The muddied water around drug-eluting stents is starting to clear. Two new studies show, in essence, that the much-maligned stents aren't as bad as some have claimed, but they're not as good as others say. In effect, their worth is situational: In some patients, they work great. In others, not so much. The challenge to cardiologists is deciding which. To device makers, the challenge will be getting that nuanced message across. They'll have to promote their products without over-promoting them, because if they're used in the wrong patients, another safety backlash would be in the offing.
The first new study shows that drug-coated stents can not only be used to open complicated blockages in arteries they weren't designed for, but that they truly shine in those situations. In sicker, high-risk patients, the coated stents work better than bare-metal ones. The second study concludes that patients with multiple clogged arteries are better off with bypass surgery than with coated stents.
You'll recall that in late 2006, the FDA convened an advisory panel to review new evidence that off-label uses of coated stents (in patients who had large and/or multiple blockages) led to increased clotting and increased risk of death. Sales of the drug-eluting stents dropped dramatically. The panel decided the issue warranted more study. And what those early studies overlooked was the fact that off-label patients were simply sicker to start with. These two new studies are more clearly defined, but still leave lots of room for personal judgment. Invasive surgery versus non-invasive procedure, for instance. And neither study was a randomized, controlled trial. There's one thing we're completely clear on, though: More debate is coming.
Docs reconsider drug-coated stents. Report
Study: Coated stents aren't cost-effective. Report
Little common ground in stent controversy. Report
Tough times for stent market. Report