Intracoronary thrombolytic therapy

Atrium Medical Announces 1-Year Results of the INFUSE-AMI Trial

Atrium Medical Corporation, a business unit of MAQUET Cardiovascular, announced the 1-year results of the INFUSE-AMI (Abciximab and Aspiration Thrombectomy in Patients With Large Anterior Myocardial Infarction) trial. Dr. Gregg Stone, the principle investigator, presented the exciting findings at the 62nd Annual American College of Cardiology Conference in San Francisco, CA.

INFUSE-AMI’s primary endpoint was reduction in infarct size measured by the highly sensitive cMRI, at 30-days in patients who were treated with intra-lesional ClearWay RX /abciximab* versus those that did not receive intra-lesional ClearWay RX/ abciximab. 

At 30-days, the primary endpoint was achieved, and patients who were treated with intra-lesional ClearWay RX/abciximab experienced a statistically significant relative reduction in infarct size of 16%. Additionally, patients in the ClearWay RX/abciximab arm showed a favorable trend in new onset of severe heart failure in comparison to those patients that did not receive this treatment.

Clinical findings between 30 days and 1 year for patients who received intra-lesional ClearWay RX/abciximab were strongly associated with better outcomes, including significantly lower mortality rates and reduced major adverse cardiac and cerebral events compared to patients who did not receive ClearWay RX/abciximab.

Researchers also observed all mortality occurred in patients with an infarct size greater than 17.1%** (the median infarct size in the INFUSE-AMI trial was 17.2%). The median infarct size for patients treated with ClearWay RX/abciximab was 15.1%, whereas the median infarct size for patients who received an alternative treatment was 17.9%. The INFUSE-AMI data shows a relationship between infarct size and mortality. These clinical findings correlate with other published studies and could explain some of the improved results in those patients receiving intra-lesional abciximab via the ClearWay RX drug delivery balloon.

Dr. Michael Gibson, Co-PI for the INFUSE-AMI trial, stated that “ClearWay offers the interventionalists a reproducible, on the table treatment option for the preservation of heart muscle, resulting in reduced clinical events, and was associated with a mortality reduction in this mechanistic study.”

The ClearWay RX local drug delivery balloon catheter is a thin, microporous PTFE balloon mounted on a .014” rapid exchange catheter, FDA 510(k) & CE cleared for the delivery of therapeutic and diagnostic agents in the coronary and peripheral vasculature. The ClearWay RX balloon atraumatically occludes blood flow during the local infusion, thus maximizing the therapeutic agent’s concentration and residence time, enhancing the desired therapeutic effect. ClearWay RX is available in 1.0 to 4.0 mm balloon diameters and in balloon lengths ranging from 10 to 50 mm. As of October 1, 2012, the ClearWay RX drug delivery balloon was added to the American College of Cardiology guidelines as an approved device meeting the criteria for door-to-balloon time (SEQ7050-51).

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*Abciximab, which is manufactured by Centocor Ortho Biotech and distributed by Eli Lilly under the trade name ReoPro, is a platelet aggregation inhibitor mainly used during and after coronary artery procedures such as angioplasty to prevent platelets from sticking together and causing thrombus formation within the coronary arteries. Abciximab is not indicated for intracoronary delivery.

**87% of patients received a cMRI.