Permanent bilateral carotid filters plus oral anticoagulation are being evaluated in the ongoing INTERCEPT trial to determine if they reduce anterior circulation ischemic stroke compared to OAC alone.
RCT (n=2,000)
Open-label
randomized
Yes
Do permanent bilateral carotid filters added to oral anticoagulation reduce anterior circulation ischemic stroke due to large vessel occlusion in patients with atrial fibrillation and recent stroke?
The INTERCEPT trial is an ongoing phase 3 study evaluating the efficacy and safety of permanent bilateral carotid filters for secondary stroke prevention in patients with atrial fibrillation.
Abstract Background and aims Patients with atrial fibrillation (AF) and recent stroke are at increased risk of recurrent ischemic stroke, particularly those with stroke while on oral anticoagulation (OAC). Approximately 90% of strokes in this population occur in the anterior circulation. Permanent bilateral common carotid artery filters designed to capture proximal emboli ≥1.4 mm in length or diameter may reduce stroke (Figure). Methods To investigate whether permanent bilateral carotid filters used in addition to OAC reduce stroke compared to OAC alone. Results INTERCEPT (NCT05723926) is an ongoing, global, phase 3, prospective, open-label, randomized trial with blinded endpoint evaluation. Approximately 2,000 patients with AF and stroke in the preceding year will be randomized to receive or not receive permanent bilateral carotid filters (VineTM, Javelin Medical) deployed percutaneously under ultrasound guidance. All study participants will receive OAC, and those randomized to undergo bilateral carotid filter implantation will receive additional single antiplatelet therapy for 6 months following implantation. The trial is coordinated at World Health Research (Hamilton, Canada). Conclusions The primary efficacy endpoint is anterior circulation ischemic stroke due to large vessel occlusion (90% power to detect a 62% relative risk reduction). The secondary efficacy endpoint is total ischemic stroke (80% power to detect a 30% relative risk reduction). The primary safety endpoints are (1) serious device or procedure related complication and (2) ISTH major bleeding occurring during the first 6 months following randomization. Conflict of interest Figure 1 - belongs to Background and aims
Benz et al. (Fri,) conducted a rct in Atrial fibrillation and recent stroke (n=2,000). Permanent bilateral carotid filters (VineTM) plus OAC vs. OAC alone was evaluated on Anterior circulation ischemic stroke due to large vessel occlusion. Permanent bilateral carotid filters plus oral anticoagulation are being evaluated in the ongoing INTERCEPT trial to determine if they reduce anterior circulation ischemic stroke compared to OAC alone.