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 findout whether primary angioplasty was better than prehospital fibrinolysis. Methods: We did a randomised multicentre trial of 840 patients (of 1200 planned) who presented within 6h 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 reinfartion, and non-fatal disabling stroke at 30 days. Analyses were by intention to treat. Findings: 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 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 fihrinolysis and 20 (4.8%) assigned primary angioplasty died (p=0.61). Interpretation: 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.