Circulation, Vol 85, 2090-2099, Copyright © 1992 by American Heart Association
EJ Topol, RM Califf, M Vandormael, CL Grines, BS George, ML Sanz, T Wall, M O'Brien, M Schwaiger and FV Aguirre
BACKGROUND. Experimental and observational clinical studies of acute
coronary occlusion have suggested that late reperfusion prevents infarct
expansion and facilitates myocardial healing. The purpose of this trial was
to assess whether infarct vessel patency could be achieved in late-entry
patients and what benefit, if any, can be demonstrated. METHODS AND
RESULTS. In a double-blind fashion, 197 patients with 6 to 24 hours of
symptoms and ECG ST elevation were randomly assigned to tissue-type
plasminogen activator (100 mg over 2 hours) or placebo. Coronary
angiography within 24 hours was used to determine infarct vessel patency
status. Patients with infarct-related occluded arteries were then eligible
for a second randomization to either angioplasty (34 patients) or no
angioplasty (37 patients). Ventricular function and cavity size were
reassessed at 1 month by gated blood pool scintigraphy and at 6 months by
repeat cardiac catheterization. The primary end point, infarct vessel
patency, was 65% for plasminogen activator patients compared with 27% in
the placebo group (p less than 0.0001). There were no differences between
these groups in ejection fraction or infarct zone regional wall motion at 1
or 6 months. At 6 months, infarct vessel patency was 59% in both groups. In
the placebo group, there was a significant increase in end- diastolic
volume from acute phase of 127 ml to 159 ml at 6-month follow- up (p =
0.006) but no increase in cavity size for the plasminogen activator group
patients. Coronary angioplasty was associated with an initial 81%
recanalization success and improved ventricular function at 1 month, but by
late follow-up no advantage could be demonstrated for this procedure, and
there was a 38% spontaneous recanalization rate in the patients assigned to
no angioplasty. CONCLUSIONS. The study demonstrates that it is possible to
achieve infarct vessel recanalization in the majority of late-entry
patients with either thrombolytic therapy or angioplasty. Thrombolytic
intervention had a favorable effect on prevention of cavity dilatation and
left ventricular remodeling, but there are no late benefits on systolic
function after thrombolysis or coronary angioplasty. The conclusions
concerning overall potential benefit of applying late reperfusion therapy
will require data from large-scale trials designed to assess mortality
reduction.
ARTICLES
A randomized trial of late reperfusion therapy for acute myocardial infarction. Thrombolysis and Angioplasty in Myocardial Infarction-6 Study Group
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195.
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