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EXPEDITED PUBLICATION

Efficacy and Safety of Immediate Angioplasty Versus Ischemia-Guided Management After Thrombolysis in Acute Myocardial Infarction in Areas With Very Long Transfer Distances

Results of the NORDISTEMI (NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction)

Ellen Bøhmer, MD^_*,||, Pavel Hoffmann, MD, PhD, Michael Abdelnoor, PhD, Harald Arnesen, MD, PhD and Sigrun Halvorsen, MD, PhD^_*,_*

^_* Cardiology
Radiology
Center for Clinical Research
Department of Cardiology and Center for Clinical Heart Research, Oslo University Hospital, Ulleval, Oslo
^|| Department of Medicine, Innlandet Hospital Trust, Lillehammer, Norway

Manuscript received June 22, 2009; revised manuscript received August 3, 2009, accepted August 4, 2009.

^_* Reprint requests and correspondence: Dr. Sigrun Halvorsen, Department of Cardiology, Oslo University Hospital, Ulleval, N-0407 Oslo, Norway (Email: sigrun.h{at}online.no).

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).

Key Words: acute myocardial infarction • ST-segment elevation • pre-hospital thrombolysis • percutaneous coronary intervention

Abbreviations and Acronyms   CI = confidence interval   ECG = electrocardiogram   HR = hazard ratio   IQR = interquartile range   PCI = percutaneous coronary intervention   SPECT = single-photon-emission computed tomography   STEMI = ST-segment elevation myocardial infarction   TIMI = Thrombolysis In Myocardial Infarction

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