For Clinicians

General Information

The American College of Cardiology and American Heart Association currently recommend 12 months of dual antiplatelet therapy (thienopyridine plus aspirin) after placement of a drug-eluting stent (DES), and the European Society of Cardiology currently recommends 6-12 months of dual antiplatelet therapy following drug-eluting stent placement. However, some physicians continue prescribing these medications considerably longer than 12 months in hopes of preventing very late stent thrombosis. The lack of randomized data within the international scientific community regarding the risks versus benefits of extending dual antiplatelet therapy beyond one year has created significant variation in clinical practice regarding the optimal approach to protect against late stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following percutaneous coronary intervention (PCI) with DES.

The DAPT Study will enroll approximately 20,000 PCI patients receiving drug-eluting or bare metal stents to compare the benefits of 12 months versus 30 months of dual antiplatelet therapy. Because the DAPT Study will follow a large number and broad spectrum of patients treated with stents for nearly three years, and will look at both stent-related and clinical outcomes, the study's results will be instrumental in helping to establish the standard-of-care following a DES procedure.

The DAPT Study is an international initiative that came in response to a U.S. Food and Drug Administration (FDA) request following the recommendation of a December 2006 Advisory Panel for post-market studies of DES that would yield sufficient data to answer these important public health questions. A unique public-private collaboration to design and conduct the DAPT Study has since formed amongst the U.S. FDA, stent and thienopyridine manufacturers and the Harvard Clinical Research Institute. Harvard Clinical Research Institute is the sole holder of the DAPT Study’s Investigational Device Exemption (IDE) and is responsible for the scientific conduct and independent analysis of the overall study.