The Danish Multicenter Randomized Trial on Thrombolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction
Henning Andersen
Skejby University Hospital
Aarhus, Denmark

In this study, investigators treated ST elevation myocardial patients with front loaded tPA, or had them transported to an invasive center for angioplasty. Results show a relative risk reduction of more than 40% at 30 days for patients who received the interventional procedure. The results suggest delayed percutaneous coronary intervention is preferable to immediate thrombolysis, even if patients must be transported a long distance for the procedure.

The Danish Multicenter Randomized Trial on Thrombolytic Therapy versus Acute Coronary Angioplasty in Acute Myocardial Infarction (DANAMI) study included 1,572 patients enrolled at 5 invasive centers and 24 referral hospitals in Denmark. The service areas of the 29 hospitals cover 62% of Denmark's 5.4 million inhabitants.

Investigators in DANAMI randomized ST elevation myocardial infarction (MI) patients to either fibrinolysis or percutaneous coronary intervention (PCI) with stenting. The fibrinolysis regimen was 100 mg front-loaded tPA.

Patients enrolled directly in the invasive centers received fibrinolysis or the interventional procedure. Patients enrolled at referral hospitals received fibrinolysis, or else ambulance transfer to an invasive center for a procedure. The maximum transport distance possible was about 95 miles. Transfer time could not exceed 3 hours.

The primary endpoint was the composite of death, reinfarction or disabling stroke at 30 days. For all 1,572 patients, incidence was 8% in the PCI arm, and 13.7% in the thrombolysis arm (P = 0.0003). The number needed to treat to avoid one event was 18. Further analysis revealed a significant reduction in reinfarction (1.6% for intervention vs. 6.3% for fibrinolysis, P < 0.0001).

DANAMI-2: Primary Endpoints within 30 Days (n = 1,572)
 
Fibrinolysis
PCI
P value
Death
7.6 %
6.6 %
0.35
Reinfarction
6.3 %
1.6 %
< 0.0001
Disabling Stroke
2.0 %
1.1 %
0.15
Combined
13.7 %
8.0 %
0.0003

For patients enrolled at the referral hospitals only, results also favored transport to intervention over immediate thrombolysis. The cumulate event rate at 30 days was 8.5% for intervention and 14.2% for thrombolysis (P = 0.002).

The finding was the same for the 443 patients enrolled directly at the invasive centers, albeit not as significant, probably due to the low number of patients in this arm. Investigators stopped the DANAMI study before completing planned enrollment at the invasive centers. They stopped the study because they enrolled enough patients in the referral hospitals to determine whether transport for intervention was preferable to thrombolysis.

Transport appears safe. There were no deaths or intubations during transport. Incidence of atrial fibrillation, ventricular tachycardia and ventricular fibrillation were 2.5%, 0.2% and 1.4%, respectively. Mean transport distance was 35 miles.

These new findings confirm previous trial results suggesting primary PCI, in an invasive center, is superior to thrombolysis. The DANAMI study adds more to the discussion. It shows that transporting patients from a referral hospital to an invasive center does not obviate the benefit of the intervention vs. thrombolysis.


Reporter: Andrew Bowser