Four stent makers and 4 drug companies have agreed to fund a $100 million study to determine how long vigorous but risky anti-platelet therapy should be continued in patients who receive stents following balloon angioplasty.
Anti-platelet therapy with aspirin and Plavix helps prevent blood clot formation around the stent (pictured), an event which can be serious, even fatal. The downside of anti-platelet therapy is an increased risk of bleeding and stroke.
In patients receiving stents, physicians typically prescribe aggressive anti-platelet therapy for about one year, but many patients have developed clots after that time. The study will randomize patients to receive one year versus 2 ½ years of aggressive anti-platelet therapy.
The global market for stents, particularly the more profitable drug-eluting variety, has diminished to about $5 billion per year primarily due to concerns about blood clots and bleeding from anti-platelet therapy.
Four of the study’s funding companies are stent-makers: Johnson & Johnson, Boston Scientific Corp. Abbott Laboratories, Inc. and Medtronic, Inc.
The other four are drug companies. They include Sanofi-Aventis and Bristol-Meyers Squibb, which co-market Plavix, and Eli Lilly & Co. and Daiichi Sankyo, which co-developed prasugrel, a Plavix competitor that is edging toward FDA approval.
Plavix by the way, is the world’s second largest selling drug with $5.9 billion in annual sales. It has patent protection until November, 2011. It is anticipated that the current study will take 4 years to complete.