How do the stent manufacturers’ post-market studies contribute to the DAPT Study?
Due to the large sample size necessary for this study to detect small but clinically important differences, the FDA has allowed a limited amount of data to be contributed to the final DAPT Study analysis from several drug-eluting stent manufacturer-sponsored studies. The manufacturer-run studies have been designed to reproduce the DAPT Study randomization to 12 versus 30 months of therapy, and follow the same data collection, adjudication, and analytic processes as the DAPT Study. Several manufacturer-run studies have begun enrollment. The final analysis performed by the Harvard Clinical Research Institute will contain data from each of these sources to achieve overall enrollment of over 20,000 subjects.
