Adjunctive thrombolytic therapy during angioplasty for ischemic rest angina. Results of the TAUSA Trial. TAUSA Investigators. Thrombolysis and Angioplasty in Unstable Angina trial.
BACKGROUND
Acute closure is increased after angioplasty in unstable angina, and adjunctive intracoronary thrombolytic therapy has been used successfully to increase angiographic success. The role of prophylactic thrombolytic therapy during angioplasty in unstable angina is unknown.


RESULTS
Four hundred sixty-nine patients with ischemic rest pain with or without a recent (< 1 month) infarction were randomized in double-blind fashion to intracoronary urokinase or placebo. Randomization was carried out in two sequential phases. In phase I, 257 patients were randomized to 250,000 U of urokinase or placebo given in divided doses at the time of angioplasty. In phase II, 212 patients were randomized to 500,000 U of urokinase or placebo in divided doses. All patients were pretreated with aspirin, and activated clotting times were followed to maintain them at > 300 seconds during angioplasty. Angiographic end points of thrombus after angioplasty were insignificantly decreased by urokinase (30 [13.8%] versus 41 [18.0%] with placebo; P = NS). Acute closure, on the other hand, was increased with urokinase (23 [10.2%] versus 10 [4.3%] with placebo; P < .02). The difference in acute closure between urokinase and placebo was more striking at the higher dose of urokinase (P < .04) than in phase I at the lower urokinase dose (P = NS). Adverse in-hospital clinical end points (ischemia, infarction, or emergency coronary artery bypass surgery) were also increased with urokinase versus placebo (30 [12.9%] versus 15 [6.3%], respectively; P < .02). Angiographic and clinical end points were worse with urokinase in unstable angina without recent infarction than with angioplasty after a recent infarction.


CONCLUSIONS
Adjunctive urokinase given prophylactically during angioplasty for ischemic rest angina as administered in this trial is associated with adverse angiographic and clinical events. These detrimental effects may be related to hemorrhagic dissection, lack of intimal sealing, or procoagulant or platelet-activating effects of urokinase.
Department of Medicine, Mount Sinai Medical Center, New York, NY 10029.
J A
JA
Ambrose
O D
OD
Almeida
S K
SK
Sharma
S R
SR
Torre
J D
JD
Marmur
D H
DH
Israel
D E
DE
Ratner
M B
MB
Weiss
C E
CE
Hjemdahl-Monsen
R K
RK
Myler
D000789:Angina, Unstable / Q000150:complications / Q000628:therapy*; D015906:Angioplasty, Balloon, Coronary; D003323:Coronary Aneurysm / Q000209:etiology; D017023:Coronary Angiography; D003326:Coronary Circulation; D003328:Coronary Thrombosis / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D009203:Myocardial Infarction / Q000150:complications; D011183:Postoperative Complications; D012008:Recurrence; D012086:Reoperation; D015912:Thrombolytic Therapy; D014568:Urokinase-Type Plasminogen Activator / Q000627:therapeutic use
D014568:Urokinase-Type Plasminogen Activator