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 - 05/08/11
, Jochen Wöhrle, MD b, Petra Neuhaus, PhD c, Oana Brosteanu, PhD c, Peter Sick, MD d, Roland Prondzinsky, MD e, Ralf Birkemeyer, MD f, Marcus Wiemer, MD g, Sebastian Kerber, MD h, Helmut Schuehlen, MD i, Klaus Kleinertz, MD j, Christoph Axthelm, MD k, Rainer Zimmermann, MD l, Harald Rittger, MD m, Rüdiger C. Braun-Dullaeus, MD n, Bernward Lauer, MD o, Wolfgang Burckhardt, MD p, Markus Ferrari, MD, PhD q, Martin W. Bergmann, MD r, Rainer Hambrecht, MD s, Gerhard Schuler, MD aon behalf of the Abciximab Intracoronary versus intravenously Drug Application in ST-Elevation Myocardial Infarction (AIDA STEMI) Investigators
Résumé |
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.
Study design |
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.
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| RCT reg #NCT00712101. |
Vol 159 - N° 4
P. 547-554 - avril 2010 Retour au numéro
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