NORDISTEMI TRIAL
Problem STEMI (thrombolysed)
Format Multi-center RCT
Treatment Immediate PCI
Control PCI for rescue or clinical deterioration
Population 266 patients
Inclusion criteria 1. Age 18-75 yrs
2. Symptoms of myocardial infarction present for 6 h
3. ECG indicative of an acute STEMI: 2 mm ST-segment elevation in 2 contiguous precordial leads or 1 mm ST-segment elevation in 2 contiguous extremity leads or new left bundle branch block
4. Expected time delay from ï¬Årst medical contact to PCI 90 min
5. Receiving thrombolytic treatment with tenecteplase
6. Informed consent for participation
Exclusion criteria 1. Standard exclusion criteria for tenecteplase
2. Cardiogenic shock or serious arrhythmias at randomization
3. Pregnancy
4. Known serious renal failure (serum creatinine 250 mmol/l)
5. Other diseases with life expectancy 12 months
6. Psychiatric disease, mental retardation, dementia, drug abuse, alcoholism, or conditions that can severely reduce compliance
Follow-up 12 months
Primary endpoint Composite of death, reinfarction, stroke, or new ischemia at 12 months
Secondary endpoint(s) Composite of death, stroke, or reinfarction at 12 months, transport-related complications, bleeding at 30 days, and infarct size.

Bleeding complications were classiï¬Åed according to the GUSTO (Global Use of Strategies To Open coronary arteries) severity scale (10).

Infarct size was assessed by SPECT (11,12), and by troponin T levels (13,14).
Details All patients received standard weightadjusted dose tenecteplase, aspirin 300 mg orally, and
enoxaparin 30 mg intravenously followed by a subcutaneous
dose of 1 mg/kg repeated every 12 h up to hospital discharge
or revascularization for a maximum of 7 days. All patients also
received clopidogrel 300 mg on
the ï¬Årst day (9).
Eligible patients were asked
for participation at the same time
as thrombolysis was given, and
randomized in a 1:1 way to an
early invasive or a conservative
strategy. Permuted block randomization stratiï¬Åed by site, and
sealed envelopes containing treatment modality according to random numbers were used. The
random allocation sequence was
generated at the Center for Clinical Research, Oslo University
Hospital, Ulleval.
Patients assigned to the early invasive strategy were
transferred to the PCI center as soon as possible after
thrombolysis, for immediate coronary angiography and
angioplasty of the infarct-related artery if indicated
(50% diameter stenosis). The choice of stent type and
use of glycoprotein IIb/IIIa inhibitor were at the operator’s discretion. Likewise, referral for surgery in case of
left main coronary artery disease or serious 3-vessel
disease was left to the judgment of the operator.
Patients assigned to conservative treatment were admitted to (in case of pre-hospital thrombolysis) or kept in
the community hospitals for continued care, with referral
for urgent angiography if persistent chest pain and 50%
reduction of ST-segment elevation 60 min after initiation of thrombolysis (rescue indication) or hemodynamic
instability. Referral for early coronary angiography was
recommended if the patient had spontaneous recurrent
ischemia with or without electrocardiogram (ECG) changes,
or if signs of ischemia (chest pain, signiï¬Åcant STsegment changes, hypotension, or ventricular tachycardia) occurred in the exercise ECG recommended before
hospital discharge. In all other patients, coronary angiography as a routine assessment after successful thrombolysis was encouraged within 2 to 4 weeks after discharge.
Beta-blockers and statins were administered to all
patients unless contraindicated, angiotensin-converting
enzyme inhibitors when indicated. Patients receiving
stents were recommended clopidogrel 75 mg daily for 9
months. The other patients were recommended clopidogrel until angiography was performed or for 9 months,
at the discretion of the treating physician. Complete
clinical follow-up was performed at 3 and 12 months, and
telephone follow-up was performed at 1 and 7 months.
Troponin-T levels were measured in all patients the third
morning after onset of STEMI, and myocardial perfusion
single-photon emission computed tomography (SPECT)
was scheduled after 3 months.
Brief summary: PCI following thrombolysis reduced death/stroke/reinfarction at 1 year
PAPER: 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
Date 12 Jan 2010
Journal J Am Coll Cardiol. 2010 Jan 12;55(2):102-10.
Information Immediate PCI transfer for STEMI in rural patients after thrombolysis
-Median transfer time 130min

Primary endpoint (composite death, reinfarction, stroke, new myocardial ischemia)
-Reduced primary endpoint @ 30d for PCI (RR 0.49; p=0.03)
-No significant reduction @ 12m (HR 0.72; p =0.19)

Secondary endpoint (composite death, stroke, reinfarction)
-No significant reduction @ 30d for PCI (RR 0.45; p=0.14)
-Significant reduction @ 12m (HR 0.36; p=0.01)

No significant difference in bleeding - all severe bleeds were intracranial
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