PRISM Assesses Penumbra’s Indigo Aspiration System to Treat Thromboembolism in the Peripheral Vasculature
September 21, 2016—Richard R. Saxon, MD, presented data from the PRISM trial during the third Late-Breaking Trials session at VIVA 16, the 14th annual Vascular InterVentional Advances meeting, which was sponsored by VIVA Physicians, Inc. and held September 18–22, 2016 at the Wynn Las Vegas in Las Vegas, Nevada.
The PRISM trial is evaluating the Indigo aspiration system (Penumbra, Inc.) for mechanical aspiration thromboembolectomy in the revascularization of peripheral arterial occlusions.
At VIVA 16, Dr. Saxon reported that a total of 85 patients were enrolled in PRISM with 43 patients (50.6%) treated with the Indigo system as the initial therapy. In the other 42 patients (49.4%), thrombolysis or other mechanical intervention was attempted before the study device was used. Vessel patency was determined via angiography before and after the various treatments and at completion of all therapies using the thrombolysis in myocardial infarction (TIMI) score to evaluate efficacy. Study device-related adverse events and periprocedural serious adverse events were documented.
The locations of occlusions were below the knee (n = 46, 54.1%) and in the femoral or superficial femoral arteries (n = 29, 34.1%), with the remainder in the superior mesenteric (n = 3), renal (n = 2), common iliac (n = 1), external iliac (n = 1), sciatic (n = 1), brachial (n = 1), and pulmonary (n = 1) arteries.
TIMI 2 to 3 flow (ie, flow past the lesion to the distal vascular bed or normal flow) was achieved using the study device alone as an initial therapy in 81.4% of patients (n = 43). After additional endovascular interventions, TIMI 2 to 3 flow was recorded in 95.3% of these patients. TIMI 2 to 3 flow was achieved in 92.9% (39/42) of patients who had the study device used as salvage therapy after other endovascular techniques had failed. Overall, complete restoration of flow (TIMI 3) was achieved in 77.6% of patients (n = 66). No device-related adverse events occurred (0%).
Mechanical aspiration thromboembolectomy using the Indigo system is effective for revascularization of peripheral arterial occlusions; the Indigo system was equally effective as a frontline, primary therapy and as a salvage therapy after other endovascular techniques had failed, concluded Dr. Saxon at VIVA 16.