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New study finds that AF patients under 65 years of age but with a CHA2DS2-VASc score of 1 are unlikely to benefit from anticoagulation therapy.
Anna GarrettPatients with atrial fibrillation (AF) and ≥1 point on the CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke/transient ischemic attack, vascular disease, age 65–74 years, sex) stroke risk scale are considered at increased risk of future stroke, but the risk associated with a score of 1 differs markedly between studies.
A new retrospective review suggests that patients with AF who have a CHA2DS2-VASc score of 1 may not benefit from anticoagulation therapy. The Swedish study included 140,420 patients with AF. The goal of the review was to assess the risk of AF-related stroke among patients with a score of 1 on the CHA2DS2-VASc . The researchers used a broad definition of stroke diagnosis (hospital discharge diagnoses of ischemic stroke, unspecified stroke, transient ischemic attack, and pulmonary embolism) and found a 44% higher annual risk than when only ischemic strokes were counted. When stroke events were included in conjunction with the index hospitalization for AF, the long-term risk was doubled beyond the first four weeks. Overall, depending on which event definition was used, the annual stroke rates varied between 0.1% and 0.2% for women and between 0.5% and 0.7% for men.
The authors concluded that given the low risk of stroke in this study, AF patients <65 years of age but with a CHA2DS2-VASc score of 1 are unlikely to benefit from anticoagulation therapy.
Source: Friberg L, Skeppholm M, Terént A. Benefit of anticoagulation unlikely in patients with atrial fibrillation and a CHA2DS2-VASc Score of 1. J Am Coll Cardiol. 2015;65(3):225–232.
NOACs Require careful attention in the ICU
A small study of 21 patients in the intensive care unit showed that a high percentage of patients on novel oral anticoagulants (NOACs) receive inappropriate doses of the drugs at some point during their stay. Patients typically receive these medications for stroke prevention in atrial fibrillation.
Failure to adjust for renal function was implicated in six of the seven cases in which problems were identified. NOACs are an attractive treatment option owing to the rapid onset and conclusion of their action, lack of need for routine coagulation monitoring, and fewer drug and food interactions, but renal function can change rapidly in this patient population. NOACs require dose adjustments to prevent bleeding problems in patients with moderate renal dysfunction and should be completely avoided in cases of end-stage renal disease.
The author suggested development of a trigger notification in the electronic medical record to alert the ICU team to potential NOAC dosing problems when creatinine clearance drops below a certain level.
Source: Kalabalik J, et al. Evaluation of the use of novel oral anticoagulants in a medical intensive care unit. SCCM 2015; Abstract 463.
FDA approves new anticoagulant for AF, DVT, and PE
FDA has approved edoxaban (Savaysa; Daiichi Sankyo) to reduce the risk of stroke and systemic embolism in patients with nonvalvular AF and for deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days.
The safety and efficacy of edoxaban was established in a clinical trial of 21,105 participants. The study compared two doses of edoxaban with warfarin. The effects of the higher dose of edoxaban were shown to be similar to those of warfarin for stroke risk reduction. Edoxaban demonstrated significantly less major bleeding than warfarin.
Edoxaban for the treatment of patients with DVT and PE was studied in 8,292 participants. The study compared the safety and efficacy of edoxaban with warfarin for treating patients with a DVT and/or PE to reduce the rate of recurrence of symptomatic venous thromboembolism (VTE). In the trial, 3.2% of participants taking edoxaban tablets had a symptomatic recurrent VTE compared with 3.5% of those taking warfarin.
The most common side effects observed in all trial participants were bleeding and anemia.
Edoxaban has a boxed warning indicating that edoxaban is less effective in AF patients with a creatinine clearance >95 mL/min. Patients with creatinine clearance >95 mL/min have an increased risk of stroke compared with similar patients given warfarin.
Source: www.fda.gov. FDA approves anti-clotting drug savaysa. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm. Accessed February 4, 2015.