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Circulation, Vol 86, 1400-1406, Copyright © 1992 by American Heart Association
SG Ellis, MR Mooney, BS George, EE da Silva, JD Talley, WH Flanagan and EJ Topol
BACKGROUND. After thrombolytic therapy for patients with acute myocardial
infarction (MI), percutaneous transluminal coronary angioplasty (PTCA) is
frequently performed because of the presence of a "significant" infarct
vessel stenosis demonstrated at predischarge coronary angiography. Several
studies have shown PTCA performed early after thrombolysis to be
unnecessary or even harmful. However, PTCA in these trials was generally
performed 1-3 days after MI, when the milieu in the infarct artery may be
unsuited for PTCA, and the incidence of major ischemic complications was
high. To date, no trial has assessed whether delayed PTCA (4-14 days)
should be performed in patients without evidence of ischemia on stress
testing. METHODS AND RESULTS. To test the hypothesis that delayed PTCA
might provide clinical benefit compared with medical therapy alone, 87
patients treated within 6 hours of chest pain onset with thrombolytic
therapy and with negative functional test were randomized between PTCA to
be performed 4-14 days after MI versus no PTCA. Both groups received
medical therapy. Patients with postinfarct angina or prior Q wave
infarction in the infarct distribution were excluded. The primary study end
point was increase in left ventricular ejection fraction with exercise
measured by radionuclide studies 6 weeks after MI, a parameter known from
other studies to correlate inversely with future ischemic events. Clinical
outcome was also monitored for 12 months. There were no differences between
the study groups for any prerandomization variable recorded. Mean age was
57 +/- 10 years, 84% of patients were male, 21% had prior MI, 36% had
anterior MI, 7% had multivessel disease, and the infarct stenosis measured
70 +/- 17% before randomization. PTCA was successful in 38 of 42 patients
(88%) but resulted in non-Q wave MI due to acute closure of the treated
site in three of 42 (9.5%). There was no difference in 6-week resting
ejection fraction or increase in ejection fraction with exercise between
the two groups (47 +/- 12% and 6 +/- 8%, respectively, in the PTCA group;
49 +/- 10% and 5 +/- 9% in the no-PTCA group; p = NS for both.) There were
no deaths in either group. Actuarial 12-month infarct-free survival was
97.8% in the no-PTCA group and 90.5% in the PTCA group (p = 0.07).
CONCLUSIONS. There was no functional or clinical benefit from routine late
PTCA after MI treated with thrombolytic therapy in this relatively low-risk
cohort of patients. These data strongly suggest that patients with an
uncomplicated MI after thrombolytic therapy, even if they have a
"significant" residual stenosis of the infarct vessel, should be treated
medically if they are without evidence of ischemia on stress testing before
hospital discharge.
ARTICLES
Randomized trial of late elective angioplasty versus conservative management for patients with residual stenoses after thrombolytic treatment of myocardial infarction. Treatment of Post-Thrombolytic Stenoses (TOPS) Study Group
Department of Cardiology, Cleveland Clinic Foundation, Ohio 44195-5066.
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