Comparative study of on-label versus off-label treatment of intracranial aneurysms with the Pipeline embolization device

Abstract

OBJECTIVE The Pipeline embolization device (PED) is widely used for the treatment of intracranial aneurysms, including in off-label applications. In this work, the authors compared the real-world efficacy and safety of PED use in on-label and off-label aneurysm treatments. METHODS Clinical and angiographic data of patients who underwent PED placement at a high-volume academic medical center were retrospectively obtained. Treatments were classified as on-label if they fell within the applications approved by the United States Food and Drug Administration as of 2021. Recorded outcomes included aneurysm occlusion, procedural complications, ischemic events, in-stent stenosis, intracranial hemorrhage, postprocedural functional status, and death. RESULTS In total, 416 aneurysms in 330 patients were treated with PED, comprising 256 aneurysms that received on-label treatments and 160 that received off-label treatments. The overall rate of complete aneurysm occlusion was 76.4% for on-label aneurysms and 75.6% for off-label aneurysms (p = 0.898). The risk of ischemic stroke in patients who underwent off-label treatments was 15.2%, which was higher than the 4.2% rate in patients who underwent on-label treatment (p = 0.003). All other clinical complications, procedural complications, and long-term functional status were comparable between the on-label and off-label groups. CONCLUSIONS In real-world practice, off-label use of PED is common and can achieve similar efficacy as on-label use. However, in aggregate, off-label use was found to carry an increased rate of ischemic complications. With judicious attention to safety and individual patient characteristics, these results highlight the scale and general feasibility of off-label PED use by experts.

In Reply: Safety and Efficacy of the Off-Label Use of Pipeline Embolization Device Based on the 2018 Food and Drug Administration-Approved Indications for Intracranial Aneurysms: A Single-Center Retrospective Cohort Study

“…There was a mildly higher rate of intracranial hemorrhagic complications for the off-label group (4.7% in our group and 5.7% for the study by Cler et al 4 ) compared with on-label (1.6% and 2.8%, respectively). For both studies, these differences were not significant.…”

“…2 They have recently published their experience, 3 which showed similar results to our published paper detailing the Beth Israel Deaconess Medical Center experience. 4…”

Aneurysm healing after endovascular treatment in the Helsinki sidewall aneurysm model: a systematic review

“…Since their introduction to clinical practice, flow diverters have greatly impacted the endovascular treatment of intracranial aneurysms. These devices are now arguably the standard of care for paraclinoid aneurysms and show promise for the treatment of complex aneurysms at other locations in both the anterior and posterior circulations 32. Flow diverters are less porous than traditional intracranial stents, which facilitates the redirection of blood flow away from the aneurysm and down the parent artery.…”

Parent artery occlusion after pipeline embolization device implantation of intracranial saccular and fusiform aneurysms

“…Since its introduction, the pipeline embolization device (PED; Covidien/Medtronic), alone or with assisted coiling, has gained significant recognition. It has been extensively used for the interventional therapy of intracranial aneurysms (IAs) over the years 1–3. After PED implantation, hemodynamic changes occur in the parent arteries and aneurysmal sacs that facilitate endothelialization across the aneurysmal neck.…”