Off-label use of new oral anticoagulants: a one-way ticket to nowhere.

ore than 40 years ago, the rudimentary train of secondary stroke prevention reached a milestone station: the demonstration in several randomized controlled trials that oral vitamin K antagonists reduce the risk of recurrent ischemic event in patients with stroke and nonvalvular atrial fibrilla-tion (AF). Warfarin rapidly became an evidence-based standard of care. This stroke prevention paradigm was then easily translated, and blessed by the church of the eminence-based medicine, into recommendations for adding other non-AF car-dioembolic wagons in the train of oral anticoagulation (OAC). Recently, large randomized controlled trials have shown that new oral anticoagulants (NOACs) are an alternative for vitamin K antagonists to prevent stroke in patients with AF. This novel milestone led not only to a rapid implementation of NOACs in AF population but also encouraged its off-label use in several non-AF cardioembolic strokes where OAC is indicated. However, given the complexity of contemporary evidence-based stroke care, the off-label use of NOACs represents heavy wagons that may derail the train of stroke prevention in the uncertainty station. Drs Choi and Hill like long trains. They consider that given the safety benefit of NOACs in AF trials, it would be reasonable to translate and apply the favorable NOACs profile to our patient with low ventricular ejection fraction and sinus rhythm. Conversely, Dr Donnan prefers a short but strong engine train. He warns us of the risk of getting lost in translation from the results of AF trials to non-AF conditions. He argues that there is no evidence to support the safety and efficacy of adding a NOAC to antiplatelet therapy and that this combination is unlikely to provide benefit over a dual antiplatelet therapy. Does our patient require OAC? If after complete workup including long-term ECG monitoring a paroxismal AF is detected, then OAC should be considered. However, the decision making on OAC in our patient needs to balance between the risk of stent thrombosis, embolic stroke, and major bleeding. Several phase II trials have shown a definite increase in the incidence of bleeding with the combination of OAC and dual antiplatelet therapy. Recent evidence indicates that single rather than dual antiplatelet therapy may be adequate when an OAC is used in a patient with a recent coronary stent. If long-term cardiac monitoring is negative and echocardiographic assessment does not show any alternate source of cardioembolism (large aortic arch plaque, anteroseptal akinesia, intracardiac throm-bus, and so on) and a …