METHODS AND RESULTS: One hundred eighty-three patients suffering from a first acute
myocardial infarction were randomly allocated to either
APSAC (30 units over 5 minutes) or single-chain rt-PA (100 mg over a 3-hour period) within 4 hours of the onset of symptoms. Global and regional left ventricular function were assessed from contrast angiography an average of 5.3 +/- 2.3 days after initial
therapy.
Radionuclide angiography and
thallium-201 single-photon emission computerized tomography were performed before hospital discharge.
Infarct size was assessed by single-photon emission computerized tomography and expressed in percentage of the total myocardial volume. Ninety patients received
APSAC and 93 received rt-PA within a mean period of 172 +/- 52 minutes after the onset of symptoms. The two groups were similar in age, location of the acute
myocardial infarction, Killip class, and time of randomization. The patency rate of the
infarct-related artery was 72% in the
APSAC group and 76% in the rt-PA group (NS). Initial and predischarge left ventricular ejection fraction as well as
infarct size were similar in both therapeutic groups (0.50 +/- 0.14 versus 0.52 +/- 0.12 for initial and 0.48 +/- 0.10 versus 0.47 +/- 0.10 for predischarge ejection fraction, 11 +/- 7% versus 9 +/- 7% for
infarct size, respectively, for
APSAC- and rt-PA-treated patients).
Bleeding complications requiring
blood transfusion occurred in one
APSAC patient and in two rt-PA patients. One patient in the rt-PA group died of a massive
intracranial hemorrhage. At the end of the 3-week follow-up period, five
APSAC patients (5.5%) and seven rt-PA patients (7.5%) had died.
CONCLUSIONS: The early infusion of
APSAC or rt-PA in acute
myocardial infarction produced a similar patency rate, limitation of
infarct size, and preservation of left ventricular systolic function with an equivalent rate of
bleeding complications.