Atrium Commences Enrollment in INFUSE AMI Trial

December 7, 2009—Atrium Medical Corporation (Hudson, NH) announced the commencement of enrollment in the INFUSE AMI (acute anterior myocardial infarction) study. INFUSE AMI is a multicenter, multinational, prospective, randomized, single-blind trial examining how patients with heart attacks are treated. The study’s aim is to help determine the best way to treat patients with an acute anterior wall AMI with ST-segment elevation (STEMI).

The Cardiovascular Research Foundation in New York City is conducting the multinational INFUSE AMI trial. Gregg Stone, MD, is the principal investigator and Michael Gibson, MD, is the co-principal investigator. The first patient was enrolled by Jochen Wöhrle, MD, at the University of Ulm in Germany.

According to the company, INFUSE AMI will enroll 452 patients at up to 40 sites in the United States and Europe in a two-by-two factorial design (four study arms). The study will assess four different ways to treat the thrombus causing the heart attack: intracoronary (IC) infusion of abciximab via Atrium’s ClearWay RX local therapeutic infusion catheter; thrombus aspiration; thrombus aspiration followed by IC infusion of abciximab with ClearWay RX; and the current standard of care, which is traditional percutaneous coronary intervention, often with a stent.

The study will help to identify which of these four study arms can provide better patient outcomes with the goal of reducing the infarct size during a heart attack and restoring flow in the infarct-related artery and microvasculature in the heart muscle. The study’s endpoints will include measuring infarct size at 30 days using cardiac MRI, microvascular obstruction, ST-segment resolution, myocardial perfusion, impact on thrombus burden, and outcomes on bleeding.

The company stated that the Atrium ClearWay RX local therapeutic infusion catheter, which is being utilized in two arms of the trial, provides super-selective, local intracoronary infusion of medication, allowing more medication to act locally at a higher concentration and for a longer period of time to enhance its therapeutic effect on the occluding blood clot and diseased artery.