Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction - AIDA STEMI

Description:

The goal of the trial was to evaluate treatment with intracoronary bolus administration of abciximab compared with intravenous bolus administration among patients with ST-elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).

Hypothesis:

Intracoronary bolus administration of abciximab will improve clinical outcomes.

Study Design

  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • STEMI patients with symptoms <12 hours undergoing primary PCI

    Number of enrollees: 2,065
    Mean patient age: 63 years
    Percentage female: 25%
    Ejection fraction: 50%

Exclusions:

  • Contraindication to abciximab

Primary Endpoints:

  • All-cause death, reinfarction, or CHF at 90 days

Secondary Endpoints:

  • Time to occurrence of combined clinical endpoint
  • TIMI-flow post-PCI
  • ST-segment resolution
  • Infarct size by area under the curve of creatine kinase release
  • GUSTO bleeding
  • Life-threatening arrhythmia/hemodynamic compromise during abciximab injection

Drug/Procedures Used:

All patients were given unfractionated heparin 50-70 U/kg, and aspirin 500 mg. Clopidogrel 600 mg (or prasugrel 60 mg) was recommended pre-PCI.

Concomitant Medications:

STEMI patients undergoing PCI were randomized to intracoronary bolus abciximab (n = 1,032) versus intravenous bolus abciximab (n = 1,033). Patients in both groups received a 12-hour infusion of abciximab post-PCI.

Principal Findings:

Overall, 2,065 patients were randomized. The median age was 63 years, 25% were women, 20% were diabetics, median body mass index was 28 kg/m2, and median left ventricular ejection fraction was 50%. The infarct-related artery was: left anterior descending in 43%, circumflex in 13%, right coronary artery in 44%, left main in <1%, and bypass graft in <1%. Aspiration thrombectomy was performed in 21%, bare-metal stents were used in 66%, and 89% had TIMI 3 flow post-PCI. Median door-to-balloon time was 32 minutes. An ADP receptor antagonist was preloaded in 58% of patients.

The primary outcome of death, reinfarction, or congestive heart failure (CHF) occurred in 7.0% of the intracoronary bolus group versus 7.6% of the intravenous bolus group (p = 0.58).

Death: 4.5% versus 3.6% (p = 0.36), reinfarction: 1.8% versus 1.8% (p = 0.99), CHF: 2.4% versus 4.1% (p = 0.04), respectively, for intracoronary versus intravenous abciximab.

Stroke: 1% versus 1% (p = 0.58), stent thrombosis: 1.7% versus 2.0% (p = 0.65), life-threatening/severe GUSTO bleeding: 2.6% versus 1.8% (p = 0.63), hemodynamic compromise during bolus: 0.1% versus 0.6% (p = 0.06), life-threatening arrhythmia during PCI: 1.7% versus 2.1% (p = 0.22), respectively, for intracoronary versus intravenous abciximab.

Cardiac magnetic resonance imaging (CMR) substudy (n = 795 patients): CMR was obtained using late gadolinium enhancement within 1 week of randomization. The median area at risk (edema) was similar between the intracoronary and intravenous abciximab arms (35% vs. 35%, p = 0.97). Final infarct size (16% vs. 17%, p = 0.52) and microvascular obstruction (47% vs. 52%, p = 0.19) on CMR were similar, respectively.

One-year follow-up: Data were available for 1,846 patients. Primary composite outcome was similar in the intracoronary versus intravenous abciximab arms (9.2% vs. 9.8%, p = 0.69). Other outcomes including death (5.5% vs. 4.6%, p = 0.39), reinfarction (2.9% vs. 2.9%), and CHF (2.9% vs. 4.6%, p = 0.07) were similar.

Interpretation:

Among STEMI patients undergoing primary PCI, administration of intracoronary abciximab compared with intravenous abciximab failed to improve composite clinical outcomes or reduce infarct size up to 1 year of follow-up. There was no signal for harm from this route of administration. AIDA STEMI is an important contribution to the literature, as it is the largest randomized trial on the topic. Observational studies and smaller randomized trials had inconsistently shown benefit from intracoronary abciximab; however, those studies did not routinely pre-treat patients with clopidogrel.

The reduction in CHF at 90 days was likely attributed to chance since there was no reduction in infarct size, and the difference was no longer statistically significant at 1 year. This was confirmed with the CMR substudy as well, which noted no difference in final infarct size or microvascular obstruction.

References:

Thiele H, Wöhrle J, Hambrecht R, et al. Intracoronary versus intravenous bolus abciximab during primary percutaneous coronary intervention in patients with acute ST-elevation myocardial infarction: a randomised trial. Lancet 2012;379:923-31.

Desch S, Wöhrle J, Hambrecht R, et al. Intracoronary Versus Intravenous Abciximab Bolus in Patients With ST-Elevation Myocardial Infarction: 1 Year Results of the Randomized AIDA STEMI Trial. J Am Coll Cardiol 2013;Jul 10:[Epub ahead of print].

Eitel I, Wohrle J, Suenkel H, et al. Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention in ST-segment elevation myocardial infarction: cardiac magnetic resonance substudy of the AIDA STEMI trial. J Am Coll Cardiol 2013;61:1447-54.

Presented by Dr. Holger Thiele at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2012), Miami, FL, October 25, 2012 (cardiac MRI substudy).

Presented by Dr. Holger Thiele at the American Heart Association Scientific Sessions, Orlando, FL, November 13, 2011.

Clinical Topics: Anticoagulation Management, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Aortic Surgery, Cardiac Surgery and Heart Failure, Acute Heart Failure, Interventions and Imaging, Magnetic Resonance Imaging

Keywords: Myocardial Infarction, Stroke, Heparin, Ticlopidine, Edema, Piperazines, Immunoglobulin Fab Fragments, Magnetic Resonance Imaging, Purinergic P2Y Receptor Antagonists, Stents, Percutaneous Coronary Intervention, Body Mass Index, Thrombectomy, Thrombosis, Heart Failure, Stroke Volume, Diabetes Mellitus


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