Use of a p64 MW Flow Diverter with Hydrophilic Polymer Coating (HPC) and Prasugrel Single Antiplatelet Therapy for the Treatment of Unruptured Anterior Circulation Aneurysms: Safety Data and Short-term Occlusion Rates

Abstract

Purpose: To assess the safety and short-term occlusion rates in procedures using the p64 MW hydrophilic polymer-coated (HPC) flow diverter (FD) with prasugrel single antiplatelet therapy (SAPT) for the treatment of anterior circulation saccular aneurysms.

Methods: We retrospectively identified patients who underwent treatment of one or more intracranial anterior circulation saccular aneurysms between March 2020 and December 2021 with a p64 MW HPC FD and prasugrel SAPT with verified P2Y12 platelet receptor inhibition. Patients diagnosed with fusiform, dissecting, or recently ruptured aneurysms were excluded. Periprocedural and postprocedural complications, clinical outcomes, and angiographic follow-up results were evaluated.

Results: One hundred and two patients with 132 intracranial aneurysms met the inclusion criteria. Previous or concomitant treatments (e.g., coil occlusion) had been performed on 18 of these aneurysms. The technical success rate (i.e., implantation of the intended FD) was 100% with an average of 1.1 devices implanted per patient. Periprocedural and postprocedural complications occurred in 13.6% and 6.8% of these patients, respectively. No mortality or permanent clinical deterioration (i.e., modified Rankin scale score ≥ 3) were reported. Early follow-up digital subtraction angiography revealed aneurysmal occlusion rates of 72.6% and 83.8% at four and nine months, respectively.

Conclusions: The implantation of a p64 MW HPC FD with prasugrel SAPT is safe and results in rapid, reliable and effective aneurysmal occlusion.

Keywords: Aneurysm; Anti-thrombogenic coating; Flow diverter; Prasugrel; Single antiplatelet therapy.

Conflict of interest statement

VH has a consultancy agreement with the BALT Group; EH has a consulting agreement with phenox GmbH; HH is co-founder and shareholder of phenox GmbH; all other authors report no conflict of interest.

© 2022. The Author(s).

Figures

Fig. 1

Digital subtraction angiography (DSA). a–d DSA imaging of an aneurysm of the supraclinoid segment of the left internal carotid artery (ICA). a Lateral projection prior to placement of a flow diverter (FD). b Lateral projection after deployment of a 3/15 mm p64 MW HPC; left, a non-contrast-enhanced image demonstrating complete opening of the FD and right, contrast-enhanced image after deployment of the FD showing complete coverage of the aneurysm neck. Follow-up (FU) angiography at c 39 days and d 251 days postprocedure. The lateral view documents the complete occlusion of the aneurysm (OKM D). In panels b–d, the distal and proximal ends of the FD are indicated by the black and blue arrows, respectively. e–i DSA imaging of a large symptomatic aneurysm of the cavernous segment of the right ICA and a small aneurysm at the origin of the choroidal artery. e Posterior-anterior projection before placement of the first FD. (f) Lateral (non-contrast-enhanced) image and anterior–posterior projection after deployment of a 3.5/21 mm p64MW HPC FD (black arrows indicating the ends of the device). g FU angiography at 56 days postprocedure revealed the complete occlusion of the cavernous aneurysm (OKM D) (black arrows indicating the ends of the FD device; the small aneurysm at the choroidal segment of the ICA is as indicated by the red arrow). h This lesion was treated in the same session with a 4/12 mm p64 MW HPC FD (blue arrows indicating the ends of the second FD; non-contrast-enhanced lateral view after the deployment of a second FD). i FU angiography at 91 days postprocedure with a lateral view that revealed complete occlusion of both aneurysms (OKM D) with mild intimal hyperplasia in the distal FD (blue arrows at the ends of the distal FD and a black arrow indicating the distal end of the proximal FD; the proximal end of this latter FD is not shown in this picture)

Fig. 2

Progressive increase in aneurysmal occlusion over time. Occlusion was evaluated (a) overall, and for (b) ICA aneurysms; (c) MCA aneurysms; (d) MCA bifurcation aneurysms; (e) ACA aneurysms; and (f) AcomA aneurysms. FU, follow-up; OKM, O'Kelly-Marotta; ICA, internal carotid artery; MCA, middle cerebral artery; ACA, anterior cerebral artery; AcomA, anterior communicating artery

Fig. 2

Progressive increase in aneurysmal occlusion over time. Occlusion was evaluated (a) overall, and for (b) ICA aneurysms; (c) MCA aneurysms; (d) MCA bifurcation aneurysms; (e) ACA aneurysms; and (f) AcomA aneurysms. FU, follow-up; OKM, O'Kelly-Marotta; ICA, internal carotid artery; MCA, middle cerebral artery; ACA, anterior cerebral artery; AcomA, anterior communicating artery