Kl. Neuhaus et al., IMPROVED THROMBOLYSIS IN ACUTE MYOCARDIAL-INFARCTION WITH FRONT-LOADED ADMINISTRATION OF ALTEPLASE - RESULTS OF THE RT-PA APSAC PATENCY STUDY (TAPS), Journal of the American College of Cardiology, 19(5), 1992, pp. 885-891
Thrombolysis with recombinant tissue-type plasminogen activator (rt-PA
) and anisoylated plasminogen streptokinase activator (APSAC) in myoca
rdial infarction has been proved to reduce mortality. A new front-load
ed infusion regimen of 100 mg of rt-PA with an initial bolus dose of 1
5 mg followed by an infusion of 50 mg over 30 min and 35 mg over 60 mi
n has been reported to yield higher patency rates than those achieved
with standard regimens of thrombolytic treatment. The effects of this
front-loaded administration of rt-PA versus those obtained with APSAC
on early patency and reocclusion of infarct-related coronary arteries
were investigated in a randomized multicenter trial in 421 patients wi
th acute myocardial infarction. Coronary angiography 90 min after the
start of treatment revealed a patent infarct-related artery (Thromboly
sis in Myocardial Infarction [TIMI] grade 2 or 3) in 84.4% of 199 pati
ents given rt-PA versus 70.3% of 202 patients given APSAC (p = 0.0007)
. Early reocclusion within 24 to 48 h was documented in 10.3% of 174 p
atients given rt-PA versus 2.5% of 163 patients given APSAC. Late reoc
clusion within 21 days was observed in 2.6% of 152 patients given rt-P
A versus 6.3% of 159 patients given APSAC. There were 5 in-hospital de
aths (2.4%) in the rt-PA group and 17 deaths (8.1%) in the APSAC group
(p = 0.0095). The reinfarction rate was 3.8% and 4.8%, respectively.
Peak serum creatine kinase and left ventricular ejection fraction at f
ollow-up angiography were essentially identical in both treatment grou
ps. There were more bleeding complications after APSAC (45% vs. 31%, p
= 0.0019). Two intracranial hemorrhages (0.9%) occurred in each group
; one of these (in the APSAC group) was fatal. Front-loaded administra
tion of 100 mg of rt-PA yields a significantly higher early patency ra
te of the infarct-related artery in comparison with that achieved with
APSAC. Although more early reocclusions occur after rt-PA than after
APSAC treatment, hospital reinfarction rates are similar. The statisti
cally significant difference in hospital mortality between the two pat
ient groups needs to be confirmed by a further trial with mortality as
a primary end point.