Peripheral artery occlusion: treatment with abciximab plus urokinase versus with urokinase alone--a randomized pilot trial (the PROMPT Study). Platelet Receptor Antibodies in Order to Manage Peripheral Artery Thrombosis.
OBJECTIVE
To evaluate the combination of a platelet glycoprotein IIb/IIIa complex receptor inhibitor and urokinase for treatment of recent (<or=6 weeks) arterial occlusion of the legs.


METHODS
Seventy patients with lower extremity arterial occlusion of less than 6 weeks duration were randomly separated into two treatment groups: urokinase plus abciximab or urokinase plus placebo. Primary end points were the rate of major complications at 30 days after randomization and the rates of amputation-free survival and survival without open surgery or major amputation at follow-up of 90 days. Two readers unaware of the patients' treatment group assignments analyzed digital subtraction angiograms as they related to the study end points, with a final consensus reading.


RESULTS
Thrombolysis relative to clot length was faster in the urokinase-plus-abciximab group (odds ratio, 0.52; 95% CI: 0.35, 0.76; P < .001). There were no procedure-related deaths or intracranial hemorrhages, but the rate of nonfatal major bleeding was higher with urokinase plus abciximab (four of 50 patients) than with urokinase alone (none of 20 patients; P = .32). At 90 days, amputation-free survival was 96% (48 of 50 patients) in the urokinase-plus-abciximab group compared with 80% (16 of 20 patients) in the urokinase alone group. The hazard ratio for the two Kaplan-Meier curves was 0.42 (95% CI: 0.16, 0.96; P = .04).


CONCLUSIONS
In patients with lower extremity arterial occlusion who were undergoing urokinase thrombolysis, adjunctive abciximab treatment resulted in faster thrombus dissolution and improved amputation-free survival, despite an increase in major bleeding.
Duda
S H
SH
Dept of Diagnostic Radiology, Univ of Tübingen, Germany. stephan.duda@med.uni-tuebingen.de
Tepe
G
G
Luz
O
O
Ouriel
K
K
Dietz
K
K
Hahn
U
U
Pereira
P
P
Marsalek
P
P
Ziemer
G
G
Erley
C M
CM
Claussen
C D
CD
D000077284:Abciximab; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015901:Angiography, Digital Subtraction; D000911:Antibodies, Monoclonal / Q000008:administration & dosage* / Q000009:adverse effects; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage* / Q000009:adverse effects; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010960:Plasminogen Activators / Q000008:administration & dosage*; D019039:Platelet Glycoprotein GPIIb-IIIa Complex / Q000008:administration & dosage*; D011446:Prospective Studies; D016037:Single-Blind Method; D016019:Survival Analysis; D015912:Thrombolytic Therapy / Q000009:adverse effects; D014568:Urokinase-Type Plasminogen Activator / Q000008:administration & dosage* / Q000009:adverse effects
D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D019039:Platelet Glycoprotein GPIIb-IIIa Complex; D010960:Plasminogen Activators; D014568:Urokinase-Type Plasminogen Activator; D000077284:Abciximab