2011 Late-Breaking Clinical Trial/Clinical Science: Special Reports Abstracts

Abstract

HomeCirculationVol. 124, No. 212011 Late-Breaking Clinical Trial/Clinical Science: Special Reports Abstracts Free AccessAbstractPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessAbstractPDF/EPUB2011 Late-Breaking Clinical Trial/Clinical Science: Special Reports Abstracts Originally published22 Nov 2011https://doi.org/10.1161/CIR.0b013e31823c86a1Circulation. 2011;124:2365–23742011 Late-Breaking Clinical Trial/Clinical Science: Special Reports AbstractsSession Title: Late-Breaking Clinical Trials IIntracoronary Compared with Intravenous Bolus Abciximab Application During Primary Percutaneous Coronary Intervention: AIDA STEMI TrialHolger Thiele1, Jochen Wöhrle2, Rainer Hambrecht3, Harald Rittger4, Ralf Birkemeyer5, Bernward Lauer6, Petra Neuhaus7, Oana Brosteanu7, Peter Sick8, Marcus Wiemer9, Sebastian Kerber10, Ingo Eitel1, Klaus Kleinertz11, Gerhard Schuler11Herzzentrum Leipzig, Leipzig, Germany 2Univ of Ulm, Ulm, Germany 3Klnikum Links der Weser, Bremen, Germany 4Klnikum Coburg, Coburg, Germany 5Klnikum Villingen-Schwenningen, Villingen-Schwenningen, Germany 6Zentralklinik Bad Berka, Bad Berka, Germany 7KKSL, Leipzig, Germany 8Krankenhaus Barmherzige Brüder, Regensburg, Germany 9HERHerz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany 10Herz- und Gefäβ-Klinik, Bad Neustadt, Germany 11Ambulantes Herzzentrum Chemnitz, Chemnitz, GermanyBackground: Intracoronary (IC) abciximab bolus application during PCI results in high local drug concentration, improved perfusion, reduction of infarct size, and less microvascular obstruction in comparison to intravenous (IV) bolus application. Metaanalyses of randomized small to medium-sized trials suggest a reduction of death and reinfarction with the IC bolus application. The hypothesis of this trial is that IC abciximab bolus in comparison to standard IV application will improve the outcome of patients undergoing primary PCI in STEMI. Methods and Results: The AIDA STEMI study randomized 2072 STEMI patients at 27 tertiary centers in a 1:1 fashion from July 2008 to April 2011 to either IC or IV bolus abciximab administration during primary PCI with subsequent IV infusion for 12 h. The primary efficacy endpoint is the composite of all-cause mortality, recurrent infarction or new congestive heart failure within 90 days of randomization. Secondary clinical endpoints are each individual component of the endpoint within 90 days after randomization. Furthermore, ST-segment resolution and infarct size assessed indirectly by enzyme release are assessed. The trial is registered under www.clinicaltrials.gov: NCT00712101 and the study design has been published previously.1 Current patient characteristics showed no significant differences in baseline characteristics. The last clinical follow-up will be performed in the end of July 2011 and the final study results will be available during the Late Breaking Clinical Trial session. Conclusions: The AIDA STEMI study is the first adequately powered trial for clinical endpoints addressing important questions regarding efficacy and safety of IC versus IV abciximab bolus administration during primary PCI in patients with STEMI. The trial results will impact the route of glycoprotein IIb/IIIa-inhibitor administration.