Breaking News

Beta blocker use challenged, and J&J's controversial Impella pump gets a win

April 7, 2024
elaine-chen-avatar-teal
Cardiovascular Disease Reporter

I'm back with news from the second day of the conference. We have updates on drugs and devices, and some thoughts on whether any of them will make a dent in global disease rates. You can reach me at elaine.chen@statnews.com.

clinical practice

Questioning post-heart attack care

Beta blockers, a mainstay in cardiovascular care, are commonly prescribed to patients after a heart attack. But trial results presented today challenge this long-standing convention.

The study, also published in NEJM, found that long-term use of beta blockers specifically in patients who had preserved ejection fraction after a heart attack did not significantly lower the combined risk of death or a new heart attack.

The evidence that had been backing up the use of beta blockers stems from research conducted decades ago. But times have changed, and doctors now have new procedures to open blocked arteries. Patients these days tend to have smaller heart attacks with less injury to their heart muscle, leading many doctors to wonder about the utility of beta blockers.

"This is one of those studies at ACC that I think is potentially practice changing," said Kim Eagle, director of the Frankel Cardiovascular Center at the University of Michigan, who wasn't involved in the trial.

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health tech

Positive data for a contentious heart pump

The Impella heart pump made by J&J's Abiomed reduced the rate of deaths in heart attack patients with cardiogenic shock, in the first large randomized trial conducted of the device (also published in NEJM), my colleague Lizzy Lawrence reports.

Academic researchers, with funding from Abiomed, found that after 180 days, 46% of patients who got the device had died, compared with 59% of patients who got standard care. Up until this point, doctors have debated how much benefit the pump provides, as it hit the market decades ago without a randomized trial, which is typical for medical devices.

There were severe side effects — 24% of patients who got the device had complications like serious bleeding and the need for kidney therapy, compared with 6% in the control group.

And though not seen in this trial, the pump in real-life use can puncture ventricles or interfere with other heart devices if not properly inserted. Abiomed has been admonished by the FDA for not disclosing these risks to the agency as required under law.

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hypertension

Would doctors use a twice-a-year shot for blood pressure?

Alnylam reported Phase 2 results showing that their biannually-dosed RNAi drug for hypertension, called zilebesiran, durably lowered blood pressure when taken on top of certain commonly used pills.

The company pitches the drug as a solution to a long-standing problem: Despite the availability of cheap pills, there are still high rates of uncontrolled hypertension, in part because people aren't good at taking pills. But some doctors are skeptical that if zilebesiran makes it to market, it would be easily accessible and widely used.

Howard Weintraub, a preventive cardiologist at NYU Langone who wasn't involved in the trial, said that insurers won't be sympathetic to the idea of paying for an expensive therapy because a patient isn't consistently taking their pills: "They're going to say [to doctors], 'well, figure out a way to get them to do it.'"

Alnylam's response is focusing further research on patients who have especially high cardiovascular risk and who don't have blood pressure under control despite taking multiple pills. The company plans to run an outcomes study to see if the drug can, in addition to lowering blood pressure, actually cut the risk of cardiovascular complications. 

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heart failure

More analysis on Wegovy in heart failure

Yesterday, researchers reported trial results showing that Novo Nordisk's Wegovy improved physical function in patients with heart failure with preserved ejection fraction (HFpEF) along with obesity and diabetes. This followed positive trial findings last year in a similar population but without diabetes. Researchers have now pooled the data from these two trials in an analysis published in the Lancet today. Here are some interesting tidbits:

In subgroup analyses, they found that Wegovy led to greater improvements in symptoms in patients who started out with higher NT-proBNP levels and who had a history of atrial fibrillation, which are both markers of more severe heart failure. The fact that more advanced patients seemed to benefit more from Wegovy points to the idea that the drug "does something fundamental to changing the pathobiology of heart failure," said Mikhail Kosiborod, lead investigator and vice president of research at Saint Luke's Health System.

Those subgroups saw greater heart failure improvements even though the amount of weight they lost on Wegovy was about the same as other participants, supporting the emerging hypothesis that Wegovy benefits the heart through mechanisms beyond just weight loss, such as reducing inflammation and direct actions on the heart.

In the pooled analysis, the researchers also saw that there was a lower rate of infectious disease complications in people treated with Wegovy. The authors noted that obesity, diabetes, and heart failure are all conditions that increase inflammation and raise the risk of infections.


equity

How to actually get global heart disease rates down

Amid the stream of data coming out on novel drugs and devices, some researchers reminded us of the sobering reality that these innovations are out of reach for much of the world, and different approaches are needed to address rising rates of obesity, diabetes, and cardiovascular disease, particularly in low- and middle-income countries.

At a symposium today hosted by ACC and the European Society of Cardiology, Annika Rosengren, a professor at the University of Gothenburg in Sweden, said that at a population level, what's needed to bring down disease rates are lifestyle and policy changes.

"Even though we now have access to effective medications, this will only reduce part of the problem. Most of the people in the world can't even afford cardiovascular medications," she said. "Medicines won't solve this."

Meanwhile, Valentin Fuster, president of Mount Sinai Heart, touted the use of a polypill, a single compound made up of multiple drugs that can be cheaply manufactured and distributed, and is more convenient for patients to take consistently. He and other researchers showed in 2022 that a polypill reduced the risk of heart complications compared with regular care. That pill has been added to the World Health Organization's list of essential medicines, but is not currently available in the U.S.

When asked how the idea of widely distributing a polypill meshes with the trend toward understanding each patient's risk factors and personalizing treatment, Fuster said, "when you talk about the overall world, my friend, there's very little to personalize."


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