Article Text
Abstract
Background Patients with cerebral aneurysms treated with the Pipeline embolization device (PED) are maintained on dual antiplatelet therapy (DAPT) to prevent thromboembolic complications. Rates of minor, “nuisance” bleeding in these patients remain unknown. We sought to evaluate the frequency and factors associated with this bleeding and its effect on DAPT compliance.
Methods We performed a multicenter retrospective cohort study on consecutive cases of intracranial aneurysms treated with PED. Patient characteristics, aneurysm characteristics, and bleeding complications were analyzed. Severity of bleeding was defined according to a previously published classification defining nuisance bleeding as easy bruising, bleeding from small cuts, petechia, and ecchymosis.
Results 245 PED aneurysm procedures on 243 patients were retrospectively collected from three academic centers over a 4.25-year period. Sixty-seven patients (27%) had nuisance bleeds. Patients with a higher risk of nuisance bleeding were older (59.1±3.4 vs . 54.7±2.2, P=0.032). Patients with nuisance bleeds were more likely to have their DAPT regimen changed or dose lowered (29% vs 8.3%, P<0.001), were on DAPT for less time (10.0 months±2.60 vs. 14.6 months±1.95, P=0.005) and were more likely to have aneurysm occlusion at 6 months (P<0.001). Stepwise logistic regression found age predictive of a nuisance bleed (OR=1.033)
Conclusions Nuisance bleeding was a common complaint of PED-treated aneurysm patients maintained on DAPT. Increasing age and aneurysmal occlusion at 6 months were the only factors predictive of nuisance bleeds. Clinicians were more likely to adjust antiplatelet regimens or stop DAPT early given a nuisance bleed.
- aneurysm
- flow diverter
- hemorrhage
- platelets
- stent
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Footnotes
Contributors EP: conception or design of the work, data collection, data analysis and interpretation, drafting the article, final approval of the version to be published. CADLG: data collection, critical revision of the article, final approval of the version to be published. FC: data collection, final approval of the version to be published. JF: data collection, final approval of the version to be published. MW: conception or design of the work, data collection, critical revision of the article, final approval of the version to be published. AS: critical revision of the article, final approval of the version to be published. KS: critical revision of the article, final approval of the version to be published. JD: critical revision of the article, final approval of the version to be published. EL: critical revision of the article, final approval of the version to be published. PK: conception or design of the work, data collection, critical revision of the article, final approval of the version to be published. ZR: conception or design of the work, critical revision of the article, final approval of the version to be published. MM: conception or design of the work, data analysis and interpretation, drafting the article, critical revision of the article, final approval of the version to be published.
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 AS: stocks: Amnis Therapeutics, Apama Medical, BlinkTBI, Inc., Buffalo Technology Partners, Inc., Cardinal Health, Cerebrotech Medical Systems, Inc., Claret Medical, Cognition Medical, Endostream Medical, Ltd, Imperative Care, International Medical Distribution Partners, Rebound Therapeutics Corp., Silk Road Medical, StimMed, Synchron, Three Rivers Medical, Inc., Viseon Spine, Inc. Consultant/Advisory Board: Amnis Therapeutics, Boston Scientific, Canon Medical Systems USA, Cerebrotech Medical Systems, Inc., Cerenovus, Claret Medical, Corindus, Endostream Medical, Ltd, Guidepoint Global Consulting, Imperative Care, Integra, Medtronic, MicroVention. KS: consultant: Penumbra, Canon Medical Systems, Medtronic, Jacobs Institute, Neurovascular Diagnostics. JD: stock/stock options: Rist Neurovascular, Inc. Consultancy: Cerevenous, Medtronic; payment for lectures including service on speakers bureaus: PEEL. Consultant: Penumbra, NextGen Biologics, Rapid Medical, Cognition Medical, Three Rivers Medical, Stryker, MedX, Endostream Medical. PK: consultant: Stryker, Covidien, Cerenovus, and MicroVention. Stockholder: InNeuroCo. MM: Grant NIH R21NS109575. Consultant: Medtronic, Canon Medical, Cerenovus. Stock options: Serenity Medical, Synchron, VICIS, Endostream.
Patient consent for publication Not required.
Ethics approval This research was approved by each respective institution’s Institutional Review Board (IRB; University of South Florida: Pro00019619; University of Buffalo: 030-578913; Baylor University: H31363). The requirement for informed consent was waived by each IRB.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data were presented in this article