New Therapy Data: Guideline Implementation Delays

Top pharmacists consider the reasons for delays in implementing new data into the treatment guidelines for CAD/PAD.

Paul Dobesh, PharmD: These data have been out for over a year, at least, but yet the uptake in the utilization of this regimen has been slower. It kind of puzzles me, and I think you and I have had discussions offline about this, but we know that the uptake of information, study data come out—beta-blockers took what, 4 or 5 years before they started being used post MI [myocardial infarction], right? So we understand that there’s a delay. But in a modern era, when you look at the magnitude of benefit these patients can see, why do we think we’re seeing a delay, or what are your thoughts around this?

James Groce III, PharmD: Well, I did a little research, knowing and suspecting that you might ask me that. You know it’s 1 of my, I guess, peeves. It’s frequently stated that, on average, not just specific to this particular clinical trial or even the use of beta-blockers, but on average—the statistic I’m about to reveal is shameful, I believe—but it takes about 17 years, on average, for things to really come, for research evidence to be implemented into clinical practice. If we put that in context now, go back to all the statistics that I cited earlier, you had asked me what was the incidence and the prevalence of these disease states. When you think about those numbers that we discussed earlier, and now the thought of whether it’s just 4 or 5 years, as it was for beta-blockers, or worst-case scenario, if there’s not uptake and even if it were to last for 17 years, I think, again, that’s something that we must correct upon.

I think there are some ways in which we really need to ready ourselves to act upon. One, be familiar with the clinical trial and what it may mean for our patients. Today, it’s just not enough to pursue knowledge, but in our pursuit of knowledge, we really have to absorb it, think about it, communicate it with each other; what we’re doing here today, I hope, translate that into, again, what it might mean for patients who we see within our practice, and then, most importantly, it has to be implemented.

I think when we were talking about our risk factors for CAD [coronary artery disease], one of the things that we identified is that there are so many vascular beds that are impacted upon, and so often we see so many, a multitude or multiple different providers, caring for those different vascular beds. It’s not as if you go to 1 provider and all vascular beds are cared for by the 1 provider. You have coronary artery disease, of course you go to the cardiologist. You have stroke disease, you go to the neurologist. You have peripheral arterial disease, you go to the vascular medicine specialist or a vascular surgeon. I think that’s been one of the issues that I’ve seen and observed within our own community that no one is really willing to—it’s what I call pull the trigger, if you will, on seeing this done. I see this often with our internal medicine training program here, or it can be any physician, and I think we’ve all heard this as pharmacists. It goes something like this: “Well, I wasn’t the person or the provider who commits the patient on the single agent for their stable CAD or PAD [peripheral artery disease]. I don’t feel comfortable now adding the second component or the antithrombotic component to the regimen based upon the evidence, based upon the data.”

I think this is one of those situations where if we can get the American College of Cardiology [ACC], the American Heart Association [AHA] to have uptake of these data and they get incorporated into the guidelines, then we’re on a different playing field, if you will, in terms of what it means for those who often cite that they worship at the altar of evidence-based medicine. Then we’re going to have to incorporate the role of this antithrombotic drug with the antiplatelet agent that we’ve been doing. I believe this should be the driver of the ACC and AHA treatment guidelines incorporating these data. We know the European Society of Cardiology—the ESC guidelines for prevention, for death prevention in CAD patients, already have implemented the role of not just an antiplatelet agent but actually [also add] a second agent, that of an antithrombotic drug. Within their guidelines, they cite generically the role, based upon the COMPASS data and the COMPASS clinical trial, the role of rivaroxaban, 2.5 mg twice daily, administered with concomitant aspirin. So I think that’s the kind of thing that we have to look to here within our practice…for ACC and AHA to similarly incorporate these findings into their guidelines for us as providers here in the states.

Paul Dobesh, PharmD: What I really like about the European Society of Cardiology guidelines that you mentioned is that they do a good job of really kind of following the COMPASS trial design, in that they talk about clopidogrel with aspirin, ticagrelor with aspirin, prasugrel with aspirin, dual antiplatelet therapy a year, and then low-dose rivaroxaban plus low-dose aspirin after the year, which is, once again, getting to the point: This is not in competition with what we do after the first year of ACS [acute coronary syndrome] or patients get a stent. This is really what you are going to do long term to provide better outcomes. I think that’s part of it, too, as we look at why are people not embracing this. There’s not an event, right? It’s not like there was an ACS event and now we do this, or there’s other times there’s a DVT [deep vein thrombosis] and we do this, or they have AFib [atrial fibrillation] and we do this. This is really going into the patient who is doing well, hopefully, and asking ourselves, “Can we do better?” I really think that we maybe should just start saying that every time we’re about to walk into that patient’s room, whether it be in the clinic or the hospital, and we’re looking at their chart, whether that be on our iPad or whatever, and thinking, “All right, what can we do better?” Now we see, with the results of the COMPASS trial, that even in the patients who aren’t having any type of quote, unquote, acute episodes or events, we can do better. So I think that’s something for us to kind of focus on.