Facilitated PCI in Patients with ST-Elevation Myocardial Infarction
Stephen G. Ellis, M.D., Michal Tendera, M.D., Mark A. de Belder, M.D., Ad J. van Boven, M.D., Petr Widimsky, M.D., Luc Janssens, M.D., H.R. Andersen, M.D., Amadeo Betriu, M.D., Stefano Savonitto, M.D., Jerzy Adamus, M.D., Jan Z. Peruga, M.D., Maciej Kosmider, M.D., Olivier Katz, M.D., Thomas Neunteufl, M.D., Julia Jorgova, M.D., Maria Dorobantu, M.D., Liliana Grinfeld, M.D., Paul Armstrong, M.D., Bruce R. Brodie, M.D., Howard C. Herrmann, M.D., Gilles Montalescot, M.D., Franz-Josef Neumann, M.D., Mark B. Effron, M.D., Elliot S. Barnathan, M.D., Eric J. Topol, M.D., for the FINESSE Investigators
Background We hypothesized that percutaneous coronary intervention(PCI) preceded by early treatment with abciximab plus half-dosereteplase (combination-facilitated PCI) or with abciximab alone(abciximab-facilitated PCI) would improve outcomes in patientswith acute ST-segment elevation myocardial infarction, as comparedwith abciximab administered immediately before the procedure(primary PCI).
Methods In this international, double-blind, placebo-controlledstudy, we randomly assigned patients with ST-segment elevationmyocardial infarction who presented 6 hours or less after theonset of symptoms to receive combination-facilitated PCI, abciximab-facilitatedPCI, or primary PCI. All patients received unfractionated heparinor enoxaparin before PCI and a 12-hour infusion of abciximabafter PCI. The primary end point was the composite of deathfrom all causes, ventricular fibrillation occurring more than48 hours after randomization, cardiogenic shock, and congestiveheart failure during the first 90 days after randomization.
Results A total of 2452 patients were randomly assigned to atreatment group. Significantly more patients had early ST-segmentresolution with combination-facilitated PCI (43.9%) than withabciximab-facilitated PCI (33.1%) or primary PCI (31.0%; P=0.01and P=0.003, respectively). The primary end point occurred in9.8%, 10.5%, and 10.7% of the patients in the combination-facilitatedPCI group, abciximab-facilitated PCI group, and primary-PCIgroup, respectively (P=0.55); 90-day mortality rates were 5.2%,5.5%, and 4.5%, respectively (P=0.49).
Conclusions Neither facilitation of PCI with reteplase plusabciximab nor facilitation with abciximab alone significantlyimproved the clinical outcomes, as compared with abciximab givenat the time of PCI, in patients with ST-segment elevation myocardialinfarction. (ClinicalTrials.gov number, NCT00046228
[ClinicalTrials.gov]
.)
Source Information
The affiliations of the authors are listed in the Appendix.
Address reprint requests to Dr. Ellis at the Department of Cardiovascular Medicine, the Cleveland Clinic, F25, 9500 Euclid Ave., Cleveland, OH 44195, or at elliss{at}ccf.org.
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