Replacing warfarin with a novel oral anticoagulant: Risk of recurrent bleeding and stroke in patients with warfarin ineligible or failure in patients with atrial fibrillation (The ROAR study)
Atrial fibrillation (AF) is the most common sustained cardiac dysrhythmia seen routinely in clinical practice. AF affects about 6.1 million individuals in the United States and 4.5 million adults in Europe and the prevalence is expected to double by 2050 with the increase in aging population.1 AF is associated with an increased risk of morbidity and mortality from stroke and systemic thromboembolism (STE).1 Oral anticoagulation (OAC) with warfarin is highly effective for stroke prevention in AF.4 For the past several decades’ warfarin was the only available option. Recently, direct oral antagonists (DOAC) such as direct thrombin inhibitors (dabigatran) and factor Xa inhibitors (apixaban, rivaroxaban, and edoxaban) have demonstrated noninferiority, and in some cases superiority, when compared with warfarin for the prevention of stroke and STE with a significantly lower risk of major bleeding (MBE), especially intracranial bleeding (ICH) in large scale randomized controlled trials.6
Despite their effectiveness, studies have demonstrated that up to 25% of AF patients may be ineligible for warfarin due (WI) to increased risk of MBE or recurrent STE.10 These high‐risk WI patients were also excluded in the recent DOAC trials.6 Currently, there is limited real—world data on the risks and benefits of transitioning such patients to DOACs.12 Furthermore, certain patients may benefit from left atrial appendage (LAA) closure strategies such as Watchman or LARIAT.14 However, some of these devices still need periprocedural short‐term anticoagulation at this moment. Hence, we report a large multicenter real‐world experience of the use of DOACs in these WI patients to provide more insight on these issues.