Jose Merino gives an overview of the ENSURE-AT and EMANATE trials along with future studies planned for new oral anticoagulants (NOACs).
Disclosures: Jose Merino has received consultory and speaker fees from Daiichi-Sankyo, Bayer, BMS, Boheringhe, Sanofi and Cardiome.
FILMED AT THE CARDIOSTIM ANNUAL MEETING, JUNE 2016
WHAT ARE THE RISKS OF NEW ORAL ANTICOAGULANT USE IN PATIENTS UNDERGOING CARDIOVERSION?
00:11 – The use of NOACs for cardioversion is something that is really appealing because it’s a very easy to manage treatment. The problem is that we presently don’t know if they are as effective as warfarin in order to prevent clots formation after cardioversion. And at the same time, safety is also an issue that needs to be proven if these agents are safer than warfarin and enoxaparin, in order to avoid bleeding in the peri-cardioversion period.
COULD YOU GIVE US AN OVERVIEW OF THE ENSURE-AF AND EMANATE TRIALS?
00:48 – The ENSURE-AF is a really interesting trial. In fact it’s designed to enroll over 2,000 patients, 2,200 patients. So it will be the largest cardioversion trial with the use of a novel agent. And it will be comparing the use of warfarin plus enoxaparin, versus a new agent, edoxaban. So this trial will produce results about the convenience of this new treatment in terms of easy to use and also efficacy and safety.
WHAT ARE THE OTHER LIMITATIONS OF CURRENTLY AVAILABLE NEW ORAL ANTICOAGULANTS?
01:32 – Limitations of the novel agents are few compared to what was the case with warfarin. There are a few limitations but still there are some. For example, interaction with other drugs that can be used in the setting of cardioversion, like for example, drohedarone. Drohedarone is contraindicated when you are using dabigatran, that is one of these novel agents. And there are limited information about the use in combination of drohedarone with other novel agents. We have in fact recently reported a short series of the use of rivaroxaban and drohedarone, and apparently it’s safe. Apart from this limitation, there are few other interactions. So I think that most of these drugs are really safe.
WHAT FUTURE STUDIES ARE PLANNED FOR NEW ORAL ANTICOAGULANTS?
02:26 – These are exciting new drugs. So originally they were tested in the setting of the general AF population. However, once the efficacy of this drug and safety profile of them have been proven, now the new trials are trying to expand the field of treatment for over subpopulations. Like for example those patients who are undergoing PCI or patients with a suspicion of underlying atrial fibrillation, like for example patients having a cryptogenic stroke.