Abiomed announces results of FDA STEMI door-to-unloading safety trial
Abiomed announces the results of the FDA STEMI Door-to-Unloading safety and feasibility randomized controlled trial, which show unloading the left ventricle with Impella CP for 30 minutes prior to reperfusion in patients presenting with anterior ST-segment elevation myocardial infarction without cardiogenic shock is safe and feasible, when compared to Impella patients reperfused immediately. The results of the prospective, 50 patient, randomized, multi-center trial were presented at Tufts Medical Center, at the American Heart Association Scientific Sessions 2018 in Chicago. The study found that unloading first and delaying reperfusion by 30 minutes did not increase 30-day major adverse cardiovascular and cerebrovascular events or infarct size, compared to the immediate reperfusion arm of the trial. Infarct size is a measure of damage to the heart muscle after a heart attack. It is feasible to delay reperfusion in a heart attack patient in a clinical trial, as demonstrated by a 100% adherence to the 30 minute unloading protocol and 100% Impella CP insertion success in both study arms. Unloading the left ventricle for 30 minutes prior to reperfusion appears to reduce infarct size as a percentage of area at risk among patients with a ST sum greater than 6. Abiomed also announces that, in agreement with the FDA, it will move forward with a pivotal, multi-center, prospective, randomized controlled trial comparing unloading with delayed reperfusion to the current standard of care. The pivotal trial is planned to begin next year. The safety and feasibility study design was approved by the FDA, with an independent steering committee and data and safety monitor overseeing the trial and a blinded clinical events committee independently adjudicating study endpoints. Infarct size was evaluated using a cardiac magnetic resonance imaging technique assessed at a blinded core lab. The trial was sponsored by Abiomed.