Lytic Infusion versus Bolus Therapy for Peripheral Arterial Thrombosis Management: The LIBRA Pilot Study.

ABSTRACT

Objective: To compare two intra-arterial catheter-directed thrombolysis (CDT) techniques (bolus vs infusion) with respect to clinical outcomes and resource utilization in the management of peripheral arterial thrombosis. Methods: In a retrospective single-center study, 20 consecutive patients with acute or sub-acute thrombosis received tissue plasminogen activator (tPA) treatment administered either as a bolus via an irrigating balloon catheter (CDT-CLEARWAY group; n=10) or as a bolus followed by a continuous infusion using a traditional infusion catheter (CDT-INFUSION; n=10). Adjunctive therapies were administered at the discretion of the operator. Patients were followed for 30 days post-intervention for complications and major adverse clinical events. Results: All 20 patients (12 men; median age 71) had Rutherford clinical stages 4-6 at presentation. Procedural success was achieved in all cases. The mean tPA amount required was reduced in the CDT-CLEARWAY group (8.9 mg vs 32.9 mg), as was the mean time to patency (2.2 hrs vs 16 hrs, P<.001). There were no bleeding complications in the CDT-CLEARWAY group while one patient in the CDT-INFUSION developed intracranial and gastrointestinal hemorrhage. The CDT-CLEARWAY procedure was associated with a significant reduction in mean length of hospital stay (2.2 vs. 5.6 days, P<.001) and mean total cost, which were mostly due to the lack of ICU requirement for the CDT-CLEARWAY group. More patients in the CDT-CLEARWAY group (7/10 patients vs. 1/10 patients) underwent adjunctive thrombectomy procedures following disruption of the thrombus in the target vessel. Conclusion: Significant reductions in total cost, amount of tPA used, and hospital stay were accomplished using a bolus dose of thrombolytic therapy through an irrigating balloon catheter versus a maintenance infusion dose through a standard infusion catheter, while maintaining the efficacy in restoring flow in target vessels.