The Door-to-Unloading (DTU) STEMI Safety & Feasibility Trial
Navin Kapur, MD, executive director of the CardioVascular Center for Research and Innovation at Tufts Medical Center, discusses the results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial. These results were presented at the American Heart Association Scientific Sessions 2018 in Chicago on Sunday, November 11.
What did we learn from this pilot study?
- The Door-To-Unload in STEMI Pilot Trial demonstrates for the first time that LV unloading using the Impella CP device with a 30-minute delay before reperfusion is safe and feasible within a relatively short DTB Time.
- No prohibitive safety signals that would preclude proceeding to a larger pivotal study of LV unloading and delaying reperfusion for 30 minutes were identified.
- Compared to LV unloading and immediate reperfusion, LV unloading and delaying reperfusion for 30 minutes does not increase infarct size.
- Among patients with sum STE>6mm, infarct size normalized to the area at risk was significantly lower with 30 minutes of LV unloading before reperfusion compared to LV unloading and immediate reperfusion.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/