The Study of Access site for Enhancement of ST-Elevation MI for Seniors: Safe STEMI for Seniors
This project will assess the utility and efforts associated with integration of electronic data capture infrastructure, linked to the American College of Cardiology-National Cardiovascular Data registry (ACC-NCDR) Cath-PCI Registry and Claims Data, to evaluate reduction in access site bleeding, revascularization with second generation DES and clinical benefit/risk of complete revascularization. SAFE-STEMI for Seniors entails a three year prospective registry study of STEMI patients over 64 undergoing primary PCI via the radial artery access randomized to either infarct artery only or complete revascularization. The aims of the project are to:
- Assess major bleeding comparing the radial vs. femoral artery access
- Assess 1-year outcome of infarct-target vessel failure and major adverse cardiovascular events (MACE) comparing a drug-eluting vs. bare metal stent
- Assess major adverse cardiovascular events (MACE) comparing infarct-artery PCI only vs. complete revascularization
This project will leverage the NIH-funded National Cardiovascular Research Infrastructure, which utilizes the ongoing ACC-NCDR Cath PCI Registry as the data collection platform. In addition, the Duke Clinical Research Institute (DCRI) has developed a software interface, in collaboration with the ACC Foundation, through which data collected as part of the registry “autopopulates” a clinical trial case report form.