Clinical Research & Data, Unloading, AMI Cardiogenic Shock
The Door-to-Unloading (DTU) STEMI Safety & Feasibility Trial
Navin Kapur, MD, 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. Dr. Kapur is the executive director of the Cardiovascular Center for Research & Innovation at Tufts Medical Center.
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® heart pump with a 30-minute delay before reperfusion is safe and feasible within a relatively short door-to-balloon (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.