AEIOU: Apixaban Evaluation of Interrupted or Uninterrupted
Yeah the purpose of the trial was to learn a little bit about the safety and effectiveness of a pixum ban at the time of an afib ablation procedure specifically we wanted to look at two dosing strategies the so-called uninterrupted strategy which means not holding any doses at all and an interrupted strategy which in this case just meant hold in one dose the
Morning dose and the day the procedure it’s a twice daily drug so we wanted to compare the safety and effectiveness of those two regimens of a pic seban and then also combine a compare apixaban in general to the prior standard of uninterrupted warfarin it was a slightly unusual design it was a multicenter randomized trial of the two apixaban doses so in the
End we randomized 300 patients to those two apixaban dosing strategies simultaneously we had a retrospective matched cohort of warfarin patients so the comparisons between the overall apixaban group and the warfarin group were non randomized but this allowed us to get the study done more quickly we in the end we enrolled 295 what we call the valuable patients
These are patients who were randomized and actually had a procedure performed into the apixaban group so 150 in one group 145 in the other and then we did successfully match all 295 of those patients to the warfarin patients we had a couple of important outcomes mainly its stroke or systemic embolism for effectiveness and then for safety we looked at both
What we call the clinically significant bleeding and major bleeding using specific criteria there were no strokes or systemic embolic events in any of the groups so that we’re very pleased and felt reassured by that there were a couple of transient ischemic attacks equally distributed among the study groups so a total of two and the two apixaban arms and
Two in the warfarin group with respect to bleeding the rate of clinically significant bleeding that was defined using the so called barc criteria bleeding academic research consortium those rates were in the neighborhood of 10% overall for the apixaban groups it was about ten and a half percent and that did not appear to differ in a significant way between
The interrupted and uninterrupted strategies it was about you know 11 percent versus 10 percent and in the warfarin group clinically significant bleeding again was in the neighborhood of 10 percent major bleeding in all groups was around 2 percent or less so for the total combined apixaban cohort 1.7 percent rate of major bleeding versus 1.4 percent in the
Warfarin patients we think they’re similar with one important so research as your viewers are probably aware was a comparison a randomized comparison of dabba gat ran and warfarin in that trial they also had no strokes so all of these strategies appear to be effective at avoiding this very undesirable outcome of stroke in research they reported a significant
Advantage for dabigatran and major bleeding where they had about a 1.5 or 2% rate of major bleeding with the bigoted ran but almost a 7% rate of major bleeding with warfarin so our opinion is that that warfarin result in the research at trial was unexpectedly high and if you look at you know external literature on this subject no one else has really reported 7%
Major bleeding with warfarin two percent major bleeding seems more typical and that’s what we had in our study so we’re certainly pleased again that there’s a very very low risk of stroke with all of these regimens and in the context of this procedure and we think the results of aeiou we’re very similar with the apixaban group to what’s been seen with the big
Of tran and other novel drugs in the setting so in terms of clinical practice there is certainly practice variation right now on this point of whether or not to hold a dose on the day of the procedure or not to just do it fully uninterrupted we feel like this at least adds a little bit of information that both of those strategies are reasonable that there’s
Nothing concerning coming out of you know a limited sample here with those two strategies certainly there’s room for more information again we it has to be remembered that our comparisons of apixaban and warfarin in this study were not randomized there is a fully randomized trial that’s ongoing in europe so dr. paulus kershaw is the principal investigator of
That study and they are expecting results within 12 months i believe of a study fully randomizing apixaban versus warfarin
Transcribed from video
Apixaban Evaluation for Ablation of Atrial Fibrillation By Radcliffe
