The Pipeline embolization device (PED) is commonly used to treat cerebral aneurysms, including off-label uses. The authors compared the efficacy and safety of PED use in on-label and off-label aneurysm therapies in a study. Patients who underwent PED placement at a high-volume academic medical center had their clinical and angiographic data collected retrospectively. Treatments were classed as on-label if they fit within the allowed applications by the US Food and Drug Administration as of 2021. All recorded outcomes were aneurysm occlusion, procedural complications, ischemic events, in-stent stenosis, cerebral hemorrhage, postprocedural functional status, and death.
Researchers used PED to treat 416 aneurysms in 330 patients, with 256 aneurysms receiving on-label treatment and 160 aneurysms receiving off-label treatment. On-label aneurysms had a 76.4% complete aneurysm occlusion rate, while off-label aneurysms had a 75.6% complete occlusion rate (P=0.898). The risk of ischemic stroke was 15.2% in patients who received off-label therapies, compared to 4.2% in those who received on-label treatments (P=0.003). The on-label and off-label groups had similar clinical problems, procedural issues, and long-term functional status. Off-label use of PED is frequent in real-world practice and can achieve equal efficacy as on-label use. On the other hand, they found off-label usage to increase the risk of ischemic problems in the long run. These findings illustrate specialists’ size and general feasibility of off-label PED usage while paying careful regard to safety and individual patient features.
