Pipeline Flex‐Shield Device Shows Promise for Reducing DAPT Duration in Aneurysm Treatment

Introduction The use of flow‐diverting stents requires dual antiplatelet therapy (DAPT) to prevent thromboembolic complications, though DAPT carries a high risk of hemorrhagic events—reported in 27% of cases in one multicenter study. Newer devices, such as the Pipeline TM Flex Embolization device with‐Shield Technology™, using a synthetic phosphorylcholine polymer to reduce thrombogenicity with minimal surface thickness (<3 nm). In vitro data show significantly lower thrombin generation and platelet activation with PED Shield compared to other devices. This advancement may reduce or eliminate the need for prolonged DAPT. A prospective, single arm, open label EFS was conducted to evaluate the safety and preliminary effectiveness of PED Shield with reduced duration of DAPT (60 days). Methods Ten patients were enrolled and monitored by a DSMB for safety. All received 60 days of DAPT with aspirin (325 mg) and clopidogrel (75 mg); clopidogrel non‐responders (P2Y12 > 200) received ticagrelor (90 mg BID) instead. After 60 days, DAPT will transition to lifelong aspirin monotherapy. Results All treated aneurysms were unruptured internal carotid artery aneurysms, with no periprocedural complications. Six patients were discharged on clopidogrel; all discontinued DAPT at 60 days. At 90 days, all patients underwent digital subtraction angiography, which revealed persistent aneurysms. One‐year follow‐up is pending. Two patients experienced ischemic events—one major stroke and one minor stroke—both of which fully resolved. Conclusion The preliminary results demonstrate early promise for discontinuing DAPT at 60 days following PED Shield placement. The study is now progressing to accelerated enrollment to include a larger cohort and generate more robust evidence supporting early DAPT cessation. In parallel, a separate 30‐day Shield study is underway, aiming to evaluate the safety and feasibility of even earlier DAPT discontinuation.