Intralesional abciximab and thrombus aspiration in patients with large anterior myocardial infarction: one-year results from the INFUSE-AMI trial.

Abstract

BACKGROUND:

Whether intralesional abciximab administration and thrombus aspiration confer clinical benefits to patients undergoing primary percutaneous coronary intervention for ST-segment-elevation myocardial infarction is controversial.

METHODS AND RESULTS:

A total of 452 patients with ST-segment-elevation myocardial infarction caused by proximal or mid left anterior descending artery occlusion undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation were randomized in a 2×2 factorial design to bolus abciximab delivered locally at the infarct lesion site versus no abciximab and to manual thrombus aspiration versus no aspiration. Treatment with intralesional abciximab, thrombus aspiration, or both therapies compared with no active therapy before stent implantation resulted in lower 1-year rates of death (4.5% versus 10.4%; P=0.03), severe heart failure (4.2% versus 10.3%; P=0.02), and stent thrombosis (0.9% versus 3.8%; P=0.046). Between 30 days and 1 year of follow-up, treatment with intralesional abciximab compared with no abciximab was associated with a lower rate of death (1.4% versus 4.9%; P=0.04) and composite major adverse ischemic events (3.3% versus 7.8%; P=0.04), with nonsignificantly different overall 1-year rates of mortality, composite ischemic events, and heart failure-related events. Thrombus aspiration compared with no aspiration was associated with lower rates of new-onset severe heart failure between 30 days and 1 year (0.9% versus 4.5%; P=0.02) and of rehospitalization for heart failure from randomization to 1 year (0.9% versus 5.4%; P=0.0008), with nonsignificantly different rates of mortality.

CONCLUSIONS:

Intralesional abciximab and thrombus aspiration may have long-term benefits in patients with anterior ST-segment-elevation myocardial infarction presenting early after symptom onset and undergoing primary percutaneous coronary intervention with bivalirudin anticoagulation.

CLINICAL TRIAL REGISTRATION URL:

http://www.clinicaltrials.gov. Unique identifier: NCT00976521.

• Authors: Gregg W Stone, Bernhard Witzenbichler, Jacek Godlewski, Jan-Henk E Dambrink, Andrzej Ochala, Saqib Chowdhary, Magdi El-Omar, Thomas Neunteufl, David Christopher Metzger, Jose M Dizon, Steven D Wolff, Sorin J Brener, Roxana Mehran, Akiko Maehara, C Michael Gibson
• Journal: Circulation. Cardiovascular interventions (Circ Cardiovasc Interv) Vol. 6 Issue 5 Pg. 527-34 (Oct 01 2013) ISSN: 1941-7632 [Electronic] United States
• PMID: 24084626 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Monoclonal
• Anticoagulants
• Immunoglobulin Fab Fragments
• Abciximab

Topics

• Abciximab
• Antibodies, Monoclonal (administration & dosage, adverse effects)
• Anticoagulants (administration & dosage, adverse effects)
• Follow-Up Studies
• Humans
• Immunoglobulin Fab Fragments (administration & dosage, adverse effects)
• Injections, Intralesional
• Myocardial Infarction (drug therapy, mortality, surgery)
• Percutaneous Coronary Intervention
• Stents (statistics & numerical data)
• Survival Analysis
• Thrombectomy
• Time Factors
• Treatment Outcome