Background Dolichoectatic vertebrobasilar fusiform aneurysms (DVBFAs) have poor natural history when left untreated and high morbimortality when treated with microsurgery. Flow diversion (FD) with dual-antiplatelet therapy (DAPT) is feasible but carries high risk of perforator occlusion and progression of brainstem compression. Elaborate antithrombotic strategies are needed to preserve perforator patency while vessel remodeling occurs. We compared triple therapy (TT (DAPT plus oral anticoagulation)) and DAPT alone in patients with DVBFAs treated with FD.
Methods Retrospective comparison of DAPT and TT in patients with DVBFAs treated with FD at eight US centers.
Results The groups (DAPT=13, TT=14) were similar in age, sex, clinical presentation, baseline disability, and aneurysm characteristics. Radial access use was significantly higher in the TT group (71.4% vs 15.3%; P=0.006). Median number of flow diverters and adjunctive coiling use were non-different between groups. Acute ischemic stroke rate during the oral anticoagulation period was lower in the TT group than the DAPT group (7.1% vs 30.8%; P=0.167). Modified Rankin Scale score decline was significantly lower in the TT group (7.1% vs 69.2%; P=0.001). Overall rates of hemorrhagic complications (TT, 28.6% vs DAPT, 7.7%; P=0.162) and complete occlusion (TT, 25% vs DAPT, 54.4%; P=0.213) were non-different between the groups. Rate of moderate-to-severe disability at last follow-up was significantly lower in the TT group (21.4% vs 76.9%; P=0.007).
Conclusions Patients with DVBFAs treated with FD in the TT group had fewer ischemic strokes, less symptom progression, and overall better outcomes at last follow-up than similar patients in the DAPT group.
- Flow Diverter
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Contributors Conception and design: AHS, EIL, RAH, AKW, PK. Data acquisition: AM. Data analysis and interpretation: all authors. Drafting the manuscript: AM. Critically revising the manuscript: all authors. Final approval of the manuscript: all authors.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests AHS: Consulting fees: Amnis Therapeutics, Apellis Pharmaceuticals, Inc., Boston Scientific, Canon Medical Systems USA, Inc., Cardinal Health 200, LLC, Cerebrotech Medical Systems, Inc., Cerenovus, Cerevatech Medical, Inc., Cordis, Corindus, Inc., Endostream Medical, Ltd, Imperative Care, InspireMD, Ltd, Integra, IRRAS AB, Medtronic, MicroVention, Minnetronix Neuro, Inc., Peijia Medical, Penumbra, Q’Apel Medical, Inc., Rapid Medical, Serenity Medical, Inc., Silk Road Medical, StimMed, LLC, Stryker Neurovascular, Three Rivers Medical, Inc., VasSol, Viz.ai, Inc. Leadership or fiduciary role in other board, society, committee or advocacy group: Secretary, Board of the Society of NeuroInterventional Surgery 2020–2021, Chair, Cerebrovascular Section of the AANS/CNS 2020–2021. Stock or stock options: Adona Medical, Inc., Amnis Therapeutics, Bend, IT Technologies, Ltd, BlinkTBI, Inc., Cerebrotech Medical Systems, Inc., Cerevatech Medical, Inc., Cognition Medical, CVAID Ltd, E8, Inc., Endostream Medical, Ltd, Galaxy Therapeutics, Inc., Imperative; Care, Inc., InspireMD, Ltd, Instylla, Inc., International Medical Distribution Partners, Launch NY, Inc., Neurolutions, Inc., NeuroRadial Technologies, Inc., NeuroTechnology Investors, Neurovascular Diagnostics, Inc., Peijia; Medical, PerFlow Medical, Ltd, Q’Apel Medical, Inc., QAS.ai, Inc., Radical Catheter Technologies, Inc., Rebound Therapeutics Corp. (purchased 2019 by Integra Lifesciences, Corp.), Rist Neurovascular, Inc. (purchased 2020 by Medtronic), Sense Diagnostics, Inc., Serenity Medical, Inc., Silk Road Medical, Sim & Cure, SongBird Therapy, Spinnaker Medical, Inc., StimMed, LLC, Synchron, Inc., Three Rivers Medical, Inc., Truvic Medical, Inc., Tulavi Therapeutics, Inc., Vastrax, LLC, VICIS, Inc., Viseon, Inc. Other financial or non-financial interests: National PI/Steering Committees: Cerenovus EXCELLENT and ARISE II Trial; Medtronic SWIFT PRIME, VANTAGE, EMBOLISE and SWIFT DIRECT Trials; MicroVention FRED Trial & CONFIDENCE Study; MUSC POSITIVE Trial; Penumbra 3D Separator Trial, COMPASS Trial, INVEST Trial, MIVI Neuroscience EVAQ Trial; Rapid Medical SUCCESS Trial; InspireMD C-GUARDIANS IDE Pivotal Trial. AM: none. RAH: Grants or contracts: NIH, Interline Endowment, MicroVention, Stryker, CNX; Consulting fees: Medtronic (also a proctor), Balt, Stryker (also a proctor), Q’Apel Medical Inc, Codman Neuro (J&J), Cerenovus, MicroVention, Imperative Care Inc., Phenox Inc, Rapid Medical; Participation on a Data Safety Monitoring Board or Advisory Board: MiV, eLuma, Three Rivers, Shape Medical, Cordindus; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: InNeuroCo, Cerebrotech, eLum, Endostream, Three Rivers Medical Inc., Scientia, RisT, Blink TBI, Corindus. PK: Grant: NIH U18EB029353-01, Medtronic unrestricted research grant, Joe Niekro Foundation research grant; Consulting Fees: Stryker Neurovascular, Imperative Care, MicroVention; Leadership or fiduciary roles in other board society, committee or advocacy group, paid and unpaid: JNIS editorial board member. AM: none. GMC: none. MR: none. CM: Grant: NIH R21NS119992; Consulting fees: Penumbra, Stryker, Silk Road Medical; Speaker: Penumbra; Silk Road Medical; Other financial or non-financial interest: Steering Committee Member (ADVANCE, Medtronic). NS: none. CR: none. JS: none. KE: Consulting fees: Stryker Neurovascular, MicroVention; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Joint Guidelines Review Committee member. LF: none. SKN: none. BO-A: none. SO-G: Consulting fees: Medtronic, MicroVention, Stryker. JV-S: none. AKW: Grants or contracts: Philips, Medtronic fellowship grant, Microbot; Consulting fees: Stryker Neurovascular, Philips, Cerenovus, Microbot; Leadership or fiduciary role in other board, society, committee or advocacy group, paid or unpaid: Deinde Med, Neurofine, InNeuroCo, Prometheus, ThrombX, NovaSignal, Neurostream. Shareholder: Corvista, Neurostream, Medtronic RIST, Prometheus, InNeuroCo, ThrombX, NovaSignal, Neurofine, Neurostream, Hyperion. EIL: Shareholder/ownership interest: NeXtGen Biologics, RAPID Medical, Claret Medical, Cognition Medical, Imperative Care, Rebound Therapeutics, StimMed, Three Rivers Medical; Patent: Bone Scalpel; Honorarium for training & lectures: Medtronic, Penumbra, MicroVention, Integra, Consultant: Clarion, GLG Consulting, Guidepoint Global, Imperative Care, Medtronic, StimMed, Misionix, Mosiac; Chief Medical Officer: Haniva Technology; National PI: Medtronic- Steering Committees for SWIFT Prime and SWIFT Direct Trials; Site PI Study: MicroVention (CONFIDENCE Study) Medtronic (STRATIS Study-Sub 1); Advisory Board: Stryker (AIS Clinical Advisory Board), NeXtGen Biologics, MEDX, Cognition Medical; Endostream Medical, IRRAS AB (Consultant/Advisory Board, Medical Legal Review: render medical/legal opinions as an expert witness; leadership or fiduciary roles in other board society, committee or advocacy group, paid and unpaid: CNS, ABNS, UBNS.
Provenance and peer review Not commissioned; externally peer reviewed.
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