Trial of iloprost versus aspirin treatment for critical limb ischaemia of thromboangiitis obliterans. The TAO Study

Lancet. 1990 Mar 10;335(8689):555-7. doi: 10.1016/0140-6736(90)90346-7.

Abstract

152 patients with thromboangiitis obliterans (Buerger's disease) and pain from critical leg ischaemia were randomly allocated to receive iloprost, a chemically stable prostacyclin analogue, or low-dose aspirin, for 28 days in a double-blind trial. On review, 19 patients did not fulfil the stringent entry criteria. Of the other 133 patients, 98 also had leg ulcers. After 21-28 days, 58 (85%) of 68 iloprost-treated patients showed ulcer healing or relief of ischaemic pain, compared with 11 (17%) of 65 in the aspirin-treated group. 43 (63%) on iloprost treatment had complete relief of pain, compared with 18 (28%) on aspirin. Ulcers healed completely in 18 of 52 (35%) who received iloprost compared with 6 of 46 (13%) who received aspirin. 6 months after the start of treatment, the response rate was 45 of 51 (88%) patients treated with iloprost compared with 12 of 44 (21%) patients treated with aspirin.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Amputation
  • Anti-Arrhythmia Agents / administration & dosage
  • Anti-Arrhythmia Agents / adverse effects
  • Anti-Arrhythmia Agents / therapeutic use*
  • Arm / blood supply*
  • Aspirin / administration & dosage
  • Aspirin / adverse effects
  • Aspirin / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Evaluation
  • Epoprostenol / administration & dosage
  • Epoprostenol / adverse effects
  • Epoprostenol / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Iloprost
  • Ischemia / drug therapy*
  • Ischemia / etiology
  • Leg / blood supply*
  • Leg / surgery
  • Middle Aged
  • Multicenter Studies as Topic
  • Randomized Controlled Trials as Topic
  • Thromboangiitis Obliterans / complications*
  • Thromboangiitis Obliterans / surgery

Substances

  • Anti-Arrhythmia Agents
  • Epoprostenol
  • Iloprost
  • Aspirin