Stent makers and the drugmakers who treat their patients want to settle the clotting question once and for all. So device and pharma companies are joining forces on a major trial to test blood-thinner use in stent patients. And when we say major, we mean major: four years; 20,000 patients; $100 million.
The trial will test whether stent patients should take clot-busters for one year after the device is placed, or for at least two and one-half years afterward. Abbott Laboratories, Medtronic, Boston Scientific and Johnson & Johnson are holding up the stent side of the equation. Sanofi-Aventis and Bristol-Myers Squibb, which co-market Plavix, will participate on the drug side, along with Eli Lilly and Daiichi Sankyo, whose potential Plavix competitor prasugrel is waiting in the FDA approval queue.
The aim is to develop a stent-and-drug protocol that might quell worries about blood clots. You'll recall the brouhaha over the safety of drug-eluting stents versus bare stents, and over stents versus drug treatment. Well, FDA asked stent and drug makers to determine the best clot-prevention approach. As Bram Zuckerman, an FDA official who helped lay the groundwork for the study, told the Wall Street Journal, "The results will lead to greater clarity of an extremely important problem."