Heart stent alternative may yield better outcomes

Hello Health Rounds readers! Today we have three studies presented at medical meetings, including one testing a device that may represent an improvement over traditional heart stents. The others, presented at a kidney disease meeting, identify a new sign of possible organ rejection after transplant and show that the kidney and heart protective benefits of the diabetes drug Jardiance can wane over time if the drug is discontinued. 

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A new device to prop open heart arteries after interventions to unclog them adapts over time to allow restoration of the artery's natural motion and may be an improvement over traditional stents, researchers said at a medical meeting.

Initially, Elixir Medical's DynamX bioadaptor acts like a conventional stent, holding its shape and releasing a drug to prevent reclogging following an angioplasty procedure.

But over six months, its coating is resorbed and the chromium-cobalt strands that support the device separate, allowing the artery to grow, adapt to the new blood flow, and resume its natural functions. The device is no longer a rigid structure but it continues to provide dynamic support to the vessel, according to the manufacturer's website.

In a year-long trial of 2,399 patients with heart disease in Sweden, the bioadaptor was associated with lower rates of heart attacks caused by the original site of the blockage, need for a repeat unclogging procedure, or heart-related death than Medtronic's widely used drug-eluting stent, researchers reported at the Transcatheter Cardiovascular Therapeutics conference in Washington.

The benefits were seen in the overall trial population as well as in high-risk subgroups, the researchers noted. The trial results were also published in The Lancet.

The researchers said they plan to follow these study participants for a total of five years.

The Elixir device received breakthrough designation from the U.S. Food and Drug Administration in June, meaning the agency regards it as a potentially important advance in the field.

"The available evidence suggests that the bioadaptor might become a promising treatment... with the potential to mitigate the high occurrence of stent-related events," the researchers said.

Identification of a previously unrecognized signal of kidney transplant rejection will help doctors detect and treat the problem earlier, researchers reported at the American Society of Nephrology's Kidney Week meeting in San Diego.

Their study showed microvascular inflammation, or inflammation in even the tiniest blood vessels around the kidneys, "predicts trouble down the road," study leader Dr. Vikas Dharnidharka of Rutgers Robert Wood Johnson Medical School in New Jersey said in a statement.

In 2022, surgeons around the world began to collect biopsy data on microvascular inflammation to determine whether it was in fact a warning sign. For the current study, they analyzed biopsies obtained from 6,798 kidney recipients in Europe and North America between 2004 and 2023.

Among the more than 16,000 biopsies, 503 showed microvascular inflammation but no other typical signs of rejection. Yet these patients had more than twice the five-year graft-failure risk as patients with no signs of organ rejection, according to a report in The New England Journal of Medicine.

Another 285 biopsies showed some mild inflammation, with a minimal amount of antibodies present, that in the past would not have been interpreted as showing rejection. Patients with these biopsies were nearly three times as likely to experience graft failure than patients with no such signs.

Patients with these findings were also at higher risk for more severe rejection or chronic kidney damage over time.

"These data indicate that we should be treating patients who fall into these categories differently," and doing tests to determine what those treatments should be, Dharnidharka said.

Two years after patients with chronic kidney disease completed a randomized trial of the type 2 diabetes medicine Jardiance from Boehringer Ingelheim and Eli Lilly, some of the drug's protective effect on the kidneys and the heart were still evident, researchers reported at the Kidney Week meeting.

But the benefits waned over time, indicating that long-term treatment is needed to maximize the benefits of Jardiance and other diabetes drugs in the class known as SGLT2 inhibitors on kidneys and the heart, the researchers wrote in a report of the study published in The New England Journal of Medicine.

Patients with kidney disease could enroll in the trial even if they did not have diabetes. The initial report, published in 2022, showed the drug, known chemically as empagliflozin, substantially slowed patients' kidney disease progression and reduced their risk for cardiovascular events, compared to a placebo.

Of the 6,609 patients in the original two-year trial, 4,891 enrolled in a two-year-long follow-up study. About 43% who had been randomly assigned to receive Jardiance continued to take it, and about 40% of those who had been in the placebo group also began to take the daily pill.

During the combined active- and post-trial periods, kidney disease progression or a cardiovascular event occurred in 26.2% of the empagliflozin group and in 30.3% in the placebo group.

During the post-trial period only, the odds of one of those outcomes was 13% lower in the Jardiance group, the researchers said.

"In relative terms, the carryover effect... was less than the effect of receiving empagliflozin during the active-trial period and appeared to last for up to 12 months, with most additional benefit seen in the first 6 months after the active trial ended," the researchers said.

This newsletter was edited by Bill Berkrot.

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