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ORLANDO, FL—Intracoronary abciximab does not reduce rates of death or myocardial infarction (MI) compared to standard intravenous (IV) administration of the glycoprotein IIb/IIIa inhibitor in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). However, it may decrease the incidence of new congestive heart failure.
The findings emerged from the randomized, multicenter, large-scale AIDA STEMI (Abciximab Intracoronary versus intravenous Drug Application in ST-Elevation Myocardial Infarction) trial presented November 13 at the American Heart Association Scientific Sessions 2011 by Holger Thiele, MD, of the University of Leipzig (Leipzig, Germany).
According to Dr. Thiele, an earlier meta-analysis of small studies comparing intracoronary with IV administration of abciximab revealed a reduction in 30-day mortality and a trend toward reduction in recurrent MI and need for coronary revascularization with the intracoronary route. The reason for the AIDA STEMI trial, however, was the absence of large-scale trials of intracoronary abciximab powered for clinical endpoints, he noted.
German investigators randomized 2,065 patients with suspected STEMI at 27 tertiary centers to abciximab (0.25 mg/kg) delivered by either intracoronary (n = 1,032) or IV (n = 1,033) bolus during primary PCI, with subsequent infusion of 0.125 µg/kg/min for 12 hours. All patients also received 500 mg of aspirin plus 600 mg of clopidogrel or 60 mg of prasugrel.
No Difference in Primary Endpoint
At 90 days, no differences were seen between the intracoronary and IV groups for the primary outcome (composite of all-cause mortality, reinfarction, or new congestive heart failure) or the component endpoints of death and reinfarction. However, the rate of new congestive heart failure was lower in the intracoronary than the IV arm (table 1).
Table 1. Clinical Outcomes at 90 Days
OR (95% CI)
New Congestive Heart Failure
In addition, the frequency of early ST-segment resolution and infarct size were similar for the treatment groups (P = 0.37 and P = 0.74, respectively).
Analysis showed no interactions with a number of patient subgroups, including use of prasugrel vs. no prasugrel, thrombectomy vs. no thrombectomy, anterior vs. nonanterior MI, age less than 75 years vs. 75 years or greater, and post-PCI TIMI flow 0 to II vs. III.
No safety issues were reported (table 2).
Table 2. Safety Endpoints
GUSTO Bleeding, Life-Threatening/Severe
Hemodynamic Compromise During Bolus Administration
Life-Threatening Arrhythmias During PCI
Dr. Thiele concluded that while intracoronary administration of abciximab is safe, it does not add benefit in comparison to the standard IV bolus with respect to the primary outcome. “The intracoronary route might be related to reduced rates of new congestive heart failure, but because we could not confirm this by ST-segment resolution or infarct size, it might be an effect of chance,” he added.
Discussant Alice K. Jacobs, MD, of Boston University Medical Center (Boston, MA), noted that the trial was somewhat underpowered and moderate differences in outcome cannot be excluded. In addition, it is unclear whether the inclusion of lower-risk patients, more rapid distribution of IV abciximab or the use of dual antiplatelet therapy may have reduced differences between the 2 routes of administration, she observed.
Nonetheless, Dr. Jacobs concluded, “AIDA STEMI suggests no change in clinical practice, and IV abciximab should remain the standard of care.”
Determining whether intracoronary abciximab should be used in patients with large infarcts and thrombus burden and/or no reflow will require further study, she said. Dr. Jacobs also noted that an ongoing trial is evaluating intracoronary abciximab in STEMI patients treated with bivalirudin.
Finally, Dr. Jacobs pointed out that the recently updated PCI ACC/AHA/SCAI guidelines state: “In patients undergoing primary PCI with abciximab, it may be reasonable to administer intracoronary abciximab (level of evidence IIb/B).”
The mean age of patients was 62.5 years and about 75% were male.