Feature | March 27, 2012

Antiplatelet Drug Reduces Damage to Heart Muscle in Heart Attack Patients

Results of the INFUSE-AMI trial presented at ACC; clot aspiration not effective

Atrium Medicals ClearPath infusion catheter.

Medtronics Export aspiration catheter.

Data from the INFUSE-AMI trial, showing little difference in patients treated with clot aspiration, versus no aspiration.

Data from the INFUSE-AMI trial, showing little difference in patients treated with clot aspiration, versus no aspiration.

March 27, 2012 – Researchers found the antiplatelet drug abciximab significantly decreased damage to the heart muscle in patients with ST-segment-elevation myocardial infarction (STEMI), the most severe type of heart attack. Results of the INFUSE-AMI trial were presented at the American College of Cardiology’s 61st Annual Scientific Session and published simultaneously in the March 25 online issue of the Journal of the American Medical Association. Researchers also found that clot aspiration did not significantly reduce the damage to the heart muscle.

“Results from the INFUSE-AMI trial suggest that in patients with large heart attacks reaching the hospital early, the extent of heart damage can be reduced with a bolus of intracoronary abciximab delivered directly to the infarct lesion,” said lead investigator, Gregg W. Stone, M.D. He is professor of medicine at Columbia University College of Physicians and Surgeons, and director of research and education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital. Stone also serves as co-director of the medical research and education division at the Cardiovascular Research Foundation.

The primary efficacy endpoint was heart attack size at 30 days, as measured by cardiac magnetic resonance imaging (MRI) for 382 of 439 surviving patients (87.1%). Abciximab was delivered locally to the site of the blocked artery using a novel catheter, the ClearWay Rx (Atrium Medical). Heart attack size was measured by calculating infarct size as a percentage of total heart muscle tissue. Patients in the two abciximab arms had significantly smaller heart attacks than patients in the two no-abciximab arms (median 15.1 vs. 17.9%).

In contrast, aspiration thrombectomy did not significantly decrease heart attack size (17%) compared with no aspiration (17.3%). The aspiration plus abciximab group showed the lowest median heart attack size of 14.7%, compared with 17.6% for the other three groups combined. There were no significant differences among the four groups for any major measures of safety or efficacy at 30 days. Patients will be assessed again at six months and one year.

“A large randomized clinical trial of intracoronary abciximab delivered to the site of the infarct lesion through the ClearWay Rx catheter is needed to determine whether this therapy results in improved clinical outcomes without excessive bleeding,” Stone said.

“Additionally, in this trial, aspiration did not reduce infarct size. However, the final word about aspiration in STEMI will be spoken by the results from two large ongoing randomized trials of aspiration powered for mortality,” Stone added. These trials include TOTAL and TASTE.

The INFUSE-AMI trial used a 2 x 2 factorial design, isolating the impact of each intervention to maximize the chance of identifying any reduction in heart attack size. The trial, conducted at 37 sites in six countries, screened 6,318 patients and enrolled only 452 (7.2 percent) with large heart attacks presenting early, during the time when reduction in the size of the heart attack is still possible. The trial was a single-blind study in which the operator knew the randomization assignments.

All study subjects were treated with the anticoagulant bivalirudin, and randomly assigned to one of four arms: (1) aspiration plus abciximab, (2) aspiration without abciximab, (3) no aspiration plus abciximab, and (4) no aspiration or abciximab (control). In the two abciximab arms, a balloon catheter (ClearWay Rx) delivered the drug right to the site of the lesion, which invariably has thrombus present. Aspiration was accomplished through an Export (Medtronic) catheter. All patients who had angioplasty were also treated with bivalirudin, an anticoagulant that keeps bleeding and mortality low.

The INFUSE-AMI trial was funded by Atrium Medical, manufacturer of the ClearWay RX catheter, and Medtronic Inc., manufacturer of the Export catheter, and conducted by the Cardiovascular Research Foundation. Stone reported consulting fees from Abbott Vascular, Boston Scientific, Medtronic, Atrium, The Medicines Company, Merck, Daiichi Sankyo and Eli Lilly.

This study was simultaneously published in the Journal of the American Medical Association and released online at the time of presentation.

For more information: www.crf.org

Related Content

Image courtesy of Boston Scientific

Feature | Business| February 10, 2016 | Dave Fornell
After five years of almost constant lobbying efforts and numerous attempts by the U.S.
CeloNova, COBRA REDUCE trial, first patient enrolled, Cobra PzF coronary stent
News | Stents| February 10, 2016
CeloNova BioSciences Inc. announced this week that the first patient has been enrolled in its COBRA REDUCE trial. The...
new study, titin protein, blood pumping, heart failure
News | Heart Failure| February 10, 2016
In a finding that could lead to new drugs to treat heart failure, researchers have uncovered the molecular mechanism...
Mount Sinai Heart, TANSNIP-PESA study, worksite lifestyle intervention, cardiovascular risk
News | Cardiac Diagnostics| February 09, 2016
Mount Sinai Heart is undertaking a three-year study to determine whether a workplace-based lifestyle intervention,...
cardiomyocytes, electrical stimulation, human stem cells, Columbia Engineering

Electrically conditioned human cardiomyocytes. Striated ultrastructure containing troponin ( stained in green) forms around cell nuclei (stained in blue.) Image courtesy of Benjamin Lee, Columbia Engineering

News | Stem Cell Therapies| February 09, 2016
Columbia Engineering researchers have shown, for the first time, that electrical stimulation of human heart muscle...
ACC late breakers
News | ACC| February 09, 2016
February 9, 2016 — The late-breaking clinical trial presentations have been announced for the 2016 American College o
transcatheter repair of a mitral valve paravalvular leak

Transcatheter repair of a surgical mitral replacement paravalvular leak with an Amplatzer Vascular Plug II.

Feature | Heart Valve Repair| February 08, 2016 | Dave Fornell
Off-label use of the St.
News | Cardiac Diagnostics| February 08, 2016
February 8, 2016 — A parent’s incarceration has immediate, devastating effects on a family.
medical imaging, low-dose radiation, cancer, LNT model study
News | Radiation Dose Management| February 04, 2016
The widespread belief that radiation from X rays, CT scans and other medical imaging can cause cancer is based on an...
caffeine consumption, extra heartbeats, UCSF study, UC San Francisco, Journal of the American Heart Association
News | EP Lab| February 04, 2016
Contrary to current clinical belief, regular caffeine consumption does not lead to extra heartbeats, which, while...
Overlay Init