Effect of systemic urokinase infusion after lower limb percutaneous transluminal angioplasty on limb salvage rate in patients with late-stage critical limb ischemia.

OBJECTIVE

To evaluate the effect of systemically administered urokinase (UK) after percutaneous transluminal angioplasty with or without stent (PTA ± stent) on the reduction in the rate and level of amputation in patients with critical limb ischemia (CLI) with tissue loss.

METHODS

This was an observational, nonrandomized, retrospective study of 183 Taiwanese patients with Rutherford stage 5 or 6, and Fontaine stage 4 lower extremity CLI. Patients received either PTA ± stent or PTA ± stent + UK infusion (250,000 IU, daily for 5 days). PTA of the iliac, femoral, anterior tibial artery, posterior tibial artery, and peroneal arteries was included. Amputation was classified as minor, with direct wound healing, and minor amputation or surgical debridement of toes and major, with below- (BKA) and above-knee amputation (AKA).

RESULTS

In groups of patients with comparable baseline characteristics, 85 and 90 patients received PTA ± stent and PTA ± stent + UK, respectively. There were 24 major limb amputations performed. A significant majority (20/24 (83.3%) were performed in patients who did not receive adjuvant urokinase, compared with 4/24 (16.7%) of patients who did receive urokinase (p = 0.000287). There was a significant increase in the limb salvage rate for infrapopliteal lesions in patients treated with PTA + UK (12/72 with UK; 60/72 without UK; p ≤ .0001). Intracranial hemorrhage (n = 1) and bleeding at the inguinal puncture site (n = 2) were reported in the PTA ± stent + UK group. Eight deaths (one in the PTA ± stent + UK group; seven in the PTA ± stent) occurred during the study.

CONCLUSION

Systemic administration of UK with the PTA ± stent procedure may reduce the requirement for major amputation in patients with CLI with tissue loss (Rutherford 5 or 6). The difference is more pronounced in patients undergoing infrapopliteal interventions. However, these findings need to be confirmed in a randomized prospective study.