Purpose: We report the efficacy and safety on a subset analysis of patients with atrial fibrillation in the PRISM trial. This trial examined efficacy and safety of XTRACT (a power aspiration-based extraction technique) using the Penumbra Indigo System (Penumbra, Inc., Alameda, CA) as a frontline and secondary treatment for peripheral arterial occlusions.
Materials and Methods: The PRISM trial was a single-arm, multicenter, retrospective analysis of patients with acute or subacute arterial occlusions who met the inclusion criteria of peripheral arterial occlusion (Thrombolysis in Myocardial Infarction [TIMI] score 0–1). The primary endpoints were vessel patency immediately after XTRACT and after any other subsequent endovascular procedure as measured by TIMI score and the rate of serious adverse events (SAEs) within 24 hours of treatment. Results: PRISM enrolled 79 patients at five sites in the United States. XTRACT was the frontline treatment for 49.4% (39 of 79) of patients, and 50.6% (40 of 79) were treated with XTRACT secondary to failure from catheter-directed thrombolysis and/ or other endovascular therapies. Overall, vessel patency (TIMI 2–3) was achieved in 87.2% (68 of 78) of patients immediately after XTRACT and in 96.2% (76 of 79) of patients after additional adjunctive interventions. In the subgroup analysis of patients with atrial fibrillation (n = 12; 8 women), XTRACT was the frontline treatment for 7 patients (58.3%) and the secondary treatment for 5 patients (41.7%). Vessel patency (TIMI 2–3) was achieved in 71.4% (5 of 7) of patients with XTRACT as the frontline treatment and 100% (5 of 5) of patients with XTRACT as a secondary treatment. Overall, vessel patency (TIMI 2-–3) was achieved in 83.3% (10 of 12) immediately after XTRACT and in 100% (12 of 12) of patients after additional adjunctive interventions. SAEs within 24 hours were reported in 8.9% (7 of 79) patients overall and 8.3% (1 of 12) of patients with atrial fibrillation. None were device related.
Conclusions: The Penumbra Indigo system using XTRACT technique is a safe and effective intervention in atrial fibrillation patients with underlying peripheral arterial occlusions. XTRACT was useful both as a frontline therapy and as a salvage technique when other endovascular techniques or thrombolysis had failed. Future prospective trials are needed.