Safety and efficacy of ultra-high-dose, short-term thrombolysis with rt-PA for acute lower limb ischemia

Abstract

Objectives: The evaluation of success and complication rates of ultra high-dose recombinant tissue plasminogen activator (rt-PA) administered over a short time frame in the treatment of acute lower limb ischemia.

Methods: This was a prospective single-center study. The outcome of treatment in 97 patients with acute limb ischemia (<14 days) with the use of catheter directed rt-PA infusion was evaluated. The mean total dose of rt-PA was 54.1 mg (50-60 mg) and was administered for a mean of 2.51 hours (2-4 hours). Thrombolytic success was defined as 95% thrombolysis of an occluded segment with return of antegrade flow. Thirty-day complication and amputation-free survival rates were calculated.

Results: Thrombolytic success was achieved in 83.5%. Overall clinical success was 88.7%. The 30-day amputation-free survival rate was 93.8%. Major bleeding complications occurred in 10 patients (10.3%). There were two deaths (2.1%) and four amputations (4.1%). Long-term amputation-free survival was 70%.

Conclusions: Administration of ultra-high doses of rt-PA over a short time period gives promising results. Such delivery improves patient tolerance by rapid restoration of limb perfusion; however further studies are required to confirm these results.