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Research ArticleNeurointervention
Open Access

Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial

W. Boisseau, T.E. Darsaut, R. Fahed, B. Drake, H. Lesiuk, J.L. Rempel, J.-C. Gentric, J. Ognard, L. Nico, D. Iancu, D. Roy, A. Weill, M. Chagnon, J. Zehr, P. Lavoie, T.N. Nguyen and J. Raymond
American Journal of Neuroradiology March 2023, DOI: https://doi.org/10.3174/ajnr.A7815
W. Boisseau
aFrom the Department of Radiology (W.B., D.I., D.R., A.W., J.R.), Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
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T.E. Darsaut
bDepartment of Surgery (T.E.D.)
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R. Fahed
dDepartments of Neurology (R.F.)
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B. Drake
eNeurosurgery (B.D., H.L.), University of Ottawa, the Ottawa Hospital, Ottawa, Ontario, Canada
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H. Lesiuk
eNeurosurgery (B.D., H.L.), University of Ottawa, the Ottawa Hospital, Ottawa, Ontario, Canada
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J.L. Rempel
cDivision of Neurosurgery and Department of Radiology and Diagnostic Imaging (J.L.R.), University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta, Canada
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J.-C. Gentric
fDepartment of Radiology (J.-C.G., J.O.), University Hospital of Brest, Brest, France
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J. Ognard
fDepartment of Radiology (J.-C.G., J.O.), University Hospital of Brest, Brest, France
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L. Nico
gDepartement of Radiology (L.N.), Service of Interventional Neuroradiology, Centre Hospitalo-universitaire de Saint-Etienne, Saint-Etienne, France
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D. Iancu
aFrom the Department of Radiology (W.B., D.I., D.R., A.W., J.R.), Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
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D. Roy
aFrom the Department of Radiology (W.B., D.I., D.R., A.W., J.R.), Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
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A. Weill
aFrom the Department of Radiology (W.B., D.I., D.R., A.W., J.R.), Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
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M. Chagnon
hDepartment of Mathematics and Statistics (M.C., J.Z.), Pavillon André-Aisenstadt, Montreal, Québec, Canada
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J. Zehr
hDepartment of Mathematics and Statistics (M.C., J.Z.), Pavillon André-Aisenstadt, Montreal, Québec, Canada
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P. Lavoie
iDepartment of Neurosurgery (P.L.), Centre Hospitalier Universitaire de Québec-Université Laval, Québec, Canada
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T.N. Nguyen
jDepartments of Neurology (T.N.N.)
kRadiology (T.N.N.), Boston Medical Center, Boston, Massachusetts
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J. Raymond
aFrom the Department of Radiology (W.B., D.I., D.R., A.W., J.R.), Service of Neuroradiology, Centre Hospitalier de l’Université de Montréal, Montreal, Québec, Canada
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    FIG 1.

    STAT participant flow CONSORT diagram.20

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    FIG 2.

    Subgroup analysis of the primary outcome at 1 year. ACA indicates anterior cerebral artery.

Tables

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    Table 1:

    Patient and index aneurysm characteristics

    CharacteristicsCA (n = 111)SAC (n = 94)Total (n = 205)
    Patient
     Age at treatment (mean) (SD) (yr)58.6 (10.4)58.0 (8.8)58.3 (9.7)
     Female (No.) (%)77 (69.4)65 (69.1)142 (69.3)
    STAT type lesion
     STAT-1: unruptured aneurysm, never treated, with a dimension of ≥ 10 mm (No.) (%)21 (18.9)17 (18.1)38 (18.5)
     STAT-2: major recurrent aneurysm after previous coiling, but no previous stent placement (No.) (%)41 (36.9)34 (36.2)75 (36.6)
     STAT-3: small (<10 mm), wide-neck (≥ 4 mm) aneurysm (No.) (%)49 (44.1)43 (45.7)92 (44.9)
    Pretreatment mRS score (No.) (%)
     084 (75.7)70 (74.5)154 (75.1)
     121 (18.9)20 (21.3)41 (20.0)
     25 (4.5)2 (2.1)7 (3.4)
     31 (0.9)1 (1.1)2 (1.0)
     401 (1.1)1 (0.5)
    Presentation
     Symptomatic4 (3.6)4 (4.3)8 (3.9)
     Additional aneurysm to a previously ruptured and treated one13 (11.7)6 (6.4)19 (9.3)
     Incidental finding94 (84.7)84 (89.4)178 (86.8)
    Index aneurysm location (No.) (%)
     Anterior circulation78 (70.3)58 (61.7)136 (66.3)
      Ophthalmic/paraophthalmic7 (6.3)3 (3.2)10 (4.9)
      Posterior communicating/anterior choroidal7 (6.3)13 (13.8)20 (9.8)
      Carotid terminus6 (5.4)1 (1.1)7 (3.4)
      MCA bifurcation/M118 (16.2)14 (14.9)32 (15.6)
      Anterior communicating/A140 (36.0)25 (26.6)65 (31.7)
      Distal ACA02 (2.1)2 (1.0)
     Posterior circulation33 (29.7)36 (38.3)69 (33.7)
      PCA03 (3.2)3 (1.5)
      Basilar terminus24 (21.6)23 (24.5)47 (22.9)
      SCA3 (2.7)5 (5.3)8 (3.9)
      Basilar trunk2 (1.8)02 (1.0)
      Vertebrobasilar junction2 (1.8)2 (2.1)4 (2.0)
      PICA2 (1.8)3 (3.2)5 (2.4)
    Index aneurysm maximal external size (mean) (SD) (range) (mm)9.2 (6.4)9.2 (5.9)9.2 (6.1)
    (2–50)(3–35)(2–50)
     <10 (No.) (%)74 (66.7)63 (67.0)137 (66.8)
     ≥10 (No.) (%)37 (33.3)31 (33.0)68 (33.2)
    Index aneurysm neck size (mean) (SD) (range) (mm)4.4 (2.2)4.1 (1.6)4.3 (1.9)
    (2–20)(2–9)(2–20)
    Aneurysm neck ≥4 mm (No.) (%)72 (64.9)58 (61.7)130 (63.4)
    • Note:—ACA indicates anterior cerebral artery; PCA, posterior cerebral artery; SCA, superior cerebellar artery.

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    Table 2:

    Primary outcome in intent-to-treat analysis

    Intent-to-treat analysis 1-year outcomeaCA
    (n = 111)
    SAC
    (n = 94)
    Treatment failure (composite) (No.) (%)30 (27.3)28 (30.1)
     Clinical
      mRS 62 (1.8)3 (3.2)
      mRS 3–53 (2.7)3 (3.2)
      Intracranial hemorrhage00
      Retreatment03 (3.2)
     Angiographic
      Immediate failure3 (2.7)1 (1.1)
      Residual aneurysm (core lab)22 (19.8)18 (19.4)
     Missing primary outcome1 (0.9)1 (1.1)
    • ↵a RR = 1.10; 95% CI, 0.71–1.71; P = .656.

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    Table 3:

    Secondary outcomes in intent-to-treat analysis

     CA (n = 111)SAC (n = 94)RR (95% CI)P Value
    Hospitalization0.78 (0.48–1.28).325
     Patients hospitalized for >3 days (No.) (%)30 (27.3)20 (21.3)
    Discharge location (No.) (%)1.18 (0.35–3.96).788
     Home106 (95.5)89 (94.7)
     Other than home5 (4.5)5 (5.3)
      Other hospital1 (0.9)0
      Rehabilitation center2 (1.8)2 (2.1)
      Death2 (1.8)3 (3.2)
    mRS at discharge (No.) (%)1.18 (0.35–3.96).788
     084 (75.7)69 (73.4)
     117 (15.3)16 (17.0)
     25 (4.5)4 (4.3)
     32 (1.8)1 (1.1)
     41 (0.9)0 (0.0)
     50 (0.0)1 (1.1)
     62 (1.8)3 (3.2)
    1 -Year mRS (No.) (%)1.17 (0.43–3.22).761
     066 (60.0)54 (57.4)
     130 (27.3)26 (27.7)
     27 (6.4)7 (7.4)
     31 (0.9)2 (2.1)
     42 (1.8)0 (0.0)
     51 (0.9)0 (0.0)
     63 (2.7)5 (5.3)
     Missing mRS data1 (0.9)0
     Time of 1-year mRS assessment (mean) (SD) (mo)15.7 (10.5)15.3 (8.0)
     Morbidity and mortality at 1 year (mRS > 2), (No.) (%)6 (5.4%)8 (8.5%)
     Retreatment of index aneurysm during follow-up (No.) (%)03 (3.2)
    Immediate angiographic outcome0.97 (0.42–2.23).936
     Complete occlusion (No.) (%)67 (60.4)55 (58.5)
     Residual neck (No.) (%)33 (29.7)30 (31.9)
     Residual saccular aneurysm (No.) (%)11 (9.9)9 (9.6)
    Angiographic outcome at 1 year (core lab) (Detailed results in Online Supplemental Data)
     Complete occlusion (No.) (%)38 (34.2)42 (44.7)
     Residual neck (No.) (%)43 (38.7)24 (25.5)
     Residual saccular aneurysm (No.) (%)27 (24.3)24 (25.5)
     1-year imaging not availablea (No.) (%)3 (2.7)4 (4.3)
    Time of 1-year imaging assessment (mean) (SD) (mo)13.5 (5.2)14.8 (9.5)
    Follow-up vascular imaginga (No.) (%)108 (97.3)90 (95.7)
     MRA (No.) (%)82 (73.9)53 (56.4)
     Catheter angiography (No.) (%)24 (21.6)35 (37.2)
     CTA (No.) (%)2 (1.8)2 (2.1)
    • ↵a Three deaths in the CA group, 4 deaths in the SAC group. For 1 patient in the SAC group (who died 298 days after treatment), the 1-year imaging was adjudicated using the 3-month follow-up angiogram.

    • View popup
    Table 4:

    Clinical outcomes (mRS > 2 at 12 months) in intent-to-treat analysis

    Intent to treatCA (n = 111)SAC (n = 94)
    Death (No.) (%)3 (2.7)5 (5.3%)
      Related23
      Unrelated12
    mRS 3–5 (No.) (%)3 (2.7)3 (3.2)
    Total (No.) (%)6 (5.4)8 (8.5)
    • View popup
    Table 5:

    Primary outcome in as-treated analysis

    As-treated analysis 1-year outcomeaCA
    (n = 94)
    SAC
    (n = 104)
    Treatment failure (composite) (No.) (%)29 (30.9)27 (26.0)
     Clinical
      mRS 61 (1.1)4 (3.9)
      mRS 3–53 (3.2)3 (3.1)
      Intracranial hemorrhage00
      Retreatment03 (3.2)
     Angiographic
      Immediate failure3 (3.3)1 (1.1)
      Residual aneurysm (core lab)22 (25.3)16 (17.6)
     Missing primary outcome02 (1.9)
    • ↵a RR = 0.86; 95% CI, 0.55–1.34; P = .498.

    • View popup
    Table 6:

    Clinical outcomes (mRS > 2 at 12 months) in as-treated analysis

    As-treatedCA (n = 94)SAC (n = 104)
    Death (No.) (%)1 (1.1)7 (6.7)
      Related14
      Unrelated03
    mRS 3–5 (No.) (%)3 (3.2)3 (2.9)
    Total (No.) (%)4 (4.3)10 (9.6)
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W. Boisseau, T.E. Darsaut, R. Fahed, B. Drake, H. Lesiuk, J.L. Rempel, J.-C. Gentric, J. Ognard, L. Nico, D. Iancu, D. Roy, A. Weill, M. Chagnon, J. Zehr, P. Lavoie, T.N. Nguyen, J. Raymond
Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7815

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Stent-Assisted Coiling in the Treatment of Unruptured Intracranial Aneurysms: A Randomized Clinical Trial
W. Boisseau, T.E. Darsaut, R. Fahed, B. Drake, H. Lesiuk, J.L. Rempel, J.-C. Gentric, J. Ognard, L. Nico, D. Iancu, D. Roy, A. Weill, M. Chagnon, J. Zehr, P. Lavoie, T.N. Nguyen, J. Raymond
American Journal of Neuroradiology Mar 2023, DOI: 10.3174/ajnr.A7815
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