XTRACT as Potential Frontline Treatment in Peripheral Arterial Thromboembolism-Results from the Multicenter PRISM Trial.
Libby Watch, MD,1, Richard R. Saxon, MD.2, James F. Benenati, MD, FSIR1, Corey Teigen, MD.3, Luke Sewall, MD.4, George L. Adams, MD5.
1Miami Cardiac & Vascular Institute, Miami, FL, USA, 2San Diego Cardiac And Vascular Institute, San Diego Imaging Medical Group, San Diego, CA, USA, 3Department of Interventional Radiology Sanford Health, Fargo, ND, USA, 4Adventist Health Partners, Downers Grove, IL, USA, 5North Carolina Heart And Vascular Research, Raleigh, NC, USA.
The purpose of the trial was to examine the safety and clinical efficacy of XTRACT in a patient population with peripheral arterial occlusion. We report the outcome of the PRISM Trial on the use of Penumbra/Indigo System as an initial and secondary approach for peripheral revascularization.
The PRISM is a single-arm, multicenter and retrospective analysis of enrolled consecutive patients meeting the inclusion criteria of peripheral arterial occlusion (TIMI 0-1) prior to treatment with the Penumbra/Indigo System. The primary endpoints were vessel patency immediately post-procedure as measured by TIMI scores, and the rate of serious adverse events (SAE) within 24h of treatment with the study device.
PRISM concluded with 79 patients enrolled. XTRACT was the primary treatment modality for 39 patients (49.4%), while the remaining 40 patients (50.6%) were treated with XTRACT secondary to failure from CDT, other endovascular therapies, and distal emboli from preceding interventions. Procedural outcome by treatment mode are provided in Table. As primary intervention, XTRACT was successful in 79.5% (31/39) of patients; as secondary therapy, 92.5% (37/40) were successfully revascularized with XTRACT to TIMI 2-3. Overall, vessel patency (TIMI 2-3) was achieved in 87.2% (68/78) immediately after XTRACT, and in 96.2% (76/79) of patients following additional adjunctive interventions. Procedural SAEs were reported in five patients (6.3%); none were device-related.
Treatment for peripheral arterial thromboembolism, such as catheter-directed thrombolysis (CDT) or surgical intervention, face the risks of extended treatment time, incomplete revascularization, and considerable morbidity, in addition to the inherent risk of surgical intervention. The Penumbra/Indigo System offers a consistent power aspiration-based thrombo-embolectomy for effective and safe extraction (XTRACT) of arterial occlusions. Thrombectomy using XTRACT was safe and effective as both primary and secondary intervention in patients with peripheral arterial occlusions.
Table 1. Revascularization outcome by treatment mode.
|Treatment Mode||TIMI 2-3 Post Penumbra/Indigo||TIMI 2-3 Post All Interventions|
|Penumbra/Indigo as initial therapy||79.5% (31/39)||94.9% (37/39)|
|tPA prior to Penumbra/Indigo||91.7% (11/12)||91.7% (11/12)|
|Mechanical thrombectomy prior to Penumbra/Indigo||92.9% (13/14)*||100% (15/15)|
|Both adjunctive tPA + mechanical therapies prior to Penumbra/Indigo||100% (13/13)||100% (13/13)|
|Total||87.2% (74/78)||96.2% (76/79)|
*TIMI score post procedure was unavailable for one patient.
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