Utility of a Power Aspiration-Based Extraction Technique as an Initial and Secondary Approach in the Treatment of Peripheral Arterial Thromboembolism: Results of the Multicenter PRISM Trial.

PURPOSE: To investigate the safety and initial efficacy of XTRACT, a power aspiration-based extraction technique for treatment of peripheral arterial thromboembolism with the use of the Penumbra/Indigo system.

MATERIALS AND METHODS: A total of 79 patients were enrolled: 39 (49.4%) underwent XTRACT as the initial therapy and 40 (50.6%) underwent XTRACT after failed catheter-directed thrombolysis or other mechanical intervention or for removal of distal emboli that occurred during an intervention. Occlusion locations were as follows: 36.7% (n = 29) in the profunda, common, or superficial femoral artery; 35.4% (n = 28) in the popliteal artery; 15.2% (n = 12) in the tibial artery; 7.6% (n = 6) in the peroneal artery; and the remainder in the common iliac (n = 1), external iliac (n = 1), sciatic (n = 1), and brachial (n = 1) arteries.

RESULTS: Complete or near-complete revascularization (Thrombolysis In Myocardial Infarction [TIMI] grade 2/3 flow) was achieved in 87.2% of patients (68 of 78) immediately after the XTRACT procedure and before any other intervention. Successful revascularization was achieved in 79.5% of patients (31 of 39) as an initial treatment and in 92.5% (37 of 40) as salvage or secondary therapy. After additional adjunctive endovascular interventions, TIMI grade 2/3 flow was achieved in 96.2% of patients (76 of 79). Complete thrombus removal and restoration of normal flow (TIMI grade 3) was achieved in 77.2% of patients (61 of 79) after all endovascular treatment was completed. No patients required surgical revascularization. No device-related adverse events occurred.

CONCLUSIONS: XTRACT was safe and effective for revascularization of acute or subacute peripheral arterial occlusions as a primary therapy or as a secondary therapy after other endovascular techniques had failed.