Intracoronary compared with intravenous bolus abciximab application during primary percutaneous coronary intervention: design and rationale of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) trial.
BACKGROUND
Intravenous abciximab reduces major adverse cardiac events in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Intracoronary abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction. The hypothesis of this trial is that abciximab bolus intracoronary in comparison to standard intravenous application will improve the outcome of patients undergoing primary PCI in STEMI.


METHODS
The Abciximab Intracoronary versus intravenously Drug Application in STEMI (AIDA STEMI) study is a 1,912-patient, prospective, multicenter, randomized, open-label, controlled trial. The study is designed to compare the efficacy and safety of intracoronary versus intravenous bolus abciximab administration during primary PCI with subsequent intravenous infusion for 12 hours. Patients will be randomized in a 1:1 fashion to 1 of the 2 treatments. The primary efficacy end point of AIDA STEMI is the composite of all-cause mortality, recurrent MI, or new congestive heart failure within 90 days of randomization. The primary safety outcome assessment will be major bleeding.


CONCLUSIONS
The AIDA STEMI study addresses important questions regarding the efficacy and safety of intracoronary abciximab bolus administration during primary PCI in patients with STEMI, potentially optimizing the route of administration of glycoprotein IIb/IIIa inhibitors in the catheterization laboratory.
Thiele
Holger
H
Universität Leipzig-Heart Center, Department of Internal Medicine-Cardiology, Germany. thielh@medizin.uni-leipzig.de
Wöhrle
Jochen
J
Neuhaus
Petra
P
Brosteanu
Oana
O
Sick
Peter
P
Prondzinsky
Roland
R
Birkemeyer
Ralf
R
Wiemer
Marcus
M
Kerber
Sebastian
S
Schuehlen
Helmut
H
Kleinertz
Klaus
K
Axthelm
Christoph
C
Zimmermann
Rainer
R
Rittger
Harald
H
Braun-Dullaeus
Rüdiger C
RC
Lauer
Bernward
B
Burckhardt
Wolfgang
W
Ferrari
Markus
M
Bergmann
Martin W
MW
Hambrecht
Rainer
R
Schuler
Gerhard
G
D000077284:Abciximab; D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D007269:Injections, Intra-Arterial; D007275:Injections, Intravenous; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000188:drug therapy / Q000628:therapy*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D000077284:Abciximab