Author + information
- Received June 22, 2009
- Revision received August 3, 2009
- Accepted August 4, 2009
- Published online January 12, 2010.
- Ellen Bøhmer, MD*,∥,
- Pavel Hoffmann, MD, PhD†,
- Michael Abdelnoor, PhD‡,
- Harald Arnesen, MD, PhD§ and
- Sigrun Halvorsen, MD, PhD*,* ()
- ↵*Reprint requests and correspondence:
Dr. Sigrun Halvorsen, Department of Cardiology, Oslo University Hospital, Ulleval, Kirkeveien 166, N-0407 Oslo, Norway
Objectives The goal of this study was to compare a strategy of immediate transfer for percutaneous coronary intervention (PCI) with an ischemia-guided approach after thrombolysis in patients with very long transfer distances to PCI.
Background Thrombolysis remains the treatment of choice in ST-segment elevation myocardial infarction (STEMI) when primary PCI cannot be performed within 90 to 120 min. The optimal treatment after thrombolysis is still unclear.
Methods A total of 266 patients with acute STEMI living in rural areas with more than 90-min transfer delays to PCI were treated with tenecteplase, aspirin, enoxaparin, and clopidogrel and randomized to immediate transfer for PCI or to standard management in the local hospitals with early transfer, only if indicated for rescue or clinical deterioration. The primary outcome was a composite of death, reinfarction, stroke, or new ischemia at 12 months, and analysis was by intention to treat.
Results The primary end point was reached in 28 patients (21%) in the early invasive group compared with 36 (27%) in the conservative group (hazard ratio: 0.72, 95% confidence interval: 0.44 to 1.18, p = 0.19). The composite of death, reinfarction, or stroke at 12 months was significantly reduced in the early invasive compared with the conservative group (6% vs. 16%, hazard ratio: 0.36, 95% confidence interval: 0.16 to 0.81, p = 0.01). No significant differences in bleeding or infarct size were observed.
Conclusions Immediate transfer for PCI did not improve the primary outcome significantly, but reduced the rate of death, reinfarction, or stroke at 12 months in patients with STEMI, treated with thrombolysis and clopidogrel in areas with long transfer distances. (Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction; NCT00161005).
- acute myocardial infarction
- ST-segment elevation
- pre-hospital thrombolysis
- percutaneous coronary intervention
This study was funded by grants from the Scientific Board of the Eastern Norway Regional Health Authority, Hamar, Norway; Ada and Hagbarth Waage's Humanitære og Veldedige Stiftelse, Oslo, Norway; and the Innlandet Hospital Trust, Hamar, Norway. The funding sources had no role in the design and organization of the trial, data collection, data analysis, or writing of the report. Dr. Bøhmer received speakers' honoraria and travel grants (2008) from Boehringer Ingelheim. Dr. Hoffmann received travel grants from Eli Lilly and Medtronic. Dr. Arnesen received speakers' honoraria from Bristol-Myers Squibb and Nycomed AS. Dr. Halvorsen received speakers' honoraria from Sanofi, Bristol-Myers Squibb, Eli Lilly, and Boehringer Ingelheim.
- Received June 22, 2009.
- Revision received August 3, 2009.
- Accepted August 4, 2009.
- American College of Cardiology Foundation