Dual Antiplatelet Therapy (DAPT) Trial

Nearly 700,000 patients a year are implanted with drug-eluting stents (DES), a treatment that has proven considerably more effective than implantation with bare metal stents (BMS). However, FDA is concerned that DES might lead to higher rates of stent thrombosis. Clinical experts concur that the risk of stent thrombosis can be reduced by administering dual antiplatelet therapy (DAPT) to patients for an extended duration. But clinical trials conducted on any of the five FDA-approved DESs have not validated the optimal duration of DAPT administration following stent implantation. Additionally, although extending the duration of DAPT administration may lower the risk of very late stent thrombosis, this strategy could also result in an increased risk for major bleeding complications.

FDA’s Office of Critical Path Programs (OCPP) is facilitating the design and conduct of a DAPT trial by regulated industry and the clinical community to resolve issues related to this vital combination product. The effort will leverage the shared resources of project participants to enable collaborators to find answers to DES treatment challenges faster and at less cost. The study requires an unprecedented level of cooperation among the drug and device industries as well as the clinical community.