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Updated AF guidelines recommend newer oral anticoagulants for stroke prevention
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Non-vitamin K oral anticoagulants are now recommended over warfarin to reduce the risk for stroke in patients with atrial fibrillation, excluding those with moderate to severe mitral stenosis or a mechanical heart valve, according to a focused guideline update issued by the American Heart Association, American College of Cardiology and Heart Rhythm Society.
The newer non-vitamin K oral anticoagulants include dabigatran (Pradaxa, Boehringer Ingelheim), rivaroxaban (Xarelto, Janssen/Bayer), apixaban (Eliquis, Bristol-Myers Squibb) and edoxaban (Savaysa, Daiichi Sankyo).
The new recommendations serve as an update to a 2014 guideline issued by the societies.
“A goal of treating [AF] patients is to make blood less likely to form clots, which reduces the risk of stroke. New scientific studies show that [novel oral anticoagulants] may be safer for patients because there is less risk of bleeding, and they may also be more effective at preventing blood clots than warfarin,” writing committee chair Craig T. January, MD, PhD, FACC, professor in the division of cardiovascular medicine at University of Wisconsin-Madison, said in a press release.
The aforementioned oral anticoagulants, in addition to warfarin, are strongly recommended for appropriate patients with AF and an elevated CHA2DS2-VASc score. The guidelines continue to recommend assessment of stroke risk by CHA2DS2-VASc score. warfarin treatment for stroke prevention in patients with AF who have mechanical heart valves, and INR determined at least weekly upon initiation of anticoagulation and then monthly once anticoagulation is stable.
New recommendations: Reversal agents, weight loss
The updated guidelines also include new recommendations for reversal agents, based on evidence and novel agents available to reverse the effects of specific oral anticoagulants.
Idarucizumab (Praxbind, Boehringer Ingelheim) is the recommended agent for reversal of dabigatran in patients with life-threatening bleeding or an urgent procedure. Idarucizumab is approved by the FDA.
The guidelines state that andexanet alfa (Andexxa, Portola Pharmaceuticals) “can be useful” for reversal of rivaroxaban and apixaban in patients with life-threatening or uncontrolled bleeding. Andexanet alfa received both U.S. Orphan Drug and FDA Breakthrough Therapy designations and was approved under the FDA’s accelerated-approval pathway in May. Continued approval of andexanet alfa is contingent upon post-marketing study results and a requirement to conduct a clinical trial randomizing patients to andexanet alfa or usual care.
Weight loss, in combination with risk factor modification including assessment and treatment of underlying sleep apnea, hyperlipidemia, hypertension, glucose intolerance, and alcohol and tobacco use, is now recommend for patients with AF who are overweight or obese. This recommendation was based on new data that show beneficial effects of weight loss and risk factor modification in this patient population.
Other notable updates
The guidelines also focus on nonpharmacologic options for stroke prevention in patients with AF. Percutaneous left atrial appendage occlusion may be considered as a treatment option for patients with AF and elevated risk for stroke who have contraindications to long-term anticoagulation. This recommendation was based on clinical trial data and FDA approval of the Watchman Left Atrial Appendage System (Boston Scientific) in 2015.
There is also a new recommendation for AF catheter ablation in selected patients with symptomatic AF and HF with reduced left ventricular ejection fraction, based on new evidence that demonstrates reductions in mortality and HF hospitalization compared with medical therapy.
The full focused update, published in Circulation, Journal of the American College of Cardiology and HeartRhythm contains additional recommendations and updates on areas including specific patient groups, AF complicating ACS, device detection of AF and atrial flutter, bridging and more.
The societies continue to emphasize proper selection of anticoagulation and shared decision making in this patient population.
“[AF] patients should talk to their health care provider about any concerns they have about their prescribed medications and whether or not losing weight would benefit their health,” January stated in the release. – by Darlene Dobkowski
Disclosures: January reports no relevant financial disclosures. Please see the focused update for all other authors’ relevant financial disclosures.
Perspective
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Jagmeet P. Singh, MD, ScM, DPhil
This is a thoughtful update taking into consideration data from recent studies. No. 1, the guidelines delve into lowering the threshold for recommending oral anticoagulants and also recommend newer oral anticoagulants over warfarin in newer oral anticoagulant-eligible patients. These largely include most patients with AF, excluding those with valvular heart disease and/or a mechanical valve.
No. 2, it was heartening to see the attention being paid to preventative strategies. A strong Class I recommendation has been made for weight loss in obese and overweight patients.
No. 3, the update also reinforces that catheter ablation of AF may be useful in a selected patient population of patients with AF and reduced heart function.
There were additional takeaways with respect to combinations of dual antiplatelet therapy with oral anticoagulants and the need to adjust therapy to reduce the risk for bleeding.
There are several clinical areas in the care of patients with AF that guidelines might actually impact clinical care.
The recommendation of switching to newer oral anticoagulants when patients are eligible only makes sense. Newer oral anticoagulants are easier to adhere to and have a more reproducible anticoagulant effect with less bleeding risk compared with warfarin. Additionally, there is no need for blood testing and changing one’s diet to avoid vacillations in the international normalized ratio.
I hope with the further accrual of data inclusive of the results of CABANA, we can be more specific with the data on catheter ablation of AF in HF and other subsets of these patients. Also, additional guidelines on the remote monitoring of AF via digital strategies would be useful in looking after this patient population.
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