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A Randomized Controlled Trial

Albert Schömig, MD; Julinda Mehilli, MD; David Antoniucci, MD; Gjin Ndrepepa, MD; Christina Markwardt, MD; Francesco Di Pede, MD; Stephan G. Nekolla, PhD; Klaus Schlotterbeck, MD; Helmut Schühlen, MD; Jürgen Pache, MD; Melchior Seyfarth, MD; Stefan Martinoff, MD; Werner Benzer, MD; Claus Schmitt, MD; Josef Dirschinger, MD; Markus Schwaiger, MD; Adnan Kastrati, MD; for the Beyond 12 hours Reperfusion AlternatiVe Evaluation (BRAVE-2) Trial Investigators

JAMA. 2005;293:2865-2872.

Context  No specifically designed studies have addressed the role of primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction (STEMI) presenting more than 12 hours after symptom onset. Current guidelines do not recommend reperfusion treatment in these patients.

Objective  To assess whether an immediate invasive treatment strategy is associated with a reduction of infarct size in patients with acute STEMI, presenting between 12 and 48 hours after symptom onset, vs a conventional conservative strategy.

Design, Setting, and Patients  International, multicenter, open-label, randomized controlled trial conducted from May 23, 2001, to December 15, 2004, of 365 patients aged 18 to 80 years without persistent symptoms admitted with the diagnosis of acute STEMI between 12 and 48 hours after symptom onset.

Interventions  Random assignment to either an invasive strategy (n=182) based predominantly on coronary stenting with abciximab or a conventional conservative treatment strategy (n=183).

Main Outcome Measures  The primary end point was final left ventricular infarct size according to single-photon emission computed tomography study with technetium Tc 99m sestamibi performed between 5 and 10 days after randomization in 347 patients (95.1%). Secondary end points included composite of death, recurrent MI, or stroke at 30 days.

Results  The final left ventricular infarct size was significantly smaller in patients assigned to the invasive group (median, 8.0%; interquartile range [IQR], 2.0%-15.8%) vs those assigned to the conservative group (median, 13.0%; IQR, 3.0%-27.0%; P<.001). The mean difference in final left ventricular infarct size between the invasive and conservative groups was –6.8% (95% confidence interval [CI], –10.2% to –3.5%). The secondary end points of death, recurrent MI, or stroke at 30 days occurred in 8 patients in the invasive group (4.4%) and 12 patients in the conservative group (6.6%) (relative risk, 0.67; 95% CI, 0.27-1.62; P = .37).

Conclusion  An invasive strategy based on coronary stenting with adjunctive use of abciximab reduces infarct size in patients with acute STEMI without persistent symptoms presenting 12 to 48 hours after symptom onset.

Author Affiliations: Deutsches Herzzentrum (Drs Schömig, Mehilli, Ndrepepa, Markwardt, Schühlen, Pache, Martinoff, Schmitt, and Kastrati), 1 Medizinische Klinik rechts der Isar (Drs Schömig, Seyfarth, and Dirschinger), and Klinik und Poliklinik für Nuklearmedizin rechts der Isar (Drs Nekolla and Schwaiger), Technische Universität, Munich, Germany; Azienda Ospedaliera Careggi, Florence, Italy (Dr Antoniucci); Ospedale Umberto I, Mestre, Italy (Dr Di Pede); Klinikum Traunstein, Germany (Dr Schlotterbeck); and Landeskrankenhaus Feldkirch, Austria (Dr Benzer).

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