How the PIONEER-HF and PARADIGM-HF trials have focused on varied, but realistic heart failure patients.
With the completion of the PIONEER-HF extension assessment, clinicians now have 2 full-bodied trials’ worth of data to observe sacubitril/valsartan in patients with heart failure. Luckily, they address a varied, yet real-world applicable, population of patients.
In an interview with MD Magazine® while at the American College of Cardiology (ACC) 2019 Annual Scientific Session in New Orleans, LA, Adam DeVore, assistant professor of Medicine at Duke University, defined the assessed clinical trial heart failure patients, and who else will be focused on in future sacubitril/valsartan assessments.
MD Mag: With new data, are physicians more confident to prescribe sacubitril/valsartan to hospitalized patients with HF?
DeVore: You know, the implementation here is very important. And I think 1 thing that's important to remember is that when the PIONEER-HF study—when the whole program was put together, it was meant to be easily translated into clinical practice. And so, to get into PIONEER-HF, you had to have a low ejection fraction, you had to be in the hospital for heart failure, and then you had to have hemodynamic stability.
And that definition is something that's fairly easy to remember and actionable as a blood pressure of 100 or more, systolic blood pressure of 100 or more for 6 hours—not the whole hospitalization—and they couldn't have changes in their IV diuretics or their vasodilators for 6 hours. Again, something that's a very common scenario. And then, no inotropes for 24 hours.
So we think that's a large cohort of patients—something that we all will encounter in clinical practice. And I do think that can be translated into practice.
Have we properly assessed every iteration of realistic heart failure patient for sacubitril/valsartan?
DeVore: So, I think about a couple populations of heart failure patients. And I think for sacubitril/valsartan there now 2 large published randomized clinical trials. One was PARADIGM-HF. Those are outpatients, ambulatory heart failure patients, all low ejection fraction, a large study, a lot of different types of comorbid conditions included there.
And it seemed like a huge benefit in terms of clinical outcomes for PIONEER-HF. That's more of the acutely ill population of patients. It could be a new diagnosis, could be an old diagnosis, it doesn't matter. It's just that they're acutely decompensated. And again, whenever we looked across the subgroups—their age, race, differences in ejection fraction or renal function—we saw the same signals.
So it seemed like it really helped a broad population of patients. I think putting those together, we've learned a lot. There's an ongoing trial that Duke is happy to be a part of that's called the LIFE trial—that's more of the chronically advanced heart failure population. And so, we're going to learn a lot as that trial completes, too.