Primary angioplasty versus prehospital fibrinolysis in acute myocardial infarction: a randomised study.
BACKGROUND
Although both prehospital fibrinolysis and primary angioplasty provide a clinical benefit over in-hospital fibrinolysis in acute myocardial infarction, they have not been directly compared. Our aim was to find out whether primary angioplasty was better than prehospital fibrinolysis.


METHODS
We did a randomised multicentre trial of 840 patients (of 1200 planned) who presented within 6 h of acute myocardial infarction with ST-segment elevation, initially managed by mobile emergency-care units. We assigned patients to prehospital fibrinolysis (n=419) with accelerated alteplase or primary angioplasty (n=421), and transferred all to a centre with access to emergency angioplasty. Our primary endpoint was a composite of death, non-fatal reinfarction, and non-fatal disabling stroke at 30 days. Analyses were by intention to treat.


RESULTS
The median delay between onset of symptoms and treatment was 130 min in the prehospital-fibrinolysis group and 190 min (time to first balloon inflation) in the primary-angioplasty group. Rescue angioplasty was done in 26% of the patients in the fibrinolysis group. The rate of the primary endpoint was 8.2% (34 patients) in the prehospital-fibrinolysis group and 6.2% (26 patients) in the primary-angioplasty group (risk difference 1.96, 95% CI -1.53 to 5.46). 16 (3.8%) patients assigned prehospital fibrinolysis and 20 (4.8%) assigned primary angioplasty died (p=0.61).


CONCLUSIONS
A strategy of primary angioplasty was not better than a strategy of prehospital fibrinolysis (with transfer to an interventional facility for possible rescue angioplasty) in patients presenting with early myocardial infarction.
Bonnefoy
Eric
E
Coronary Care Unit, Hôpital Louis Pradel, Hospices Civils de Lyon, Lyon, France.
Lapostolle
Frédéric
F
Leizorovicz
Alain
A
Steg
Gabriel
G
McFadden
Eugène P
EP
Dubien
Pierre Yves
PY
Cattan
Simon
S
Boullenger
Eric
E
Machecourt
Jacques
J
Lacroute
Jean-Micel
JM
Cassagnes
Jean
J
Dissait
François
F
Touboul
Paul
P
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000706:statistics & numerical data; D002423:Cause of Death; D003131:Combined Modality Therapy; D004632:Emergency Medical Services / Q000706:statistics & numerical data; D005260:Female; D005602:France; D006801:Humans; D008297:Male; D008875:Middle Aged; D008952:Mobile Health Units; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D010043:Outcome and Process Assessment, Health Care; D012008:Recurrence; D015996:Survival Rate; D015912:Thrombolytic Therapy / Q000706:statistics & numerical data; D013996:Time and Motion Studies