The results of a closely-watched trial involving an experimental heart stent made by Abbott Labs that dissolves in your body over time are out, and the findings contain both good news and bad news for the company.
Abbott, which has invested 15 years of research and testing in the technology, has been aiming for a blockbuster product that would dominate the estimated $3.82 billion global market for the devices. The old stents -- tiny metal coils that prop open arteries -- have been very effective at restoring blood flow to the heart, but in the longer term they sometimes lead to a rare but very serious complication of clotting. Absorb, new biodegradable stent that is broken down by the water in your body, was designed to be a superior product that minimized that danger.
The main conclusion of the large study involving two groups of patients -- one with 1,322 participants and another with 686 -- and published in the New England Journal of Medicine on Monday, is very positive, showing that the new stent did about as well as the old kind in preventing deaths and heart attacks.
"Naturally dissolving heart stents are the next revolution in percutaneous coronary intervention… Absorb does its job and then restores the vessel to its natural state," Dean Kereiakes, a professor of clinical medicine at Ohio State Medicine and a co-author of the study, said in a release from Abbott.
The issue for the company is that the results failed to show Absorb is any better than what's already available.
The study found that 1.4 percent of those who got the dissolving stent experienced blood clotting, compared with 0.7 percent of patients with the regular old stent. The difference between those numbers was not statistically significant. Moreover, the new stent didn't appear to hold an advantage in reducing chest pain.
In a critical opinion piece in the New England Journal of Medicine accompanying the results, German cardiology researcher Robert A. Byrne summarized his take:
Although the concept of self-degrading stents is intuitively attractive, promise alone is not enough to make us unconditionally embrace this technology. For the moment, the trends toward higher event rates with the Absorb scaffold and the additional challenges associated with implantation must be considered. Against this background, the advantages of the Absorb scaffold must be evident and tangible; otherwise, acceptance of these limitations will not be broad.
The company says Absorb is the first and only fully dissolving heart stent to reach this stage of clinical review in the United States. Globally, it has been used to treat more than 125,000 people with coronary artery disease in more than 100 countries.
This post has been updated.
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