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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. Herein, we report the outcome of the PRISM Trial on the use of this system as an initial and secondary approach for peripheral revascularization.
The PRISM retrospective case series 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 86.1% (68/79) immediately after XTRACT, and in 96.2% (76/79) of patients following additional adjunctive interventions. Procedural SAEs were reported in seven patients (8.9%); none were device-related.
|Treatment Mode||N||TIMI 2-3 Post Penumbra/Indigo||TIMI 2-3 Post All Interventions|
|Penumbra/Indigo as initial therapy||39||79.5% (31/39)||94.9% (37/39)|
|tPA prior to Penumbra/Indigo||12||91.7% (11/12)||No Change|
|Mechanical thrombectomy prior to Penumbra/Indigo||15||92.9% (13/14)*||100% (15/15)|
|Both adjunctive tPA + mechanical therapies prior to Penumbra/Indigo||13||100% (13/13)||No Change|
|Total||79||87.2% (74/78)||96.2% (76/79)|
Thrombectomy using XTRACT was safe and effective as both primary and secondary intervention in patients with peripheral arterial occlusions.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention