Roughly 24 patients with chronic HFrEF would need to be treated to prevent one CV death/HF hospitalization, say researchers.
Radha Gopalan, MD (Banner—University Medicine Heart Institute, Phoenix, AZ), a transplant and HF specialist who wasn’t involved in VICTORIA, called the results a win for patients. While the results are significant, the benefit of treatment was relatively modest, he said. But that doesn’t imply they won’t have a meaningful impact in clinical practice.
“In heart failure, we have very few therapies that are available for this particular population,” he told TCTMD. “In this particular group of patients who have been hospitalized or who have received intravenous diuretics as an outpatient, when they are seen in the hospital, we normally think about the next level of treatment, which is not continued medical therapy but tends to be mechanical circulatory support or heart transplant eligibility. When you think of it that way, you could consider this a game changer. It’s something heart failure specialists will try before committing a patient to transplant or mechanical circulatory support.”
Both Gopalan and Yancy highlighted the characteristics of patients enrolled in the trial, with Gopalan pointing out that 75% were male and Yancy noting that just 5% were black. “That’s important because there are prevailing concerns that this unique patient population may exhibit exquisite nitric oxide bioavailability concerns,” said Yancy, referring to black patients. Gopalan made a similar point, adding, like Yancy, that further study of vericiguat in black HF patients will be warranted.
In VICTORIA, there was a significant interaction with baseline NT-proBNP levels, with investigators observing that patients with the highest levels (> 5,314 pg/mL) did not appear to benefit from vericiguat. Whether this is a play of chance or whether these patients might have HF too advanced to benefit from treatment is uncertain, they state. Overall, the benefit of vericiguat was generally consistent across all subgroups, including patients taking an ARNI.
The rates of symptomatic hypotension and syncope tended to be higher with vericiguat, as was the rate of anemia, but the rates of serious adverse events were similar between the two treatment groups. There were no adverse effects of vericiguat on electrolytes or renal function. “Without the need for monitoring of renal function or electrolytes, [vericiguat] may play a useful role in patients with recent worsening heart failure,” said Armstrong.
“Polypharmacy for heart failure with reduced ejection fraction is now officially a problem,” added Yancy, noting the plethora of drugs available for this population. “I think that’s a good one to have because we didn’t have that concern for many years and now we have to recognize there are multiple choices. With that recognition, we have to understand the time is now to be even more focused on precision medicine and understanding which patient under which circumstances should the current availability of treatments be administered.
Gopalan noted that HF patients tend to have low blood pressure and the struggle can be adding medications that can be tolerated with limited side effects. In VICTORIA, hypotension and syncope were numerically higher with vericiguat, which isn’t surprising given the drug’s mechanism of action on the nitric oxide pathway. If and when the drug becomes commercially available, tolerability of vericiguat will need to be established with each patient, he said.
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