About - Overview
The DAPT Study is an independent, large-scale study in size and scope that is investigating the benefits of 12 versus 30 months of dual antiplatelet therapy to protect patients from stent thrombosis and major adverse cardiovascular and cerebrovascular events (MACCE) following the implantation of drug-eluting coronary stents (DES).
The American College of Cardiology and American Heart Association currently recommend 12 months of dual antiplatelet therapy after placement of a drug-eluting stent, and the European Society of Cardiology currently recommends 6-12 months of dual antiplatelet therapy following drug-eluting stent placement. There is currently considerable uncertainty and variation in clinical practice regarding whether patients should discontinue dual antiplatelet therapy one year following stent placement, per current treatment guidelines, or whether patients should continue dual antiplatelet therapy for more than one year to prevent these adverse events.
Following a December 2006 U.S. Food and Drug Administration (FDA) advisory committee meeting in which these important questions were examined, the idea emerged of an international clinical trial that would potentially address this concern. A formal U.S. FDA request followed, in the form of post-market studies of DES that would yield sufficient data to answer these important public health questions, and has resulted in a unique collaboration amongst the U.S. FDA, drug and device manufacturers and Harvard Clinical Research Institute, who is responsible for the scientific management and independent analysis of the study.
The outcome of the DAPT Study will bring clarity to the global medical community regarding the benefits of 12 versus 30 months of dual antiplatelet therapy in percutaneous coronary intervention (PCI) patients treated with DES.