ASCP 2022 session presenters review the evidence that tipped the scales against the use of aspirin for primary prevention in patients aged 60 years or older.
Pharmacy Times® interviewed Taylor Naberhaus, PharmD, BCGP, ambulatory care clinical pharmacist at the Saint Luke’s Health System, and Thu Nguyen, PharmD, a clinical pharmacist at the Carl T. Hayden VA Medical Center, discusses their presentation at the American Society of Consultant Pharmacists (ASCP) 2022 Annual Meeting titled The End of an Era: The Diminishing Role of Aspirin in Primary Prevention.
Naberhaus and Nguyen’s session addresses the US Preventive Services Task Force recommendation against the use of aspirin for primary prevention in patients aged 60 years or older and reviews the evidence that tipped the risk versus benefit scales. Additionally, the presenters discuss methods to assess patients’ cardiovascular risk and mitigate risk and identify how to appropriately discontinue therapies for primary prevention.
The ASCP 2022 Annual Meeting will be held at the JW Marriott San Antonio Hill Country Resort & Spa in San Antonio, Texas.
Pharmacy Times®: How did the change in aspirin’s role in primary prevention come about?
Taylor Naberhaus: Yeah, from the historic perspective, previously, aspirin has been widely recommended for use for primary prevention. For example, in 2009, the US Preventive Service Task Force (USPSTF) recommended aspirin for individuals, if they're male, between ages 45 to 79, and females aged 55 to 79 if the benefits outweigh the risks.
So as time has gone on, our armamentarium for primary prevention has grown with statins and more conservative blood pressure goals and medications for diabetes that are having promising effects on cardiovascular risk. Our subsequent studies have found diminishing returns with the aspirin use for primary prevention. So, in 2018 were several landmark trials, the ASPREE trial, the ASCEND trial, and the ARRIVE trial. Those all showed very minimal benefit from aspirin use in terms of reduction in risk of myocardial infarction or stroke, and also showed some concerns in terms of bleeding risk, especially GI bleed, and extracranial bleeding.
So with that mounting evidence, our 2019 guideline update for primary prevention from ACC/AHA and our most recent 2022 USPSTF update have pulled back on that recommendation and given us a C recommendation for the use of aspirin for primary prevention, in very specific populations, and using risk versus benefit discussion and patient-centered discussions in those decisions for its use.
Pharmacy Times®: How have the US Preventive Services Task Force and ACC/AHA Primary Prevention Guidelines changed the process of identifying when to use aspirin for primary prevention?
Taylor Naberhaus: So in the past, there was kind of, as I alluded to, broad age categories where you're discussing the risk versus benefit. As time has gone on, especially in the USPSTF guidelines, there's been discussion of incorporating risk calculators, so the [atherosclerotic cardiovascular disease (ASCVD)] risk calculator, into that decision making process. So the most updated guidelines recommend considering use in the patients that have a ASCVD 10-year risk greater than 10%.
But they also encourage utilizing risk factors for patients. So things that we call risk enhancing factors. So these are things like if they have a family history of premature heart disease, or MI, patients that aren't able to be optimized on other medications, or meet their LDL goals, and CKP. So really, looking at the patient as a whole since our risk calculators to have some limitations, looking at both that risk calculation, but also individual risks to make that decision, and then balancing that with risk of bleeding. So looking at if there are other blood thinners, NSAIDS, corticosteroids, or CKD. Again, is there a risk factor for bleeding? So really balancing that and looking at the patient, understanding we're going to have a small likelihood of benefit, and then taking into account patient desire to take aspirin and then also the risk of bleeding.
Pharmacy Times®: How do you recommend pharmacists assess their patients’ cardiovascular risk?
Taylor Naberhaus: The ASCVD Risk Calculator—I think that's a great place to start. We have realized that that calculator isn't perfect. It's a great tool to have in our pocket, but it will overestimate risk in some patients, depending on things like race, and it will underestimate risk in some patients, again, based on race and other risk factors. So it's a good starting point.
But then we also want to look at other risk factors to see what risk factors would guide us more toward wanting to fully arm the patient with primary prevention. If they have strong family history, if we cannot get these other disease states to goal, they're not tolerating things, if they have diabetes and are not tolerating other medications that could potentially be helpful to getting them to a one single blood pressure goal, things like that—then that's a great patient for aspirin. But really taking a look at the patient individually and then having those patients in their conversations. So having a shared decision-making conversation with a patient, I think has become really important, especially for aspirin use and primary prevention strategies.
Pharmacy Times®: How do you determine when discontinuation of aspirin for primary cardiovascular prevention is appropriate?
Taylor Naberhaus: So in terms of aspirin use for primary prevention, especially in the ASPREE trial, we found an increased risk of mortality, which really wasn't associated with bleeding risk or things like that. So just an increased concern in our older patient population. That was a trial done in an older population. So that is why we've really ratcheted down on the age that we're considering these patients for initiation.
As far as discontinuation goes, we don't have a lot of studies that necessarily address what a patient's risk is of removing this medication, if they've been on it for a long period of time. I do think looking at a patient who's older, older than 65, older than 70—we know they're at an increased risk for bleeding, and this is a medication that we haven't seen as much benefit from. So we want to make sure that we ask them all the questions, if just to make sure they have their own personal history correct, we want to make sure that they aren't on it for secondary prevention in any way if we're going to discontinue it. We want to prioritize those patients that have an increased risk for bleeding, whether that be additional medications that increase that risk or disease states, we want to prioritize discontinuation in those patients. Then if they have a limited life expectancy, that's another reason to prioritize discontinuation as well.
Then really having those patient-centered conversations. So I think it would be appropriate to discontinue aspirin for primary prevention after 70 and have start having those conversations. But if a patient does not have high risk and feels strongly that they're going to benefit from aspirin because they have a long life expectancy and low risk of bleeding other than age, that could be a patient that could continue it a little while longer.
Pharmacy Times®: What are some recommendations for alternative primary cardiovascular prevention strategies based on updated guidelines?
Thu Nguyen: We just talked about the pros and cons of aspirin, and the thing that we do want to emphasize in our presentation is that there are other options for primary prevention and cardiovascular primary prevention too. So if you deem your patients not appropriate for aspirin, there are still other options you could use to help patients reduce their risk of developing any of these events.
In the presentation, we talk a lot about modifiable and non-modifiable cardiovascular risk. A lot of the modifiable risk, we can definitely discuss and help the patient get to some of those healthier goals.
So for example, implementing healthy diet and exercise and stop quitting tobacco, for example, those are some really big lifestyle changes, as well as if you are managing diabetes, blood pressure, or hyperlipidemia, we're aiming for the proper goals for these patients, but also we're using medications that are known to have cardiovascular protection.
Pharmacy Times®: How do you recommend pharmacists work to implement primary prevention approaches in their practice?
Thu Nguyen: Unlike aspirin, where we're telling patients to take this medication and it's going to prevent a lot of these cardiovascular events—lifestyle modification and managing a lot of these disease states and comorbidities are going to require a lot of collaboration between pharmacists and patients. A lot of it is determining if the patient is ready to make these changes. No matter what you're doing, whether it's implementing a new diet, a healthier lifestyle, putting more exercise into your day, or remembering to take your medications daily—let's get your blood pressure under control.
All of that is a component of habit building in our patients and really understand and where the patients are in the stages of change. So are they just kind of thinking about making these changes? Are they ready for these changes? We really need to kind of collaborate with our patients rather than lecture and nag and all of that. It's a lot of usage of motivational interviewing to ask the right questions of, ‘What are your thoughts about this? How do you feel about this? What can I do to support you when you do make decide to make this change.’
I've had a lot of experiences with my own patients where I'm not the one to lecture to them about nutrition, but they've felt ready to begin this new journey in their life. That is when you can swoop in and provide them with the resources to help ease them into this new lifestyle. A lot of it is habit building—what goals are we setting for you? How do we make this so that you can continue to repeat this and make it sustainable? How do we make it fun to repeat? How do we allow you to fail and then get back into it? How do you find social support? A lot of it is that relationship between pharmacists and patients. So I really do want to focus on how we get to that level with our patients.
Areas of practice that pharmacists can really play a role in this with a huge one would be medication therapy management. We do call patients—a lot of pharmacists call patients at home to provide a comprehensive medication review, and I think that would be a good area to discuss habit changing and building these healthier lifestyles for patients. Transitions of care is a good one—but ambulatory care services, that's where pharmacists really have a long-term relationship with our patients, and that's really where a lot of those conversations can occur. So lots of opportunities for pharmacists to play a role to help patients implement these changes.