An artificial intelligence (AI)-based approach to clinical trial recruitment: The impact of Viz RECRUIT on enrollment in the EMBOLISE trial

Background EMBOLISE (NCT 04402632) is an ongoing randomized controlled trial investigating the safety and efficacy of middle meningeal artery embolization for the treatment of subacute or chronic subdural hematoma (SDH). Viz RECRUIT SDH is an artificial intelligence (AI)-based software platform that can automatically detect SDH in noncontrast computed tomography (NCHCT) images and report the volume, maximum thickness, and midline shift. We hypothesized that the mobile recruitment platform would aid enrollment and coordinate communication and image sharing among the entire research team. Materials and methods Patient enrollment in EMBOLISE prior to and after implementation of Viz RECRUIT SDH at a large comprehensive stroke center was compared along with the performance of the software platform. The EMBOLISE trial was activated on May 5, 2021, and Viz RECRUIT SDH was activated on October 6, 2021. The pre-AI cohort consisted of all patients from EMBOLISE to AI activation (153 days), and the post-AI cohort consisted of all patients from AI activation until August 18, 2022 (316 days). All alerts for suspected SDH candidates were manually reviewed to determine the positive predictive value (PPV) of the algorithm. Results Prior to AI-software implementation, there were 5 patients enrolled (0.99 patients/month) and one screen failure. After the implementation of the software, enrollment increased by 36% to 1.35 patients/month (14 total enrolled), and there were no screen failures. Over the entire post-AI period, a total of 6244 NCHCTs were processed by the system with 207 total SDH detections (3% prevalence). 35% of all alerts for suspected SDH were viewed within 10 min, and 50% were viewed within an hour. The PPV of the algorithm was 81.4 (CI [75.3, 86.7]). Conclusion The implementation of an AI-based software for the automatic screening of SDH patients increased the enrollment rate in the EMBOLISE trial, and the software performed well in a real-world, clinical trial setting

Abstract Number ‐ 187: Short‐term Clinical Outcomes Amongst Patients On Anticoagulation and DAPT Who Underwent Stenting and Mechanical Thrombectomy

Introduction Dual antiplatelet therapy has long been established as the preferred treatment option for patients with intracranial or extracranial stenting. Anticoagulation is the preferred treatment option for patients at high risk of stroke with embolic risk factors. There is no data currently available analyzing patients presenting with acute ischemic stroke on anticoagulation who require an intracranial and or extracranial stent (IC/EC), requiring DAPT and anticoagulation with mechanical thrombectomy. Our objective is toinvestigate differences in recanalization and outcomes as well as safety of DAPT and AC in the setting of AIS post MT with stenting when compared to patients without AC. Methods A retrospective search at a large comprehensive stroke center was conducted and data was analyzed from 2013 to 2022. Patients presenting with AIS on AC who had MT and required IC/EC stent were selected and compared to patients not on AC. Outcomes were measured as symptomatic ICH and mortality. Patient demographics, stroke risk factors and stroke severity were abstracted amongst other variables. Results There were 301 patients out of 917 (42.9% Female) who presented with anticoagulation use prior to mechanical thrombectomy requiring ic/ec stent placement and DAPT therapy. See Table 1 for baseline demographics. Symptomatic ICH was seen in 24 (7.9%) compared to 50 (8.1%), Odds ratio 0.86/ p‐value = 0.573, Mortality was seen in 51 (16.9%) patients who received DAPT and a/c compared to 129 (20.9%) (OR 0.67) p = 0.028. Logistic regression model did not show any significant difference (See Table 2). Conclusions There was no statistical difference in symptomatic ICH in acute ischemic stroke patients treated with mechanical thrombectomy and acute stenting on anticoagulation when compared to those without anticoagulation. There was statistical difference in mortality and DAPT/AC actually had lower mortality rates. This data suggests that performing intracranial and extracranial stenting in the acute stroke setting while on anticoagulation and adding DAPT is safe. A larger multicenter study with longer follow up is needed to further confirm these findings

Abstract 169: Antiplatelet regimens after pseudoaneurysm embolization with phosphorylcholine coated flow diverters: a series of 180 cases

Introduction Indications for flow diversion for the treatment of cerebral aneurysms have increased remarkably in recent years.1 This has been particularly useful for aneurysms that are difficult to treat via endosaccular or open approaches, such as pseudoaneurysms.2 Flow diversion, however, typically requires dual antiplatelet therapy (DAPT), which can contribute to greater morbidity particularly in patients with ruptured aneurysms or other comorbidities.3 The third‐generation iteration of the Pipeline Embolization Device (PED) incorporates Shield technology, a phosphorylcholine coating designed to reduce thrombogenicity via mimicry of native cell membranes.4 In light of this reduced thrombogenicity, there have been reports of early transition to single antiplatelet therapy (SAPT), or other variations on DAPT, in patients treated with PED Shield. We therefore aim to characterize the antiplatelet regimens, and associated thromboembolic/hemorrhagic outcomes, utilized in patients with aneurysms treated with PED Shield. Methods Factors including demographics, comorbidities, rupture status, devices placed, and antiplatelet regimen, among others, were collected. Follow‐up data including aneurysm thromboembolic complication, hemorrhagic complication, new neurological deficit, aneurysm occlusion, and in‐stent thrombosis were also recorded. Results One‐hundred and eighty patients were included in analysis, 18 of which were acutely ruptured. One hundred and sixty‐two patients had a single device placed, while the remaining had two devices placed. Three patients were maintained on SAPT post‐procedurally (aspirin or clopidogrel), with two additional patients treated with SAPT plus an anticoagulant for other purposes. One hundred and seventy‐two patients were maintained on DAPT, most commonly aspirin/clopidogrel (115), followed by aspirin/ticagrelor (40), and aspirin/prasugrel (16). Seven patients had strokes of any kind, three of which were unrelated to the treatment territory, and two of the remaining 4 were non‐compliant with antiplatelet therapy. One patient had a new intraparenchymal hemorrhage, but no appreciable deficit. Of the 135 patients with 6‐month follow‐up, 77 had complete aneurysm occlusion, and 116 demonstrated no in‐stent thrombosis. Conclusion We demonstrate herein the similar safety profile and efficacy of PED Shield with varying antiplatelet regimens, including SAPT in isolated cases