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Abciximab infusion during intervention reduced infarct size
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CHICAGO — Administration of bolus intracoronary abciximab delivered directly to the infarct lesion site was associated with significant reductions in infarct size at 30 days in patients with large anterior STEMI who presented early after symptom onset and were undergoing primary percutaneous coronary intervention with bivalirudin. However, the same reduction was not observed in patients who had manual aspiration thrombectomy, according to results of the INFUSE-AMI trial.
The randomized, single blind, open-label trial was conducted to determine the effect of bolus intracoronary abciximab (ReoPro, Centocor and Eli Lilly), manual aspiration thrombectomy or a combination of both on infarct size in high-risk patients with STEMI.
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Gregg W. Stone, MD, of Columbia University Medical Center and New York–Presbyterian Hospital, and colleagues enrolled 452 patients who presented within 4 hours of STEMI due to proximal or mid left anterior descending artery occlusion and were undergoing primary PCI with bivalirudin (Angiomax, The Medicines Company). Patients were randomly assigned to one of four arms:
- Manual aspiration thrombectomy plus abciximab;
- Manual aspiration thrombectomy with no abciximab;
- No aspiration plus abciximab; or
- No aspiration and no abciximab.
A bolus of abciximab (0.25 mg/kg) was administered at the infarct lesion site using a local drug delivery catheter. Manual aspiration thrombectomy was performed using a 6F aspiration catheter.
primary endpoint was infarct size at 30 days as assessed by cardiac MRI in the abciximab vs. no abciximab groups. The groups were pooled across the aspiration randomization. Patients who received abciximab vs. no abciximab exhibited significant decreases in 30-day infarct size calculated as a percentage of total myocardial mass (median: 15.1% vs. 17.9%; P=.03) and absolute infarct mass (median: 18.7 g vs. 24 g; P=.03). However, there was no observed difference in abnormal wall motion score between the two arms (median: 7 vs. 8). Observations of patients who were assigned to receive aspiration thrombectomy vs. no aspiration revealed no significant differences in infarct size (median: 17% vs. 17.3%; P=.51), absolute infarct size (median: 20.3 g vs. 21 g; P=.36) or abnormal wall motion score.
No significant differences in any of the major safety or efficacy endpoints were present between any of the randomized groups at 30 days.
The data were presented at the American College of Cardiology’s 61st Scientific Sessions.
“Prior studies have reported conflicting results as to whether introcoronary abciximab or manual aspiration reduced infarct size or improved clinical outcomes, in part due to enrollment of a high proportion of small infarcts, such as non-anterior and/or with TIMI 3 flow, and patients presenting later than 4 to 6 hours,” Stone said at a press conference.
“We designed this study in order to see if either or both of these modalities would truly reduce heart attack size in patients with MI,” Stone said. “We specifically made this a study of large heart attacks because we can readily identify these patients. However, the patients also have to present early enough for us to be able to reduce the amount of damage.”
He added that a post-hoc analysis showed the aspiration plus abciximab group showed the lowest median infarct size approximately 14.7% — compared with the other three groups. He said, “I believe this aspect deserves further study.”
The INFUSE-AMI trial was conducted at 37 sites in six countries from November 2009 to December 2011. – by Robert Stott
For more information:
- Stone GW. Late-breaking clinical trials II. Presented at: the American College of Cardiology 61st Scientific Session & Expo; March 24-27, 2012; Chicago.
- Stone GW. JAMA. 2012;doi:10.1001/jama.2012.421.
Disclosure: Dr. Stone serves as a consultant to Atrium Medical, Eli Lilly, Medtronic and The Medicines Company.
This was a very important trial because in this group of patients, with large anterior MIs, how we treat them is going to be one of the key factors. What the investigators have demonstrated is that local delivery of abciximab may be of value. We used to use it frequently and then with the coming of other drugs, it has fallen off the radar screen. Now, I think going back to delivering it locally is an attractive strategy. However, it would be beneficial to see a larger study. At present, the study is [slightly] discordant with the meta-analysis of the published trials. While it doesn’t take away from the elegant nature of the study, the combined analysis has produced several thousand patients who show no clinical benefit. I am still on the fence about the clinical implications, but, nonetheless, this is an elegant study that answers an important question concerning infarct size.
– E. Magnus Ohman, MD, FRCPI, FACC
Associate Director, Duke Heart Center
Director, Program for Advanced Coronary Disease
Duke University Medical Center
Disclosures: Dr. Ohman reported consulting fees from AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Gilead Sciences, Liposcience, Merck, Sanofi Aventis, The Medicines Company and WebMD.