Oral Anticoagulation Compared to Left Atrial Appendage Closure Following Catheter Ablation: Results From the OPTION Trial

Podcast Transcript

Announcer:

Welcome to Cleveland Clinic Cardiac Consult, brought to you by the Sydell and Arnold Miller Family Heart, Vascular, and Thoracic Institute at Cleveland Clinic.

Walid Saliba, MD:

Hello everybody and welcome to another episode of Cardiac Consult. Today we are going to discuss the results of an important study in cardiac electrophysiology. I am Walid Saliba. I'm the director of the EP Lab at the Cleveland Clinic and with me is Dr. Oussama Wazni who is the section head at the Cleveland Clinic and the actually leading and primary investigator of The OPTION Study. Dr. Wazni, good afternoon.

Oussama Wazni, MD, MBA:

Thank you, Walid. Thank you for inviting me to this exciting episode.

Walid Saliba, MD:

So we will discuss today the OPTION Study, which is a study that is very important and hopefully will change the way we practice atrial fibrillation management. Dr. Wazni, can you guide us into what was the idea behind the OPTION Study and why was this study essentially designated?

Oussama Wazni, MD, MBA:

So patients come to us for atrial fibrillation ablation because of symptoms of AFib, or for example when their ejection fraction is starting to drop. So those are indications to do an ablation for atrial fibrillation. But many times patients also come to us because they think that an ablation will also result in them stopping their oral anticoagulation. And we have to clarify to the patients, and actually also to our referring physicians, that wanting to be off anticoagulants is not an indication for having an ablation. Why? The ablation again is for symptom relief and for prevention of heart failure. And when we do an ablation for atrial fibrillation, hopefully most of the time it is successful, but also there are patients who will not have a successful outcome. And here comes the issue of what do we do with anticoagulation, especially in patients who have moderate to high risk of stroke?

If you have a patient who you do an ablation and now continues to have silent AFib and silent AFib is something that is very prevalent after an ablation, up to 50% in some patients, and they have a higher risk of stroke, but now the patient doesn't feel the AFib and they don't complain to their doctor that they have atrial fibrillation, they may assume that the atrial fibrillation has been cured, but then they stop the anticoagulation and they may end up with a stroke. On the other hand, you can have a patient who had a truly successful ablation, meaning now they don't have atrial fibrillation, but because they're not continuously monitored, we can't be sure, then we continue on anticoagulation.

But then you're exposing that patient who does not need to be on a blood thinner, you're still exposing the patient to the blood thinners and also to the risk of bleeding. It is so complex that the guidelines right now say that regardless of what we think the outcome of the ablation is, whether it's successful or not, the continuation or discontinuation of the oral anticoagulation should be based on the CHA2DS2-VASc Score is the stroke risk score that we use. And if it's moderate to high, you continue the blood thinners.

Walid Saliba, MD:

That is a very important point. Actually one of the main reasons for patients to have a stroke after an ablation is their discontinuation of oral anticoagulation, either on their own or based on the fact that they thought that the ablation's successful and therefore they don't need to be on anticoagulation.

Oussama Wazni, MD, MBA:

Yeah.

Walid Saliba, MD:

Since this is a main problem and a main issue, how was the study design done to help solve and answer this question?

Oussama Wazni, MD, MBA:

So because of this issue of not wanting to put a patient who does not need anticoagulation on anticoagulation and exposing them to blood thinners and the risk of bleeding and on the other hand a patient who should be, but then exposing them to the risk of stroke, we thought that maybe if we close the left atrial appendage with a device called the Watchman FLX device, which is already approved but for a different indication. So the Watchman, let's talk about the Watchman for a little bit. So Watchman now is approved for patients or indicated for patients who should be on a blood thinner but cannot take it. Why can't they take it? Because they have bleeding.

So in such a patient, to prevent stroke and avoid long-term oral anticoagulation we can close the appendage where most of the blood clots form and that's the highest area where strokes result from in patients with AFib. If we close the appendage, will we be able to reduce the risk of stroke to the same extent as a blood thinner, but at the same time also reduce the risk of bleeding because the patients will not be on a blood thinner or anticoagulant? So that's the study in a nutshell. That's the rationale behind the study.

Walid Saliba, MD:

That's actually very interesting. So we know that the Watchman FLX now is indicated for patients who are contraindicated for taking long-term oral anticoagulation. So the new thing about the study is that this has the potential to extend the indication for left atrial appendage closure beyond just the patients who are contraindicated for oral anticoagulation.

Oussama Wazni, MD, MBA:

Exactly. So this one now, the study, is looking into whether the guidelines, like we said say now a patient who is post-ablation should stay on oral anticoagulation based on the CHA2DS2-VASc Score. But again, like we said, we have this issue of a successful patient being on anticoagulant when they don't need it and a non-successful patient stopping the anticoagulant when they really need it. So yes, this will expand indication because this is not in patients who have a bleeding indication. This is in patients who are not bleeding, they're non-bleeders, but they're post-ablation.

And the thought process was if we can close the appendage and then not have to worry about taking a blood thinner long-term either because of, well what are the issues with taking a blood thinner long-term? One is compliance. In around four years, about 25% of patients who should be on the blood thinner, should be taking it, stop taking it. The other issue is that there's bleeding that happens also in long-term with these medications. So that's why if we can close the appendage and not have to worry about increased risk of stroke or bleeding, I think that would be optimal management in these patients.

Walid Saliba, MD:

Well that is definitely very interesting. I can't wait actually to see the results. Can you guide us through the actual design of the study and maybe tell us how many patients are involved and what was the randomization process?

Oussama Wazni, MD, MBA:

We aimed to enroll patients who either had an ablation within three to six months or would be having an ablation and we randomized them to getting a Watchman device, Watchman FLX device, or to continue oral anticoagulation. And we were able to enroll 1,600 patients, roughly 800 in each arm, and we followed them for three years.

Walid Saliba, MD:

Can you tell us then, what are the main findings of this trial now that we've completed the three-year follow-up and have all the follow-up on the patients?

Oussama Wazni, MD, MBA:

After three years of follow-up we found that the composite end point, as we said, all cause mortality and stroke and systemic embolism in both groups was very similar. And actually, the implantation of the device, of the Watchman FLX device, was not inferior to anticoagulation. There were 5.3% events in the device group versus 5.8% in the oral anticoagulation group. And what's really very encouraging is that the risk of stroke, and that's what we're trying to accomplish here, reduce the risk of stroke, was low in both arms. It was 1.2% in the device group versus 1.3% in the oral anticoagulation group.

So now we implant a device and the risk of stroke is basically the same as an anticoagulant. And the important thing also about OPTION is that on the anticoagulation side, most of the anticoagulation was with the newer agents, the DOACs, and not warfarin. The original studies of Watchmen were against warfarin and that's why there was a lot of controversy whether Watchman will perform to the same extent as the newer anticoagulants. And here in OPTION we showed that is actually equivalent to oral anticoagulants with respect to decreasing the risk of stroke.

Walid Saliba, MD:

So this is very actually interesting. So now for the first time we have in patients who are non-necessarily bleeders, not contraindicated to oral anticoagulation, putting a Watchman device versus continuation of oral anticoagulation after an ablation have essentially the same efficacy endpoints as we defined it. So the other patients who continue to take anticoagulation, has there been any issues as far as the safety endpoints?

Oussama Wazni, MD, MBA:

Yeah. So the safety endpoint was actually very different. We met superiority with that, meaning that we had much less bleeding in the device group, in the Watchman FLX group, versus oral anticoagulation. So 8.5% in the device group versus 18.1% in oral anticoagulation. Again, this is non-procedural major bleeding or clinically relevant non-major bleeding at 36 months. Most of it was driven by the clinically relevant non-major bleeding, but still clinically relevant non-major bleeding means that the patient had to either go to the hospital, either they had to get treatment for that bleeding, or they had to change medications or even strategies to manage that bleeding. So there was a big difference. Again, 8.5 versus 18.1%.

Walid Saliba, MD:

That is definitely new data that might change the way we practice. So if I'm a physician taking care of patients with atrial fibrillation and I'm seeing somebody who I'm going to send for an ablation, what is it that I'm going to tell the patient in the light of these studies and the patient has a risk of stroke that warrants anticoagulation by current guidelines?

Oussama Wazni, MD, MBA:

I think the major message from OPTION now is that patients have a choice and they can choose between getting a procedure, which can actually be done with their ablation at the same time and then they won't have to take a medication versus taking a medication later. I think what we can do at this point is just present the data to the patient. The good news too, we didn't spend too much time on it, but the procedure was very safe and there was not, even when we looked at the major bleeding, procedural major bleeding, it was not anything that is significant that would say, "Oh you should not do this procedure."

So it was really very safe. I think we can talk to the patients and we can introduce them to the concept and present them with the data and they can choose between getting the ablation plus left atrial appendage closure with a Watchman device in this case because that's what the study was about versus continuation of oral anticoagulant.

Walid Saliba, MD:

This is very interesting. And you mentioned also that in the device arm, patients who had a Watchman FLX device, some of them had concomitant procedures and other had what we call a sequential procedure. Can you elaborate on that point?

Oussama Wazni, MD, MBA:

Yeah. So in the arm where we implanted a device, about 40% had the closure of the appendage concomitantly or combined with the ablation. So get the ablation and then in the same procedure we would close the appendage. 60% had an ablation remotely from the implantation of the device.

Walid Saliba, MD:

This is something that has not been practiced routinely in the United States. Has there been some experience at the Cleveland Clinic doing this kind of an approach?

Oussama Wazni, MD, MBA:

So outside of the study, again in patients who are bleeding, so these are not the patients here in this study, but yes, we have had experience in doing what we call the combined procedure where we do an ablation and then implant the Watchman device and we've had very good outcomes with it. But again, this is not now the study itself. This is in patients who are bleeding. But going back to the study, again like I said, we had 40% who had a combined procedure and 60% who had it sequentially.

Walid Saliba, MD:

So obviously it is very attractive to think that you can have two procedures done in one setting at the same time rather than have two times use of resources, double the risk, you can do two procedures at the same time. So that's definitely something very attractive to patients and possibly to physicians alike. How do you see this panning out as a result of the results of the OPTION trial?

Oussama Wazni, MD, MBA:

I think this is something that's very feasible and something that we should continue working on. Now again, OPTION is about patients who do not have current bleeding risks. So those are patients who actually can take oral anticoagulants and we're just replacing their anticoagulant with Watchman FLX. But currently at the Cleveland Clinic, we have patients who need an ablation because they have symptoms from AFib or they are developing heart failure. They need an ablation, but they also need a Watchman device right now based on current indications. Why do they need a device right now? Because they're having bleeding problems. So they have a patient who is symptomatic from AFib, but they have to take a blood thinner to reduce the risk of stroke, but as they're taking the blood thinner, they're having recurrent bleeding, GI bleeding, or they already had a major bleed like intracranial hemorrhage or a subdural hematoma.

So in those patients right now, we're actually offering them an ablation to take care of their AFib, relieve their symptoms and also reduce the risk of heart failure, and at the same time because they are already bleeding on the blood thinner, we are closing the appendage so that they don't have to take the blood thinner long-term. Our experience so far has been really very, very good. We've been doing it since at least 2000, what was it? '17.

Walid Saliba, MD:

'15.

Oussama Wazni, MD, MBA:

'15. 2015 with more than 500 patients. Of course there was a learning curve in the beginning, but right now it's really very safe and I think it makes sense to do this. Why does it make sense? It makes sense because then we don't have to expose the patient to two procedures and two times where they're exposed to getting access, doing a transeptal, being under general anesthesia. We can combine all that into one procedure and get it done because right now those patients are really indicated for both procedures and why should we separate them?

Walid Saliba, MD:

And obviously there is always the question of the financial aspect of things. Do you foresee any problems in terms of reimbursement? Does this make financial sense to do two procedures in one? And how is this going to pan out for the physicians who are practicing outside?

Oussama Wazni, MD, MBA:

This had been an issue in the past, but we, actually at the Cleveland Clinic, we decided to do what's right for the patient regardless of the financial impact. Because of rules from CMS and insurance companies, when two procedures are done, you don't get the full payment. But actually based on our own work, CMS has created a new code for the combined procedure, which just took effect in October. And now physicians can do both procedures at the same time and I think get fairly compensated.

Walid Saliba, MD:

Well that's actually very exciting news for patients and for physicians alike I believe. To summarize, what are a couple of takeaway points that came out from the OPTION trial and what is it that we want to tell the physicians who are listening to us in terms of treating their patients with atrial fibrillation? How can we help in this situation?

Oussama Wazni, MD, MBA:

So I think a very important message from OPTION is that now your patient or a patient who needs an AFib ablation but also needs to be protected from stroke, we can do an ablation and also close the appendage, whether in a combined procedure or a sequential procedure and we will have equivalence in reducing the risk of stroke, but without having to first take a medication long-term and without having to be exposed to the long-term bleeding risk associated with the oral anticoagulants. So I think this is a very important message to the physicians and to our patients that now they can have an ablation and they really don't have to worry about stroke prevention because once the device is in, and in most cases, again, it's done very safely with very low risk of complications, and then they won't have to take a blood thinner.

So that's the big takeaway. The other takeaway I think also from our work here is that until this gets into the guidelines, and it'll take some time, currently at the Cleveland Clinic we've been doing this since 2015. We have a lot of experience in doing an ablation combined with left atrial appendage closure very safely, very effectively, and we've been looking at our data with very low risk of complications and stroke and bleeding.

Walid Saliba, MD:

Well thank you very much and I believe that this definitely has the potential to change the, as Dr. Wazni said, the indications for atrial fibrillation along with left atrial appendage closure. For the first time now, we can offer left atrial appendage closure without the needs or the currently existing indications for bleeding. So as an alternative to oral anticoagulation, following an ablation, you can have a left atrial appendage closure and you can do it concomitantly, which is very important and I believe that this is something that will be very much welcomed by patients and physicians alike.

Thank you very much for joining us for this episode of Cardiac Consult and I hope that you've enjoyed listening to it and if you have any questions or any comments in the future, we will be more than happy to facilitate and answer those questions. Thank you very much.

Oussama Wazni, MD, MBA:

Thank you.

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