Stroke Prevention in NVAF: Addressing Unmet Needs

OCTOBER 06, 2018
 

Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, discuss current limitations for preventing stroke in patients with nonvalvular atrial fibrillation.


Peter Salgo, MD: Let’s talk about the future a bit. We’ve talked about these drugs, which, as you pointed out, aren’t all that new. But let’s talk about the future. Where are we going? What are the unmet needs, in terms of stroke prevention and nonvalvular atrial fibrillation [NVAF]? 

Juvairiya Pulicharam, MD: One of the most important, that we all need to focus on, is education. There are really a lot of unmet needs out there.

Peter Salgo, MD: What do you mean?

Juvairiya Pulicharam, MD: Gaps in education. I don’t think patients with atrial fibrillation realize how important it is for them to be on anticoagulants. You’d be surprised—even primary care physicians. So, I think that gap is a big gap. That’s what we figured from our atrial fibrillation registries.

Peter Salgo, MD: So, education. What else?

Gary M. Besinque, PharmD, FCSHP: It’s only been since November of 2010, when Pradaxa [dabigatran etexilate] was first introduced. We’ve actually entered a new chapter on the things that we need to educate ourselves about. Eight years is not very much time to figure out all of the stuff that is happening with these new agents. We don’t have a good idea of how they compare to one another, but we do know that they’ve been able to satisfy the FDA [Food and Drug Administration] that they’re good to go. The nuance and a little more sophistication is in the future, but it’s not quite ready for primetime.

Peter Salgo, MD: I could say to you, “These drugs are graded. We have a decrease in the incidence of hemorrhagic stroke, compared with the previous agents, and no difference in the incidence of thrombotic or embolic stroke.” That sounds pretty darn good to me. What else do we need to do? If you had a wish list, “OK, here’s NVAF. I’ve got this, this, this, and this, but I don’t have this,” what do you want?

Gary M. Besinque, PharmD, FCSHP: I want to see if INR [international normalized ratio] that’s too high and too low has a correlate in the NOAC [novel oral anticoagulant therapy] realm, where you can find that you’re not getting enough intensity of anticoagulation to get to where you want to go. 

Peter Salgo, MD: You’re the guy who was telling me, “I don’t need a meter. I don’t need to know.” Now you want a meter?

Gary M. Besinque, PharmD, FCSHP: Well, they have them in Europe. 

Peter Salgo, MD: What does that mean?

Jaime E. Murillo, MD: They’ve got to be good then, right?

Peter Salgo, MD: Maybe.
 
Gary M. Besinque, PharmD, FCSHP: These device approvals are a little more difficult.

Peter Salgo, MD: What I’m hearing is that it’s like molasses in Vermont, in the winter. 

Gary M. Besinque, PharmD, FCSHP: Well, they don’t know if they want to go there. Industry may not want to go there at all.

Peter Salgo, MD: Is there an advantage? In other words, if they’ve got these measuring tools in Europe, what is the European experience? Are they seeing fewer hemorrhagic strokes? Are they seeing fewer embolic strokes? Does it make a difference? Or, is it simply another tool that you can pay for, that doesn’t change anything?

Gary M. Besinque, PharmD, FCSHP: Well CoaguCheks are pretty popular over here.

Peter Salgo, MD: OK. What do you think? What do you want?

Ralph J. Riello III, PharmD, BCPS: I would guess that they’re probably seeing fewer embolic strokes. The guidelines over in Europe recommend anticoagulation at a score of 1, which is not how we practice over here. We wait for the score of 2 before we prescribe anticoagulation, in terms of risk versus benefit.

Peter Salgo, MD: OK. Part of that is because there’s a meter to tell them what they’re doing.

Ralph J. Riello III, PharmD, BCPS: I’m sure that factors in somewhere.

Peter Salgo, MD: It does. Do you want a meter? Is that No. 1 on your list?

Jaime E. Murillo, MD: To be honest, No. 1 on my list for stroke prevention is screening. We don’t do enough screening. And remember, the most preventable cause of a stroke, embolic stroke, is atrial fibrillation—18% to 20% of patients. So, that is where we have a huge opportunity. It goes back to education. If we educate the patient about detecting irregular pulse—that’s not rocket science. Now we have smartphones. We have a lot of technology that we could apply. I see the future there—the application and technology—in terms of early detection, screening, monitoring, and maintenance using these devices. So, screening is a way to prevent strokes by detecting atrial fibrillation earlier. 

Peter Salgo, MD: You know what my fear is with that? We have all of this technology. We have our phones. Everybody is watching everything. “Oh my, I had an extra beat 3 days ago. I’m running to the emergency department.” There’s a real risk of navel-gazing here, right? We’re so concerned about every small thing that we’re missing the enjoyment in life.

Jaime E. Murillo, MD: At some point, we’ll reach that balance. But, I’d rather have that patient not necessarily go into the emergency department. That’s where we talk about establishing a system that will allow us to have this team approach, where you have a dynamic as change that will be virtual. You don’t have to go to the emergency room. You don’t have to go to the doctor’s office. You don’t necessarily have to call your primary care office. You just need a line of communication that allows you to transmit that concern or even transmit that rhythm from the phone to a center that will tell you, “Don’t worry about it. It’s a simple extra beat. There is no reason for concern but keep an eye on it.”

Peter Salgo, MD: Technology is good, I would think. 

Jaime E. Murillo, MD: And it will be even better in health care.

Peter Salgo, MD: Pediatricians love it. Half of the time, I say, “My kid’s got pink eye.” I take a picture. “No, he doesn’t. It’s OK.”


 
 

Gary M. Besinque, PharmD, FCSHP; Jaime E. Murillo, MD; Juvairiya Pulicharam, MD; Ralph J. Riello III, PharmD, BCPS; and Peter Salgo, MD, discuss current limitations for preventing stroke in patients with nonvalvular atrial fibrillation.


Peter Salgo, MD: Let’s talk about the future a bit. We’ve talked about these drugs, which, as you pointed out, aren’t all that new. But let’s talk about the future. Where are we going? What are the unmet needs, in terms of stroke prevention and nonvalvular atrial fibrillation [NVAF]? 

Juvairiya Pulicharam, MD: One of the most important, that we all need to focus on, is education. There are really a lot of unmet needs out there.

Peter Salgo, MD: What do you mean?

Juvairiya Pulicharam, MD: Gaps in education. I don’t think patients with atrial fibrillation realize how important it is for them to be on anticoagulants. You’d be surprised—even primary care physicians. So, I think that gap is a big gap. That’s what we figured from our atrial fibrillation registries.

Peter Salgo, MD: So, education. What else?

Gary M. Besinque, PharmD, FCSHP: It’s only been since November of 2010, when Pradaxa [dabigatran etexilate] was first introduced. We’ve actually entered a new chapter on the things that we need to educate ourselves about. Eight years is not very much time to figure out all of the stuff that is happening with these new agents. We don’t have a good idea of how they compare to one another, but we do know that they’ve been able to satisfy the FDA [Food and Drug Administration] that they’re good to go. The nuance and a little more sophistication is in the future, but it’s not quite ready for primetime.

Peter Salgo, MD: I could say to you, “These drugs are graded. We have a decrease in the incidence of hemorrhagic stroke, compared with the previous agents, and no difference in the incidence of thrombotic or embolic stroke.” That sounds pretty darn good to me. What else do we need to do? If you had a wish list, “OK, here’s NVAF. I’ve got this, this, this, and this, but I don’t have this,” what do you want?

Gary M. Besinque, PharmD, FCSHP: I want to see if INR [international normalized ratio] that’s too high and too low has a correlate in the NOAC [novel oral anticoagulant therapy] realm, where you can find that you’re not getting enough intensity of anticoagulation to get to where you want to go. 

Peter Salgo, MD: You’re the guy who was telling me, “I don’t need a meter. I don’t need to know.” Now you want a meter?

Gary M. Besinque, PharmD, FCSHP: Well, they have them in Europe. 

Peter Salgo, MD: What does that mean?

Jaime E. Murillo, MD: They’ve got to be good then, right?

Peter Salgo, MD: Maybe.
 
Gary M. Besinque, PharmD, FCSHP: These device approvals are a little more difficult.

Peter Salgo, MD: What I’m hearing is that it’s like molasses in Vermont, in the winter. 

Gary M. Besinque, PharmD, FCSHP: Well, they don’t know if they want to go there. Industry may not want to go there at all.

Peter Salgo, MD: Is there an advantage? In other words, if they’ve got these measuring tools in Europe, what is the European experience? Are they seeing fewer hemorrhagic strokes? Are they seeing fewer embolic strokes? Does it make a difference? Or, is it simply another tool that you can pay for, that doesn’t change anything?

Gary M. Besinque, PharmD, FCSHP: Well CoaguCheks are pretty popular over here.

Peter Salgo, MD: OK. What do you think? What do you want?

Ralph J. Riello III, PharmD, BCPS: I would guess that they’re probably seeing fewer embolic strokes. The guidelines over in Europe recommend anticoagulation at a score of 1, which is not how we practice over here. We wait for the score of 2 before we prescribe anticoagulation, in terms of risk versus benefit.

Peter Salgo, MD: OK. Part of that is because there’s a meter to tell them what they’re doing.

Ralph J. Riello III, PharmD, BCPS: I’m sure that factors in somewhere.

Peter Salgo, MD: It does. Do you want a meter? Is that No. 1 on your list?

Jaime E. Murillo, MD: To be honest, No. 1 on my list for stroke prevention is screening. We don’t do enough screening. And remember, the most preventable cause of a stroke, embolic stroke, is atrial fibrillation—18% to 20% of patients. So, that is where we have a huge opportunity. It goes back to education. If we educate the patient about detecting irregular pulse—that’s not rocket science. Now we have smartphones. We have a lot of technology that we could apply. I see the future there—the application and technology—in terms of early detection, screening, monitoring, and maintenance using these devices. So, screening is a way to prevent strokes by detecting atrial fibrillation earlier. 

Peter Salgo, MD: You know what my fear is with that? We have all of this technology. We have our phones. Everybody is watching everything. “Oh my, I had an extra beat 3 days ago. I’m running to the emergency department.” There’s a real risk of navel-gazing here, right? We’re so concerned about every small thing that we’re missing the enjoyment in life.

Jaime E. Murillo, MD: At some point, we’ll reach that balance. But, I’d rather have that patient not necessarily go into the emergency department. That’s where we talk about establishing a system that will allow us to have this team approach, where you have a dynamic as change that will be virtual. You don’t have to go to the emergency room. You don’t have to go to the doctor’s office. You don’t necessarily have to call your primary care office. You just need a line of communication that allows you to transmit that concern or even transmit that rhythm from the phone to a center that will tell you, “Don’t worry about it. It’s a simple extra beat. There is no reason for concern but keep an eye on it.”

Peter Salgo, MD: Technology is good, I would think. 

Jaime E. Murillo, MD: And it will be even better in health care.

Peter Salgo, MD: Pediatricians love it. Half of the time, I say, “My kid’s got pink eye.” I take a picture. “No, he doesn’t. It’s OK.”


 
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