Coronary revascularization after intravenous tissue plasminogen activator for unstable angina pectoris: Results of a randomized, double-blind, placebo-controlled trial

• Published in: The American journal of cardiology Vol. 62; no. 7; pp. 368 - 371
• Main Authors: Topol, Eric J., Nicklas, John M., Kander, Nathan H., Walton, Joseph A., Ellis, Stephen G., Gorman, Laura, Pitt, Bertram
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier Inc 01.09.1988; Elsevier
• Subjects: Angina Pectoris - therapy; Angina, Unstable - drug therapy; Angina, Unstable - surgery; Angina, Unstable - therapy; Angiography; Angioplasty, Balloon; Biological and medical sciences; Blood Transfusion; Blood. Blood coagulation. Reticuloendothelial system; Clinical Trials as Topic; Coronary Angiography; Coronary Artery Bypass; Double-Blind Method; Hemorrhage - etiology; Hemorrhage - therapy; Humans; Injections, Intravenous; Medical sciences; Pharmacology. Drug treatments; Postoperative Complications; Random Allocation; Tissue Plasminogen Activator - therapeutic use; Human; Chemotherapy; Intravenous administration; Placebo; Double blind study; Cardiovascular disease; Plasminogen activator; Angina pectoris; Coronary heart disease; Fibrinolytic
• ISSN: 0002-9149; 1879-1913
• DOI: 10.1016/0002-9149(88)90960-5

To determine the role of intravenous tissue plasminogen activator (t-PA) in unstable angina, it was compared with placebo in a randomized, double-blind trial. Forty patients with angina at rest and provocable ischemia (pacing induced) had baseline coronary angiography, study drug infusion and then repeat angiography at 20 ± 9 hours. All patients received diltiazem, nitrates, β blockers, aspirin and intravenous heparin. During study drug infusion (150 mg over 8 hours), refractory ischemia necessitating emergency bypass surgery (CABG) or coronary angioplasty (PTCA) occurred in 4 of 20 t-PA patients compared with 1 of 20 placebo patients (p = 0.21). Before discharge, revascularization for persistent, provocable ischemia and a residual stenosis ≥ 60% was as follows: t-PA patients, 8 PTCA and 7 CABG; placebo patients, 11 PTCA and 8 CABG (p = 0.39). Quantitative angiographic percent diameter stenosis of the culprit artery at baseline and follow-up was: t-PA 71 ± 17 and 63 ± 22; placebo 70 ± 19 and 67 ± 22 (difference not significant). However, 3 t-PA patients compared with no placebo patients demonstrated an insignificant (< 60% diameter) residual stenosis and averted PTCA (p = 0.14). There were no complications of PTCA in the 8 t-PA patients; in contrast, 3 of 11 placebo patients had abrupt closure, necessitating emergency CABG in 2 (p = 0.23). Thus, intravenous t-PA in unstable angina can eliminate the need for PTCA in a few patients, does not appear to decrease the overall or emergency rate of revascularization procedures and may facilitate the safety of PTCA.