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1-Year Survival in a Randomized Trial of Facilitated Reperfusion

Results From the FINESSE (Facilitated Intervention With Enhanced Reperfusion Speed to Stop Events) Trial

Stephen G. Ellis, MD^_*,_*, Michal Tendera, MD, Mark A. de Belder, MD, Ad J. van Boven, MD, Petr Widimsky, MD^||, Henning R. Andersen, MD^¶, Amadeo Betriu, MD^#, Stefano Savonitto, MD^_**, Jerzy Adamus, MD, Jan Z. Peruga, MD, Maciej Hamankiewicz, MD, Waladyslaw Pluta, MD^||||, Keith Oldroyd, MD^¶¶, Patrick Ecollan, MD^##, Luc Janssens, MD^_***, Paul Armstrong, MD, Bruce R. Brodie, MD, Howard C. Herrmann, MD, Gilles Montalescot, MD^||||||, Franz-Josef Neumann, MD^¶¶¶, Mark B. Effron, MD^###, Elliot S. Barnathan, MD^_****, Eric J. Topol, MD^_* on behalf of the FINESSE Investigators

^_* Cleveland Clinic, Department of Cardiovascular Medicine, Cleveland, Ohio
Medical University of Silesia, Department of Cardiology, Katowice, Poland
The James Cook University Hospital, Cardiothoracic Unit, Middlesbrough, United Kingdom
Medisch Centrum Leeuwarden, Department of Cardiology, Leeuwarden, the Netherlands
^|| University Hospital, Kralovske Vinohrady, Czech Republic
^¶ Skejby University Hospital, Department of Cardiology, Aarhus North, Denmark
^# Hospital Clinic i Provincial, Cardiovascular Unit, Barcelona, Spain
^_** Ospedale Niguarda Ca Granda, Department of Cardiology, Milano, Italy
Centralny Szpital Kliniczny, Wojskowej Akademii Medycznej, Klinika Kardiologii (Cardiology Clinic), Warszawa, Poland
II Katedra I Klinika Kardiologii Uniwersytet Medycznego, Klinika Kardiologii, Lodz, Poland
SP Zoz Szpital Powiatowy; Oddzial Chorob Wewnetrznych, Bedzin, Poland
^|||| Wojewodzke Centrum Medyczne, Oddzial Kardiologii, Opole, Poland
^¶¶ Western Infirmary, Glasgow, United Kingdom
^## SAMU Pitie-Salpetriere, Boulevard de l'hopital, Paris, France
^_*** Algemeen Ziekenhuis, Imelda Ziekenhuis, Bonheiden, Cardiovascular Center, Bonheiden, Belgium
University of Alberta Hospital, Edmonton, Department of Medicine, Alberta, Canada
LeBauer Cardiovascular Research, Greensboro, North Carolina
Hôpital Pitiè-Salpétrière, Paris, France
^|||||| Herz-Zentrum bad Krozingen, Interventional Cardiology, Bad Krozingen, Germany
^¶¶¶ U.S. Medical Division, Cardiovascular/Critical Care, Eli Lilly and Company, Indianapolis, Indiana
^### Centocor Research and Development, Inc., Cardiovascular/Pulmonary Division, Malvern, Pennsylvania
^_**** The Scripps Research Institute and Scripps Clinic, Department of Cardiovascular Medicine, La Jolla, California

^_* Reprint requests and correspondence: Dr. Stephen G. Ellis, Cleveland Clinic, Department of Cardiovascular Medicine/J2, 9500 Euclid Avenue, Cleveland, Ohio 44195 (Email: elliss{at}ccf.org).

Objectives: The aim of this report was to evaluate 12-month outcomes of facilitated percutaneous coronary intervention (PCI) in the FINESSE (Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events) trial.

Background: Treatment delays remain common for patients with primary PCI leading to studies evaluating possible benefit of "facilitated" PCI. In the FINESSE trial, no reduction in the 90-day primary ischemic end point and an increase in bleeding were observed with both facilitated approaches, although modest favorable trends were seen for some patient subgroups.

Methods: A total of 2,452 patients with ST-segment elevation myocardial infarction (MI) and anticipated 1 to 4 h delay until catheterization were randomized to reduced-dose reteplase + abciximab, abciximab alone, or placebo, followed by expedited primary PCI. Placebo-treated patients received abciximab in the cath lab. One-year mortality was a pre-specified secondary end point.

Results: One-year mortalities in the 3 groups noted in the preceding text were 6.3%, 7.4%, and 7.0%, respectively (p = NS), representing 1.1%, 1.9%, and 2.5% increments since the 90-day outcome (p = 0.053 for combination treatment vs. primary PCI). A favorable trend with combination treatment was seen for patients with anterior MI (p = 0.09), but no other specified groups benefited or tended to benefit. Independent baseline correlates of 1-year mortality were systolic blood pressure <100 mm Hg, prior MI, age, Killip class >1, anterior MI, body mass index 25 kg/m², heart rate >100 beats/min, and no statin use.

Conclusions: These results suggest that widespread utilization of the facilitated approaches tested cannot be justified, but that high-risk patient groups such as patients with anterior MI may deserve further study. (The FINESSE trial; NCT00046228)

Key Words: acute myocardial infarction • reperfusion therapy • primary percutaneous coronary intervention

Abbreviations and Acronyms   MI = myocardial infarction   PCI = percutaneous coronary intervention   STEMI = ST-segment elevation myocardial infarction

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