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

Radiology. 2001 Dec;221(3):689-96. doi: 10.1148/radiol.2213010400.


Purpose: 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.

Materials and 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).

Conclusion: 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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Abciximab
  • Adult
  • Aged
  • Aged, 80 and over
  • Angiography, Digital Subtraction
  • Antibodies, Monoclonal / administration & dosage*
  • Antibodies, Monoclonal / adverse effects
  • Arterial Occlusive Diseases / diagnostic imaging
  • Arterial Occlusive Diseases / drug therapy*
  • Drug Therapy, Combination
  • Female
  • Humans
  • Immunoglobulin Fab Fragments / administration & dosage*
  • Immunoglobulin Fab Fragments / adverse effects
  • Leg / blood supply*
  • Male
  • Middle Aged
  • Plasminogen Activators / administration & dosage*
  • Platelet Glycoprotein GPIIb-IIIa Complex / administration & dosage*
  • Prospective Studies
  • Single-Blind Method
  • Survival Analysis
  • Thrombolytic Therapy* / adverse effects
  • Urokinase-Type Plasminogen Activator / administration & dosage*
  • Urokinase-Type Plasminogen Activator / adverse effects


  • Antibodies, Monoclonal
  • Immunoglobulin Fab Fragments
  • Platelet Glycoprotein GPIIb-IIIa Complex
  • Plasminogen Activators
  • Urokinase-Type Plasminogen Activator
  • Abciximab