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Don't Miss a Beat hosts Drs. Vaduganathan and Greene provide insight into the results of trials from ACC.22 late-breaking sessions they highlighted in the preview episode they recorded ahead of the American College of Cardiology's 71st Annual Scientific Session.
Ahead of the American College of Cardiology’s 71st Scientific Sessions, Don’t Miss a Beat, a monthly podcast presented by Inside Cardiology, launched an ACC.22 preview episode to highlight our hosts' top picks from the late-breaking sessions at the meeting.
Hosted by Practical Cardiology advisory board members Muthiah Vaduganathan, MD, MPH, a cardiologist at Brigham and Women’s Hospital, and Stephen Greene, MD, associate professor of medicine at Duke University School of Medicine, the ACC.22 preview of Don’t Miss a Beat highlighted upcoming data from the DIAMOND, SODIUM-HF, PROMPT-HF, and SCORED trials.
With embargoes surrounding the data lifted and presentations at ACC.22 complete, we caught up with both hosts for their reactions to the data and how they expect to apply this data in clinical practice.
Of note, Practical Cardiology spoke with SCORED principal investigator Deepak Bhatt, MD, MPH, at ACC.22 and coverage of that study can be found here.
Practical Cardiology: How do you interpret the results of DIAMOND?
Greene: We had the press release before the presentation. So, we knew it was going to be a positive trial in terms of the serum potassium levels, but I think there are a couple key points to takeaway that I think we’re really expertly emphasized by Dr. Javed Butler during his presentation. First, by definition, everyone in DIAMOND either had active hyperkalemia at enrollment or a history of hyperkalemia that caused the detrimental change in RAASi therapy. So, they were actively hyperkalemic or had negative consequences of hyperkalemia. They found if you take that population and give them patiromer up to 3 times a day, you were able to get 85% of them on really high quality RAASi and MRA therapy. So, you have this group that you would think maybe would have a lot of difficulty with the open-label run-in, but you got up to 85%.
When looking at secondary endpoints, and now we're talking about the blinded, randomized part of the trial, we see the serum potassium was impacted, but I think Dr. Butler said it very nicely when he explained that it was only a .1 or so change in serum potassium, which is statistically significant, but also remember that there was more RAASi therapy discontinuation in the non-patiromer group.
So, patiromer lead to lowering of serum potassium, despite more RAASi use continuing. That point one is really more even more impressive, in my opinion, when you take it in that context of it's in the context of more spironolactone and more RAAS inhibition. To me, pretty impressive results underscoring that, assuming access is not an issue, hyperkalemia should increasingly not be a reason to not optimally use GDMT. I think it's really, really important for clinical practice to have that message.
Practical Cardiology: As a clinician, what are your takeaways from SODIUM-HF?
Vaduganathan: SODIUM-HF was a critically important trial and I'm so happy to see that it was showcased here on the prominent ACC.22 stage and also simultaneously published in The Lancet. I think that we have lack foundational evidence for a lot of the practices we do on a daily basis that are nonpharmacological in heart failure care and sodium restriction is highest on that list of what patients hear and what clinicians say. Unfortunately, we haven't had a strong evidence base to guide those discussions. Conversely, patients often do significantly limit sodium intake and do so at the detriment, sometimes, to their quality of life and their own their own satisfaction with their lifestyle. So, adding evidence to this conversation is really, really important.
Practical Cardiology: How do you interpret differences, in terms of event reduction, the lack of benefit seen in SODIUM-HF compared against the robust benefit observed in SSaSS?
Vaduganathan: SODIUM-HF was an 800-patient, open-label trial that compared the strategies of usual care versus a sodium restriction counseling. There are significant differences between how the Salt Substitute and Stroke Study (SSaSS) was conducted versus SODIUM-HF. SSaSS was a cluster-randomized trial at the community level across China with a different patient population. These patients were extremely high risk for stroke, had histories of hypertension, and were generally older patients. So, these patients were enriched for the target event of stroke. Whereas SODIUM-HF was a representative heart failure trial.
The delivery of the intervention was also different between these trials. SSaSS actually implemented, at the community level, changes in how sodium was actually incorporated into routine daily practice, including routine daily cooking, and change that supply to this sodium substitute, which was a potassium enriched substitute. In contrast, in SODIUM-HF, it was direct patient counseling. SODIUM-HF did show that there was a modest reduction in sodium intake, but overall sodium intake in the trial was lower than typical. So, maybe, there was some component of this that the patients enrolled in the trial might have been on the lower risk spectrum.
Unfortunately, the trial didn't show that sodium restriction counseling actually reduced clinical events at follow-up. I think it's a critically important message that you know, we need to reshift focus, especially patient discussions, to evidence-based solutions that we know can alter the trajectory of patient care.
Practical Cardiology: What is your reaction to PROMPT-HF results?
Greene: I think PROMPT-HF was a clear win. I'm very excited about these results. We talk about clinical inertia all the time in medicine and how you see the patient time after time in the outpatient setting and we think they're stable and the patient thinks they're stable, so we make no medication changes but don't understand that that patient is leaving your office at such a high risk. Then, we're not really pushing the envelope like we should with maximally reducing that risk.
So, I think PROMPT-HF really just shows that being very prescriptive in our recommendations for what to do, at the provider level, can nudge and can make us prescribe medicines. It's not perfect, it did not get it to 100%. We saw for SGLT2 inhibitors use was still very modest. A similar trend was observed with ARNi. So, there is still huge gaps, but we know it is possible to move the needle somewhat here and there's still going to be other barriers to overcome. From the clinician perspective, we’re really trying to target clinical inertia that the clinician sees and PROMPT-HF showed that there is it is possible to make a difference.
Practical Cardiology: In the past, you helped create a heart failure dashboard for Duke health systems. With this in mind, when thinking about application of PROMPT-HF results, should health systems look to create their own alert program for EHRs or try to replicate the system created within PROMPT-HF?
Greene: I can first say that, while I was optimistic about PROMPT-HF, I certainly wasn't automatically expecting it to be a clear win, but I'm glad it was because we have seen implementation studies struggle with things that you think would be common sense or so plausible to make a difference. And they don't, you know, for example, the REVEAL-HF study presented last year was just showing clinicians the risk their patients were facing and expecting them to translate that risk to prescribing medicines. You might think that would work, but it didn't.
So, with PROMPT-HF, I’m glad that the results met expectations and backed up the possibility of the approach making an impact. In terms of next steps for this, I think the advantage thatDr. Ahmad Tariq talks about during his presentation is that this does have scalability. My personal thought is that trying to mimic what's been shown to work, aka prompt HF, is the best evidence-based approach to go and also the most efficient approach because now, there can some tweaks to the system, but starting from scratch doesn't necessarily seem to be most efficient. With PROMPT-HF you have evidence-based approach with trying to implement that and other health systems seems like a good path forward.
Editor’s note: This transcript has been edited for length and clarity.