Ultrasound-accelerated versus standard catheter-directed thrombolysis in 102 patients with acute and subacute limb ischemia.

ABSTRACT

PURPOSE: To compare the safety and efficacy of ultrasound-accelerated thrombolysis (UAT) and standard catheter-directed thrombolysis (CDT) in patients with acute and subacute limb ischemia. MATERIALS AND METHODS: Medical records of all patients treated with thrombolysis for acute and subacute limb ischemia between August 2005 and January 2012 were reviewed. Coprimary (increase in ankle-brachial index, degree of lysis) and secondary endpoints (technical success, distal embolization, bleeding complications, need for additional interventions) were assessed. UAT was performed in 75 patients, and CDT was performed in 27 patients. Patients' baseline demographic and clinical parameters and procedure details, including lytic drug infusion rate (P = .704 and P = .987), total infusion time (P = .787 and P = .377), and use of adjunctive procedures (P = .457), did not differ significantly between the two groups. RESULTS: Complete lysis was achieved in 72.0% (UAT) and 63.0% (CDT) of patients (P = .542); hemodynamic success was achieved in 91.8% (UAT) and 92.3% (CDT) (P = .956). Overall major and minor bleeding complications were observed in 6.9% (UAT) and 3.9% (CDT) of patients. Major (P = .075) and minor (P = .276) bleeding independently did not differ between UAT and CDT. Major and minor bleeding combined was lower 6.7% (UAT) versus 22.2% (CDT) (P = .025). Overall target vessel patency after 8.0 months (range, 1.5-20.5 mo) was 73.5%; target vessel patency for UAT was 75.9% versus 64.3% for CDT (P = .379). Median long-term survival was not significantly different between UAT and CDT 3.6 years (range, 2.42-5.33 y) versus 1.8 years (range, 1.33-4.92 y) (P = .061). CONCLUSIONS: Both UAT and CDT are safe and efficient treatment modalities for patients with acute and subacute limb ischemia. The observed lower risk of total bleeding for UAT versus CDT may warrant prospective comparative trials.