The Committee understood from the clinical expert that the CHADS 2‑VASc scoring system was developed to better define those who would benefit from anticoagulation because a number people with a CHADS 2 score of 1 would still benefit. The Committee noted that ENGAGE AF‑TIMI 48, like other trials of newer anticoagulants, used CHADS 2 to assess the risk of stroke rather than CHADS 2‑VASc, which is now used in clinical practice, as recommended in the NICE guideline on managing atrial fibrillation. It considered that this trial was of good quality and discussed whether the results were generalisable to people with atrial fibrillation in the UK. The Committee accepted the limitations of warfarin therapy and the considerable impact it may have on people who take it, and recognised the potential benefits of edoxaban for people with non‑valvular atrial fibrillation.Ĥ.2 The Committee considered the clinical‑effectiveness data from ENGAGE AF‑TIMI 48, that compared edoxaban with warfarin. The Committee concluded that both warfarin and the newer oral anticoagulants are relevant comparators for edoxaban. This does not recommend aspirin for the treatment of non‑valvular atrial fibrillation, which has led to a higher uptake of both warfarin and the newer oral anticoagulants. The Committee heard from the patient and clinical experts that the number of people being prescribed anticoagulation treatment for atrial fibrillation is increasing following publication of the NICE guideline on managing atrial fibrillation. The Committee was aware that non‑valvular atrial fibrillation is well‑managed with warfarin for many people, but is associated with a number of problems including the need for regular monitoring and dose adjustment, and it has multiple food and drug interactions. Among patients on warfarin, HDER and LDER who had anticoagulant interrupted, rates of SSE were 0.6, 0.5 and 0.9% (p = 0.53), rates of MB were 1.0, 1.2 and 1.1% (p = 0.94) and rates of MB or CRNMB were 3.9, 4.2 and 3.6% (p = 0.78) among patients on warfarin, HDER and LDER who had anticoagulant continued, rates of SSE were 1.1, 0.7 and 0.9% (p = 0.51), rates of MB were 3.6, 2.6 and 2.4% (p = 0.13) and rates of MB or CRNMB were 8.5, 7.9 and 6.6% (p = 0.17).Ĭonclusion In patients requiring surgery/procedure in ENGAGE AF-TIMI 48, peri-operative rates of SSE, MB and death were not significantly different in patients who received edoxaban or warfarin.4.1 The Committee heard from clinical and patient experts that the current standard treatment for non‑valvular atrial fibrillation is warfarin, although there is increasing use of newer agents. Results A total of 7,193 patients (34%) underwent surgery/procedure: 3,116 had anticoagulant interrupted, 4,077 had anticoagulant continued. The chi-square test was used to compare outcomes across treatment groups. Stroke/systemic embolism (SSE), major bleeding (MB), MB or clinically relevant non-MB (CRNMB) and death were assessed from 7 days pre- until 30 days post-procedure. Patients were classified by procedural management: anticoagulant interrupted (last dose 4–10 days pre-procedure) or anticoagulant continued (last dose ≤ 3 days pre-procedure). higher- or lower-dose edoxaban regimen ). Methods Data from patients undergoing their first surgery/procedure were analysed and results compared by anticoagulant (warfarin vs. To gain information on the peri-operative management of edoxaban, we compared outcomes in patients on warfarin or edoxaban enrolled in ENGAGE AF-TIMI 48 who underwent a surgery or invasive procedure. Background Peri-operative management of anticoagulated patients with atrial fibrillation (AF) is challenging.
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