NORDISTEMI
The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI) compared immediate transfer for percutaneous coronary intervention (PCI) with an ischaemia-guided approach after thrombolysis for patients in rural areas that had very long transfer distances to PCI centres.
In a remote area of Norway, a total of 266 patients with ST-elevation myocardial infarction (STEMI) of less than 6 h duration and more than 90 min expected time delay to PCI received thrombolysis (full-dose tenecteplase), aspirin, enoxaparin and clopidogrel, and were then randomised to either an early invasive strategy or a conservative strategy:
- Early invasive strategy: Immediate coronary angiography/PCI of the infarct-related artery if indicated (≥50% diameter stenosis).
- Conservative strategy: Admitted to hospital for continued care, with urgent transfer only for a rescue indication or with clinical deterioration.
The primary endpoint was a 12-month composite of death, re-infarction, stroke, or new myocardial ischaemia.
Secondary endpoints included a 12-month composite of death, re-infarction or stroke, transport-related complications, bleeding at 30 days, and infarct size (by SPECT and troponin T levels).
NORDISTEMI: Study design
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The results support an early invasive strategy after thrombolysis, even for patients with long transfer distances.
At 30 days, the early invasive strategy was associated with a significant reduction in the primary endpoint (relative risk 0.49; 95% CI 0.27 to 0.89; p=0.03) and a non-significant reduction in the secondary composite endpoint (relative risk 0.45; 95% CI 0.18 to 1.16; p=0.14).
At 12 months, the early invasive strategy was associated with a non-significant reduction in the primary endpoint (HR 0.72; 95% CI 0.44 to 1.18; p=0.19) and a significant reduction in the secondary composite endpoint of death, re-infarction or stroke (HR 0.36; 95% CI 0.16 to 0.81; p=0.01).
NORDISTEMI: Primary endpoint (n=266)
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NORDISTEMI: Death, reinfarction or stroke
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It is important to note that angiography was performed in the majority of patients in both the early invasive (99%) and conservative groups (95%), at an average time of 130 min and 5.5 days post-lysis respectively. PCI was also performed in the majority of patients in both groups, at an average time of 163 min and 3 days post-lysis respectively.
NORDISTEMI: Invasive procedures in the 2 randomisation groups
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The significant reduction in the composite of death, re-infarction or stroke suggests that an early invasive strategy after thrombolytic therapy may be preferable, even for patients in areas with long transfer distances.
References:
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Bøhmer E, et al. The NORwegian study on DIstrict treatment of ST-Elevation Myocardial Infarction (NORDISTEMI). Scand Cardiovasc J 2007;41:32-38.
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Bøhmer E et al. Efficacy and safety of immediate angioplasty versus ischaemia-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). J Am Coll Cardiol 2010;55:102-110.