NORDISTEMI: first trial to study the effect of early PCI after fibrinolysis in rural areas with very long transfer delays.
Results from the NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI) show that patients presenting with acute ST-elevation myocardial infarction (STEMI) in rural areas have a better treatment outcome with thrombolysis followed by immediate transfer for angiography than with thrombolysis and conservative, community-hospital follow-up.
The latest European guidelines on the treatment of STEMI put emphasis on speedy reperfusion therapy, performed by "percutaneous coronary interventions" (PCI, with balloon angioplasty and stent) and thrombolysis. Primary PCI is the preferred treatment if available within two hours of first medical contact. If PCI is not possible within two hours, the guidelines advise that pre- or in-hospital thrombolysis should be performed as soon as possible. In addition, transfer for angiography and PCI after thrombolysis is recommended, but the role and timing of early PCI after thrombolysis have not been established for patients living in rural areas with very long transfers. Which reperfusion strategy would be most effective in these cases?
NORDISTEMI is the first trial to study the effect of early PCI after fibrinolysis in rural areas with very long transfer delays. The median transfer distance to PCI was 158 km, and median transfer time was 130 minutes. Thrombolysis was given as pre-hospital treatment in 58% of patients; adjunctive anti-thrombotic medication was in accordance with the latest European guidelines. The results of the study suggest that in areas with long transfer delays an early invasive strategy (with angiography following thrombolysis) might be preferable to a more conservative approach.
About the study
The NORDISTEMI was a randomised, open, multicentre study conducted in Norway between February 2005 and April 2009. It compared two different strategies after fibrinolysis in a region with long transfer distances to PCI (100-400 km): to transfer all patients for immediate coronary angiography and intervention, or to manage the patients more conservatively.
A total of 266 STEMI patients, aged 18-75 years, received thrombolytic therapy and were randomised to either immediate transfer for angiography/PCI or to standard management in the community hospitals with urgent transfer only for a rescue indication or with clinical deterioration. All patients received aspirin, tenecteplase, enoxaparin and clopidogrel as anti-thrombotic medication.
The results showed a reduction in the primary composite endpoint of death, reinfarction, stroke or new ischemia within 12 months in the early invasive group, but the reduction did not reach statistical significance (hazard ratio 0.72, 95% CI 0.44-1.18, p=0.19). However, the composite of death, reinfarction or stroke at 12 months was significantly reduced in the early invasive group compared to the conservative group (6.0% versus 15.9%, hazard ratio 0.36, 95% CI 0.16-0.81, p=0.01). No significant differences in bleeding or infarct size were observed, and transfer-related complications were few.
Says associate professor Sigrun Halvorsen, the principal investigator of the study: "Our study indicates a potential for improving reperfusion strategies for patients living in rural areas with long transport distances. This may be achieved by applying a well-organised pharmaco-invasive approach, including pre-hospital thrombolysis and rapid transfer to a PCI centre".
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