Abiomed announced today the enrolment of the first patient in the FDA approved prospective feasibility study, STEMI Door to Unloading (DTU) with Impella CP system in acute myocardial infarction. This trial will focus on feasibility and safety of unloading the left ventricle using the Impella CP heart pump prior to primary percutaneous coronary intervention (PCI) in patients presenting with ST-segment elevation myocardial infarction (STEMI) without cardiogenic shock with the hypothesis that this will potentially reduce infarct size.
The study, which received FDA approval in October 2016, is a prospective, multicentre feasibility study led by principal investigators Navin K Kapur of Tufts Medical Center and William W O’Neill of Henry Ford Medical Center (both USA). Up to 50 patients at 10 sites will be enrolled in the study, which is expected to be completed within 18 months. The first patient in the study was enrolled in late April at Northwell Health System in Long Island, USA, under the leadership of Perwaiz Meraj.
The primary endpoints of the feasibility study will focus on safety, including major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days. All patients will undergo cardiac magnetic resonance (MR) imaging to assess infarct size as percent of left ventricular mass at 30 days post-PCI. Patients will be randomised to Impella CP placement with immediate primary PCI, or to Impella CP placement with 30 minutes of unloading prior to primary PCI.
A press release explains that the hypothesis of this novel approach to treating STEMI patients, based on extensive mechanistic research, is that unloading the left ventricle prior to PCI reduces myocardial work load, oxygen demand and also initiates a cardioprotective effect at the myocardial cell level, which may alleviate myocardial damage caused by reperfusion injury at the time of revascularisation. This feasibility study will help refine the protocol and lay the groundwork for a future pivotal study with more sites, patients and will be designed for statistical significance.