First Patient Enrolled in Abiomed's STEMI DTU Feasibility Study

May 5, 2017—Abiomed, Inc. announced the enrollment of the first patient in the prospective feasibility study of ST-segment elevation myocardial infarction (STEMI) door to unloading (DTU) with the company's Impella CP system in acute myocardial infarction. The DTU study was approved by the US Food and Drug Administration in October 2016. The prospective, multicenter DTU study will be led by Principal Investigators Navin K. Kapur, MD, and William W. O`Neill, MD.

The first patient in the study was enrolled in late April at Northwell Health System in Long Island, New York, under the leadership of Perwaiz Meraj, MD. Abiomed does not plan to announce additional enrollment status.

According to Abiomed, up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months. Patients will be randomized to Impella CP placement with immediate primary PCI or to Impella CP placement with 30 minutes of unloading before primary percutaneous coronary intervention (PCI).

The DTU study will focus on the safety and feasibility of unloading the left ventricle using the Impella CP heart pump before primary PCI in patients presenting with STEMI without cardiogenic shock; the study's hypothesis is that this will potentially reduce infarct size.

The primary endpoints will focus on safety, including major adverse cardiovascular and cerebrovascular events at 30 days. All patients will undergo cardiac MRI to assess infarct size as percent of left ventricular mass at 30 days after PCI.

The company explained that the hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle before PCI reduces the myocardial workload and oxygen demand and initiates a cardioprotective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularization.

This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites and more patients and will be designed for statistical significance, stated Abiomed.