Most cardiologists agree that the drug-eluting coronary stents have revolutionized the care of patients with critical coronary disease, and this may be one example where the product lives up to the hype, even if the marketing does not.
|Intracoronary stent coated with Sirolimus, a medication
to prevent restenosis.
Since the introduction of drug-eluting coronary stents in 2003, there have been an impressive array of clinical trials showing the remarkable effectiveness of this new technology. Prior to drug-eluting stents, bare metal stents were used to open coronary arteries. They worked well in the short term, but over time approximately 20-50% of the stented arteries would clog back up, a process known as restenosis.
Cardiologists searched for years for a way to prevent restenosis, and now it appears they have found oneŇ the drug-eluting stent. Drug-eluting stents are small metal stents that are coated with an ultra-thin coating of medication. This medication has been designed to prevent the regrowth of harmful tissue. Data from thousands of patients receiving these stents have consistently shown drug-eluting stents cut the rate of restenosis to approximately 5-8%.
So why do some patients and their doctors sometimes question the use of a drug-eluting stent? Part of the reason may be marketing, or lack thereof. Despite the publication of multiple randomized controlled trials showing a significant benefit to patients, and the near elimination of restenosis in a lot of patients, negative stories about problems in the manufacturing and quality-control arena continue to grab headlines. One recent story told of problems at a major production facility, although the actual problems had already been discussed with the FDA, and changes made weeks before the article hit the newspapers. In the context of major recalls in the cardiac implantable defibrillator area, patients and their doctors are appropriately cautious about the potential downside of new technology.