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A Randomized Controlled Trial

Adnan Kastrati, MD; Julinda Mehilli, MD; Klaus Schlotterbeck, MD; Franz Dotzer, MD; Josef Dirschinger, MD; Claus Schmitt, MD; Stephan G. Nekolla, PhD; Melchior Seyfarth, MD; Stefan Martinoff, MD; Christina Markwardt, MD; Günther Clermont, MD; Hans-Wilhelm Gerbig, MD; Johannes Leiss, MD; Markus Schwaiger, MD; Albert Schömig, MD; for the Bavarian Reperfusion Alternatives Evaluation (BRAVE) Study Investigators

JAMA. 2004;291:947-954.

Context  The optimal pharmacological strategy for bridging the delay between admission and performance of percutaneous coronary intervention (PCI) in patients with acute myocardial infarction (MI) is not known.

Objective  To assess whether early administration of reteplase plus abciximab produces better results compared with abciximab alone in patients with acute MI referred for PCI.

Design, Setting, and Patients  Open-label, randomized controlled study conducted from May 3, 2001, through June 2, 2003, of 253 patients who were admitted to 13 community hospitals without catheterization facilities (n = 186) and to 5 hospitals with catheterization facilities (n = 67), with the diagnosis of an ST-segment elevation acute MI within 12 hours from onset of symptoms.

Interventions  Patients received intravenously either the combination of a half-dose reteplase (two 5-U boluses, 30 minutes apart) with a standard dose of abciximab (0.25 mg/kg bolus, 0.125 µg/kg per minute infusion [maximum 10 µg/min for 12 hours]) or the standard dose of abciximab alone; all patients were then transferred for PCI.

Main Outcome Measure  Final infarct size according to a single-photon emission computed tomography study with technetium Tc 99m sestamibi performed between 5 and 10 days after randomization in 228 patients (90.1% of entire sample).

Results  Of the 253 patients enrolled, 125 were assigned to reteplase plus abciximab and 128 to abciximab alone. The median (interquartile range) of the final infarct size of the left ventricle was 13.0% (3.0%-28.0%) in the reteplase plus abciximab group and 11.5% (3.0%-26.3%) in the abciximab-alone group (P = .81). The mean difference in final infarct size of left ventricle between the reteplase plus abciximab group and the abciximab group was 1.3% (95% confidence interval [CI], –3.1% to 5.7%). Within 6 months after randomization, the composite secondary end point of death, recurrent MI, or stroke occurred in 8 patients (6.4%) in the reteplase plus abciximab group and 6 patients (4.7%) in the abciximab group (relative risk, 1.4; 95% CI, 0.5-3.9; log-rank P = .56). Major bleeding complications were observed in 7 patients (5.6%) in the reteplase plus abciximab group and 2 patients (1.6%) in the abciximab group (P = .16).

Conclusion  Early administration of reteplase plus abciximab does not lead to a reduction of infarct size compared with abciximab alone in patients with acute MI referred for PCI.

Author Affiliations: Deutsches Herzzentrum, Technische Universität, Munich (Drs Kastrati, Mehilli, Schmitt, Seyfarth, Martinoff, Markwardt, and Schömig); Klinikum Traunstein (Drs Schlotterbeck and Clermont); Klinikum Garmisch-Partenkirchen (Dr Dotzer); 1 Medizinische Klinik rechts der Isar, Technische Universität, Munich (Drs Dirschinger and Schömig); Klinik und Poliklinik für Nuklearmedizin rechts der Isar, Technische Universität, Munich (Drs Nekolla and Schwaiger); Asklepios Stadtklinik, Bad Tölz (Dr Gerbig); and Kreiskrankenhaus Erding/Dorfen, Erding (Dr Leiss), Germany.

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