This interview with Jens Cosedis Nielsen from Aarhus University Hospital, Aarhus, DK discusses Apixaban Versus Heparin/Vitamin K Antagonist in Anticoagulation-naïve Patients with Atrial Fibrillation Scheduled for Cardioversion at ESC 2017.
First nielsen’s pledged to me you say we’re going to discuss the results of the emanate trial which were released in the late-breaking trials today at esc can you tell us a little bit about the trial thank you for inviting me here yes the the imminent trial is the randomized control trial investigating a pixel ban one of the new oral anticoagulants vs warfarin
Vitamin k antagonists which we usually have used in patients undergoing a direct current cardi version they investigated number of events stroke events and bleeds within the first 30 days after car diversion mmm with these two treatments and they included all together 1500 patients that’s right yeah they were randomized equally into the two groups and followed
Forwards and they the main finding was that if you compared strokes between the two groups it was different in favor of a pizza ban but if you looked at also the other influence bleeds and deaths there was no significant difference between the two groups yeah and i think actually the most important finding was that the event number in both groups was very low yes
Absolutely yeah so as their i was looking at the presentation in earlier on and they’re only six strokes is that right yeah among these 1500 patients so and but that is that’s accordant we know from from other randomised trials as well as observationally data that if patients are proper properly anticoagulated it is not so dangerous yeah how’d you version yeah
And i think that is very very reassuring yeah yeah so do you think the improvement was was genuine or is it just that we might have just picked up a very small number of of cases in the warfarin arm yeah if it was a spurious result you think that’s a real advantage to using a pic seban because anything we’ve seen that the other director alan to be honest i do not
Think that we can rely on statistical comparisons yeah having only six events yeah this is not reliable and the study is not powered to do a superiority comparison between these two with that few events so it has to be considered expiratory yeah yeah and we cannot say that a pic seban is better yeah but if we take it together with the other trials we have yeah it
Seems as if the risk is close to similar yeah yeah between the new oral antibiotic and use i think these data support yeah that you can use whatever you find best yes no x or vka yeah we have no indication that that one is truly inferior yeah with respect to stroke or bleats it was very interesting because i the meta-analysis of all the other similar studies with
The other yeah derek’s work was presented as well in the discussion and yeah again it seemed very similar but they seem to be a slight trend towards using a dog yeah i would agree with what emanate i agree if we if we yeah yeah maybe the the the incidence is a little lower with the new chicagoans but if we should say that that we should have a properly powered
Randomized trial hmm and that would require as they had calculated around 50,000 patients yes titta to do that and then you would be able to show that using a dog or knowing or whatever to call it instead of vitamin k antagonists you may say one or two strokes yes treating 1000 patients yes and i agreed it’s not realistic to do it and in my mind it’s not it would
Be questionable from an ethical point of view yeah that many money yeah an effort yes into proving that yes so i think i guess one kind of clinical challenge that we have when used when when doing cardio versions and using doe axes issue of compliance because with warfarin you can always measure the inr to provide you with some assurance that the patient is taking
Their medication but we don’t necessarily do that with directs some some some centers of trotty’s transesophageal echo to guide their cardio versions well what are your thoughts on that and in the context of this trial yeah yeah that is true that is that’s a true difference between these two kinds of treatment i think we what we do in our institution and i think
Most cases in most places we we ask the patients and they have to reassure us yeah that they have really taken it yeah and they are informed that it is important that you answer this question correct and and and we we believe them yeah and in this study what what what what measures were performed to assess for our compliance was there a transesophageal echo done
Or in in the emanate that they did a transesophageal echo in more than half the patients as i remember 800 and something occasion but not i have not university not not all no no so despite that so even if there were people who said they had taken medication and hadn’t even then we’re we’re not seeing a big increase in no exact is reassuring yeah yeah i think it
Is yes yeah excellent sir person nielsen is that pageanty about stan it indeed it was thank you
Transcribed from video
Apixaban Versus Heparin/Vitamin K Antagonist in Anticoagulation-naïve Patients with AF By Radcliffe