Ever since the BASKET-LATE study came out suggesting an increase in the rate of death and myocardial infarction in patients treated with drug-eluting stents, the stent market has experienced a mild tremor of its own. Total stent usage has indeed tapered off this year, dropping about 16 percent according to some estimates.*
Still, stent manufacturers are forging ahead – some with plans to roll out new drug-eluting stent platforms in 2008. This optimism is further backed by the FDA’s “Update to FDA Statement on Coronary Drug-Eluting Stents,” in which an FDA Advisory Panel determined that, “The concerns about thrombosis do not outweigh the benefits of drug-eluting stents compared to bare metal stents when drug-eluting stents are implanted within the limits of their approved indications for use.” Never mind that about 60 percent of the time stents are used for “off-label” indications. Regardless, this is presumably good news for patients, physicians, manufacturers and all involved in the deployment of drug-eluting stents.
But drug-eluting stent makers should not become complacent. The newly developed Paclitaxel-eluting angioplasty balloon might prove a formidable competitor. The new balloons are indicated for treating in-stent restenosis and possibly for bifurcations as well. Already available for use in Europe, these balloons deliver medication directly to the lesion site, and reportedly do not leave any metal scaffolding or polymer behind after the procedure that can lead to complications.
The PEPCAD II study, which was presented at this year’s Transcatheter Cardiovascular Therapeutics (TCT) show, marks the first head-to-head comparison of the drug-eluting balloon to a drug-eluting stent. Investigators anticipate that the balloon will prove to have a clear advantage over drug-eluting stents in that the drug compound can be distributed along the entire length of the balloon and better treat the vessel segment.
Although more research is needed, the new balloons might have just what it takes to burst the drug-eluting bubble.
Reference: *Goodroe Healthcare Solutions LLC