Atrium Medical has reported positive results of intracoronary abciximab infusion and aspiration thrombectomy in patients undergoing percutaneous coronary intervention for anterior ST segment elevation myocardial infarction (INFUSE-AMI) study.
The prospective, randomized, single-blind trial, which enrolled 452 patients, was designed to determine the optimal treatment strategy for patients with an acute anterior wall myocardial infarction with ST segment elevation (STEMI).
The goal of the trial was to identify which treatment could provide better patient outcomes with the goal of reducing the infarct size during heart attack and restoring flow in the infarct related artery and microvasculature in the heart muscle without an increase in major and minor bleeding.
Study endpoints included impact on infarct size at 30 days as measured by cardiac MRI, ST segment resolution, myocardial perfusion, impact on thrombus burden and outcomes on bleeding.
Results demonstrated that patients who had local therapeutic infusion of intracoronary abciximab with Atrium’s ClearWay RX local therapeutic infusion catheter compared to no abciximab had a reduction in 30 day infarct size.
In addition, patients randomized to local infusion of intracoronary abciximab also showed reduction in absolute infarct mass.
ClearWay is a thin, microporous PTFE balloon, mounted on a .014 rapid exchange catheter which provides intracoronary infusion of medication.
Atrium said it has presented the study data at the American College of Cardiology’s (ACC) annual scientific session in Chicago and published online in the Journal of the American Medical Association (JAMA).