Effects of delivering recombinant tissue plasminogen activator on a new infusion system during endovascular intervention in patients with lower limb ischemia

Abstract

Background: To evaluate the feasibility and effects of recombinant tissue plasminogen activator (rt-PA) delivered by a new infusion system during endovascular intervention therapy in patients who had limb ischemia within 6 months.

Methods: From November 2006 to December 2010, 103 consecutive patients were randomly distributed in two groups. 10 mg (group A) and 5 mg (group B) bolus of rt-PA was respectively injected into the proximal occlusive lesion by a new infusion system. Subsequently, additional rt-PA of 10 mg (group A) and 5 mg (group B) was injected into the thrombotic occlusion, respectively. Significant underlying lesions were treated by endovascular intervention or surgery. Rates of major and minor complication, procedural success, and clinical success were evaluated statistically.

Results: Rates of complete lysis and partial lysis success were 12.6% (13 of 103) and 87.4% (90 of 103), respectively. To treat underlying lesions, 84.5% (84 of 103) patients received balloon angioplasty/stent implantation and 4.9% (5 of 103) patients received surgical correction. After final definitive treatment, procedural success rate was up to 99% (102 of 103) and clinical success rate was 100%. Comorbidity conditions and patient characteristics did not statistically influence the rates of success and complication. During the follow-up period of 30-day, 6-, 12- month, there was no statistical difference in the amputation-free survival rates between these two groups.

Conclusion: It is safe and effective to treat lower limb ischemia by combining adjunctive endovascular intervention with bolus of rt-PA (10 to 20 mg) given by a new infusion system. But long-term effects of thrombolysoangioplasty therapy in treating lower limb ischemia must be confirmed by large-scale population studies before routine use.