March 22, 2023

The ARTESiA trial involves 4000 patients at approximately 240 sites in 16 countries, and is led by PHRI. Co-Principal Investigators of the trial are Jeff Healey, Marco Alings, and Renato Lopes.

Hello my name is stuart connolly and i’m here today with dr. jeff healey and we’re going to discuss silent atrial fibrillation and the artesia trial this is an ongoing clinical trial that has already enrolled almost a thousand patients and we like to bring you up to date with some progress but also to talk about the underlying rationale for why this study is

Important jeff how are you today very well thanks stuart so jeff tell us why a silent atrial fibrillation also known as subclinical atrial fibrillation is important so subclinical atrial fibrillation we now know to be very common in the pacemaker population somewhere between 30 and 50 percent of all patients who receive a pacemaker or defibrillator will develop

This and there’s a lot we have yet to learn earlier studies like the cert trial have shown that it is indeed associated with an increased risk of stroke however this risk of stroke is lower than we see with typical clinical forms of atrial fibrillation so we need further data to to determine if it’s appropriate to treat this with oral anticoagulants or if one waits

To see the development more long-lasting hov do we only see silent atrial fibrillation in pacemaker patients or has it been seen in other populations so excellent question and for which we have some recent answers large studies including a sir to the reveal af and the pre date af trial have all shown that if you look in older individuals with cardiovascular risk

Factors that you see a similar large proportion of these patients will also have atrial fibrillation detected with implantable subcutaneous monitors so if there’s so much atrial fibrillation around how come we never learned about it before so in the past it was simply a matter of picking it up nowadays with modern implantable monitors with sophisticated dual-chamber

Pacemaker xin defibrillators we see a lot of arrhythmia that was otherwise undetected so the early studies like framingham and other large cohort studies simply didn’t see this arrhythmia and these patients were classified incorrectly as having no atrial fibrillation so silent atrial fibrillation is really something new that’s been discovered because we have these

Devices that do long term monitoring for absolutely and we we as clinicians have to resist the urge to simply treat this automatically as atrial fibrillation that we traditionally know because i think it is very much a distinct condition and recent guidelines have really highlighted this since said that we have a need for much more information in this area before

We can make blanket statements about treatment so how is subclinical hr fibrillation different from the usual forms of atrial fibrillation that we’re used to treating okay so first of all patients don’t report symptoms these episodes are typically short in duration and they only are picked up with continuous long-term monitoring and when we look at the studies like

The assert trial like the trends trial the risk of stroke although elevated with these episodes is actually quite low in comparison to a chor fibrillation and this is of course important because we are talking here about older individuals whose risk of bleeding complications with treatments like anticoagulation are higher we we have to then consider this low stroke

Risk when you’re weighing the risks of treatment versus the risk of stroke so when do you think we should today treat a patient who’s picked up with subclinical atrial fibrillation by his pacemaker so the recent guidelines including those published by the european heart rhythm association say that we do need more data for this and that the majority of patients where

We detect atrial fibrillation subclinical h or ablation of short duration there’s no clear guidance on whether we should or should not treat i think typically in clinic we all see some patients where we think our our treatment is appropriate when patients have a recent cardio bollock type stroke we would typically intervene with an anticoagulant and when patients

Have longer and longer episodes we would also consider intervention and a a nice recent analysis from the assert trials suggest that when episodes lost more than 24 continuous hours the risk of stroke does increase to the same level that we see with more typical clinical atrial fibrillation so the patient has got a few minutes to a few hours of subclinical atrial

Fibrillation occurring say every once a month or so what do we know about that patient to be treated should he be anticoagulated well i think we honestly don’t know if it is the right thing to treat that patient or simply wait until they develop longer-lasting episodes they do have an increased risk of stroke but this risk is lower in an absolute number and these

Patients have a non-trivial risk of bleeding so i think these are the perfect type of patients for the artesia trial where we are comparing the two strategies to see which is superior for this type of patient so subclinical atrial fibrillation detected by a device really is different from the usual garden-variety atrial fibrillation that we see on 12-lead ecg these

Patients are higher risk for bleeding than many of the atrial fibrillation patients we treat so i guess that’s the rationale for wanting to do a randomized trial of a pixy band versus aspirin absolutely and there’s been several nice reviews written on this subject recently in nice journals like jama cardiology circulation and of course as mentioned the euro guidelines

Which have recently come out and summarizing very nicely the data on the topic and i think it is very fair to say this is a different entity we really do have to answer this question to know best how to treat our patients in pacemaker clinic but also how to manage all these patients that we are now detecting with longer term cattiness monitoring outside the pacemaker

Clinic so very much right now is a problem for pacemaker and icd patients but of course with long-term implantable monitors with patch monitors home-based devices for continuous long-term ecg monitoring this is going to become a larger and larger issue for a wide range of patients and i think it’s important that we address this issue now determine what the best

Therapy is when the problem is still a relatively modest one and before we are starting to do with all sorts of patients from outside the pacemaker clinic all right so there you have it the artesia trial really is going to be an important study to guide our therapy for years to come we’re gonna literally be seeing millions of patients with subclinical atrial

Fibrillation not just in device clinics but also from other types of monitoring and really we don’t know what to do about these patients anticoagulation is not an entirely benign therapy lifelong treatment definitely poses a risk we really need to know how much these patients benefit artesia now has almost a thousand patients enrolled we need to keep enrolling

These patients to finally get the answer to whether anticoagulation really benefits these patients thanks for listening this afternoon and good luck enrolling patients

Transcribed from video
S Connolly & J Healey, PHRI: ARTESiA – Apixaban for Reducing Thromboembolism in Device-Detected SCAF By PHRI Population Health Research Institute