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Concerns raised over dissolvable cardiac stents

Bioresorbable stents were created to overcome issues with traditional metal stents such as scar tissue and blood clots.

By Amy Wallace

April 6 (UPI) -- A cardiologist is warning about potential dangers of bioresorbable cardiac stents due to the increased risk of a blood clot forming on the stent itself.

In the March issue of the New England Journal of Medicine, Dr. Debabrata Mukherjee, chief of cardiovascular medicine at Texas Tech University Health Sciences Center in El Paso, Texas, encourages the continued use of conventional drug-eluting stents instead of the newer bioresorbable option.

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Cardiac stents are used to keep open arteries and are inserted surgically into a narrowed artery to improve blood flow. Traditional stents are round, tubular metal structures. Improvements were made to traditional metal stents by replacing them with drug-eluting versions coated in anti-tissue growth medication slowly released to the bloodstream to prevent the recurrence of a blockage.

The drawback of conventional stents is that blood clots and scar tissue would form where the stent was placed, so drug-eluting stents were created to overcome this problem.

"If you think about it, stents are pieces of metal that are permanently placed into the heart and people are not born with metal in their hearts; it's not normal and it may sometimes cause problems," Mukherjee said. "Just by being there, the stent will affect the blood vessel lining."

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There is a risk that drug-eluting stents could fall out of position and the artery would become blocked again, a condition known as restenosis.

To overcome restenosis, bioresorbable stents were developed. The first bioresorbable stent was approved by the FDA in 2016 and marketed as Absorb. Bioresorbable stents naturally dissolve in the body three years after implantation to allow an artery to heal more naturally.

However, in the most recent clinical trial, Absorb was linked to an increased risk of device thrombosis, a side effect where a blood clot forms on the stent itself.

Trial results showed thrombosis formed on 31 patients with an Absorb implant compared to just eight with drug-eluting stents.

"Because the current generation of metallic drug-eluting stents is associated with excellent outcomes, there is little rationale to use bioresorbable vascular scaffolds at this time," Mukherjee said. "They are also no more effective, and less safe. As a physician, why am I going to use something that costs more if it can cause risk or harm to my patients?"

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