Circulation, Vol 83, 1543-1556, Copyright © 1991 by American Heart Association
RM Califf, EJ Topol, RS Stack, SG Ellis, BS George, DJ Kereiakes, JK Samaha, SJ Worley, JL Anderson and L Harrelson-Woodlief
Recent trials of myocardial reperfusion using single-agent thrombolytic
therapy and sequential cardiac catheterization have supported a
conservative approach to the patient with acute myocardial infarction. To
evaluate combination thrombolytic therapy and the role of a previously
untested strategy for the aggressive use of cardiac catheterization, we
performed a multicenter clinical trial with a 3 x 2 factorial design in
which 575 patients were randomly allocated to one of three drug
regimens--tissue-type plasminogen activator (t-PA) (n = 191), urokinase (n
= 190), or both (n = 194) - and one of two catheterization
strategies--immediate catheterization with angioplasty for failed
thrombolysis (n = 287) or deferred predischarge catheterization on days
5-10 (n = 288). Patients with contraindications to thrombolytic therapy,
cardiogenic shock, or age of more than 75 years were excluded. Global left
ventricular ejection fraction was well preserved and almost identical at
predischarge catheterization (54%), regardless of the catheterization or
thrombolytic strategy used (p = 0.98). Combination thrombolytic therapy was
associated with a less complicated clinical course, most clearly documented
by a lower rate of reocclusion (2%) compared with urokinase (7%) and t-PA
(12%) (p = 0.04) and a lower rate of recurrent ischemia (25%) compared with
urokinase (35%) and t-PA (31%). When a composite clinical end point (e.g.,
death, stroke, reinfarction, reocclusion, heart failure, or recurrent
ischemia) was examined, combination thrombolytic therapy was associated
with greater freedom from any adverse event (68%) compared with either
single agent (urokinase, 55%; t-PA, 60%) (p = 0.04) and with a less
complicated clinical course when the composite clinical end points were
ranked according to clinical severity (p = 0.024). Early patency rates were
greater with combination therapy, although predischarge patency rates after
considering interventions to maintain patency were similar among drug
regimens. No difference in bleeding complication rates was observed with
any thrombolytic regimen. The aggressive catheterization strategy led to an
overall early patency rate of 96% and a predischarge patency rate of 94%
compared with a 90% predischarge patency in the conservative strategy (p =
0.065). The aggressive strategy improved regional wall motion in the
infarct region (-2.16 SDs/chord) compared with deferred catheterization
(-2.49 SDs/chord) (p = 0.004). More patients treated with the aggressive
strategy were free from adverse outcomes (67% versus 55% in the
conservative strategy, p = 0.004), and the clinical course was less
complicated when the adverse outcomes were ranked according to severity (p
= 0.016). No significant increase in use of blood products resulted from
the aggressive strategy.(ABSTRACT TRUNCATED AT 400 WORDS)
ARTICLES
Evaluation of combination thrombolytic therapy and timing of cardiac catheterization in acute myocardial infarction. Results of thrombolysis and angioplasty in myocardial infarction--phase 5 randomized trial. TAMI Study Group
Department of Medicine, Duke University Medical Center, Durham, N.C. 27710.
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