About - Overview
The DAPT Study was an independent, large-scale study in size and scope that investigated 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. The DAPT Study was needed because there is currently a lack of data within the international scientific community to determine the optimal duration of dual antiplatelet therapy following drug-eluting stent placement, and as a result, considerable uncertainty and variation in clinical practice.
A U.S. Food and Drug Administration (FDA) request for a trial to determine the optimal duration of dual antiplatelet therapy resulted in a unique collaboration amongst the FDA, drug and device manufacturers and Harvard Clinical Research Institute, who was responsible for the scientific management and independent analysis of the study.
Final results of the DAPT Study were released in November 2014. Data from the study demonstrated that continuation of dual antiplatelet therapy beyond one year had a significant beneficial effect of reducing stent thrombosis and in preventing heart attack in other vessels compared with aspirin alone. While longer-term dual antiplatelet therapy expectedly increased bleeding, severe and/or fatal bleeding was uncommon and not different between study groups. The study investigators believe that the overall benefits of continuing dual antiplatelet therapy to 30 months after coronary stenting outweigh the bleeding risks and that these results warrant a shift in clinical practice towards longer-duration treatment in most patients.