Four pharmaceutical companies and four stent manufacturers have agreed to launch a $100 million, 20,000-patient drug-eluting stent (DES) study, the Dual Antiplatelet Therapy (DAPT) trial.
According to the Wall Street Journal, the trial will look at whether 30 months of DAPT is better than 12 months for preventing stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE). The study will also attempt to assess whether continued dual antiplatelet therapy relates to reducing stent thrombosis with DES.
The current guidelines call for patients who receive a DES to remain on aspirin and clopidogrel for at least a year. But concern that clots occasionally can form in the devices well over a year after they are implanted, with potentially lethal consequences, has left doctors and patients in a quandary over how long treatment should be prescribed, the WSJ reported.
Boston Scientific, Johnson & Johnson, Medtronic and Abbott Laboratories— rivals in the $5 billion global stent market—are jointly sponsoring the trial. Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly and Daiichi Sankyo will co-sponsor the study.
“It's created a lot of anxiety in patients' and physicians' minds, not knowing the answer to the long-term safety question," co-principal investigator Laura Mauri, a cardiologist at Brigham and Women's Hospital in Boston, told WSJ. She is also chief scientific officer at Harvard Clinical Research Institute, which has been chosen by the companies to run the study.
The other co-principal is Dean Kereiakes, MD, CEO and director of research of the Ohio Heart and Vascular Center and professor of clinical medicine at Ohio State University in Cincinnati.
The study is the result of an FDA request for stent and drug makers to determine the optimal duration for blood thinning. "The results will lead to greater clarity of an extremely important problem," Bram Zuckerman, an FDA official who helped lay the groundwork for the study, told the WSJ.