Coronary revascularization after intravenous tissue plasminogen activator for unstable angina pectoris: results of a randomized, double-blind, placebo-controlled trial.
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, beta 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 greater than or equal to 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 (less than 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.
Topol
E J
EJ
Department of Internal Medicine, University of Michigan Medical Center, Ann Arbor.
Nicklas
J M
JM
Kander
N H
NH
Walton
J A
JA
Ellis
S G
SG
Gorman
L
L
Pitt
B
B
D000787:Angina Pectoris / Q000628:therapy*; D000789:Angina, Unstable / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D000792:Angiography; D000800:Angioplasty, Balloon; D001803:Blood Transfusion; D002986:Clinical Trials as Topic; D017023:Coronary Angiography; D001026:Coronary Artery Bypass; D004311:Double-Blind Method; D006470:Hemorrhage / Q000209:etiology / Q000628:therapy; D006801:Humans; D007275:Injections, Intravenous; D011183:Postoperative Complications; D011897:Random Allocation; D010959:Tissue Plasminogen Activator / Q000627:therapeutic use*
D010959:Tissue Plasminogen Activator