to twelve months of initial anticoagulation. The NOACs studied in the included trials were apixaban, rivaroxaban and dabigatran. All trials used aspirin as the single antiplatelet therapy studied. The main outcomes were major bleeding and intracranial bleeding, and other outcomes included fatal, gastrointestinal, clinically relevant nonmajor and minor bleeding.

The researchers found that 2.16% of patients had major bleeding and .66% had intracranial hemorrhage. The absolute risks for both major bleeding and intracranial hemorrhage were similar for therapeutic dose apixaban and dabigatran compared to aspirin but higher with rivaroxaban use than with aspirin. These findings can help ease challenges physicians face in accurately balancing the risks and benefits of prescribing NOACs versus aspirin for patients with AF.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Michael Ke Wang, MD please email Adam Ward at warda17@mcmaster.ca.

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2. Results of interventions to reduce overuse of medical care not sustained after discontinuation

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-02738

URL goes live when the embargo lifts          

A pragmatic, cluster randomized trial evaluating the long-term effectiveness of behavioral interventions to reduce over testing and overtreatment in older adults found that the effects of the interventions did not last in the year after the intervention ended. The findings are published in Annals of Internal Medicine.

Researchers from Northwestern University and colleagues studied data from 60 primary care practices in Chicago, Illinois to determine the sustained effectiveness of a behavioral intervention to reduce over testing and overtreatment of older adults in three areas identified by the American Geriatrics Society “Choosing Wisely” campaign—prostate-specific antigen screening (PSA), testing for urinary tract infections (UTIs) in women without specific reasons, and overtreatment of diabetes with drugs causing hypoglycemia. The intervention was clinical decision support (CDS) delivered to 371 clinicians through the electronic health record and was designed to increase attention to the harms of overuse of care. The primary outcomes measured were changes in annual rates of PSA screening in men aged 76 years or older without history of prostate cancer; urine testing in women aged 65 years or older obtained for nonspecific reasons; and treating patients with diabetes aged 75 years or older to a hemoglobin A1c level of less than 7.0% using insulin, a sulfonylurea, or meglitinide. By the end of the intervention period, the intervention group lowered the rates of overtreatment and over testing in all three primary outcomes. The researchers then evaluated the persistence of the intervention effectiveness during a 12-month postintervention period in which the CDS was no longer delivered to clinicians and found that the results were not sustained. The findings suggest that to maintain benefits CDS interventions should be left in place or provided on a less frequent basis to reduce alert fatigue.

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Lucia C. Petito, PhD, please email lucia.petito@northwestern.edu.

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3. Experts debate management of patient with recent onset atrial fibrillation

This ‘Beyond the Guidelines’ feature is based on a discussion held at the General Medicine Grand Rounds conference held on 26 September 2024

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-03490  

URL goes live when the embargo lifts          

In a new Annals “Beyond the Guidelines” feature, two physicians discuss treatment recommendations for a patient with atrial fibrillation (AF) in the context of the collaborative guideline addressing care of patients with AF published in 2023 by the American College of Cardiology, American Heart Association, American College of Chest Physicians and the Heart Rhythm Society. AF is the most common arrhythmia and substantially increases the risk for stroke and is associated with higher rates of mortality. Clinical decisions regarding the management of existing AF are complex and require the consideration of many factors. As such, asking “How would you manage this patient with recent onset atrial fibrillation?” is an important clinical question. 

They reviewed the case of Dr. G, a 63-year-old man who noticed an irregular heart rate while biking to work and an electrocardiogram confirmed AF. Dr. G has a history of hypertension and hyperlipidemia and his family history is significant for AF. He was prescribed apixaban, 5 mg twice daily, and metoprolol tartrate, 25 mg twice daily, which he never took because his episodes were limited. He saw a cardiologist who recommended an ablation, but Dr. G did not go through with it because he did not have any further episodes. He obtained a second opinion, and that cardiologist gave three options: an ablation, use a ‘pill-in-pocket' approach; or defer procedure and monitor symptoms. Dr. G remains uncertain about the best way to proceed. 

The first discussant, Eli Gelfand, MD, is a general cardiologist, member of the Division of Cardiology at Beth Israel Deaconess Medical Center and an Assistant Professor of Medicine at Harvard Medical School, Boston, Massachusetts. Dr. Gelfand notes optimal blood pressure control, weight loss and multi-factor risk management should be used for primary and secondary prevention of AF. He also notes that when deciding to administer anticoagulation, clinical risk scores for stroke such as CHA₂DS₂-VASc and GARFIELD-AF, should be used as a starting point for management recommendations. In the case of Dr G, Dr. Gelfand notes his low risk for stroke and major bleeding, active lifestyle, good control of hypertension and low burden of AF as reasons for recommending against anticoagulation, catheter ablation or chronic antiarrhythmic therapy. He emphasizes that the risks and benefits of starting Dr G on anticoagulation should be reassessed regularly. 

The second discussant, Patricia Tung, MD, is a cardiac electrophysiologist, is a member of the Division of Cardiology at Beth Israel Deaconess Medical Center and an Assistant Professor of Medicine at Harvard Medical School, Boston, Massachusetts. Dr. Tung asserts that both sleep apnea and physical inactivity are important risk factors for AF and advocates for moderate exercise as a primary strategy for AF prevention. She agrees that anticoagulation is not required in the case of Dr G and recommends continued monitoring for AF. Dr. Tung recommends proceeding with ablation once Dr G’s AF episodes become more frequent.

All “Beyond the Guidelines” features are based on selected clinical conferences at Beth Israel Deaconess Medical Center (BIDMC) and include multimedia components published in the Annals of Internal Medicine.   

Media contacts: For an embargoed PDF, please contact Angela Collom at acollom@acponline.org. To speak with corresponding author Gerald W. Smetana, MD, please email Kendra McKinnon at Kmckinn1@bidmc.harvard.edu.

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Also new in this issue:

Caring for young patients with traumatic knee injury: why surgery isn't the only option

Jonas B. Thorlund, PhD; Ewa M. Roos, PT, PhD; L. Stefan Lohmander, MD, PhD; and Søren T. Skou, PT, PhD

Ideas and Opinions

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-02619

Hemochromatosis

William C. Palmer, MD; Fernando F. Stancampiano, MD

In the Clinic

Abstract: https://www.acpjournals.org/doi/10.7326/ANNALS-24-03710