Heart Stents Reconsidered by Medical CommunityOct 25, 2006 | NewsInferno For the better part of the last decade, heart stents have been celebrated as one of the most important developments in the medical field, and, with sales of heart stents reaching $6 billion annually, it’s also been one of the fastest-growing segments of the industry. Yet, it seems with each passing day that more and more questions arise regarding their long-term safety.
Recent evidence points to an increased risk of fatal blood clotting associated with a particular type of stent, the drug-coated stent. Drug-coated stents were virtually non-existent as recently as five years ago, but now they command more than 85 percent of the stent market. The FDA has scheduled meetings for this coming December in order to discuss the issue in more detail and perhaps call for further studies.
This week, an FDA official urged Boston Scientific and Johnson & Johnson, the two largest stent producers, to conduct further research into the matter. “The real question is how to expand the knowledge base for many thousands of patients being treated ‘off-label,’” said Bram Zuckerman, director of the FDA’s division for cardiac devices.
The debate over the use of stents has divided the medical community. Most agree that the use of stents–mesh tubes used to hold open clogged arteries–have been instrumental in saving thousands of lives. Beyond that, other questions remain: Are too many doctors recommending the stenting process rather than more traditional treatments such as medication or surgery? Are the more expensive drug-coated stents more dangerous than cheaper non-coated ones? Are the safety risks connected to the method and accuracy of implantation, rather than the product itself?
Several studies this year have pointed to long-term risks of clotting associated with the drug-coated stents in particular. The coated stents are used to prevent tissue from reforming in the arteries. What seems most alarming about them, according to recent studies, is that the risk of clotting has not diminished over time, forcing some patients to remain on anti-clotting medication for extended periods.
Last week, a New England Journal of Medicine study reported that the risk of stroke or death was more than two times higher for patients receiving stents than it was for patients who are treated by endarterectomy (an invasive surgical treatment). That study specifically regarded patients suffering from carotid artery blockage. In a commentary in the same issue of the NEJM, Dr. Anthony J. Furlan said, “The benefits of surgery in reducing the long-term risk of stroke need to be weighed against the immediate risk of death or stroke as a complication of the surgery.” He also said that, based on current FDA guidelines, stenting should be reserved for those patients with a significant (more than 70 percent) blockage who have displayed stroke symptoms and are at a high risk of surgical complications.