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Thrombolytic therapy vs primary percutaneous coronary intervention for myocardial infarction in patients presenting to hospitals without on-site cardiac surgery: a randomized controlled trial.

CONTEXT
Trials comparing primary percutaneous coronary intervention (PCI) and thrombolytic therapy for treatment of acute myocardial infarction (MI) suggest primary PCI is the superior therapy, although they differ with respect to the durability of benefit. Because PCI is often limited to hospitals that have on-site cardiac surgery programs, most acute MI patients do not have access to this therapy.


OBJECTIVE
To determine whether treatment of acute MI with primary PCI is superior to thrombolytic therapy at hospitals without on-site cardiac surgery and, if so, whether superiority is durable.


DESIGN
The Atlantic Cardiovascular Patient Outcomes Research Team (C-PORT) trial, a prospective, randomized trial conducted from July 1996 through December 1999.


SETTING
Eleven community hospitals in Massachusetts and Maryland without on-site cardiac surgery or extant PCI programs.


PATIENTS
Four hundred fifty-one thrombolytic-eligible patients with acute MI of less than 12 hours' duration associated with ST-segment elevation on electrocardiogram.


INTERVENTIONS
After a formal primary PCI development program was completed at all sites, patients were randomly assigned to receive primary PCI (n = 225) or accelerated tissue plasminogen activator (bolus dose of 15 mg and an infusion of 0.75 mg/kg for 30 minutes followed by 0.5 mg/kg for 60 minutes; n = 226). After initiation of assigned treatment, all care was determined by treating physicians.


MAIN OUTCOME MEASURES
Six-month composite incidence of death, recurrent MI, and stroke; median hospital length of stay.


RESULTS
The incidence of the composite end point was reduced in the primary PCI group at 6 weeks (10.7% vs 17.7%; P =.03) and 6 months (12.4% vs 19.9%; P =.03) after index MI. Six-month rates for individual outcomes were 6.2% vs 7.1% for death (P =.72), 5.3% vs 10.6% for recurrent MI (P =.04), and 2.2% vs 4.0% for stroke (P =.28) for primary PCI vs thrombolytic therapy, respectively. Median length of stay was also reduced in the primary PCI group (4.5 vs 6.0 days; P =.02).


CONCLUSIONS
Compared with thrombolytic therapy, treatment of patients with primary PCI at hospitals without on-site cardiac surgery is associated with better clinical outcomes for 6 months after index MI and a shorter hospital stay.